[00:00:38] Speaker 05: All set, Mr. Feldman? [00:00:43] Speaker 04: May it please your court, Your Honors. [00:00:44] Speaker 04: Stephen Feldman on behalf of Apotex. [00:00:48] Speaker 04: Your Honors, the district court legally erred in ruling the 18th statutory disclaimer of the 703 patent depriving of jurisdiction in this case. [00:00:59] Speaker 05: Can I ask you, is there any new information about the FDA process on your ANDA and whether there is now or [00:01:09] Speaker 05: soon will be a tentative approval? [00:01:11] Speaker 04: So, Your Honor, I checked on Friday and our ANDA is not yet tentatively approved, but our understanding is it's under consideration and we're expecting it to be tentatively approved in due course. [00:01:23] Speaker 05: What might due course mean? [00:01:25] Speaker 05: Anything more than what you said in your brief about an average pendency of 36 months? [00:01:32] Speaker 04: So we believe we'll fall within that, but it's really hard to predict exactly what the FDA is going to. [00:01:37] Speaker 05: And we're around the 36 month mark now. [00:01:40] Speaker 04: Next month, I think, would be the 36 month. [00:01:42] Speaker 05: Can I also ask you this question to see if I'm understanding the statute correctly? [00:01:50] Speaker 05: If there had been no 703 patent at all, ever, am I understanding the statute and the FDA regulations [00:02:02] Speaker 05: to mean that the adverse judgment on the 599 turned the paragraph four certification into a paragraph three certification. [00:02:13] Speaker 05: And then there's a follow-up question, which is, does that mean that Mylan no longer lawfully maintains a paragraph four certification for the 599? [00:02:28] Speaker 05: You're correct on both counts, Your Honor. [00:02:32] Speaker 05: So, I'm sorry, so without the 703, you would, they would have no exclusivity? [00:02:37] Speaker 05: No exclusivity, and we... Is that a contested answer that you just gave? [00:02:43] Speaker 04: I don't believe it is. [00:02:46] Speaker 04: Okay. [00:02:46] Speaker 04: Your Honor, the fundamental error that the district court made is in assuming that as soon as the 703 patent is disclaimed, that the Attorney General had any interest in it and that that patent was dead. [00:02:56] Speaker 04: In fact, that patent is not dead in the eyes of the Hatch-Waxman and FDA. [00:03:01] Speaker 04: because it continues to be listed in the FDA Orange Book. [00:03:04] Speaker 04: The consequence of it being listed in the FDA Orange Book is this. [00:03:08] Speaker 04: When Apotex filed its ANDA with a paragraph four certification to the 703 patent, that constituted a technical act of infringement under 35 USC 271E2. [00:03:19] Speaker 04: Just because that patent continued to be listed, as a result of that, we're in the position of being an infringer. [00:03:26] Speaker 04: And of course, Daiichi is the patentee. [00:03:28] Speaker 04: So there is adversity there. [00:03:31] Speaker 03: So what's the nature of the injury that Apotex is trying to redress here? [00:03:37] Speaker 04: So Apotex is trying to redress an economic injury. [00:03:41] Speaker 04: In other words, if we're able to get our judgment on the 703 patent that's not infringed, we'll be eligible to go to market on day one of generic exercise. [00:03:50] Speaker 03: There's no beef with the 599 patent. [00:03:53] Speaker 04: Right now, there's no beef with the 599 patent. [00:03:55] Speaker 03: Because your interest here is to be able to trigger the statutory procedure that's going to undermine the 180 days. [00:04:06] Speaker 04: We want to utilize the statute to cause forfeiture of the 180 days. [00:04:11] Speaker 03: It depends on. [00:04:12] Speaker 03: You can phrase it. [00:04:12] Speaker 03: Right. [00:04:13] Speaker 04: Trigger of forfeiture. [00:04:14] Speaker 04: I understand. [00:04:14] Speaker 04: We can do semantics. [00:04:16] Speaker 04: But the real point is this. [00:04:18] Speaker 03: Because if you're successful at this stage in the game, you're likely to get your district court judgment, the final judgment, [00:04:24] Speaker 03: more than 75 days before the expiration of the 599, right? [00:04:30] Speaker 04: Correct, yeah. [00:04:32] Speaker 03: So there's really nothing that mainland can do to