ASCENDIS PHARMA A/S v. BIOMARIN PHARMACEUTICAL INC.
Oral Argument — 02/09/2026 · Case 26-1026 · 36:50
0:00
Judge Lourie
Our last case this morning is Ascendus Farmer et al. v. Biomarin Pharmaceutical, 2026-1026.
0:11
Mr. Bell, good morning.
0:14
Appellant Attorney
Good morning, Judge Lurie. May I please the court?
0:16
Gabe Bell on behalf of the appellant, Ascendus.
0:19
The district court here erred in denying a Section 1659 stay to Ascendus.
0:25
Such a stay is mandatory where, as here, there's a co-pending ITC action.
0:30
Judge Chen
Could you start with standing?
0:32
Appellant Attorney
Of course. Standing here is present for two reasons, Your Honor.
0:37
First, it's our view, and I think supported by the record, that the ruling below is adverse to Ascendus.
0:44
It denies them a procedural right that Congress provided to them in the form of certainty about a stay that extends as long as the ITC action.
0:54
We think that's a good thing.
0:55
That alone is enough.
0:57
Second, though, compounding that problem is the threats that Biomarin has made about seeking to pursue further litigation in short order.
1:07
That just heightens the injury.
1:09
Judge Chen
I guess the procedural rights, maybe they are sometimes good enough, sometimes they are not good enough, alone without more.
1:19
And then here, we don't really know what the district court would do if, hypothetically,
1:25
Biomarin, after an FDA approval, sought to lift the stay and maybe seek a preliminary injunction motion.
1:33
So, I guess I'm trying to figure out just how hypothetical or speculative is your situation.
1:42
Appellant Attorney
Understood, Your Honor.
1:43
And that, I think, goes to the second basis for standing.
1:46
Looking at the first basis for standing, the procedural error,
1:49
we think simply the denial of the mandatory statutory stay is enough,
1:55
because it puts the threat of litigation, the scythe of Damocles, if you will, over the head of Ascendus.
2:01
Judge Chen
That, at a minimum, got mitigated by the grant of a discretionary stay.
2:07
Appellant Attorney
And we don't think it went far enough.
2:09
We think the discretionary stay denied Ascendus the full rights to which it was entitled.
2:15
I'd point the court, for example, to the Praxis case that we cited in our brief.
2:19
Now, that's a Third Circuit decision.
2:21
But there, the court granted a 45-day stay.
2:25
As a matter of discretion, but denied the full 90-day stay that the statute in that case provided.
2:32
And that was in a different context.
2:33
It involved savings and loans and receiverships and so forth.
2:37
But it's telling, I think, to me that by the time it got up onto appeal,
2:41
the only issue that remained was the issue of whether that stay, although long since passed, even,
2:48
and the litigation had settled, whether that stay was properly denied.
2:52
And that's in footnote 10 of that.
2:54
So there was a justiciable controversy there.
2:57
It was framed in terms of a lack of mootness.
2:59
But it's the same principle that applies here, that the mere denial of that stay,
3:05
even in favor of another stay that is more limited, is enough to give adversity.
3:11
It's enough to give this court jurisdiction to correct it, just as, for example, it did in.
3:17
Judge Stoll
Isn't it true that that, you know, as a practical matter, only matters if you do have some sort of,
3:24
as a consequence, as a result of it being discretionary versus mandatory, right?
3:30
And so then you kind of have to get into your argument that there's some sort of cloud hanging over your client
3:36
or some sort of threat in the event there's approval by the FDA, right?
3:41
I mean, do I understand that correctly?
3:43
Appellant Attorney
I think that certainly heightens the injury.
3:45
But in our view, it's the simple denial of that stay that creates the cloud.
3:49
So we don't have to show that they actually intend to do anything with it,
3:53
although we think they do.
3:54
And I think they've made that abundantly clear.
3:56
And I don't think they'll get up here and say otherwise.
3:59
Now, you know, hypothetically, if they got up and said, we commit here in open court not to seek to undermine the stay
4:06
or do anything in district court until the ITC action is done, it would moot this case.
4:12
And this court actually looked to precisely such a representation in the Grit v. Oren case,
4:17
where the patentee refused to give such a representation about reinstituting litigation that had been voluntarily dismissed.
4:24
This court noted in a footnote or suggested in a footnote that had it made that representation,
4:29
that would have been enough to moot it.
4:31
And we would agree that would moot this appeal entirely.
4:34
But I suspect they won't get up here and do that.
4:37
Just as they have maintained fastidiously that they have the right to seek to lift the stay and pursue a preliminary injunction.
4:44
Judge Chen
Is February 28 still the date we're expecting to hear from the FDA?
