[00:00:00] Speaker 00:
The last case this morning is Jazz Pharmaceuticals versus Avedale CNS Pharmaceuticals, 2024, 2274, 77, and 78.

[00:00:14] Speaker 00:
Mr. Bell.

[00:00:17] Speaker 03:
Good morning, Your Honor.

[00:00:19] Speaker 03:
May it please the Court.

[00:00:21] Speaker 03:
Gabe Bell for the appellant, Avedale.

[00:00:24] Speaker 03:
The district court's injunction in this case goes directly to the heart

[00:00:29] Speaker 03:
of the safe harbor protection that Congress provided, precisely for companies like Avidel that are developing, investigating, and ultimately seeking approval for new and unique treatments that can benefit the patients and the public.

[00:00:47] Speaker 03:
District Court's injunction even goes so far as to prevent Avidel from seeking FDA approval.

[00:00:53] Speaker 03:
That is the absolute core of what Congress wanted to protect and encourage.

[00:00:58] Speaker 03:
especially here, where we have a product that the FDA has deemed clinically superior in a related context that's as to narcolepsy.

[00:01:08] Speaker 03:
And all Avidel is trying to do here is allow FDA to make that same, we believe will be a readily apparent conclusion for FDA in a different context, related context, of IH.

[00:01:21] Speaker 01:
The safe harbor provision applies with respect to non-infringing activity.

[00:01:27] Speaker 01:
Is that correct?

[00:01:28] Speaker 03:
It deems non-infringing categories of activity that are about the regulatory process.

[00:01:34] Speaker 03:
So developing and submitting information to a regulatory body, such as FDA, for the purpose of, for example, getting approval for a new treatment.

[00:01:44] Speaker 03:
That's the core of the Safe Harbor provision.

[00:01:47] Speaker 03:
And Congress further provided, and that was at subsection E1.

[00:01:52] Speaker 03:
And in E3, Congress went so far as to say, no injunction shall issue.

[00:01:58] Speaker 03:
as to conduct covered by Section E1.

[00:02:01] Speaker 03:
Congress anticipated that there would be these attempted end runs to try to nonetheless stop the regulatory process in its tracks before it can even get to FDA.

[00:02:13] Speaker 03:
Congress, of course, had in mind rectifying the twin aims at the front end of a patent term and at the back end of the patent term.

[00:02:21] Speaker 03:
And it did so very deliberately.

[00:02:22] Speaker 03:
It recognized that the regulatory process can be involved.

[00:02:26] Speaker 03:
It can take some time.

[00:02:27] Speaker 03:
So at the front end, the patentee shouldn't be penalized for the regulatory process initially.

[00:02:33] Speaker 03:
So you can provide a patent term extension.

[00:02:34] Speaker 03:
That's in section 156.

[00:02:37] Speaker 00:
The court went through the four factors with respect to an injunction.

[00:02:44] Speaker 00:
Do they really matter?

[00:02:46] Speaker 00:
If you're presenting data to the FDA, isn't that ipso facto?

[00:02:56] Speaker 00:
exempted from infringement?

[00:02:58] Speaker 03:
Yes.

[00:02:59] Speaker 03:
It is, Your Honor.

[00:03:00] Speaker 03:
And especially in this context where we're talking about what's the proper scope of the remedy.

[00:03:05] Speaker 03:
So the district court had in front of it a request for an injunction.

[00:03:08] Speaker 03:
And the safe harbor certainly plays into, according to Congress in subsection E3, what the scope of that injunction can entail.

[00:03:17] Speaker 03:
And if it cuts at activity that is even reasonably related to seeking FDA approval or reasonably related to submitting information,

[00:03:25] Speaker 03:
That is, as a matter of law, as this court held in Klassen, the 2015 version, as this court held in Edwards, as this court held in Abtox, as a matter of law, that conduct is non-infringing.

[00:03:39] Speaker 03:
But here, we're even more straightforward.

[00:03:42] Speaker 00:
Well, infringing on non-infringing would seem not to be the issue.

[00:03:46] Speaker 00:
If it's non-infringing, the exemption doesn't really matter.

[00:03:50] Speaker 00:
The exemption matters if there would otherwise be infringement.

[00:03:54] Speaker 00:
in the wood here, because you've got a composition claim, which would dominate the use for IH purposes.

[00:04:04] Speaker 03:
I think there would otherwise be infringement as to the clinical studies at minimum.

[00:04:10] Speaker 03:
But then the safe harbor kicks in and says, it shall not be infringing to conduct these trials.

[00:04:16] Speaker 03:
And I don't think there's any meaningful dispute that the revitalized trial that Abadel is doing is precisely to get

[00:04:23] Speaker 03:
FDA approval in a supplemental NDA for an additional indication.

[00:04:28] Speaker 03:
And that aligns it exactly with Clawson, we submit.

[00:04:30] Speaker 00:
Now, this patent's got a long way to go, as I noticed.