save itself. [00:04:36] Speaker 03: That's correct. [00:04:38] Speaker 03: And that's what... Your argument is that condition is created by the statute, not by your behavior. [00:04:43] Speaker 04: Exactly. [00:04:44] Speaker 04: That's the intended result here. [00:04:46] Speaker 05: The forfeiture would not be triggered, I assume you agree, [00:04:52] Speaker 05: If you never have tentative approval. [00:04:55] Speaker 05: If we never get tentative approval. [00:04:56] Speaker 05: It's just that your position is you don't need it at the beginning of the declaratory adjustment process. [00:05:01] Speaker 05: And is that correct? [00:05:03] Speaker 05: That's correct. [00:05:04] Speaker 05: And is it part of our inquiry or should it be a question that the district court did not look at, which is [00:05:14] Speaker 05: As a factual matter, how likely or unlikely is it that you will get your tentative approval? [00:05:23] Speaker 05: Because my understanding is that in some Article 3 case of controversy context, there is, I think, even Supreme Court authority for making a factual inquiry into the degree of contingency to use a shorthand. [00:05:40] Speaker 04: Yeah, I think in cases, these Hatch-Waxman type cases, where the [00:05:44] Speaker 04: applicant has actually filed the ANDA, the train is on the tracks, they're seeking regulatory approval, and they're expected to get it in due course, and FDA is supposed to give it to them in due course unless there's some significant problem with the application. [00:05:56] Speaker 05: But there certainly are some cases in perhaps different contexts, maybe suits against the FDA, a TEVA suit maybe into the District of Columbia a few years ago that found the absence of tentative approval to [00:06:14] Speaker 05: count against standing. [00:06:18] Speaker 05: It's not quite the same here, but sometimes that has been a basis for finding no standing. [00:06:26] Speaker 05: That's correct, Your Honor. [00:06:29] Speaker 05: Have any of our cases, either in the Hatch-Waxman and the context, regardless of which side initiates the action, spoken about [00:06:41] Speaker 05: the role of tentative approval or its actions? [00:06:45] Speaker 04: I don't believe so, Your Honor. [00:06:46] Speaker 04: And in fact, as we said in the brief, we demonstrated in the brief that in several of the cases, at the time that the applicant filed this action, the DJ action, they didn't have tentative approval. [00:06:56] Speaker 03: Well, there's no assurance that your client will get tentative approval, and there's no assurance that your client would come to market if they had tentative approval. [00:07:09] Speaker 03: Things can change. [00:07:10] Speaker 03: Your client could be acquired by someone and have a different view. [00:07:14] Speaker 03: So what I'm getting at is whether or not the absence of tentative approval here somehow informs the rightness inquiry. [00:07:24] Speaker 03: The ripeness is part of, I believe, under Med Immune or assessment of whether or not there's already country jurisdiction at this moment in time. [00:07:36] Speaker 04: Sorry, let me answer it this way. [00:07:37] Speaker 04: One thing that, first of all, under the declaratory judgment part of the statute, which is 355J5C, okay, it says nothing about tentative approval. [00:07:47] Speaker 04: So having tentative approval is not a prerequisite to filing the DJ action. [00:07:52] Speaker 03: But can you address my concern? [00:07:56] Speaker 03: I mean, I'm just wondering whether or not there are right and wrong considerations here, given the fact that you don't have the tentative approval. [00:08:07] Speaker 03: Because the effect of what's going to happen once you have tentative approval is pretty severe. [00:08:13] Speaker 03: It's going to wipe out 180 exclusivity that was fairly earned by Monland in the order of events, right? [00:08:23] Speaker 03: Correct. [00:08:23] Speaker 03: And the Congress intended, they didn't intend to get rid of the 180 exclusivity period with the 2003 amendments. [00:08:31] Speaker 03: That's true. [00:08:31] Speaker 03: They intended to leave a situation where the holder of the 180 days would have an option to be able to save the 180 days by coming to market within 75 days. [00:08:42] Speaker 03: But in