[00:00:00] Speaker 00: Case number 23, 5, 3, 11, Norwich Pharmaceuticals, Inc. [00:00:03] Speaker 00: Appellant versus Robert F. Kennedy Jr. [00:00:06] Speaker 00: in his official capacity as Secretary of Health and Human Services at all. [00:00:10] Speaker 00: Mr. Prince for the Appellant, Mr. Dave for the Federal Appellees, and Mr. Killian for the African-Science Pharmaceuticals, Inc. [00:00:17] Speaker 03: Good morning, your honors, and may it please the court. [00:00:19] Speaker 03: When Norwich first submitted its generic refaxman application to FDA, it sought approval to treat both IBSD, which is irritable bowel syndrome with diarrhea, and HE, hepatic encephalopathy. [00:00:33] Speaker 03: In ensuing patent litigation between Norwich and the brand Salix, the Delaware court concluded that Salix's drug product patent and IBSD patents were either invalid or not infringed, but that Norwich's then application did infringe Salix's patent covering the HE indication. [00:00:51] Speaker 03: The Delaware court accordingly issued what's known as a resetting order under the Patent Act directing that FDA approval of that application not be made effective until the HE patents expire. [00:01:02] Speaker 03: As permitted, Norwich amended its ANDA to remove the infringing HE use from its application and requested that FDA then approve it. [00:01:12] Speaker 03: At that time, FDA correctly recognized that the application no longer contained the infringing HE use and certifications, but incorrectly concluded that it was still blocked by the prior resetting order issued in connection with the HE certification. [00:01:29] Speaker 03: That decision's inconsistent with the Delaware Court's judgment, the plain language of the Patent Act as interpreted by the Federal Circuit in our very patent appeal, and the Food, Drug, and Cosmetic Act in its implementing regulations. [00:01:42] Speaker 03: I'd like to start with the judgment, if I might, because my friend suggests that I'm at war with it and I'm trying to ignore its language. [00:01:49] Speaker 03: or clatterly attack it. [00:01:51] Speaker 03: But we fully accept the Delaware Court's judgment was lawful. [00:01:55] Speaker 03: It just does not mean, and as the Federal Circuit went on to explain, cannot mean what FDA says it means. [00:02:02] Speaker 03: Indeed, the Delaware Court's judgment was the only lawful judgment it could issue in the circumstances, delaying approval of the ANDA before it and naming it by name, because that's what we were talking about. [00:02:14] Speaker 03: And as Salix has argued before, that's what resetting orders always look like. [00:02:19] Speaker 03: The implications of FDA's argument. [00:02:22] Speaker 04: Can I just clarify something upfront, which I think you were hinting at? [00:02:26] Speaker 04: I completely understand the argument that we ought to assume the Delaware court understands the law. [00:02:31] Speaker 04: And so that's why we would look to the statute and the regulation to understand how this is supposed to work. [00:02:37] Speaker 04: Yes. [00:02:38] Speaker 04: But you are not arguing, and you didn't argue below, [00:02:42] Speaker 04: that the FDA in some sense was not bound or for any other reason was free not to follow that judgment if the judgment said effectively even in amended and will be delayed until October 2029. [00:02:58] Speaker 03: I have my own views about how the statute should work in that circumstance, but that's correct. [00:03:02] Speaker 03: We've we've accepted that in this case. [00:03:05] Speaker 04: Okay, thank you. [00:03:07] Speaker 06: If FDA in your position is that the Delaware course judgment, [00:03:13] Speaker 06: does not block the FDA from approving your amended ANDA. [00:03:18] Speaker 06: That's what we're here about, right? [00:03:19] Speaker 03: That's correct, because as the Federal Circuit went on to explain, a resetting order is a remedy for the specific act of infringement defined in 271E4 or E2, which is the submission of an application containing an infringing use for which the submitter seeks approval. [00:03:41] Speaker 06: Why did you move in Delaware District Court for them to amend their judgment? [00:03:45] Speaker 03: Because we were admittedly confused at that time about what the patent attorneys in that case were confused about what the resetting order would do. [00:03:55] Speaker 03: And by the way, not just we were confused, Salix was confused too, because they were taking the other position then. [00:04:00] Speaker 03: Their position was, this isn't going to have the effect you're saying it is. [00:04:04] Speaker 03: They were instead arguing that what we're going to need is a second litigation. [00:04:08] Speaker 03: They said they need discovery on it, and so they were not taking the position that it blocked FDA. [00:04:14] Speaker 06: It seems like in the dispute of what the order meant, you prevailed. [00:04:24] Speaker 06: The district court concluded that Salix was wrong and you were right that the order would preclude and amended ANDA's approval. [00:04:35] Speaker 03: I don't think the district court entered SALEX's form of judgment, not our form of judgment. [00:04:44] Speaker 03: And what I think the district court thought was happening was that, and I can understand why in retrospect it thought we were doing this. [00:04:51] Speaker 03: It thought we were effectively trying to get an advisory opinion that once we carved out the ANDA, it would no longer be infringing. [00:04:59] Speaker 03: And that's why the parties are discussing and the district court discusses in its reconsideration order that that would be unfair because just because we carve out doesn't automatically mean it would be non-infringing in the future. [00:05:12] Speaker 03: It almost certainly does mean that. [00:05:14] Speaker 03: And in this case, it did mean that. [00:05:16] Speaker 03: And we know that because Salick sued us in the 370 case we're going to talk about and did not claim the application was still infringing on those grounds. [00:05:24] Speaker 03: But in theory, it would be possible for the carve-out not to remove the infringement. [00:05:29] Speaker 03: And that typically comes up, for example, not in these method of use cases, but if you're reformulating your products to try and avoid an infringement. [00:05:38] Speaker 06: Let me ask you, as a bit of a hypothetical, because I'm not asking you to concede that this is what happened. [00:05:45] Speaker 06: But if you argued in the Rule 60 motion to the Delaware District Court, [00:05:52] Speaker 06: that the unamended, the order as originally issued by the Delaware District Court would preclude the FDA from approving an amended ANDA. [00:06:04] Speaker 06: And the Delaware District Court and the Federal Circuit agreed with you that that is the effect of the Delaware District Court's judgment [00:06:16] Speaker 06: Then you have successfully told the Delaware District Court that that interpretation is the proper interpretation, contrary to what Salix may have been saying in the Delaware District Court. [00:06:30] Speaker 06: Now you come here and you argue the opposite, that the Delaware District Court's judgment does not preclude the FDA's approval of an amended ANDA. [00:06:41] Speaker 06: And if that is what happened, that seems like an example, that seems like you've satisfied the elements of judicial stop, where you're not allowed to argue here what you [00:06:52] Speaker 06: argued to the Delaware District Court and successfully persuaded the Delaware District Court that your argument about the meaning of its original judgment was, in fact, the correct meaning. [00:07:02] Speaker 03: Right, but we did not convince either the district court or the federal circuit that that was the correct interpretation of the order. [00:07:10] Speaker 03: In fact, those courts said, we are deeply confused, and we don't know what you're talking about, Norwich. [00:07:16] Speaker 03: At JA 221, which is the Delaware court's explanatory order, it explains the scope of its