[00:04:34] Speaker 00:
So either if you get that approval, it's going to be held up, or else you're going to prove the patent invalid.

[00:04:41] Speaker 03:
So it's a good point, Your Honor.

[00:04:43] Speaker 00:
And so I would take this opportunity to note that- Most points from the court are presumed to be good.

[00:04:49] Speaker 03:
Thank you, Your Honor, and I do so presume.

[00:04:51] Speaker 03:
And that leads me to point out the kind of procedural quirk here, where the district court decided to address the injunction before addressing J. Maul's on invalidity, which we expect to raise.

[00:05:03] Speaker 03:
I probably would have done it in the reverse order.

[00:05:11] Speaker 04:
I don't want to ask.

[00:05:13] Speaker 04:
Suppose you win here and you get to file, do your studies and get to file your application for the IH indication on your draft.

[00:05:37] Speaker 04:
of this appeal, I mean, the overall case, what you were just referring to.

[00:05:39] Speaker 03:
Sure.

[00:05:40] Speaker 03:
Absolutely, Your Honor.

[00:05:41] Speaker 04:
Is that until, what, 2036?

[00:05:42] Speaker 03:
36, thereabouts.

[00:05:44] Speaker 03:
That's right.

[00:05:45] Speaker 03:
So a couple of things I would foresee happening.

[00:05:48] Speaker 03:
If FDA is allowed to do its job, and as we believe it will find it clinically superior, that would be a material change in the circumstances.

[00:05:57] Speaker 03:
And we would go back to the district court and say, you should change the injunction to make this align with your ruling.

[00:06:03] Speaker 03:
In the narcolepsy context, would the district court recognize

[00:06:06] Speaker 03:
that a clinically superior drug that benefits patients shouldn't be enjoined.

[00:06:10] Speaker 04:
So then we're in a very different- I'm not sure it quite went that far in the absence of generics competing.

[00:06:18] Speaker 03:
And there's and the litigation ongoing.

[00:06:20] Speaker 03:
We don't know what the landscape will look like two years from now.

[00:06:23] Speaker 04:
Let's assume all of that away.

[00:06:26] Speaker 04:
Well, at the end of the day, if- But let's suppose, as I think the other side has suggested, that in fact

[00:06:33] Speaker 04:
superiority over your product may well not be decided by the FDA.

[00:06:59] Speaker 04:
drug is not yet met with any competition, you're then barred by this injunction in the absence of a Rule 60-type ground for a change of circumstances for getting relief from it?

[00:07:18] Speaker 03:
In the absence of that or in the absence of a subsequent appeal that would show the patent to be invalid, that's the other thing that's coming down the pipe eventually.

[00:07:28] Speaker 03:
And so I suppose if we lose all of those, then yes, the injunction would still stand.

[00:07:35] Speaker 03:
That would lead me, though, to our second basis for challenging the injunction was that the eBay factors themselves were improperly weighted in the sense of looking at harm that's speculative.

[00:07:47] Speaker 03:
In Monsanto, the Supreme Court said it has to be imminent.

[00:07:50] Speaker 03:
And they relied not on anything imminent.

[00:07:51] Speaker 03:
They relied on the possibility of marketing, which was at least two years away.

[00:07:56] Speaker 03:
And all these things could happen in the meantime.

[00:07:59] Speaker 03:
Generics could come on the market.

[00:08:00] Speaker 03:
There could be a clinical superiority finding by the FDA.

[00:08:03] Speaker 03:
It doesn't make sense, we argue to the district court and argue here, to do that in a vacuum weighing the eBay factors.

[00:08:10] Speaker 03:
Now, of course, our primary argument is, at the very bare minimum, the scheme that Congress put in place in 1984

[00:08:18] Speaker 03:
requires the regulatory process to at least come up to the point of being approved.

[00:08:25] Speaker 03:
And then you deal with the patent stuff, the consequences after that.

[00:08:27] Speaker 03:
That's what the HR report said that accompanied the bill.

[00:08:31] Speaker 04:
So for the application that you want to submit for the IH indication on what is it?

[00:08:43] Speaker 04:
Loomriser.

[00:08:48] Speaker 04:
uh... the uh... that would not come with a thirty-month automatic sale so if the injunction is lifted for the application for that approval and you get the approval will there then be a new application for

[00:09:13] Speaker 04:
preliminary injunction by Jazz, and you'll have to litigate that under extremely rushed circumstances.

[00:09:19] Speaker 03:
I mean, I would assume that.

[00:09:21] Speaker 03:
They've shown propensity to do that.

[00:09:22] Speaker 03:
I would assume they would do that in this case.

[00:09:24] Speaker 03:
And the point I'd like to make there is the reason we're not dealing with an automatic stay is we're not dealing with an orange book listed patent here.

[00:09:33] Speaker 03:
Jazz doesn't practice the patent that they're asserting.

[00:09:36] Speaker 03:
They don't have an extended release version.

