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