order. [00:07:23] Speaker 03: And it says, this contains the HE indication, which would infringe the patents. [00:07:28] Speaker 03: Norwich has proposed and has that. [00:07:30] Speaker 03: I cannot rule on facts that are not before me, including the possibility of an amended ANDA, which it recognizes we're entitled to submit under the statute. [00:07:40] Speaker 03: That label is not before me. [00:07:41] Speaker 03: It's immaterial. [00:07:43] Speaker 03: The Federal Circuit was extremely explicit about this on appeal. [00:07:47] Speaker 03: It said, Norj, I don't know what you're talking about because a resetting order is a specific remedy. [00:07:53] Speaker 03: It's directed to a specific infringing use in the application. [00:07:57] Speaker 03: It specifically says it does not [00:07:59] Speaker 03: cover non-infringing uses. [00:08:02] Speaker 03: And that's why the federal circuit said nothing in the Delvert court. [00:08:06] Speaker 04: The hardest fact for you, in my opinion, is that they never said it doesn't block your amended ANDA. [00:08:14] Speaker 04: And so it would have been the easiest thing in the world for the district court to say when you come to them, understandably complaining, [00:08:23] Speaker 04: It's absurd for you to have a complete prohibition on our amended ANDA. [00:08:28] Speaker 04: It's not infringing. [00:08:28] Speaker 04: Easiest thing in the world for the district court to say, no problem. [00:08:33] Speaker 04: I don't even need to change the judgment because that's clearly not what it does. [00:08:37] Speaker 04: And as I understand your cross appeal in the federal circuit, this was essentially the whole issue. [00:08:42] Speaker 04: And again, it says you can file a new ANDA, but it doesn't say [00:08:48] Speaker 04: This whole cross appeal is of no moment because the judgment doesn't bar the amended ANDA. [00:08:54] Speaker 04: And I could grant you that that might make no sense. [00:08:58] Speaker 04: But they never said the judgment doesn't bar your amended ANDA. [00:09:01] Speaker 04: So why isn't that a powerful point against you? [00:09:04] Speaker 03: Well, I too, of course, wish those courts had said it exactly in the way you're saying. [00:09:08] Speaker 03: But I think that's effectively what they are saying, especially the Federal Circuit, which says the statute is appropriately directed [00:09:16] Speaker 03: to approval of the particular uses involved in the infringement, not the non-infringing uses. [00:09:22] Speaker 03: And it described the remedy provision as delaying approval of the drug involved in the infringement. [00:09:28] Speaker 03: It did very explicitly say, Norwich says that this would block approval of a new ANDA. [00:09:34] Speaker 03: And the Federal Circuit says that's absolutely wrong. [00:09:36] Speaker 03: Nothing in the order suggests that. [00:09:38] Speaker 03: And I know this is difficult because it does say the word new. [00:09:41] Speaker 03: But we were never arguing in the Federal Circuit. [00:09:43] Speaker 03: nobody was arguing in the Federal Circuit that it would have blocked literally a new ANDA, right? [00:09:48] Speaker 03: The only new ANDA that was at all at issue at that point, this 370 wasn't even in the world. [00:09:53] Speaker 03: The only new ANDA we were talking about is the amendment to the 369 ANDA that we had then submitted. [00:10:00] Speaker 03: So that's what the Federal Circuit is talking about. [00:10:02] Speaker 03: But I totally get that the language is a little- I'm sorry. [00:10:05] Speaker 02: You just said that nobody was arguing that in the Federal Circuit. [00:10:08] Speaker 03: Nobody in the Federal Circuit was arguing that the order would block approval of a different ANDA. [00:10:14] Speaker 03: Of the amended ANDA? [00:10:16] Speaker 03: No, we were only arguing about whether it would block approval of the amended ANDA. [00:10:20] Speaker 02: And that's why I say you were definitely arguing. [00:10:22] Speaker 03: No, we were absolutely. [00:10:24] Speaker 03: That was our whole point. [00:10:25] Speaker 03: And when the Federal Circuit said, no, it would not block approval of a new ANDA, it's talking about our amended ANDA. [00:10:32] Speaker 03: But I recognize the language. [00:10:34] Speaker 04: So what does footnote 10 mean? [00:10:37] Speaker 04: It says, it's exactly after this discussion. [00:10:40] Speaker 04: And it says, basically, Norwich got approval of its amended ANDA. [00:10:46] Speaker 04: The tentative approval letter noted that final approval cannot be granted until October 2, 2029 as specified in the court order. [00:10:54] Speaker 04: There's not a next sentence that says, that makes no sense. [00:10:57] Speaker 04: The judgment doesn't apply to the amended ANDA. [00:11:02] Speaker 03: Right. [00:11:03] Speaker 03: It does not address the issue because it recognized there was pending litigation in D.C. [00:11:07] Speaker 03: And that's not the Federal Circuit's issue to decide. [00:11:09] Speaker 03: That's this court's issue to decide and the D.C. [00:11:12] Speaker 03: and the D.C. [00:11:13] Speaker 03: district courts. [00:11:15] Speaker 03: So I think it was just reserving the issue without getting into the weeds of it. [00:11:19] Speaker 03: But if I could just take one minute. [00:11:21] Speaker 03: FDA's interpretation of this is entirely inconsistent with the entire way the Food, Drug, and Cosmetic Act is structured, which specifically tells it to apply timing rules only to the certification made in the application. [00:11:33] Speaker 03: Our application, at the time it ran those timing rules, did not contain this certification. [00:11:38] Speaker 03: And its regulations not only contemplate us doing exactly what we did, they require it. [00:11:46] Speaker 02: I mean, there are some distinctions. [00:11:51] Speaker 02: You chose to file an amended, and I think the premise in the District of Delaware and the Federal Circuit was you could file a new one. [00:12:00] Speaker 02: And the distinction there, is that about filing fees or is that about [00:12:07] Speaker 02: where you are in the queue or why an amended and rather than a separate one or as you've done with the 370. [00:12:18] Speaker 02: Sure. [00:12:18] Speaker 02: So there are that one, which is distinct from the 369. [00:12:21] Speaker 03: Right. [00:12:22] Speaker 03: There are lots of reasons why you wouldn't want to file literally an entirely separate and including the filing fees, which are very significant. [00:12:28] Speaker 03: many hundreds of thousands of dollars. [00:12:30] Speaker 03: You go back to the queue in the line, there could be other, you know, there's a possibility of an additional 30 months stay potentially when you file that application that would delay approval, you know, not just at the back of the queue, but for many more years. [00:12:45] Speaker 03: So there's a lot of reasons why the statute wouldn't require you to do that and why FDA's own regulations don't contemplate you doing that instead. [00:12:53] Speaker 03: they provide specifically. [00:12:55] Speaker 03: You can either accept the patent court judgment and change it to a paragraph 3 certification in which case the patent court's judgment is effectuated or you can change your application to remove the infringing use to make a section 8 statement to that use to carve it out and then you're immediately approvable. [00:13:12] Speaker 03: literally what its regulations say. [00:13:14] Speaker 03: There's no other way to read the regulations and I don't read my friends to even be disputing that. [00:13:20] Speaker 03: They're just trying to wish it away, wish away their regulations and wish away the entire structure of the act that instructs them how it's supposed to read at court judgments. [00:13:29] Speaker 02: So given the other case, what are the stakes here, given the 370 case? [00:13:35] Speaker 02: So if everyone agrees, you can file a new ANDA without the infringing use, and you've effectively done that in amending that 370 ANDA. [00:13:47] Speaker 02: What's at