[00:09:38] Speaker 03:
That's what Avidel came up with.

[00:09:39] Speaker 03:
That's what Jazz couldn't do.

[00:09:41] Speaker 03:
That's why Avidel's product is clinically superior for narcolepsy, because you can take an extended release dose that lasts over time, and you can take a higher dose.

[00:09:50] Speaker 03:
You can go up to nine grams, whereas theirs is limited to six grams, and immediate release.

[00:09:55] Speaker 03:
And just speaking as somebody who's had medications that are immediate release and extended release, that can make a very meaningful difference in your life.

[00:10:03] Speaker 03:
And that was shown to be true in the narcolepsy context, and we think it will equally be shown true

[00:10:08] Speaker 03:
in the IH context, and all they're asking is to allow FDA to do its job as Congress intended.

[00:10:15] Speaker 04:
Can I ask you a question?

[00:10:16] Speaker 04:
Why doesn't your stipulation to entrenchment, which is quite broadly worded, prevent you from relying on E1 here?

[00:10:25] Speaker 03:
So the stipulation says pursuant to 271A.

[00:10:30] Speaker 03:
That's how it reads.

[00:10:32] Speaker 03:
And so our position is we didn't mean to convert

[00:10:35] Speaker 03:
per se non-infringing conduct into infringing conduct, 271A itself says, except as otherwise provided in this section, comma.

[00:10:44] Speaker 04:
Right, but your stipulation was that your activities infringe under 271A.

[00:10:49] Speaker 04:
Well, I think in the context of the case of... It may have been unfortunately worded, but it didn't make an exception for the exception to 271A.

[00:11:00] Speaker 03:
Well, our position is that it's implicitly there.

[00:11:02] Speaker 03:
If you cut and paste the 271A language in there, we're stipulating that under this provision, the whole thing, not part of it, we infringe, meaning still subject, of course, to things like submitting paperwork to the FDA, which I don't think, frankly, is even a use of a drug to begin with.

[00:11:20] Speaker 03:
So if you want to talk about the actual language of 271A, make, use, import, et cetera,

[00:11:25] Speaker 03:
simply submitting papers, like submitting papers to this court about this patented invention.

[00:11:29] Speaker 03:
That's not a use of it, right?

[00:11:31] Speaker 03:
Submitting information in a database isn't use of a drug, as this court held in the last iteration of this.

[00:11:37] Speaker 04:
But would it also be the case that use is specifically addressed by 271E2 for which very well-defined remedies are specified in the statute, and those remedies do not include this kind of injunction?

[00:11:52] Speaker 03:
Absolutely.

[00:11:53] Speaker 03:
So let's presume it was an orange book listed patent, which is what E2 goes to.

[00:11:58] Speaker 03:
It's not in the text necessarily, but the Supreme Court has read it to be related.

[00:12:02] Speaker 04:
You're not that.

[00:12:03] Speaker 04:
You're a 505E2.

[00:12:05] Speaker 03:
We're not that.

[00:12:06] Speaker 03:
There's no orange book listed patent.

[00:12:07] Speaker 03:
There's no paragraph four certification that would trigger E2 infringement.

[00:12:11] Speaker 03:
But let's even assume there was.

[00:12:12] Speaker 03:
The court is absolutely right.

[00:12:13] Speaker 03:
There are four and only four remedies.

[00:12:15] Speaker 03:
that you can get even for that artificial act of infringement.

[00:12:19] Speaker 03:
And not one of those is in joining the submission to FDA.

[00:12:22] Speaker 03:
You could delay FDA approval, if there's an orange book.

[00:12:25] Speaker 03:
That's not what we're dealing with here.

[00:12:27] Speaker 03:
But the others all relate to damages and non-injunctive relief.

[00:12:30] Speaker 03:
And in C3, the Congress couldn't have been more clear.

[00:12:33] Speaker 03:
No injunctive relief shall issue for safe harbor activities.

[00:12:36] Speaker 03:
We think that's the start and the end of this case.

[00:12:39] Speaker 03:
And with that, I'll reserve my rebuttal time.

[00:12:42] Speaker 00:
We will save it for you.

[00:12:43] Speaker 03:
Thank you.

[00:12:45] Speaker 00:
Mr. Kalfosa.

[00:12:52] Speaker 02:
Good morning, and may it please the court.

[00:12:53] Speaker 02:
Frank Kalfosa from Quinnamania, or Cardin Sullivan on behalf of Jazz Pharmaceuticals.

[00:12:59] Speaker 02:
The district court used this discretion to carefully craft a limited injunction in this case.

[00:13:04] Speaker 02:
The patent to this issue has already been tried.

[00:13:07] Speaker 02:
Abedal stipulated to infringement.

[00:13:09] Speaker 02:
Abedal failed to succeed on its invalidity defenses.

[00:13:13] Speaker 02:
With respect to the injunction, Avidil already has its infringing products commercially available on the market, which makes this unlike other cases where the safe harbor is at issue.