4:48
Appellant Attorney
It is. Yes, Your Honor. It is, as far as I know.
4:51
What's the state of the ITC proceeding?
4:53
The Markman.
4:54
The Markman hearing was on Friday.
4:56
As I understand, it was continued to today.
4:58
So it may be ongoing as we speak, along with a conference for scheduling.
5:03
Judge Chen
We're still far away from the initial determination.
5:06
Appellant Attorney
Right. The initial determination, what I have down, the target final ID date is August of this year,
5:14
with a target completion date of December of this year.
5:17
So we're still a fair ways away from that.
5:21
Judge Stoll
To be clear, will the February 28?
5:24
The communication from the FDA be a thumbs up, thumbs down?
5:27
What are the possibilities of what the information would be?
5:31
Appellant Attorney
Our hope certainly is that it's a thumbs up.
5:34
But based on past experience, it could be a thumbs up, it could be a thumbs down,
5:38
or it could be another wait and see for some reason.
5:40
Judge Chen
If it's thumbs up, how long would it take for Ascendus to launch?
5:45
Appellant Attorney
I don't know that we've officially said.
5:48
I think certainly a number of weeks or months it would take to launch.
5:54
Beyond that, there's things that they have to do internally.
5:57
I'm not privy to all of them, but my understanding, it wouldn't be instant,
6:00
but it would be relatively soon thereafter.
6:03
And statements made by my friends on the other side have indicated that they think that's immediate enough
6:09
for other purposes, but not for purposes of standing here.
6:13
And again, all of those threats aside, which I think make abundantly clear what they intend to do,
6:18
and if this court were to say, for example, there's no jurisdiction,
6:21
we could be back here in September.
6:23
Seven days, 14 days, 20 days, whatever, saying,
6:27
and now they have sought a preliminary injunction.
6:29
And that, of course, is their CEO's stated strategy.
6:31
We pointed it out in our 28J response that their strategy is to seek to disrupt launches.
6:37
So even before launch, in other contexts there, it was in the European context,
6:42
but their purpose is to disrupt the launch.
6:45
And we think that is their purpose here, too.
6:47
We pointed that out in our opening brief, pages 13 and 18.
6:51
In their responsive brief,
6:53
they didn't deny, they wanted to maintain the option.
6:57
And that option is itself what Congress sought to prohibit.
7:01
And so on the merits, we think it's straightforward, I won't say clear,
7:06
but we think it's straightforward as an application of the plain language
7:09
that the district court must stay.
7:13
It uses the word shall.
7:14
It shall stay if certain conditions are met.
7:17
And the district court even found those conditions were met in this case.
7:22
Now, the district court,
7:23
the district court then went on to say it had discretion to nonetheless deny the stay
7:28
because 30 days had elapsed since the prior action.
7:32
But the statute we submit is plain that it's this action that matters,
7:37
30 days of this action, not a previously voluntarily dismissed action
7:41
that starts the running of the clock.
7:45
Judge Chen
So I guess you could have had a litigation that went on for a year or two in district court
7:53
and then voluntarily dismissed it.
7:55
Dismissed it and then immediately turned around and refiled
7:58
and sought your 1659A right to an immediate stay?
8:06
Appellant Attorney
I think that's unlikely for the following reason.
8:08
It's governed by the constraints of...
8:10
Just trying to understand your position here.
8:13
The constraints are provided by FRCP 41.
8:16
So 41 gives you the right to voluntarily dismiss,
8:20
and it's treated as if that suit didn't exist,
8:22
as long as the other side didn't file an answer.
8:25
Or didn't file a summary judgment motion.
8:27
Now, here they elected to file a motion to dismiss.
8:29
They could have filed an answer,
8:31
and we would be having a different conversation,
8:32
maybe in a different venue.
8:34
But they elected to move to dismiss.
8:36
That, in turn, gives the plaintiff the right under FRCP 41
8:39
to voluntarily dismiss, walk away,
8:41
and perhaps file another suit, or perhaps not.
8:44
So there's an inherent constraint built in.
8:46
I'm sorry, Your Honor.
8:47
Judge Stoll
What is the difference between the two complaints?
8:50
Is there a difference?
8:51
So in our view,
8:54
Appellant Attorney
the first one was focused primarily, not solely,
8:56
but primarily on the safe harbor.
8:59
And so the idea was to quickly get a safe harbor ruling
9:03
that could then be used to show
9:06
that the ITC action shouldn't proceed.
9:08
So at this point, we were importing,
9:11
simply for clinical purposes, is our contention.
9:13
Now, they disagree.
9:13
But our contention is it was for purposes
9:16
of getting FDA approval.