the mixture and the facts of this case, my own is helpless, totally helpless. [00:08:48] Speaker 03: It's 180, so we will be eradicated if the case comes forward. [00:08:52] Speaker 03: And at the same time, we have some possible residual doubt as to whether your client will get pending approval. [00:09:01] Speaker 03: Why doesn't that inform, if not elevate, brightness considerations here? [00:09:08] Speaker 04: Well, to address your concern about myelin, if we don't get tentative approval, they're not going to forfeit their 180 days. [00:09:14] Speaker 04: The way the statute is directed is that only... There's no way for them to save themselves. [00:09:19] Speaker 03: Getting to market within 75 days is a way of Congress saying, oh, well, if somebody does go out and get a judgment that pulls the pins out from underneath you, if you hurry up and go to market, you get to keep your 180 days. [00:09:31] Speaker 03: So to me, that's a way of Congress saying we are still giving lots of weight [00:09:36] Speaker 03: in the order of things to the gift, if you will, the earning of the 180 days. [00:09:42] Speaker 04: Right. [00:09:42] Speaker 04: So the 180 days is not a gift. [00:09:44] Speaker 04: It's not an earning. [00:09:45] Speaker 04: They're eligible for it, but they don't have it until they can go to market. [00:09:48] Speaker 04: And the point of the statute is to reward someone who can get to market early. [00:09:52] Speaker 04: And the reason myelin can't get to market early here and the reason it feels bad for them is that they've lost on the 599 patent. [00:09:58] Speaker 04: So had they won on the 599 patent, they'd already be on the market. [00:10:01] Speaker 03: We'd have no issues. [00:10:02] Speaker 03: We're talking about that moment in time when the 599 is gone. [00:10:05] Speaker 03: No one is harmed by the 599 in the terms of this lawsuit. [00:10:09] Speaker 04: Correct, John. [00:10:09] Speaker 04: But the other thing that they could have done is that they could have brought a declaratory judgment action on the 703 patent and gotten a judgment on it. [00:10:16] Speaker 05: How could they have done that? [00:10:17] Speaker 05: I mean, it was disclaimed by Daiichi. [00:10:23] Speaker 05: How would there have been a case of controversy? [00:10:26] Speaker 05: Daiichi, having disclaimed it, [00:10:30] Speaker 05: Because they could not assert it, so they were under no threat of enforcement. [00:10:35] Speaker 05: And the only effect of their bringing the declaratory judgment action on the 703 would be to harm their half of the duopoly profits for 180 days. [00:10:49] Speaker 05: So how could they have a case or controversy against Baiichi to bring the 703 action? [00:10:59] Speaker 04: I think you have to go back to the purpose of the MMA amendment and Congress's recognition that there are certain patents out there that are not strong. [00:11:06] Speaker 04: And in particular, a disclaim patent is among the weakest types of patents. [00:11:11] Speaker 04: And what Congress wanted to have happen is to allow parties to bring declaratory judgments to get the declaration that these patents are invalid or not. [00:11:18] Speaker 05: I understand the point that if there were no 703, Congress did not, this is my first question, did not want them to have an exclusivity period. [00:11:27] Speaker 05: They get it only if they have some measure of success, not if they simply lose on the only patent at issue. [00:11:36] Speaker 05: That's why I thought that that was important. [00:11:39] Speaker 05: I don't understand how they could have brought a 703 DJ action against Daiichi after the disclaimer because it could only have harmed them. [00:11:52] Speaker 04: Well, it would have eliminated the 703 patents ability to exclude. [00:11:57] Speaker 05: Can I just ask one other question? [00:11:58] Speaker 05: And I know you're into your remodel. [00:12:03] Speaker 05: If this went to the merits in the district court on your DJ action, is that over in a second because a disclaimed patent can't be infringed? [00:12:13] Speaker 04: Correct, Your Honor. [00:12:17] Speaker 05: You said you wanted to save 10 minutes? [00:12:19] Speaker 04: Yeah, all reserve minutes. [00:12:20] Speaker 04: OK, thank you. [00:12:21] Speaker 04: Thank you, Your