[00:13:29] Speaker 02:
And under the injunction, Avidil is permitted to continue and expand upon its infringement in the narcolepsy market, where Avidil does not dispute that it claims it will make billions of dollars.

[00:13:40] Speaker 02:
What the injunction does is it very limitedly says Avidol can expand that infringement even further.

[00:13:46] Speaker 02:
And it focuses on the IH market, where Jazz already has an FDA-approved safe and effective once-nightly drug for the treatment of IH.

[00:13:56] Speaker 02:
That was a distinguishing factor in narcolepsy.

[00:13:58] Speaker 02:
Jazz only had twice-nightly.

[00:14:00] Speaker 02:
The district court found, based on clinical research and competing expert declarations that there was factual evidence amid factual findings,

[00:14:09] Speaker 02:
that JAZZ's once-nightly dosage is not substantially different than its twice-nightly dosage in IH.

[00:14:16] Speaker 04:
Can I just ask?

[00:14:17] Speaker 02:
Yes, you're on.

[00:14:17] Speaker 04:
On the irreparable harm part of the district court's analysis with respect to the IH use, my recollection is that the district court said that if IH is marketed

[00:14:42] Speaker 04:
that the specifically enjoined activities here that are at issue on appeal, namely asking for approval from the FDA, conducting clinical studies to get that approval, and allowing the patients in the 150-person study to continue the extra 18 or 20 weeks or something for the open label extension, that those would cause irreparable harm to your client.

[00:15:09] Speaker 04:
Is there a crucial missing element

[00:15:12] Speaker 02:
A couple things, Your Honor.

[00:15:14] Speaker 02:
First of all, Avedale did not raise the safe harbor argument below.

[00:15:18] Speaker 02:
It did not raise the open label extension argument below until the state briefing before the district court.

[00:15:24] Speaker 02:
Avedale had full view of the injunction that Jazz was seeking and raised none of these arguments during injunction briefing.

[00:15:31] Speaker 02:
And then they seek to fault the district court for not addressing it.

[00:15:34] Speaker 02:
I want to circle back to the OEL at the end because the district court did speak to that in denying Avedale's stay request.

[00:15:40] Speaker 02:
But the evidence was before the district court that harm is already taking place.

[00:15:46] Speaker 02:
Avidil is on the market, approved for narcolepsy.

[00:15:48] Speaker 02:
But the product is also being used already for IH.

[00:15:51] Speaker 02:
They have infringing sales in IH.

[00:15:53] Speaker 02:
And another portion of the injunction is that Avidil cannot make, use, or sell, or market in any condition other than narcolepsy.

[00:16:01] Speaker 00:
And that includes IH.

[00:16:03] Speaker 00:
If it's on the market for narcolepsy now, if it's being used for IH, that's sort of off label.

[00:16:10] Speaker 00:
But if they're seeking approval by the FDA for IH, that's exempted from infringement by statute.

[00:16:24] Speaker 02:
And that's another point that I think I lost in what I'm saying.

[00:16:26] Speaker 02:
In the modified injunction, the clarified injunction,

[00:16:34] Speaker 02:
In the clarified injunction, and this is at appendix 41, the district court says, Abadel, you could do your revitalized trial.

[00:16:42] Speaker 02:
Abadel, you could submit that information and results to the FDA.

[00:16:45] Speaker 02:
What is enjoined, and this is very important, is not the submission of an application to the FDA.

[00:16:51] Speaker 02:
It's seeking approval until the patent expires.

[00:16:55] Speaker 02:
The Safe Harbor does not protect FDA approval as of any certain date.

[00:17:01] Speaker 02:
It doesn't mean Avidel has to get approval now.

[00:17:04] Speaker 02:
Avidel is free to submit their application.

[00:17:07] Speaker 02:
But with that, they would have to tell the FDA, we are not seeking approval until February 18, 2036.

[00:17:12] Speaker 02:
That's what the injunction says.

[00:17:15] Speaker 02:
Avidel is free to submit their application.

[00:17:17] Speaker 02:
They're free to submit.

[00:17:19] Speaker 02:
Information in support of clinical superiority.

[00:17:21] Speaker 02:
We don't think they're going to get it.

[00:17:22] Speaker 02:
We already have one.

[00:17:23] Speaker 00:
Steve Johnson says they're not free to submit it.

[00:17:27] Speaker 02:
This is at appendix 41, Your Honor.

[00:17:29] Speaker 02:
It says, finally, while the order enjoins AVIDEL from seeking FDA-approved rights, the order is not enjoined AVIDEL from submitting information or results from ongoing clinical studies to the FDA.

[00:17:38] Speaker 02:
And ABDEL is permitted to continue the revitalized trial.

[00:17:41] Speaker 02:
And the injunction at Appendix 36 specifically says that Jazz's motion for a limited permanent injunction prohibiting ABDEL from seeking approval from the US Food and Drug Administration to market and enumerize is granted, but it's only through the expiration of the 782 patent.