9:17
We are importing certain amounts of the prodrug,
9:20
packaging it up here, sending it back off,
9:23
and then to various clinicals.
9:24
And so we are importing certain amounts of the prodrug,
9:24
around the world.
9:25
They, in our view, prematurely went to the ITC
9:28
and wanted to try to stop that,
9:30
even though it's covered, in our view,
9:32
by the safe harbor.
9:33
So the thought was, as a matter of efficiency,
9:35
we'll file a complaint, narrowly targeted,
9:38
based on the safe harbor.
9:39
Now, there was some language
9:41
that was arguably a little bit broader.
9:43
But in the initial paragraph,
9:45
this is at Appendix Page 2002,
9:48
we referenced safe harbor
9:50
in every single of the four sentences.
9:52
And we later, in one of our papers,
9:54
mentioned that that initial complaint
9:56
was narrowly targeted to safe harbor.
9:59
So at a minimum, we would say
10:00
there's some sort of constructive amendment
10:01
to limit it to that.
10:03
And then later, when we filed another complaint,
10:05
it was more broadly targeted
10:07
at a non-infringement declaration.
10:09
We think that's neither here nor there, frankly.
10:12
Judge Lourie
The district court was concerned about gamesmanship.
10:16
Appellant Attorney
Yes.
10:17
Yes, Your Honor.
10:17
The district court didn't like the optics.
10:21
And I understand there's some switching of sides.
10:24
The district court noted that the parties
10:25
kind of swapped positions to some degree.
10:27
Judge Chen
So why wouldn't judicial estoppel apply here?
10:31
Appellant Attorney
So judicial estoppel only applies
10:33
if you get the relief you're asking for.
10:35
So we did not receive the relief we're asking for.
10:39
We asked...
10:39
Judge Chen
Well, that first time around,
10:41
you were vigorously opposing
10:45
any kind of stay of the action.
10:48
And you prevailed.
10:49
And in fact, there was litigation
10:51
that was going on for a few months.
10:54
And now, this time around,
10:56
you're taking a position
10:57
that feels clearly inconsistent
11:01
and now trying to evoke a stay.
11:04
Appellant Attorney
So just to clarify,
11:05
there was no ruling by the district court on that.
11:08
So we didn't prevail in a judicial ruling
11:10
that would in any way bind us.
11:12
It was ultimately not resolved.
11:14
So a hearing had been set.
11:15
A hearing had not been moved forward, as we asked.
11:19
And so we ultimately decided
11:20
to just fight it out in the ITC.
11:22
So there's no judicial estoppel that attaches.
11:24
There's no judicial estoppel that attaches to that.
11:24
As to the inconsistency,
11:26
I understand the optics.
11:28
But the district court noted that, to some degree,
11:30
both parties were switching positions.
11:32
And the switch on our side
11:34
was simply as a matter of practicality.
11:38
Once the FDA had, on June 2nd of last year,
11:43
announced it would priority review our innovation,
11:47
that meant it would decide it soon,
11:50
as soon as November.
11:51
At that point, we didn't...
11:53
We didn't...
11:53
We didn't...
11:54
We didn't...
11:54
We couldn't get a ruling from the district court
11:55
that would be of any judicial efficiency
11:58
between June and November.
12:00
And so we ultimately acceded.
12:02
And we're very transparent about it.
12:03
Judge Stoll
The judicial efficiency of the ITC.
12:07
At what point did you realize
12:09
that you probably weren't going to get a district court ruling
12:11
that was faster than the ITC's ruling?
12:14
Appellant Attorney
Well, faster than the launch.
12:16
So the problem with the ITC action
12:18
is before there's a product on the market,
12:20
they can't show any entitlement
12:22
to prevent it from being imported.
12:24
So our view was
12:25
they were just relying on safe harbor items,
12:28
which wouldn't have given that entitlement.
12:30
Now, if we go forward to FDA approval,
12:32
and I see I'm into my rebuttal time,
12:34
but FDA approval and then launch,
12:37
then the ITC action,
12:38
it doesn't go away because of the safe harbor anymore.
12:42
It's just an ITC action.
12:44
So our view was that they were attempting
12:46
to disrupt the approval and the launch,
12:49
the approval because we needed those products
12:52
to help provide the FDA the data,
12:54
the data that it requires.
12:55
And then beyond that, the launch.
12:57
And so we were trying to do whatever we could
12:59
as a company seeking to get its product out there
13:02
that the FDA had deemed worthy of priority review.
13:06
And so we took all the steps we could muster to do that.
13:09
Judge Stoll
Okay.
13:10
I have a statutory interpretation question for you.
13:12
It's just something I've been thinking about.