Honor. [00:12:30] Speaker 05: Mr. Conde? [00:12:31] Speaker 00: Yes, Your Honor. [00:12:34] Speaker 05: You're from Daiichi. [00:12:35] Speaker 00: I am, Your Honor. [00:12:36] Speaker 00: I'm from Daiichi. [00:12:37] Speaker 00: We'll be splitting up our time 10 minutes each. [00:12:39] Speaker 00: I'll be covering basically the Janssen issues and the disclaimer, the effect of those on jurisdiction. [00:12:44] Speaker 00: And my colleague from Milan, with regard to jurisdictional issues, will deal with a tentative approval aspect of it. [00:12:51] Speaker 00: So this case is squarely within Janssen. [00:12:54] Speaker 00: In Janssen, we had two factors. [00:12:57] Speaker 00: the generic acquiesce to the first of the earlier two expired listed patents, and two, the first filers exclusivity was keeping Apotex off the market in Janssen. [00:13:09] Speaker 00: And what this court said is that the only thing that Apotex was trying to do was to trigger the 180 days, and that does not lead to a judiciable controversy. [00:13:19] Speaker 05: Right, and that little part of Janssen was about the statute before it was changed in 2003, [00:13:27] Speaker 05: to basically make forfeiture something, just to set out all these forfeiture provisions. [00:13:33] Speaker 00: So this court has said in Day and in Teba Viesai that the statute had no impact on the jurisdictional issues, and that even in the Day case where... Was that exactly the language they used, or did they say that those old cases remain our guideposts for working through these problems? [00:13:54] Speaker 00: Well, they said it in various different ways. [00:13:57] Speaker 03: You didn't recall being said exactly in the way you thought? [00:13:59] Speaker 00: Well, they said it three different ways. [00:14:00] Speaker 00: They said in Karako, it's inconsequential, I think, is the language. [00:14:05] Speaker 00: In Teva, I think, I mean, in Dei, I think what the language was was that we look back to Jansen and Karako as the most pertinent ones. [00:14:15] Speaker 00: And I think also in Dei, they used a word basically like insubstantial, it makes no difference. [00:14:20] Speaker 00: So the precedent from this court has been that the MMA doesn't affect jurisdiction. [00:14:25] Speaker 00: The forfeiture provision itself has nothing to do with jurisdiction. [00:14:29] Speaker 05: The forfeiture provision simply changed the way that the hundred... It doesn't have anything to do with jurisdiction in some statutory sense of jurisdiction, but if the question is pure Article III case or controversy, our job is in part to figure out is [00:14:49] Speaker 05: Do they stand to gain something? [00:14:50] Speaker 05: Now, if they can get into the market six months earlier than otherwise, a lot of money is going to be transferred from the two of you to them. [00:14:59] Speaker 05: That sounds like a really concrete stake unless there's an undue contingency or unless there is a statutory bar to their getting into the market. [00:15:10] Speaker 05: So the effect of the statute. [00:15:14] Speaker 05: is relevant to the contingency question on the constitutional inquiry and that statute has changed. [00:15:20] Speaker 00: But Your Honor, the change in the statute doesn't make a difference because before the statute there would be effect on the first file as well. [00:15:27] Speaker 00: You could eliminate the 180 days before the statute. [00:15:30] Speaker 00: In fact, it was easier before the MMA to trigger the 180 days. [00:15:34] Speaker 00: All you needed was a district court decision. [00:15:37] Speaker 00: Post-MMA, you need a non-appealable final decision from this court basically. [00:15:42] Speaker 00: So what the Congress actually did is made the trigger more difficult. [00:15:47] Speaker 05: Do you agree, by the way, that in this case, the merits litigation is over in a second because a disclaimed patent can't be infringed? [00:15:56] Speaker 00: Yes. [00:15:57] Speaker 00: A disclaimed patent can't be infringed, and a disclaimed patent can't provide jurisdiction either. [00:16:02] Speaker 00: With regard to the forfeiture provisions, however, I think it's important to know that the Janssen decision addressed the very thing that you were talking about, Your Honor, which is that [00:16:11] Speaker 00: In Janton, if you recall, what the court said is that the reason there was no jurisdiction was that the generic caused their own problems. [00:16:22] Speaker 00: They stipulated to the first time to expire, and the only thing that was left was that they were challenging the 180 days of the first file of generic. [00:16:35] Speaker 00: And what the Sebelius case said, which was post-MMA, which was post-Jansen said... The D.C. [00:16:41] Speaker 05: Circuit case. [00:16:41] Speaker 00: The D.C. [00:16:42] Speaker 00: Circuit case, right, Your Honor, said that Congress used the 180 days as the device to incentivize the first filer, and that courts aren't allowed to amend or change that clause. [00:16:51] Speaker 05: Right, and do you agree with the first question I asked, Mr. Feldman, that if there never had been a 703 patent, that Mylan would [00:17:03] Speaker 05: not have a exclusivity period having lost its litigation on the 599? [00:17:09] Speaker 00: That's correct. [00:17:10] Speaker 00: However, there is a 703 and when Milan filed the paragraph four notice, they paragraph four both the 599 and the 703. [00:17:17] Speaker 00: At that point, they were the first filed for both patents. [00:17:20] Speaker 00: So in order to trigger the 180 days, you had to have a judgment, not just on the 599, but also on the 703. [00:17:27] Speaker 00: And with regard to the so-called benefit to the plaintiff, the defendants in this case, [00:17:31] Speaker 00: The question isn't what happens to Mylan and Jiachi Senkyo if it's triggered. [00:17:36] Speaker 00: The question is whether Apatax is harmed. [00:17:39] Speaker 00: What is the harm to Apatax? [00:17:41] Speaker 00: And here, the argument is that harm is traceable to the fact that they acquiesced to the first patent, and the harm is traceable to the fact that the FDA did not delist. [00:17:51] Speaker 00: None of the harm is traceable to any action by Jiachi Senkyo. [00:17:55] Speaker 05: Except you're having put it in the Orange Book. [00:18:00] Speaker 00: We put it in the Orange Book, but we, of course, we disclaimed it and we requested the FDA to delist it. [00:18:05] Speaker 05: Isn't there, isn't there, I mean, they are not suggesting or let's stipulate that they're not suggesting that you were somehow acting wrongly in putting it in the Orange Book, but there's a lot of, I don't know, unjust enrichment law that says an action that was perfectly okay at the time is nevertheless litigable, but if it means that benefits are being retained, [00:18:30] Speaker 05: that shouldn't be retained. [00:18:32] Speaker 05: This seems like something like that. [00:18:36] Speaker 00: Well, it's not, because it doesn't take into consideration the position of Mylan, who rightfully challenged the 703 patent, who rightfully obtained first file of status as it. [00:18:46] Speaker 00: They challenged both. [00:18:48] Speaker 00: Mylan challenged both the 599 and the 703. [00:18:51] Speaker 00: So the fact that we disclaimed the 703 [00:18:53] Speaker 05: When Myland filed... When you say challenge, you mean that they put a Paragraph 4 certification. [00:18:58] Speaker 05: They didn't litigate it. [00:18:59] Speaker 00: No, they did not litigate it. [00:19:00] Speaker 00: But they made a Paragraph 4, which is all that's required to get to 180 days, is to make a Paragraph 4 certification on both patents. [00:19:08] Speaker 00: When that occurred, when they were the first one to occur, then it's Myland's right that that is the issue with regard to what you're talking about in terms of listing and delisting. [00:19:17] Speaker 00: That's the difference between this case and the other cases that you were referring to before. [00:19:22] Speaker 00: There's a component here that Congress has said that the 180 days is the incentive and that the courts are not allowed to disrupt that incentive. [00:19:35] Speaker 00: I wanted to briefly discuss the disclaimer issue. [00:19:39] Speaker 00: I think that there's been no court that said that you can bring suit on it, disclaim cotton. [00:19:45] Speaker 00: You can't. [00:19:46] Speaker 00: I don't think that, I haven't heard Apotec say otherwise. [00:19:49] Speaker 00: And once the patent is disclaimed and Daiichi Senku could never assert that