[00:17:59] Speaker 02:
So ABDEL is allowed to submit that application.

[00:18:01] Speaker 02:
They can't seek approval until February of 2036.

[00:18:04] Speaker 02:
They're enjoined from doing so.

[00:18:06] Speaker 02:
This is no different than any other application that somebody submits to the FDA.

[00:18:10] Speaker 00:
They can seek approval, but they can't act on it.

[00:18:15] Speaker 00:
If they acted on it by marketing, they're at risk.

[00:18:19] Speaker 02:
They're enjoined under the current injunction for marketing, and that gets lost in the argument as well.

[00:18:23] Speaker 02:
The current injunction enjoins make-use seller marketing

[00:18:27] Speaker 02:
in addition to the seeking FDA approval until a certain date.

[00:18:31] Speaker 02:
And when an applicant goes to the FDA, they say, I'm seeking approval as of before expiration of patents, as of expiration of patents at this date.

[00:18:40] Speaker 02:
The applicant can specify in their submission which date they're doing.

[00:18:44] Speaker 04:
Let me just see if I understand this.

[00:18:46] Speaker 04:
So not challenged here is the part of the injunction that prevents, that prohibits,

[00:18:57] Speaker 04:
for IH use?

[00:18:59] Speaker 02:
Abedale challenges that only on the public interest factor.

[00:19:02] Speaker 02:
That's the only challenge they make to the eBay for the make user cell, as I understand it.

[00:19:07] Speaker 02:
So when my friend said that if they were to get approval, sure.

[00:19:14] Speaker 04:
Assuming that that is not an issue,

[00:19:30] Speaker 04:
I'm assuming the injunction, I'm going to assume it bars sale and marketing.

[00:19:46] Speaker 04:
They can't actually jump into the market.

[00:19:48] Speaker 02:
Well, here's the issue, and this is what the district court foresaw, is that because they are already on the market and the product is out there,

[00:19:58] Speaker 02:
What happens is, with FDA approval, and Abedal doesn't dispute this, FDA posts the labeling on the website.

[00:20:05] Speaker 02:
Pursuant to FDA regulations, Abedal must then use that labeling with the IH indication out there when it disseminates its product.

[00:20:14] Speaker 02:
This court has been clear, on indication, use in a label is infringement.

[00:20:19] Speaker 02:
It's certainly marketing that's borrowed under the injunction.

[00:20:22] Speaker 02:
Here, because this isn't an orange book patent,

[00:20:24] Speaker 02:
The district court cannot enjoin the FDA from approving the drug.

[00:20:27] Speaker 02:
The district court cannot enjoin the FDA from posting that label on the website or requiring Abedal to use it.

[00:20:33] Speaker 02:
What the district court could and did do was enjoin Abedal from asking for FDA approval until a certain date, which is what applicants can and do all the time.

[00:21:01] Speaker 04:
Abadel when selling this product from using a label that the Food and Drug Act would require it to use?

[00:21:16] Speaker 02:
No, the District Court's injunction already

[00:21:19] Speaker 02:
precludes an infringing use, and it would be on the label at that point in time.

[00:21:24] Speaker 04:
The way this works in other cases, if there's- I don't think I'm communicated, because I didn't hear that as an answer to my question.

[00:21:29] Speaker 02:
OK, I apologize.

[00:21:30] Speaker 04:
I'm trying to get very concrete about what is the problem with allowing the FDA approval process to go forward now.

[00:21:42] Speaker 02:
The problem with that is that we'll be right back in front of the district court

[00:21:46] Speaker 02:
if Avedale were to get approval.

[00:21:48] Speaker 02:
Because then they'd have to have that new labeling out there.

[00:21:51] Speaker 02:
And the district court's injunction bars make you sell marketing.

[00:21:56] Speaker 04:
So I guess I'm taking as a premise for purposes of this question that offering the product with a label that identifies high age use would in fact be marketing contrary to the current injunction.

[00:22:16] Speaker 02:
Exactly.

[00:22:16] Speaker 02:
And then Jazz would be right back and forth from the district court for a contempt proceeding, because Avedale would be marketing.

[00:22:22] Speaker 02:
And the district court foresaw this.

[00:22:24] Speaker 02:
And the district court made factual findings that entering the market for IH would irreparably be harmed Jazz's exclusivity there.

[00:22:32] Speaker 02:
And Avedale had already had off-label sales.

[00:22:35] Speaker 02:
And Avedale's excuse was, well, we don't promote it.

[00:22:38] Speaker 02:
And that is at Appendix 9069.

[00:22:41] Speaker 02:
And they also say that in their briefing before the district court at appendix 7510, because we don't have the labeling we don't promote.

[00:22:47] Speaker 02:
But with FDA approval comes that labeling.