stake here for you? [00:13:50] Speaker 03: So the simple answer is there's two separate applications. [00:13:53] Speaker 03: And although they're ultimately going to approve the same drug product, the statute allows us to have two. [00:13:59] Speaker 03: But they're in different phases of the process, right? [00:14:01] Speaker 03: Here, we currently have an FDA decision that says we can't be approved until the expiration of the AHE patent. [00:14:08] Speaker 03: In 370, we have a different determination that says we're blocked. [00:14:12] Speaker 03: um by exclusivity and for example, um Salix in that case is arguing they have unique defenses to the approval of the basically everyone said, just go file another anda. [00:14:23] Speaker 03: So, we file the other anda. [00:14:25] Speaker 03: It's the 370 anda and now Salix is saying, oh, there needs to be a 30-month stay on that anda. [00:14:30] Speaker 03: Oh, you can't, you know, the judgments that you spent years winning, they don't actually apply to the 370 anda. [00:14:36] Speaker 03: So it you know they're intertwined they're intertwined in a way it is true that at the end of the day we will probably market the one of the two and does on which FDA approves first but there's nothing prohibits us from proceeding on parallel tracks and nobody by the way in the case has argued that we can't do that. [00:14:55] Speaker 06: Can you identify a case where a generic [00:15:01] Speaker 06: has amended after trial and then gotten approval without a court considering it in litigation. [00:15:12] Speaker 03: I was not able to identify a case either way. [00:15:15] Speaker 03: And the reason why is because this is sort of a unicorn set of factors that came up, because we invalidated or showed in applicable, depending on the patent, like the product patent and one of the use patents. [00:15:28] Speaker 03: So it's a unique situation where there's one unpatented use of the drug, but there's no broader prohibition on the drug. [00:15:35] Speaker 03: That does not come up very often. [00:15:38] Speaker 03: But again, even if there's no example I can point you to, FDA's regulations provide the example. [00:15:46] Speaker 03: They tell you, you can do it. [00:15:48] Speaker 02: Maybe you've just answered my question, but if it's... [00:15:51] Speaker 02: sort of completely consistent with the statute of regulations to do what you've tried to do, which is amend the ANDA once you hear which part of it is infringing. [00:16:05] Speaker 02: There seems like there's in the law emphasis about pre-judgment amendments. [00:16:13] Speaker 02: That's when you have to do it. [00:16:15] Speaker 02: And I'm having a little trouble squaring that with your position. [00:16:20] Speaker 03: So the law will in certain circumstances allow you to do it, but you're typically doing that in, and I'll answer the question in a couple of days because there's reasons why you would want to do that. [00:16:31] Speaker 03: But typically those cases are about, not about method of use patents, but are about formulation patents. [00:16:38] Speaker 03: So you're in the middle of trial, [00:16:40] Speaker 03: it looks like or you get a determination that your formulation is going to infringe and you said, well, wait, I can reformulate the certification or sorry, reformulate the the formulation and avoid that infringement and everybody wants it all to be resolved at the at the same time and the reason an and for example, want to do that is because if you're litigating in this preapproval posture, there's not the possibility of damages. [00:17:06] Speaker 03: right? [00:17:06] Speaker 03: So you don't have to do it that way and the act would allow would allow approval if you didn't do it that way but if you launch you you can subject yourself to some pretty substantial damages in some circumstances. [00:17:21] Speaker 04: So this the the district court thought that this fairing case from the federal circuit was analogous I'm just going to say how the district court read it which was [00:17:32] Speaker 04: It thought that at least the Federal Circuit thinks in a situation like what we have here, you do need a change to the judgment, and that's discretionary with the district court. [00:17:43] Speaker 04: Can you give us your distinction of that? [00:17:45] Speaker 04: Is it distinguishable or is it just wrong? [00:17:47] Speaker 03: That's a formulation case. [00:17:49] Speaker 03: It's exactly what I was talking about. [00:17:51] Speaker 03: And by the way, I think that case actually supports exactly what I'm saying because that case very explicitly holds that when we're talking about the application that you're litigating in the patent court, it's the operative application. [00:18:05] Speaker 03: It's the application as amended at the time you're litigating it in the patent court. [00:18:10] Speaker 04: So I think that case is actually... So why is a post-judgment change of your formulation different [00:18:17] Speaker 04: in a material way from a post-judgment change in your intended use? [00:18:23] Speaker 03: Because we would still need to, we still need to certify to that formulation. [00:18:28] Speaker 03: It doesn't work like method of use patents where you can literally drop it out and take it out. [00:18:34] Speaker 02: If there's no more questions. [00:18:35] Speaker 02: So, I mean, this is a question I have and maybe it's for the, for your friends on the other side, but [00:18:42] Speaker 02: one of the responses of the district court and of the agency is, you chose how to package your ANDA, and you kind of have to live with that. [00:18:52] Speaker 02: And I guess, why? [00:18:53] Speaker 02: I mean, if it's got components, and I take your answer to be why you don't file sort of more modularly, like an ANDA for one intended use and a separate one for another intended use, so you don't have this problem. [00:19:06] Speaker 02: You can just, okay, that one's infringing. [00:19:09] Speaker 02: don't pursue it, but the ones that are non-infringing are standalone. [00:19:12] Speaker 02: They're not [00:19:13] Speaker 02: tied up with one that's infringing. [00:19:17] Speaker 02: So one answer is to do it that way, then you'd be paying a lot more. [00:19:21] Speaker 03: Well, it's paying a lot more, and it's entirely inefficient. [00:19:24] Speaker 03: Because I take your question to be, well, why wouldn't we go in with the skinniest label possible, litigate that, get approval, and then add the uses on? [00:19:31] Speaker 03: And the answer is because when you add those uses on, you get subject to an additional 30 months. [00:19:37] Speaker 03: I mean, it would take forever. [00:19:39] Speaker 02: couldn't do it all simultaneously. [00:19:41] Speaker 02: Like we have this sublabel, this sublabel, this sublabel, and if we win them all, we put them all together. [00:19:46] Speaker 03: That's just not something. [00:19:48] Speaker 03: If I understand the question, that's not a thing. [00:19:51] Speaker 02: Can't be done or wouldn't be done. [00:19:53] Speaker 02: Which is it? [00:19:54] Speaker 02: It wouldn't be done. [00:19:55] Speaker 03: It's all part of the same. [00:19:56] Speaker 03: Maybe if you can restate your question. [00:19:58] Speaker 03: I'm not sure. [00:19:59] Speaker 02: Well, like if you have three different [00:20:03] Speaker 02: intended uses and you're not sure if one of them is going to go south and the other one's not and you want to be able to go right to market with ones that that are not infringing and if [00:20:15] Speaker 02: If your opponents are right about the one takes the whole thing down, the one that's infringing makes the whole anda invalid, then it seems like next time would you have separate andas and sort of bring them together as like a jointer of claims and not have that problem? [00:20:35] Speaker 02: And I take it that the answer is, well, first of all, you would want them to be the same case. [00:20:40] Speaker 02: You would want them to go at the same time. [00:20:41] Speaker 02: You're using largely the same