13:14
I'd like to get your thoughts on it,
13:15
which is that, you know, there's case law,
13:18
some of which are cited in the briefing,
13:22
holding that a product,
13:24
a party cannot dismiss its case
13:27
and refile a new case
13:29
in order to gain a procedural advantage
13:31
that he or she gave up, right?
13:34
And so I wonder whether Congress legislates
13:39
understanding that principle.
13:41
Because otherwise, whenever you have a statute that says,
13:45
you know, when you file, when a lawsuit is filed,
13:48
you have so much time in which to do something,
13:52
take some action, you know, ask for a jury,
13:54
whatever it is, in this case, seek a stay.
13:58
Does Congress have to say,
14:00
and when we say that you have to file it within 30 days of this case,
14:04
that includes filing it within 30 days of this case.
14:08
You can't just go ahead and dismiss this case
14:11
and file a new case in order to get a procedural advantage, right?
14:14
I mean, like, it would be kind of weird to expect Congress
14:17
to have to write that in the statute every time.
14:20
Appellant Attorney
Well, respectfully, Your Honor,
14:22
I'll look at one of the statutes that my friends pointed to
14:24
on the other side.
14:25
That's the removal statute.
14:26
And if you look at the time frame there,
14:28
it's keyed off of the, quote, initial pleading.
14:31
So Congress clearly contemplated
14:33
that there might be multiple pleadings
14:35
and keyed the time frame off the initial pleading.
14:38
And here, respectfully, Congress didn't do so.
14:41
It keyed it off of the action.
14:43
And the action is the current action.
14:45
It refers to that antecedently
14:47
when it says the district court action.
14:49
So within 30 days of the district court action.
14:52
If Congress had said,
14:53
within 30 days of the initial pleading
14:56
in the action or a prior action or something like that,
14:59
then certainly it could have had the same effect
15:01
as the removal statute, which is section 4.
15:03
Judge Stoll
Can you think of a hypothetical situation where,
15:05
and it's a good answer,
15:06
but can you think of a hypothetical situation
15:09
where the optics wouldn't look bad,
15:13
but you would have this 30-day time period
15:15
for a party that's filing another suit?
15:18
Appellant Attorney
I'm sorry, I didn't catch.
15:19
The optics would not?
15:20
Judge Stoll
The optics would not look bad.
15:22
Or you would be,
15:23
the Congress would want to make sure
15:25
there was a right to file, you know,
15:27
to seek this stay within 30 days.
15:30
Appellant Attorney
Yeah, so respectfully,
15:31
I think a situation may be similar to this one
15:34
would fit the bill
15:35
where you have two parties vigorously fighting it out
15:37
and one side wants to prevent the other side
15:39
and the other side wants to not be prevented,
15:42
where when it becomes apparent
15:44
that you're not going to get the relief,
15:45
then you go back and say,
15:46
okay, fully transparent.
15:48
Here's what we're going to do.
15:49
We're going to dismiss this one and file the new one.
15:52
And I think it's the right,
15:53
the right to not face the suit
15:54
that is ultimately belonging to the respondent,
15:56
similar to, for example,
15:58
sovereign immunity for states.
16:00
If you look at the biomedical case,
16:01
there a state voluntarily came forward,
16:04
joined itself as a plaintiff,
16:07
litigated a suit,
16:08
and then in a subsequent suit,
16:10
it invokes state sovereign immunity.
16:14
And this court said, that's fine, right?
16:17
So there's maybe an example
16:18
where the optics are a little different.
16:20
And this court nonetheless said,
16:22
it's fine.
16:23
You didn't waive it in the prior suit.
16:25
And there, the party seeking the waiver
16:27
tried to broaden it to the whole subject matter,
16:30
use the word subject matter or matter.
16:32
And this court said, no, no, that's a different suit.
16:35
And it even analogized
16:37
to federal rule of civil procedure 41.
16:40
So for those reasons,
16:41
we think this case should also be heard by this court.
16:45
We think the district court
16:46
erred under the statutory language.
16:48
And I'm way over my time.
16:49
Judge Lourie
I apologize.
16:50
We'll give you two minutes for rebuttal.
16:53
And if Mr. Reines needs that, he can have it.
16:56
Thank you, Your Honor.
16:57
Good morning, Mr. Reines.
16:58
Appellee Attorney
Good morning, Your Honor.
16:59
May it please the court.
17:01
I'd like to start at the threshold,
17:04
as we must, with appellate standing
17:07
and injury in fact.
17:09
The allegation here is of essentially
17:11
a procedural violation.
17:15
And sometimes that can be enough.
17:17
Sometimes that can't.
17:19
Here, there's the speculation
17:22
that makes this,
17:24
essentially, an advisory opinion.