[00:22:50] Speaker 02:
I don't know if this court's case law or entry, GSK v. Teva, if you have an on use indication label, that's inducing infringement.

[00:22:59] Speaker 02:
So the district court said,

[00:23:01] Speaker 02:
You could submit your information, Avedale, and we don't dispute that.

[00:23:04] Speaker 02:
They could file their application.

[00:23:05] Speaker 02:
They could submit information.

[00:23:07] Speaker 02:
They could go back and forth with the FDA.

[00:23:09] Speaker 02:
What they need to tell the FDA and what the district court's injunction says is you can't seek approval until a certain date.

[00:23:16] Speaker 02:
So you file your application.

[00:23:17] Speaker 02:
You say, we're enjoined from getting approval until February of 2036.

[00:23:21] Speaker 04:
Can the FDA grant approval even

[00:23:30] Speaker 04:
Because you're now saying it could file its application.

[00:23:33] Speaker 02:
Yes.

[00:23:34] Speaker 02:
Abedal could do that.

[00:23:36] Speaker 02:
Our position is that the FDA would not grant approval in that case, and that's what applicants do.

[00:23:39] Speaker 04:
Or just wouldn't.

[00:23:40] Speaker 02:
Or just wouldn't.

[00:23:41] Speaker 02:
That's what applicants do all the time.

[00:23:43] Speaker 02:
If they file an application, they could say, I'd like approval before a patent expires.

[00:23:47] Speaker 02:
I'd like approval when a patent expires.

[00:23:51] Speaker 02:
This is not an injunction on seeking FDA approval on vacuum, full stop, as Avidil tries to make it seem.

[00:23:59] Speaker 02:
It's tied to a specific date because they've already been adjudicated infringers of that patent.

[00:24:04] Speaker 04:
So there's the approval request issue, there's the OLE issue, and there's the doing more clinical studies issue.

[00:24:10] Speaker 02:
For the OLE and the Doing More Clinical Studies, there is no record evidence below that that activity falls within the safe harbor.

[00:24:18] Speaker 02:
You have to look under this court's case law in the Supreme Court.

[00:24:20] Speaker 00:
Doing clinical tests necessarily, they don't do it for academic reasons.

[00:24:29] Speaker 00:
They want to get approval to sell the product.

[00:24:31] Speaker 02:
Well, the district court made a factual finding at appendix 43 that these OLE trials are marketing activities dressed up as research.

[00:24:40] Speaker 02:
It quoted from a paper that Jazz put in during the state briefing.

[00:24:44] Speaker 04:
And if it's solely for... At least in my mind, I think of there being two questions.

[00:24:49] Speaker 04:
One is new clinical trials.

[00:24:51] Speaker 04:
The second is the OLE extensions.

[00:24:54] Speaker 04:
Can you put aside the OLE extensions?

[00:24:56] Speaker 04:
Yes, Your Honor, I can.

[00:24:56] Speaker 04:
Just new clinical trials.

[00:25:04] Speaker 04:
would not be within the E1 extension.

[00:25:07] Speaker 02:
Because under both Supreme Court case law and the supports case law, you have to look at each and every use.

[00:25:11] Speaker 02:
And it is a factual question.

[00:25:13] Speaker 02:
We saw an Amgen BITC and even Haspera.

[00:25:17] Speaker 02:
Sorry.

[00:25:18] Speaker 04:
What if the injunction were modified to say the injunction does not preclude clinical trials covered by E1, but we actually have one

[00:25:34] Speaker 04:
only current one on the table and saying that that's in or out.

[00:25:38] Speaker 04:
But there's a general, there would be a general carve out for E1 effort.

[00:25:44] Speaker 02:
I think what the proper remedy here would be is that if Avidel has, under this court's case law, reasonable reason necessary clinical trial, each and every use, they would have to prove rule 60B provides for a modification.

[00:25:56] Speaker 02:
And advocates could go back to the district court.

[00:25:58] Speaker 02:
They could even come to Jazz beforehand and say, hey, the FDA told us we need to do this study.

[00:26:03] Speaker 02:
And the parties could deal with it then.

[00:26:05] Speaker 00:
You say they're doing these new clinical trials for marketing purposes, but don't those data still have to be presented to the FDA?

[00:26:14] Speaker 02:
No, Your Honor, they don't.

[00:26:15] Speaker 02:
And for example, the OLE in the Stern Declaration, that's ECF 23, Exhibit 2.

[00:26:20] Speaker 02:
page 59 to 60, for example, says the OLA is completely voluntary.

[00:26:27] Speaker 02:
It's not a requirement that the FDA put in place for that protocol.

[00:26:31] Speaker 02:
And even at page nine of that exhibit to the Stern declaration, that's exhibit two to the Stern declaration, which was ECF 23, it explains that the only efficacy information and patient population for the study is coming from the revitalized trial, not the open label extension.

[00:26:49] Speaker 02:
And in this case where Abidal is already on the market, unlike other cases.