evidence. [00:20:45] Speaker 02: And so it's a strange formalism to require that. [00:20:50] Speaker 02: And it's not even really contemplated. [00:20:54] Speaker 03: That's exactly right. [00:20:55] Speaker 02: But conceptually, that's exactly what you say how you should be treated, which is that you have one infringing, two non-infringing intended uses, and you should be able to proceed in some way. [00:21:08] Speaker 02: And you're looking for the way to proceed promptly with the non-infringing. [00:21:11] Speaker 03: Right. [00:21:12] Speaker 03: I mean, the statute wants you to file the broadest possible and you can, right? [00:21:19] Speaker 03: And that's why it'll, and then so you do, you challenge or you subject yourself to challenge on everything. [00:21:26] Speaker 03: And then specifically with method, [00:21:28] Speaker 03: method of use patents. [00:21:29] Speaker 03: Method of use patents are treated entirely different under the statutory scheme in that you are then allowed to say, OK, I'm going to carve that out. [00:21:36] Speaker 03: I mean, carve outs are an absolutely critical portion of how the generic industry operates. [00:21:44] Speaker 03: And that's exactly what we did here. [00:21:48] Speaker 03: I'll just say in closing, our interpretation [00:21:51] Speaker 03: of this order is the only one that harmonizes everything in this case. [00:21:55] Speaker 03: It harmonizes how the Federal Circuit described the Patent Act is meant to operate. [00:22:00] Speaker 03: It harmonates with how the enabling statute of FDA tells it to read patent orders and it harmonizes with FDA's regulation. [00:22:08] Speaker 03: FDA's interpretation of it is completely at war with all of those. [00:22:11] Speaker 06: Did SAILX have an opportunity to challenge the amended ANDA at trial in Delaware? [00:22:19] Speaker 03: So in the previous Pat litigation did a challenge. [00:22:23] Speaker 03: No, I mean, that's what we were arguing about before the district court litigation. [00:22:27] Speaker 03: So if Salix truly believed that that application was now infringing, it could file a second Pat litigation against us. [00:22:34] Speaker 03: But this is the key. [00:22:36] Speaker 03: It doesn't believe. [00:22:37] Speaker 03: It's all made up. [00:22:39] Speaker 03: They do not believe it's truly infringing. [00:22:40] Speaker 03: And we know that because they did not sue us on that basis on the 370 application, which is the exact same now drug. [00:22:48] Speaker 02: So the ones that were found, the intended uses that were found non-infringing in the distribution of Delaware litigation, there's a little bit of unclarity in my view in the briefing where they were not stipulated. [00:23:01] Speaker 02: They were subject to trial. [00:23:04] Speaker 02: Those and they're the, I [00:23:08] Speaker 02: IBSD and the, was it the formulation? [00:23:14] Speaker 02: Polymorph. [00:23:15] Speaker 02: Polymorph. [00:23:16] Speaker 02: Those were not stipulated to be non-infringing, but they were held to be non-infringing. [00:23:24] Speaker 03: So I want to be absolutely accurate. [00:23:26] Speaker 03: And if you look at the, I think it is the FDA's second forfeiture member on the record and I can get you the, it's in the other case, but I can get you the citation and also the tentative approval in this case, which is [00:23:42] Speaker 03: it goes through the patents. [00:23:45] Speaker 03: So there were final judgments on one of the polymorph patents and I think a couple of the IVSD patents because those were their best patents and then for other patents that also were related to that there were stipulations of non-infringement. [00:24:01] Speaker 03: So basically what happened in the Delaware court is they tried their best patents. [00:24:06] Speaker 03: And we prevailed on those paths, except for HE, which the statute allows us to carve out. [00:24:12] Speaker 03: And we did. [00:24:14] Speaker 06: I think the answer to this next question is no. [00:24:16] Speaker 06: But if we were to rule for you in the next case, would that moot this case? [00:24:22] Speaker 03: No, it wouldn't moot that case. [00:24:25] Speaker 03: And part of the reasons that I'm talking about is SALEX says it has unique defenses. [00:24:29] Speaker 03: It would basically sue for a TRO to say that FDA validated the 30 month. [00:24:35] Speaker 03: stay decision, even though they've already addressed. [00:24:39] Speaker 03: I could see, depending on how broadly you rule for us in 370, it might, not in a legal sense, but it might make the 369 appeal less important. [00:24:51] Speaker 02: But there's a whole bunch of different moving puzzle pieces here at the same time, which is- I was wondering that about the 180-day exclusivity in 370. [00:25:02] Speaker 02: If you were to prevail here, wouldn't that, you'd have to confront that here too? [00:25:05] Speaker 03: So, if we prevail on this case, the patent-related hurdle is clear. [00:25:10] Speaker 03: We're eligible for immediate approval. [00:25:12] Speaker 03: FDA would need to confront the 180-day exclusivity issue, which is the exact issue in 370. [00:25:18] Speaker 03: And so, I mean, that's why we're pushing both at the same time because if if you just we just took 370 off the table, we would just be back here in a year and we would need to go through all these really complicated statutory permissions. [00:25:30] Speaker 02: So, if that's the same in both, I I guess I'm sorry. [00:25:33] Speaker 02: Trying to absorb the answer that you had to to Walker's question. [00:25:37] Speaker 02: Is there only that 30 months stay would not not be applicable here, but would be applicable there. [00:25:45] Speaker 03: FDA concluded in the other appeal that the 30-month stay is inapplicable in that case. [00:25:51] Speaker 03: Salix, however, contends that FDA erred about that and has indicated an intent to sue FDA about it. [00:25:58] Speaker 03: But I think it did raise it in its reply brief, but it's just not before the court because their claims aren't ripe until FDA grants final approval. [00:26:15] Speaker 03: Thank you, Your Honors, I appreciate it. [00:26:28] Speaker 01: All right, Mr. Schumpel. [00:26:30] Speaker 07: Mr. Day for this case. [00:26:33] Speaker 02: Thank you. [00:26:34] Speaker 02: Thank you. [00:26:35] Speaker 02: Yeah, of course. [00:26:37] Speaker 02: Funny, the two cases sort of look alike. [00:26:40] Speaker 07: Good morning, Your Honors. [00:26:41] Speaker 07: May it please the court, Hayne Day for the government. [00:26:45] Speaker 07: Norwich's position that it was confused about the meaning of the Delaware court judgment cannot be squared with the Delaware record. [00:26:53] Speaker 07: That judgment, Norwich passed for a judgment that was narrow, that would have allowed it to carve out the H.E. [00:26:58] Speaker 07: indication and seek immediate approval from FDA. [00:27:01] Speaker 07: The district court refused to do that because it would not prejudge infringement questions about that carved out agenda. [00:27:08] Speaker 07: It instead adopted Salix's proposed language. [00:27:12] Speaker 07: Everyone, Norwich included, understood that judgment to bar even amended versions of Norwich's ANDA. [00:27:19] Speaker 07: As Norwich put it, it operated as a quote, absolute prohibition on FDA's approval of Norwich's amended ANDA. [00:27:28] Speaker 07: That's on JA83. [00:27:31] Speaker 02: But why? [00:27:32] Speaker 02: That doesn't make sense. [00:27:37] Speaker 02: in the, I mean, given what Mr. Prince was just arguing, if they'd gone to trial and the court has found that two indications are not infringing, [00:27:55] Speaker 02: What is gained by treating the way those non-infringing indications were packaged together in the ANDA with one that was found infringing? [00:28:06] Speaker 02: What is gained by having the infringement [00:28:12] Speaker 02: binding with respect here to hepatic encephalopathy prevent going to market quickly on a non-infringing indication? [00:28:24] Speaker 02: I don't really follow