17:27
And at this point,
17:29
I'd like to point out that counsel said,
17:31
well, if it's not taken up by the court now,
17:35
it may need to be taken up by the court later.
17:37
You don't get a head start, right?
17:39
Jurisdiction has to be measured
17:41
at the time in September when they filed it.
17:43
Judge Chen
Do you know what Biomarin would do
17:45
a month from now or two months from now,
17:47
assuming that the FDA approves their application?
17:51
Appellee Attorney
There's so many scenarios that,
17:53
I don't know.
17:55
I don't, I certainly am not representing to the court
17:57
that we wouldn't file a preliminary injunction motion.
17:59
So I want to be clear about that.
18:00
Judge Chen
The way these things typically go is
18:02
once a drug gets approved by the FDA
18:05
and it allegedly infringes someone else's patent,
18:08
the patent owner comes in and tries to stop the launch
18:11
by any means necessary,
18:13
including patent infringement litigation.
18:15
Appellee Attorney
Yeah, this situation, this case is,
18:17
as you may have into it by now,
18:19
is pretty different than the normal situation
18:21
because we have an ITC ongoing proceeding.
18:24
So there's all of whatever's happening at that time there
18:28
that may-
18:28
Judge Chen
You can't get a preliminary injunction in the ITC, can you?
18:31
Appellee Attorney
Certainly not per se, nothing called that,
18:33
but there might be relief that the ALJ might,
18:36
in other words, if the ALJ is about to issue his opinion,
18:39
let's say in a month,
18:40
there might be things that they could or couldn't do
18:42
that might say like, wait a minute,
18:44
don't launch if I'm going to be deciding something.
18:46
Judge Stoll
But in this case, the opinion's not close to issuing, right?
18:50
Just with claim construction today, I guess.
18:52
Appellee Attorney
Uh, no.
18:53
No, I think the dates that my colleague gave are correct,
18:56
but the, as we've seen with this drug approval,
19:00
this too is not a typical situation.
19:02
They filed a major amendment,
19:05
we just know from their press release,
19:06
a major amendment in November
19:10
that caused the FDA to bump it already out three months.
19:14
And, you know, I do think we have to take into account
19:18
in terms of the speculativeness
19:19
that in the submission that we made January 16,
19:23
the position taken by Ascendus point blank
19:27
was that the launch is in no way imminent
19:31
given the lack of marketing authorization.
19:34
So, and they would know,
19:36
first of all, it's a statement against interest,
19:38
two, they would know better than anybody
19:39
what the likelihood of it happening at all
19:42
or in February.
19:43
So this all goes to the speculativeness of it.
19:47
Yes, you can get me to say that we might seek this or that relief
19:50
and we're reserving the right,
19:51
but no one knows.
19:54
We don't know how this is going to play out
19:56
and counsel acknowledge that.
19:58
But their position, the Ascendus position in court filings
20:02
is that it's in no way imminent.
20:04
And that happens to be the legal standard we have here.
20:07
So there's no injury in fact, no appellate standing.
20:11
It's essentially an advisory opinion.
20:14
What my colleague for Ascendus is saying is
20:17
if the district court judge, if it's authorized,
20:21
if we then move for preliminary injunction,
20:23
if the district judge vacates the stay
20:27
and doesn't reconsider the mooted statutory stay request,
20:32
what do you think as to whether they have the right
20:37
to the statutory stay?
20:39
That's a lot of ifs and whats.
20:42
And it's essentially an advisory opinion
20:44
for a future situation that they have some concern about.
20:47
But there's just far too much in speculation
20:50
in all of the cases, Spokio on down.
20:53
So you can't...
20:53
have a conjectural injury. And just the mere fact right now they have a stay that's going to
21:00
pen for through the ITC unless there's a change to the status quo, it's really hard to see
21:07
appellate standing there. Council sidestepped the question of the violation of the final judgment
21:14
rule. So they have to fill through the keyhole of a collateral order doctrine. And that's not easy.
21:23
The first thing that they have to show is that the decision that's on review is conclusive.
21:29
The decision that they're complaining of is a mootness decision where the judge says,
21:33
you know what, I think you've misbehaved. You've engaged in gamesmanship. I'm going to decide this
21:40
decision and I'm going to moot yours. That is not conclusive. And moreover, it's not important
21:48
enough for the narrow collateral order doctrine that doesn't force
21:53
stay.
21:53
Rulings to come to this court here and there because litigation is not enough. This comes up
22:01
frequently. People complain of the burden of litigation.
22:05
Judge Chen
But the purpose of 1659A is to relieve people from the burden of litigation. So in this
22:12
particular instance, maybe it is important.