[00:26:54] Speaker 04:
Isn't there, I don't remember whether it's an assertion by Abidal's lawyers or something in the evidence that the use for the extra number of weeks when the patient that had been in the trial after the endpoint and now has its open label so the patient knows I'm getting the good stuff and not the placebo or something.

[00:27:18] Speaker 04:
uses it that that actually

[00:27:22] Speaker 04:
safety-related information.

[00:27:24] Speaker 02:
If you take that, then every... They made that argument, the district court didn't credit it.

[00:27:31] Speaker 02:
And furthermore... Was there evidentiary support for that argument, or was this just... This was an argument that they made, that it includes safety information.

[00:27:38] Speaker 02:
Every use of the drug would be safety information then.

[00:27:42] Speaker 02:
And under FDA requirements, once you get approval, you're required to put in adverse events and safety information.

[00:27:46] Speaker 02:
This is routine use, which under Momenta 2, the 2015 decision, isn't covered by Safe Harbor.

[00:27:52] Speaker 02:
The parties didn't get to litigate that because Avedale didn't raise it.

[00:27:55] Speaker 02:
And to the extent that the district court did address it, it rejected the OLA at a pending 43.

[00:28:00] Speaker 02:
I see I'm out of time.

[00:28:00] Speaker 02:
I'm happy to answer any other questions.

[00:28:02] Speaker 02:
But we believe the district court's decision should be approved.

[00:28:05] Speaker 00:
Thank you, counsel.

[00:28:06] Speaker 00:
Thank you, your honor.

[00:28:08] Speaker 00:
Mr. Bell has some republicans on.

[00:28:15] Speaker 03:
Thank you, your honor.

[00:28:17] Speaker 03:
I think what's clear now is what we're really talking about here is a de facto patent term extension.

[00:28:22] Speaker 03:
They want to muck up the regulatory process that Congress allowed for in the safe harbor and start to parse it out and say, you can do this part or you can do that part, but you can't do all of the things that are reasonably related.

[00:28:35] Speaker 03:
So you can submit an application, but you can't ask for FDA approval.

[00:28:40] Speaker 03:
I'm not sure I totally understand that.

[00:28:41] Speaker 03:
What Congress said is that you can't enjoin safe harbor conduct.

[00:28:45] Speaker 03:
And that includes submitting for and asking for FDA approval.

[00:28:49] Speaker 03:
I think that is squarely within the safe harbor.

[00:28:52] Speaker 03:
clinical trials leading up to it.

[00:28:54] Speaker 03:
As your honor noted, we don't do them.

[00:28:56] Speaker 04:
I'm sorry to interrupt.

[00:29:00] Speaker 04:
Why is asking for FDA approval within the language of E1?

[00:29:06] Speaker 03:
It's within the language of E1, which provides for.

[00:29:10] Speaker 04:
Asking for it, I'm going to assume that that is not actually infringing under 271A, but that's not the point you're making.

[00:29:18] Speaker 03:
Oh, if we assume it's not even infringing under 271A, then you don't need the safe harbor for it.

[00:29:23] Speaker 03:
I think that would be kind of the first line.

[00:29:25] Speaker 04:
It's not actually a use.

[00:29:27] Speaker 04:
So go tell me about E1.

[00:29:29] Speaker 03:
Sure.

[00:29:29] Speaker 03:
So E1 says, use is reasonably related to the development and submission of information under a federal law.

[00:29:38] Speaker 03:
And the whole point of this was this court in Roche had said,

[00:29:42] Speaker 03:
that you can deem those regulatory activities for seeking approval as kind of de facto marketing.

[00:29:48] Speaker 03:
That's the position Jazz wants to take now.

[00:29:50] Speaker 03:
And Congress resoundingly said, no, we're going to let the regulatory process play out.

[00:29:55] Speaker 03:
And so for in Claussen, for example, this court in 2015, very similar facts.

[00:30:00] Speaker 03:
There was an already approved drug.

[00:30:02] Speaker 03:
The party realized that there's a different interaction with food.

[00:30:05] Speaker 03:
It did voluntary, this court said, voluntary studies to determine that interaction and then put that interaction on the label via a supplemental NDA.

[00:30:14] Speaker 03:
SNDA, clinical studies, a supplemental NDA, seeking FDA approval.

[00:30:19] Speaker 03:
This court said that was, quote, clearly, all of that was, quote, clearly within the safe harbor and ruled as a matter of law on summary judgment.

[00:30:26] Speaker 01:
What's your response to the other side's argument that you waved your safe harbor argument?

[00:30:32] Speaker 03:
So a couple of things, Your Honor.

[00:30:34] Speaker 03:
I see I'm getting close on time.

[00:30:35] Speaker 03:
This is really about the scope of the injunctive relief.

[00:30:38] Speaker 03:
So we have the liability phase, which led up to the injunctive proceedings.

[00:30:42] Speaker 03:
And then it's the scope of the injunction that's at issue.