that. [00:28:25] Speaker 07: Yeah, I think there are good reasons. [00:28:27] Speaker 07: But before I get there, I want to make clear that whether or not there are good reasons, that's not really before the court. [00:28:33] Speaker 07: That's a question about the validity of the judgment. [00:28:34] Speaker 02: I understand the statute that you're defending and the logic of it. [00:28:38] Speaker 07: Yeah, and I think there are good reasons given the litigation strategy and talking about Judge Pillard, the questions you asked about what reach final judgment, what to reach settlement. [00:28:47] Speaker 07: That's sort of indicative here as well, because the patent litigation involves narrowing your claims. [00:28:53] Speaker 07: Salix had to choose to narrow its claims to come down to specific indications and that's based on the ANDA that Norwich had filed at that point. [00:29:01] Speaker 07: Had Norwich done a prejudgment carve out as the case law recognizes is appropriate, it could have focused on different claims and presented different arguments. [00:29:08] Speaker 07: So I think that's one reason it makes sense. [00:29:10] Speaker 01: Go ahead. [00:29:14] Speaker 04: it had done a prejudgment carve out, the validity and infringement of those other patents wouldn't have been litigated. [00:29:20] Speaker 04: And that's exactly what the act wants. [00:29:22] Speaker 04: Doesn't it want broad ANDA's full patent litigation to clear out bad patent litigation, bad patents, and then for the drug to come to market in a non-infringing way, rather than [00:29:36] Speaker 04: This other rule would effectively just penalize them for filing abroad and going through the patent litigation as to all of them instead of just a subset. [00:29:47] Speaker 07: So I agree that is one purpose of the statutory scheme here. [00:29:50] Speaker 07: Another is protecting patent holders rights. [00:29:53] Speaker 07: So that's the counterbalance here when you're narrowing interests. [00:29:56] Speaker 07: But I would like to step back and say that this case is not about whether it's appropriate or correct for the judgment to be entered in the way it is. [00:30:03] Speaker 07: It's only about the plain language of the judgment. [00:30:06] Speaker 04: Before those arguments, as Judge Pillard said, you agree that your position [00:30:12] Speaker 04: Or what's happened here is impossible to reconcile with this, the regulation about what's supposed to happen after a finding of infringement, right? [00:30:21] Speaker 07: No, I disagree with that. [00:30:22] Speaker 07: So I think that question as a separate issue does not need to be reached. [00:30:26] Speaker 07: But also, it's not the timing rules that govern when FDA can approve. [00:30:30] Speaker 07: It's fundamentally the order that the court entered. [00:30:33] Speaker 07: So those timing rules define internal FDA operations. [00:30:37] Speaker 07: The Federal Circuit has held this expressly in ortho McNeil. [00:30:40] Speaker 07: It reaffirmed it recently in Vanda. [00:30:42] Speaker 07: That's how the Federal Circuit has read these provisions. [00:30:45] Speaker 07: And had Norwich wanted- You say that's how they've read it. [00:30:48] Speaker 02: What are you referring to? [00:30:49] Speaker 02: That? [00:30:50] Speaker 07: Oh, that's how the Federal Circuit has read the FDCA in relation with 271E4. [00:30:56] Speaker 07: That being- That's the decision in ortho McNeil. [00:31:00] Speaker 07: that the timing rules in the FDA Act, the FDCA, do not serve to limit district court's authority to enter resetting orders outside the bounds of those timing orders. [00:31:16] Speaker 07: And because of that, the question here is only whether the district court intended its decision to bind even amended versions of the end. [00:31:25] Speaker 07: And I think on the Delaware record here, that is clear, because, you know, [00:31:30] Speaker 02: What about if we read it? [00:31:32] Speaker 02: I mean, I thought that Norwich was reading it, that it's saying, we are not addressing that. [00:31:37] Speaker 02: And they feared that it might be read to be addressing their amended ANDA, but they were told that wasn't before District of Delaware. [00:31:45] Speaker 02: We're not going to sort of, after the fact, pretend we've litigated something that we haven't, said the District of Delaware, not really, you know, [00:31:57] Speaker 02: having before it to think through the implications of that. [00:31:59] Speaker 02: But then when they come to the FDA and say, OK, you can look at that record in the District of Delaware, and you can look at whether these were stipulated or not stipulated. [00:32:10] Speaker 02: And if it's true, as Mr. Prince was saying, that Salix brought forward its strongest versions of these various claims, then is it troubling that they, which ones they stipulated away? [00:32:27] Speaker 02: in which not. [00:32:28] Speaker 02: I mean, why can't the FDA look at that and say, great, we want to get generics out if they're non-infringing. [00:32:35] Speaker 02: And we're confident on this record that the indications that were held to be non-infringing, there's not any [00:32:44] Speaker 02: cloud on the merits of that determination. [00:32:48] Speaker 02: So sure, we accept the amended ANDA. [00:32:51] Speaker 02: What's not right about that? [00:32:53] Speaker 07: I think there are a couple of responses. [00:32:55] Speaker 07: One, FDA serves a purely ministerial role. [00:32:57] Speaker 07: Its job is not to dig through the record and assess whether patent infringement would occur on the amended ANDA. [00:33:02] Speaker 07: That under the statutory structure is a question for district courts, not the FDA. [00:33:07] Speaker 07: So I think that's the first response. [00:33:09] Speaker 07: And second, I think [00:33:11] Speaker 07: that the record just doesn't bear out that Norwich feared the judgment operated as it did and tried to argue around it. [00:33:18] Speaker 07: I think fundamentally Norwich asked to modify the judgment to not ask for clarification about whether that judgment actually didn't bar amended versions of the ANDA. [00:33:27] Speaker 07: It filed a rule 60 motion saying it was inequitable for it to continue barring amended versions of the ANDA. [00:33:33] Speaker 04: So I agree there the best support for what the FDA did here is the statements in Norwich's [00:33:41] Speaker 04: rule 60 motion, and then it's briefed to the federal circuit, right? [00:33:45] Speaker 04: Saying, for example, please remove the absolute prohibition on approving our amended ANDA. [00:33:53] Speaker 04: And that may be a powerful point. [00:33:55] Speaker 04: It is the extremely odd feature that the case would be entirely different if they had started that motion by saying, [00:34:03] Speaker 04: We don't think your judgment bars are amended ANDA, but in an abundance of caution, and as any prudent lawyer would do in this situation, we are asking you to clarify that it doesn't bar our amended ANDA. [00:34:15] Speaker 04: It's a little strange if the whole case turns on that. [00:34:18] Speaker 07: I don't think the whole case turns on that. [00:34:20] Speaker 07: I think it is the relationship between what they filed in contesting the judgment, and what they filed in the Rule 60 motion, and then what the district court actually did. [00:34:29] Speaker 07: So I think it's key to focus on what the dispute was. [00:34:32] Speaker 07: So when there was a dispute about the judgment, Salix wanted a judgment that barred ANDA 214.369, period. [00:34:39] Speaker 07: Norwich wanted one that would allow carve-outs of the age sheet indication. [00:34:42] Speaker 07: The district court adopted Salix's version. [00:34:44] Speaker 07: When there's a dispute at the Rule 60 stage, Norwich said, we want to modify that. [00:34:49] Speaker 07: We think that's wrong. [00:34:50] Speaker 07: We want approval for an amended and the district court rejected that and the federal circuit affirmed it. [00:34:55] Speaker 07: So I think it's the combination of the