22:15
Appellee Attorney
I don't think, especially Wilby Halock is the one, I don't think it fits in the collateral
22:21
order doctrine.
22:23
What they said was that was for government employees, qualified immunity, that's a really
22:29
high order where we want to stop litigation. But we don't want the floodgates opening,
22:33
the people complaining about litigation and trying to fit through the collateral order
22:37
doctrine because there's all kinds of things that happen in cases where someone say this
22:41
is super important. But you, of course, as always, make a good point, which is, wait,
22:47
they have no remedy. They do have a remedy. It just happens not to be that. It's not the
22:51
one they selected, which was a notice of abuse.
22:53
That should have been DOA. It's a mandamus, as in PRINCO. And A, they didn't meet Rule
23:01
21. The Fifth Circuit has explained that there's all kinds of safeguards to Rule 21, such as
23:07
notice to the district court and an opportunity to be heard at the district court. These don't
23:12
happen frequently, but it's procedural safeguards. So there's procedural failure under Rule
23:17
21. But there's also the problem that there's an alternative remedy, right? It's a
23:23
direct remedy.
23:23
It's a drastic and extraordinary remedy. All have issued many mandamus rulings, so you know
23:31
that better than I do. But the first question is, wait, is there another way we can resolve
23:36
this so we're not having an emergency, a fire drill? There's a stay in place. So they have
23:41
the relief they want. If the relief they want is a permanent stay that never goes away and
23:45
isn't reconsidered, that's when you get back to this speculative mess. And so there's an
23:50
alternative remedy. And let's just jump to the merits, because they have to show clear and
23:56
undisputable. Council used the euphemism of optics. More than an optics problem here. Let me put you
24:04
in the district judge's seat for just a little bit. A case is filed asking the district court
24:10
to tell the ITC to stop their investigation, right? All kinds of comedy concerns. But that's
24:18
what they asked. They submitted evidence. They submitted evidence. They submitted evidence. They
24:20
submitted evidence in support of this with the original complaint and invoked something that I
24:25
hadn't really appreciated. I was a little embarrassed to say, which was under the declaratory
24:29
judgment statute, there's a specific provision that says, under the rule, that says you can
24:35
have an expedited hearing under the declaratory judgment. So they invoked that, and they said,
24:39
we want to go pursue into this little-used provision and have an expedited trial.
24:45
Judge Chen
We have sympathies for the district court judge for the way she reacted to this refiled action.
24:50
I'm seeking this statutory state. The question is, what's the best correct understanding of this
24:57
state provision in the context of this litigation? Understood. I just want, there's just a little
25:02
Appellee Attorney
nuance, especially with what was added here to address the sequence of events. It is a very
25:06
broad statute. So how do you respond to that? Okay, I'll adjust the statute first. To me,
25:12
this is the situation. It's not an optics question of, can you use Rule 41,
25:20
which is just a little bit more complicated, but it's a little bit more complicated.
25:20
General and broad to nullify a congressionally enacted statute with a specific limitation.
25:27
And to me, the most relevant case on the merits, to answer both of the good questions coming,
25:32
is the Rust case from the Ninth Circuit. The Rust case, and you'll remember probably from your prep,
25:38
that's the case where you have a certain amount of time to file a jury demand, and if you fail to,
25:45
then you lose your right for jury demand. And there was an attempt to use Rule 41 to refile,
25:51
that there, it's not the first pleading, it's the last pleading. And so it would-
25:57
Judge Stoll
That's instructive for us, right? It's not binding on us.
26:01
Appellee Attorney
Well, I mean, it's not binding on you because it's factually different. So I'm not saying
26:07
that there's like a precedential- Ninth Circuit.
26:09
Whether it's Ninth Circuit or not, I thought about-
26:12
Judge Stoll
Any other cases that are like Rust?
26:15
Appellee Attorney
Well, there's the whole body of law on remand. Those are the 30 days that
26:19
counsel-
26:20
Came up, which is that you have to remove the federal court from state court. You have 30 days
26:26
from the complaint filing, and you can't get the new, yeah, refile. But I do want to answer,
26:32
having answered that, and the Rust case is like dead on, you know, but it's not controlling.
26:37
It's just not the same top. It's not controlling. I wouldn't say that. Maybe Ninth Circuit does
26:42
apply. I mean, here's a district court applying her discretion on how to handle this. Anything
26:47
having to do with the statute 1659 is for this court.
26:50
Judge Stoll
That's a statutory interpretation issue.
26:52
Appellee Attorney
In so far as that, that's federal circuit law.
26:54
Judge Stoll
It's a statute that relates to the ITC over which we have exclusive jurisdiction.