[00:30:45] Speaker 03:
And squarely raised at least a half a dozen times at the hearing was the statutory safe harbor.

[00:30:52] Speaker 04:
And in fact, at one point, the district court in this is at a. But just to be clear, not in your actual papers.

[00:30:57] Speaker 03:
Correct.

[00:30:58] Speaker 03:
It was not in the brief.

[00:30:59] Speaker 03:
We presumed at a couple points that we would be allowed to, but didn't come out and say safe harbor.

[00:31:04] Speaker 03:
But it was teed up squarely at the hearing, and the district court said, quote, right, that's protected by statute.

[00:31:10] Speaker 03:
And when the other side was pressed on it, they didn't say there was any sort of waiver.

[00:31:14] Speaker 03:
Either during the hearing, in fact, after the hearing, in response to our letter, they said, we never contended that you couldn't do trials.

[00:31:22] Speaker 03:
And thereafter, the district court didn't find a waiver in considering the issues on the stay motion, where they raised waiver.

[00:31:29] Speaker 03:
This court didn't find it in granting a partial stay.

[00:31:32] Speaker 03:
We think the safe harbor was clearly raised, and we've cited in our brief, six different places at the hearing.

[00:31:38] Speaker 04:
Can I just come back to something?

[00:31:40] Speaker 04:
Yes, of course, Your Honor.

[00:31:41] Speaker 04:
So on the assumption that part of the injunction not having to do with the FDA, that just you cannot market, let's call it that,

[00:32:10] Speaker 04:
I'm going to assume, for purposes of this question, is marketing.

[00:32:13] Speaker 04:
What's supposed to happen?

[00:32:15] Speaker 03:
Well, I think, according to my friend, we'd end up back in front of district court.

[00:32:18] Speaker 03:
And we would sort it out there.

[00:32:19] Speaker 03:
What's the appropriate path going forward?

[00:32:22] Speaker 03:
And so that's appropriate, because Congress has kind of said, what happens up until then?

[00:32:26] Speaker 03:
Congress says you have to allow this process to play out.

[00:32:29] Speaker 03:
And not just for the benefit of the party seeking it.

[00:32:32] Speaker 03:
It's for the benefit of the patients, and it's for the benefit of the public as well.

[00:32:36] Speaker 03:
Would the district court?

[00:32:44] Speaker 04:
be irreparable harm.

[00:32:46] Speaker 04:
The FDA hasn't said that your product is superior in a meaningful way.

[00:32:52] Speaker 04:
And so in ordinary eBay injunction terms, an injunction is warranted.

[00:32:58] Speaker 04:
Would the district court be able to authorize to keep that injunction in place, notwithstanding the FDA approval?

[00:33:07] Speaker 03:
I think we would have to litigate it.

[00:33:09] Speaker 03:
I think we absolutely would have to litigate it.

[00:33:10] Speaker 03:
And I think an important point here is

[00:33:13] Speaker 03:
My friends said there would be induced infringement putting it on the label.

[00:33:17] Speaker 03:
Notably here, they asserted induced infringement initially, but that's not what the stipulation addresses.

[00:33:22] Speaker 03:
Stipulation addresses direct infringement.

[00:33:24] Speaker 03:
So we're in a world where the direct infringement is enjoined for marketing, not induced infringement.

[00:33:30] Speaker 01:
Did the court account for all this by limiting the injunction?

[00:33:35] Speaker 03:
They did not limit it enough, Your Honor.

[00:33:37] Speaker 03:
The injunction specifically says, and this is Appendix Page 36,

[00:33:42] Speaker 01:
But enough to recognize your arguments or the position that you're taking now.

[00:33:46] Speaker 03:
Well, I think it, at the hearing, seemed to recognize our arguments and saying that's protected by statute.

[00:33:52] Speaker 03:
But then, ultimately, in the actual injunction, prohibited seeking FDA approval, which simply is irreconcilable with the scheme that Congress put out, particularly in section E3, which says no injunction shall issue on safe harbor conduct.

[00:34:07] Speaker 03:
And we think that disposes of this case for the benefit of the patients and the public

[00:34:11] Speaker 03:
Avidel should be able to seek FDA approval for IH.

[00:34:14] Speaker 03:
For other indications that may come, sleep disorders are a terrible thing for the people suffering from it.

[00:34:20] Speaker 03:
And those patients shouldn't have to suffer.

[00:34:22] Speaker 03:
Avidel has a superior product in narcolepsy.

[00:34:25] Speaker 03:
We think the same will be true in IH.

[00:34:27] Speaker 03:
For that reason, the injunction should be rejected.

[00:34:30] Speaker 00:
We've heard your argument.

[00:34:31] Speaker 00:
There's no narcolepsy here.

[00:34:34] Speaker 03:
Thank you, Your Honor.

[00:34:35] Speaker 00:
The case is submitted, and that concludes today's argument.