two, not just magic words and emotions specifically. [00:35:00] Speaker 02: I know I've asked this before, but can you explain why the statute and the regulations would require that given [00:35:15] Speaker 02: that as Judge Garcia was asking, assuming one would want an ambitious [00:35:27] Speaker 02: and to clarify validity of patents, which are anti-competitive and limit the market. [00:35:38] Speaker 02: But you don't want to make that carry this downside risk of huge amounts of money and huge amounts of time if you overshoot, and as in this case, have one [00:35:53] Speaker 02: infringing indication, like dropping the correct way in FDA's understanding of its statute and regulations to drop the infringing intended use and proceed with a non-infringing label is to go back and start over. [00:36:12] Speaker 07: So I want to make our position really clear on this point, because I don't think the statute and regulations require the district court judgment necessarily to have entered an order that would bar even amended versions of the ANDA, either at the judgment stage or at the amended stage. [00:36:26] Speaker 07: So it's not a complete requirement of the statute. [00:36:30] Speaker 07: just that the district court did. [00:36:32] Speaker 02: Do they even authorize it? [00:36:33] Speaker 07: Yeah, it's within the district court's discretion at that point, at least once the judgment is entered, right? [00:36:39] Speaker 07: So on the facts of this case, you have a post-judgment amendment and this is what the federal circuit has said in its fairing decision that [00:36:46] Speaker 07: After the judgment, the court has discretion to consider whether to amend that judgment in light of an amendment to the ANDA. [00:36:54] Speaker 07: And that's what happened here. [00:36:55] Speaker 07: That's the direct avenue on direct appeal. [00:36:58] Speaker 07: The district court declined to do so and reaffirmed that its original judgment barred even the amended ANDA and the Federal Circuit affirmed. [00:37:07] Speaker 02: And why does it have authority to do that? [00:37:09] Speaker 07: through the Patent Act 271E4A provides it authority to reset the deadlines for ANDAs. [00:37:22] Speaker 07: If there are no further questions, we ask that the court affirm. [00:37:44] Speaker 05: I think underneath many of the court's questions here has been, I'll call it an assumption, which I think fed by Norwich, that the question of whether the amended ANDA truly does no longer infringes is kind of an obvious answer. [00:38:04] Speaker 05: We strongly disagree, but I don't think you need to take our word for it because Judge Andrews was presented with this very question in connection with the Rule 60B5 motion to deem the judgment satisfied. [00:38:17] Speaker 05: The way the statute works is that once you get the infringement finding under paragraph [00:38:25] Speaker 05: three, basically Roman at three, if you've made a paragraph or certification, and then if the patent holder brings the lawsuit, then there's this complicated decision tree. [00:38:34] Speaker 05: And at the end of each of the points on that decision tree, it's of whether there's been a finding of infringement or a finding of non-infringement. [00:38:42] Speaker 05: They got a finding of infringement. [00:38:44] Speaker 05: They then amended, and under the regulations, they're allowed to submit that amendment, but it doesn't automatically control the timing of the effectiveness. [00:38:52] Speaker 05: So they went back to Judge Andrews and said, we've now submitted an amendment. [00:38:57] Speaker 05: Please change your judgment. [00:38:58] Speaker 05: Deem the judgment satisfied. [00:39:00] Speaker 05: And he declined. [00:39:01] Speaker 05: And part of the reason he declined, Your Honors, this is on JA 331. [00:39:04] Speaker 05: This is his reconsideration decision. [00:39:07] Speaker 05: I'm just going to read a sentence. [00:39:09] Speaker 05: It is not a simple matter to determine whether an anti-applicant has successfully carved out language from a label to turn infringement into non-infringement. [00:39:19] Speaker 05: the defendant, that is Norwich, other than saying it has successfully carved out the H.E. [00:39:25] Speaker 05: indication and providing me the label has presented no evidence in support of its assertion. [00:39:31] Speaker 05: In other words, in this case, we came into court with well over 25 patents. [00:39:36] Speaker 05: And according to Judge Andrews, we were not going to get to try all of those. [00:39:40] Speaker 02: And so I'm sorry, I thought your position was that you were not [00:39:46] Speaker 02: challenging the substance of the Delaware District Court determinations that the two uses are in fact not infringing. [00:39:56] Speaker 05: I thought that that was because your honor, I don't believe we think that's actually what Judge Andrews held, which Andrews held as he considered eight patents [00:40:04] Speaker 05: And he found infringement as to the IBS, the HE, and validity as to those HE patents. [00:40:11] Speaker 05: And then he found infringement but in validity as to the tried IBSD patents. [00:40:17] Speaker 05: But there were almost 20 patents that we didn't get to try. [00:40:20] Speaker 05: And we put them into a stipulation. [00:40:22] Speaker 05: We stipulated to non-infringement. [00:40:24] Speaker 02: So put it another way, that you're not challenging the 370 and on the ground that the indications are infringing. [00:40:32] Speaker 05: I'm not sure I followed what the 370 had a question. [00:40:36] Speaker 02: That they're not infringing the patents that were found not infringing in the 369. [00:40:42] Speaker 05: In the 370 case, which is in its early stages in New Jersey, we are suing over patents that are applicable to the 370, and there's no HE patents in that. [00:40:52] Speaker 05: So the HE case, the HE patents, no HE patents are asserted in that case. [00:40:59] Speaker 02: So the footprint of it is, [00:41:01] Speaker 02: parallel to the attempted amended ANDA in the 369, right? [00:41:07] Speaker 02: And you're not in the 370 challenging the intended uses as infringing. [00:41:17] Speaker 05: We are. [00:41:17] Speaker 05: That is the 370 case. [00:41:18] Speaker 05: We're challenging that it's violating our IBSD patents in the 370 case. [00:41:23] Speaker 05: It's a different set of patents that were then tried in the 369 case. [00:41:27] Speaker 05: But this gets to my point, Judge Pollard. [00:41:29] Speaker 05: that we only were able to try. [00:41:31] Speaker 02: It's challenging them because as different patents from the ones that were found non-infringing. [00:41:37] Speaker 05: But to the same use, which is why when your honor asked the question about one use or another use, I think that slightly oversimplifies it because there are various patents. [00:41:45] Speaker 05: There's a lot of patents for each of the indications. [00:41:48] Speaker 05: And so [00:41:49] Speaker 04: I hesitate to cut you off, but I think you've already said that. [00:41:53] Speaker 04: Is your point that if during trial they had disclaimed the HE use, you may have asserted additional IBSD patents in that location? [00:42:02] Speaker 05: Completely different trial, yes. [00:42:04] Speaker 05: We only had 20 hours to present our case and we had to dedicate a substantial portion of that time to our HE patents. [00:42:09] Speaker 05: If they had carved out before trial, we would have been able to focus those 20 hours on IBSD. [00:42:14] Speaker 04: But we did have the assumption that you started with that [00:42:18] Speaker 04: There was a final determination that only HE use infringes and you just have to disclaim that use and you can go to market. [00:42:27] Speaker 04: Your point is that is not obvious at all. [00:42:30] Speaker 04: But it's not that it's not obvious as to the HE use. [00:42:33] Speaker 04: It's not obvious as to the other use. [00:42:36] Speaker 05: Correct. [00:42:37] Speaker 05: And I'll note to the court, when we took, we appealed this issue to the