27:00
Appellee Attorney
There's no question. That's federal circuit law. My point is that to the extent we're talking about
27:05
the district court's decision and the sequence of things to decide and some of the discretionary
27:12
docket management stuff, that might be Ninth Circuit.
27:15
Judge Stoll
What is your response to the argument that this statute, unlike others,
27:20
doesn't say things like, you know, you have to file within 30 days after the district court action
27:28
is filed, the district court action. It doesn't say after served with a complaint or the first
27:34
complaint or some other kind of language.
27:36
Appellee Attorney
And this goes to the good question you asked about whether the complaint's different.
27:40
They refiled. So I think that...
27:43
Statutory interpretation.
27:45
Right. I'm saying the action was filed once. In this case, what they did on July,
27:50
7th, was a refiling. And that's different. But I wanted to just discuss the sequence of events
27:58
because there's a new argument, which we had never heard before, that on June 2nd,
28:02
they made the decision not to pursue the district court case because of some event at the FDA
28:07
that turned out to be...
28:08
Judge Stoll
Can I ask you another question? I'm sorry. Related to the question I just asked you.
28:11
And then you can get back to this point.
28:12
Appellee Attorney
Yeah. Thank you.
28:12
Thank you.
28:13
No, no. It's your time.
28:14
Judge Stoll
It says here, in the judge's opinion, she says, although the court finds that Ascendus has met
28:20
the statutory requirements...
28:21
Requirements in the instant action. Right?
28:23
Yes.
28:24
I mean, that seems kind of problematic, right?
28:26
In terms of what you just said, the proper statutory interpretation is.
28:30
Appellee Attorney
Well, I mean, there's multiple issues. First, she just mooted their motion. So she didn't
28:35
decide it. So I don't think you need to reach that statutory...
28:38
Judge Stoll
Well, let's say that I want to.
28:39
Appellee Attorney
If you want to, then I think that the fact that she says that to me doesn't move me because
28:46
in the Russ case, it's a new action. It's a new pleading. It's a last pleading.
28:51
All those same rules apply. What the Ninth Circuit said, it's an eloquent decision,
28:56
said was you have a general rule and then you have a specific rule and the specific
29:03
controls over the general. And I think that applies here. You'd have to find the Russ
29:08
case wrong. But going back to, if you're okay, if I can go to the sequence of events. Thank
29:13
you. I really appreciate that.
29:15
Judge Stoll
Just going back to it, though, we've agreed that Russ is not controlling. You said I'd
29:18
have to...
29:19
Appellee Attorney
Yes. Russ is not controlling.
29:19
Judge Stoll
So I don't really have to, right?
29:22
Appellee Attorney
It's the only appellate court case you've been directed to on this question, right? Nothing
29:28
from the other side. Nobody ever saying you can refile and get rid of a 30-day limit. I
29:33
mean, the Congress says you have 30 days. That's it. And if you could just refile after
29:38
running the district court through the ringer, which I hope to get to, then that would essentially
29:45
vitiate the congressional rule. But not only that, what she did was...
29:52
She exercised her discretion to handle it the way she did. So I don't think she said,
29:57
there's no way I'm ever applying that. She just said, I'm not rewarding your gamesmanship
30:01
by deciding your motion first. First, I'm deciding this other motion. And I'm giving
30:06
you... Because I'm giving you the relief that you're seeking, which is a stay through to
30:12
the end of the ITC action. But getting to the schedule piece, if that's okay, is now
30:20
the argument is on June 2nd.
30:22
They made the decision to get rid of the Northern District of California case because
30:31
the things, events in...
30:34
Judge Chen
The FTA announced it was going to fast track their application.
30:37
Appellee Attorney
Yes, correct. That's not when they did it. There was multiple litigation steps in the
30:43
district court. They didn't dismiss until July 7th. What actually happened was they
30:48
wanted to get a quick and dirty...
30:51
The whole point of this was to get rid of the Northern District of California case.
30:52
this was to get a quick and dirty answer from the district court to collaterally attack the ITC.
30:58
And when the district court moved the hearing back a couple times, and it was pretty clear
31:03
that there wasn't a big uptake or affection for their position, they dropped it. And today is
31:12
the first time they've ever come up with this other story, and the timeline doesn't work.
31:16
So it's a little more than optics, because the district court, they did this days before the
31:20
actual hearing on their request for an expedited bench trial, which cited eight ITCD documents.
31:27
They put in factual evidence. The district court definitely did all the work on that,
31:32
definitely did all the, you know, not all the work, but did preparation. There's no way they
31:36
were waiting. And then on our motion to dismiss and so forth. So there's a whole lot of work that
31:42
went into it. Then they dropped it, and then they came back, and they said they were refiling the
31:46
same action. So I think that this situation is a little bit more complicated.