federal circuit. [00:42:41] Speaker 05: We only persuaded one judge that we had put on sufficient evidence to the validity of the IBSD patents. [00:42:46] Speaker 05: And it is our view that if we had not had to spend so much time in trial resources on the HE, I think we could have got at least one more judge in the federal circuit and maybe Judge Andrews himself. [00:42:55] Speaker 05: The point is these decisions have substantial repercussions. [00:43:00] Speaker 05: And so that's why the FDCA, the act, puts the patent judge as the one to decide whether or not a post-trial carve-out truly cures the infringement. [00:43:10] Speaker 05: In the Fairing case, which we've discussed. [00:43:12] Speaker 04: Are there cases? [00:43:13] Speaker 04: I'm sorry. [00:43:13] Speaker 04: Please go ahead. [00:43:14] Speaker 05: Yeah, no. [00:43:14] Speaker 05: The Fairing case, I think I was just going to use as an example, Judge Garcia, if I'm anticipating your question. [00:43:18] Speaker 05: In that case, the ANDA applicant had brought up at trial. [00:43:25] Speaker 05: And the judge, in fact, discussed at trial the possibility of a carve-out. [00:43:28] Speaker 05: And they were able, therefore, during the trial to litigate the question of whether, well, it wasn't a carve-out, but removing the formulation, changing the formulation, whether that would then leave an infringing patent or infringing ANDA or whether it be a non-infringing ANDA. [00:43:43] Speaker 05: The point is there was trial time and the patent holder had its rights vindicated because it was timely raised. [00:43:49] Speaker 02: I hear that you're making an argument about resources and the limitations of the patent court. [00:43:56] Speaker 02: You can't litigate everything, and you don't litigate everything. [00:43:58] Speaker 02: You litigate your top priorities, and those priorities may shift. [00:44:02] Speaker 02: But it does seem different. [00:44:03] Speaker 02: And this is Norwich's argument that in fairing, if it's a formulation that's an issue, that it doesn't have the sort of what I think of as this modular quality of the different [00:44:16] Speaker 02: happens with the different indications, you're not coming up with something that [00:44:23] Speaker 02: You're not changing the formulation. [00:44:25] Speaker 05: I understand there's a technical difference between carving out a use and changing the formulation. [00:44:29] Speaker 05: But the upshot is the patent holder, in either case, has advanced notice of what the target is, and then could put on the best case that it has available at the time. [00:44:39] Speaker 05: And so, as I said, I do want to clarify, Dr. Pollard, because this is not a simple matter of just whether the carve-out cures the infringement, because there were all those non-litigated IBSD and polymorph patents in the stipulation [00:44:53] Speaker 05: As we pointed out, the footnote in the stipulation very clearly says that my client will agree to a non-infringement finding, but only if the conditions of use are not amended. [00:45:04] Speaker 05: That's actually a paraphrase. [00:45:06] Speaker 05: But the point is, it was a game time decision. [00:45:09] Speaker 02: Were the conditions of use amended? [00:45:12] Speaker 05: The indications of use. [00:45:13] Speaker 05: I'm sorry, indications. [00:45:14] Speaker 02: Well, were the indications of use amended with respect to the patents that they're now [00:45:20] Speaker 02: on which they're now seeking to go, the patented uses, indications as to which they're seeking to go to market, those haven't changed. [00:45:31] Speaker 05: I don't fully follow your honor's question, but I'll try my best to answer it, which is to say that by carving out the HE, right, there is now just the IBSD indication. [00:45:41] Speaker 05: And the trial in the 370 case in New Jersey is only focused on the IBSD indication. [00:45:46] Speaker 02: But the indications with respect to IBSD haven't changed. [00:45:50] Speaker 02: Well, that is the, IBSD is the indication, so that's what I'm... But you said, say it again, I know this is all terms of art, that the stipulation was limited to circumstances in which what didn't change? [00:46:05] Speaker 05: The indications. [00:46:07] Speaker 02: Okay, so the indications for the subject [00:46:11] Speaker 02: patterns didn't change. [00:46:13] Speaker 02: The indications for the surviving ones that are in the amended ANDA, those are the same as the indications that were litigated as to those patents that were litigated in the District of Delaware. [00:46:29] Speaker 05: So it's not saying... No, because the patents in the stipulation weren't litigated. [00:46:34] Speaker 05: I think that's... [00:46:35] Speaker 05: And I'm sorry if I'm not right. [00:46:38] Speaker 05: This is the 19 patents that we didn't have any time to litigate. [00:46:41] Speaker 05: And we said, fine, we'll give you a non-infringement finding. [00:46:44] Speaker 05: But this is a recognition of the fact that we didn't get to litigate it because you put on a litigate them. [00:46:48] Speaker 02: But the ones that they're wanting to market on, you did get to litigate. [00:46:52] Speaker 05: We got to litigate a handful. [00:46:54] Speaker 05: That's correct. [00:46:54] Speaker 05: Not all. [00:46:55] Speaker 05: Let me be clear. [00:46:56] Speaker 05: In the stipulation, Your Honor, it covers HE patents, IBSD patents, and polymorph patents. [00:47:01] Speaker 05: So each of the types of patents, there were some that were litigated and some that were not litigated. [00:47:07] Speaker 02: And so it wasn't- So your claim is that to the extent that Norwich is saying, [00:47:17] Speaker 02: We don't want to infringe any of those stipulated patents. [00:47:20] Speaker 02: We're just going to use, we just want to go to market for the indicated uses on IVSD and polymorph that we want. [00:47:31] Speaker 02: If that were their position, what is the argument that the deprioritized stipulated indications are somehow an obstacle [00:47:45] Speaker 05: Well so this was presented to Judge Andrews in the reconsideration motion and he's the one who said in that quote that I won't reread to the court that it is not a simple matter to make the determination because as we presented to him we didn't get to litigate a bunch of our IBSD and polymorph patents during the trial and the stipulation that we entered into and that he so ordered recognizes that it was a conditional stipulation. [00:48:10] Speaker ?: Right. [00:48:10] Speaker 04: Um, so I imagine Mr. Prince would also say smarter things. [00:48:13] Speaker 04: But one thing that occurs to me is that he might say, you know, you're saying we had to not litigate certain IBSD patents. [00:48:24] Speaker 04: Number one, that means you made a judgment during trial. [00:48:27] Speaker 04: Those were your not your strongest patents. [00:48:29] Speaker 04: You litigate the strongest ones and you lost. [00:48:32] Speaker 04: And also if you think they're strong, sue us on the amended anda. [00:48:36] Speaker 04: initiate the litigation. [00:48:39] Speaker 05: And the reason we haven't brought that lawsuit is because, as Judge Andrews has held, the amended ANDA is not approvable until October 2029. [00:48:47] Speaker 05: And that was the longest libed patent that we litigated. [00:48:52] Speaker 05: And so, Your Honor, there's really no fight over that we could really bring right now for where the amended ANDA infringed those, because as the judgment pertains to the amended ANDA, it's not approvable during the lifetime of any of the patents. [00:49:06] Speaker 02: But that is a bit circular, because we're questioning, I think, why that is. [00:49:12] Speaker 02: Why they have that later date? [00:49:16] Speaker 05: Right. [00:49:16] Speaker 05: So they have that later date because when they lost that trial on the HE patents, that was the October 29, October 2029, was the expiration of the longest lives of the HE patents that they were found to infringe and that were deemed valid. [00:49:31] Speaker 05: And that patent, I understand, had a longer expiration date than any other patent that was at issue on our complaint. [00:49:39] Speaker 05: And so there's no, as long as that judgment blocks, there's no suit for us to bring the challenge to the amended handout, because by the time that's approved in 2029, the other patents that we didn't get to litigate will have expired. [00:49:52] Speaker 05: So I don't believe that it's circular. [00:49:54] Speaker 04: My question is counterfactual where Norwich has the right reading of the judgment and what would happen in the world is you would go ahead. [00:50:03] Speaker 04: But I understand your question. [00:50:05] Speaker 05: Sure. [00:50:05] Speaker 05: And that's the reason why Judge Andrews is the one in charge of making these determinations, because he'll have already seen, have we had our chance to litigate these questions? [00:50:14] Speaker 05: Did it come up at trial? [00:50:16] Speaker 04: And if he says... And Judge Andrews is supposed to essentially, in your view of how this scheme would work, is to weigh the unfairness and the notice and all the various interests... Exactly. [00:50:27] Speaker 04: Has the Federal Circuit held... To carve out the amended judgment, other amended andas? [00:50:30] Speaker 05: That's exactly right. [00:50:32] Speaker 05: He's the one who heard the trial. [00:50:33] Speaker 05: He knows whether it's obvious or not. [00:50:37] Speaker 05: that the carve out cures infringement. [00:50:39] Speaker 05: He knows that the parties made strategic decisions. [00:50:41] Speaker 05: He evaluates the equity. [00:50:42] Speaker 05: He evaluates the fairness. [00:50:44] Speaker 05: As your honor has noted, Norwich did appeal the rule 60B5 determination, and the Federal Circuit unanimously affirmed that. [00:50:53] Speaker 05: And so those decisions we think are consistent with the statute. [00:50:56] Speaker 05: They're certainly protective of our patent rights. [00:50:59] Speaker 05: I've gone all over my time. [00:51:02] Speaker 05: I'm happy to address other questions. [00:51:05] Speaker 06: I think this is a friendly question to the extent it makes any sense. [00:51:09] Speaker 06: I don't know if you've ever been to a basketball game at halftime and they have a competition for a fan, you get to shoot a free throw, a three pointer and a half court and you can make all three. [00:51:22] Speaker 06: I'm imagining that you have, I'm just going to simplify, but three HE patents and three IBS patents. [00:51:32] Speaker 06: And your odds of prevailing on each of those patents differ from each other. [00:51:38] Speaker 06: One might be the odds of making a free throw. [00:51:40] Speaker 06: One might be the odds of making a three pointer and one might be the odds of making a half court shot. [00:51:44] Speaker 06: And the judge here said, all those six patents, like you get, you get two, you get to take two shots. [00:51:53] Speaker 06: And so you took your, your free throw for the HE and your free throw for the IBS. [00:51:57] Speaker 06: You hit your free throw for the HE and you missed your free throw for the IBS. [00:52:01] Speaker 06: But if they had carved out the HE to begin with, you could have taken the free throw for the IBS and the three-pointer for the IBS. [00:52:10] Speaker 06: You may well have made the three-pointer for the IBS. [00:52:12] Speaker 05: With the additional nuance of Walker, that it's not just simply taking a shot. [00:52:16] Speaker 05: It's the amount of time it takes [00:52:17] Speaker 05: to win. [00:52:18] Speaker 05: So hypothetically our best HE patent may need 10 trial hours and if you only have 20 trial hours you have to make these trade-offs. [00:52:26] Speaker 05: It may be that the two best patents are each 10 hours each and that it's just a better judgment to litigate nine patents that each only need an hour and a half because of the way the court has set the the top. [00:52:37] Speaker 05: Those are strategic decisions that we're not here to second-guess and relitigate but that Judge Andrews was the one who superintended. [00:52:44] Speaker 05: And that's why we believe that his decision was correct. [00:52:47] Speaker 05: That's not the question. [00:52:48] Speaker 05: Why FDA's decision to make the effective date in accordance with this decision is correct. [00:52:54] Speaker 05: We'd be happy to address the statutory arguments that we raised as well, the regulations. [00:52:57] Speaker 05: But if the court would like me to sit down, I'll do that too. [00:53:02] Speaker 05: All right. [00:53:03] Speaker 05: OK. [00:53:03] Speaker 05: Thank you, Your Honor. [00:53:03] Speaker 01: Thank you. [00:53:05] Speaker 01: Friends, we hear you rebuttal on this appeal. [00:53:12] Speaker 03: Thank you, Your Honor. [00:53:14] Speaker 03: Maybe I'll start with FDA first and then move on to the intervener. [00:53:19] Speaker 03: FDA was sort of acting like this depends on what we were fighting about prior to the judgment and what happened in the Rule 60 proceedings. [00:53:28] Speaker 03: But I don't think that's the actual logic of its rationale. [00:53:31] Speaker 03: I don't think it's saying there's something specific about this case. [00:53:36] Speaker 03: The tentative approval decision just notes it's set [00:53:39] Speaker 03: um it's at the it's at the date so it's not clear to me FDA is doing a one-off specific interpretation because of this judgment or it's just interpreting these kind of judgments incorrectly um all the time but if it's interpret if it's interpreting this way them this way all the time that's certainly not how the statute is meant um is meant to work. [00:54:01] Speaker 03: Salix um [00:54:03] Speaker 03: keep saying that they made strategic choices and all that, but these patents are not completely distinct patent, right? [00:54:10] Speaker 03: They're all fairly similar patents. [00:54:13] Speaker 03: They chose their best patents to litigate. [00:54:16] Speaker 03: And the stipulation they're talking about was after the case was tried, right? [00:54:20] Speaker 03: So they picked their best patents and they litigated it. [00:54:24] Speaker 03: Yes, Judge Andrews did put some restrictions on the trial time. [00:54:28] Speaker 03: And most judges do that and that's just part of trial. [00:54:33] Speaker 03: It doesn't mean we should distort how the entire statutory scheme operates because of that. [00:54:39] Speaker 03: If they could have asked Judge Anders for more time if they really thought that was going to be the issue. [00:54:47] Speaker 03: But more fundamentally, the patent act gives us the solution to all of these problems. [00:54:52] Speaker 03: If it believes that we violated the stipulation in that case by amending the ANDA, [00:55:03] Speaker 03: it can sue us for patent infringement. [00:55:06] Speaker 03: But it's not going to do that because it knows there's no infringement. [00:55:10] Speaker 03: And again, I just want to say this again. [00:55:11] Speaker 03: We know that from the 370 case because they did not assert these patents against us when they sued us about the 370 case. [00:55:20] Speaker 03: So this idea that there's some hidden infringement from their HE patents that reads over to IBSD is a complete fiction, right? [00:55:29] Speaker 03: Or they would have asserted those arguments in their 370 case. [00:55:33] Speaker 03: And I think my friend was also conflating what they're doing in the 370 case. [00:55:37] Speaker 03: They're suing us on IBSD patents in the 370 case, but that has nothing to do with the patents that were at issue in 369. [00:55:45] Speaker 03: Those were later listed patents. [00:55:46] Speaker 03: They didn't exist at the time. [00:55:48] Speaker 03: So if it had claims on the patents that were litigated in 369 and it was unfairly deprived of the ability to litigate as it says, it would be asserting those in 370 now and it's not. [00:56:03] Speaker 01: I'm good. [00:56:05] Speaker 03: Thank you. [00:56:07] Speaker 01: All right. [00:56:07] Speaker 01: The case is submitted.