31:50
addresses your concern on the statutory interpretation, because it's very, you don't
31:56
have to guess. There's not an element of speculation. Was this refiled merely to circumvent
32:02
a statutory deadline? We know it was. They submitted a document saying it was.
32:09
And, you know, the final point is that the district court, you know, even regardless of
32:17
what the statutory interpretation is, she, I thought, did the equitable interpretation of the
32:21
thing as the person that's responsible for managing all these competing positions,
32:24
and said, look, I'm going to grant the stay. I'm going to hold this as moot. And that just seems
32:30
like a reasonable thing to do. And frankly, not something we really should be second guessing,
32:35
especially on an advisory basis. Thank you very much. If there's any questions.
32:43
Judge Chen
Just on my judicial estoppel question. Right. You agreed
32:49
that the district court never did anything. Right. You agreed that the district court never did anything.
32:51
Right. You agreed that the district court never made a ruling on Ascendus's request to
32:57
Appellee Attorney
oppose a stay. That's because they pulled the case days before that hearing. But also, I also do.
33:04
Judge Chen
For that reason, judicial estoppel cannot work here. That's correct. I certainly, I just happen
33:09
Appellee Attorney
to know in Ninth Circuit, that's true. I think Ninth Circuit law applies. But yeah, I believe
33:12
you need the ruling in order to be able to use it that way. And then I do want, I think I speak for
33:16
the parties when I say, we know you've got a lot of work and we appreciate you expediting.
33:21
This appeal. We don't take that lightly. Thank you. Thank you, Mr. Reines. Mr. Bell,
33:27
Judge Lourie
why don't you take your three minutes if you need it. Thank you, Your Honor. I'll try to come in
33:33
Appellant Attorney
under that. The best I can do is return to the text of the statute. And I think that really cuts
33:38
through most, if not all, of the arguments here. It's a mandatory shall. It doesn't give discretion.
33:44
If you look at the House report at 160 or 141, there is discretion the district court was afforded.
33:51
To stay or not stay, other claims. But as to the claims provided for in the statute,
33:55
it's mandatory. That's a right that is afforded to respondents in the ITC. We did not get the
34:01
relief, and I can't stress this enough, we did not get the relief to which we were entitled.
34:05
So they say, you've got to stay. And I heard that a lot. And I think the court is wrestling,
34:09
rightly so, with whether that's enough. And we submit it's not enough, similar to praxis,
34:14
where a stay was granted. A stay was granted and the appellant sought to challenge it.
34:18
Judge Chen
What would be wrong with the decision that,
34:21
essentially, followed the reasoning of Russ in the context of this case?
34:27
Appellant Attorney
Yeah. So first I'd point out that the Ninth Circuit, my friend said that Russ has not been
34:32
overruled. The Ninth Circuit has expressly said in Camel, just a couple of years ago,
34:36
three years ago, that, quote, they've never extended Russ beyond the context of Rule 39.
34:42
It's a very specific context about requesting a jury right. And it does key off of the pleading.
34:46
It does say the last pleading, but it keys off of the pleading. We have a different word,
34:51
the statute uses here. And that's the word action. And that's the same word, I would note,
34:56
that Federal Rule 41 uses. And it even talks about a preceding action in the part where it talks
35:02
about you can only do this once, right? And that's some of the built-in safeguards that 41 has. You
35:07
can only voluntarily dismiss once. And in the provision that it says, that talks about that,
35:12
it says if you've dismissed a previous action, then it will be with prejudice. And if you haven't,
35:16
so there, 41 itself distinguishes based on the word action,
35:20
we have the precise same language here. And I think the statute, Congress knows what it's doing
35:26
when it legislates, and it chose to do so based on the action, not some prior action. So 1659 does
35:34
relieve respondents of the burden of litigating when the ITC is pending. I think the First
35:39
Circuit's decision in Vicor provides a cautionary tale. In Vicor, there was precisely what we fear
35:45
here, which was a preliminary injunction sought and a TRO at the same time. And so,
35:51
before they could even get the stay, so they moved for a stay, it was denied. Before they could even
35:56
get that reviewed, they were up on appeal of the preliminary injunction ruling, which was against
36:02
them. And so, that's what we're trying to prevent here. Because I can't read minds, but I strongly,
36:09
strongly suspect that's exactly what they're going to do here. But even if that weren't what they
36:14
were going to do here, the point is this. The statute provides a right. This court addressed
36:19
that right in the print.
36:24
Mr. Bell, I think your bill has rung. Indeed, it has, Your Honor. And I thank the court for its time.
36:49
Judge Lourie
And the case is submitted.