patent, and the flip is correct as well, corollary, that it cannot be the basis of a declaratory judgment action, because it simply does not exist. [00:20:02] Speaker 05: In the context where, I mean, has anybody ever presented a case where as a result of a statutory scheme [00:20:16] Speaker 05: that makes the existence of a judgment different, a distinctive event that allows entry into a market if that event occurs with presumably lots and lots of money at stake. [00:20:32] Speaker 05: It seems to me that the cases that you're talking about in the pure patent context just don't address the question. [00:20:37] Speaker 05: They don't count against it. [00:20:39] Speaker 05: There just was nothing else at stake. [00:20:41] Speaker 05: Here there's a lot of money at stake. [00:20:43] Speaker 05: If they can get into the market earlier, [00:20:45] Speaker 05: That's a lot of money. [00:20:46] Speaker 00: And if not, then not. [00:20:48] Speaker 00: Your honor, but that's an issue that Congress needs to address if it needs to be addressed at all. [00:20:51] Speaker 00: The MMA was revised because there were complaints about what was going on vis-a-vis parking. [00:20:57] Speaker 00: The MMA got amended, amended the Hatch-Waxman Act. [00:21:02] Speaker 00: If this is an issue, if the fact that the FDA refused to delist, and if the FDA does not delist it. [00:21:07] Speaker 05: If they already had tentative approval, would you have an argument that the suit cannot proceed? [00:21:14] Speaker 00: Yes, Your Honor, it would still be the same argument if they had tentative approval because what Jansen says is that you need to challenge both the 599 and the later expiring patents. [00:21:25] Speaker 00: It's not enough just to challenge the second patent because then all you're doing is challenging the 180 days. [00:21:31] Speaker 00: You're trying to trigger that and that's not enough. [00:21:34] Speaker 00: If the consequences here are going to be changed, I respectfully submit that these should be changed either by the FDA, through the DC Circuit Court, or changed by Congress. [00:21:44] Speaker 00: It's not for this court to change the result that occurred here that's based on the statute itself. [00:21:51] Speaker 00: There's nothing in the statute that says that if you have a situation where we have here that a defendant, a second generic, should be able to file a DJ. [00:22:02] Speaker 00: There's nothing in the statute that would arise to that level in giving jurisdiction. [00:22:08] Speaker 00: Unless you have any other comments, I rest. [00:22:12] Speaker 00: Thank you. [00:22:27] Speaker 05: Mr. Chomsky. [00:22:28] Speaker 02: Good morning, and may it please the court. [00:22:31] Speaker 02: The preceding discussion makes clear that this case is all about my client Mylan's right to 180-day marketing exclusivity. [00:22:40] Speaker 02: Its six-month reward for opening the market to competition six years before the 703 patent would have allowed generics to enter, but for the initiative, the expense, and the effort [00:22:54] Speaker 02: that my client undertook to file pathbreaking paragraph four certification to that patent. [00:23:01] Speaker 02: I respectfully submit that that gives Mylan a legally cognizable interest in the outcome of this case and that the district court erred in refusing to allow Mylan to participate as a full party. [00:23:13] Speaker 05: As you know from our... Can you talk about the merits? [00:23:17] Speaker 05: I don't actually see at this point significant dispute about your right to intervene. [00:23:22] Speaker 05: You clearly have a lot of money at stake. [00:23:24] Speaker 02: Absolutely. [00:23:25] Speaker 02: And I appreciate that, Your Honor. [00:23:26] Speaker 05: By the merits, you know what I mean. [00:23:28] Speaker 02: I know exactly what you mean. [00:23:29] Speaker 02: The merits are actually jurisdiction in this case. [00:23:32] Speaker 02: And I want to focus not so much on the line between Jansen and Carrico, although this case is on all fours with Jansen. [00:23:40] Speaker 02: There is a very important distinction between this case and the other cases that this court has considered when it comes to the standing of the plaintiff in this case, the declaratory judgment plaintiff Apatow. [00:23:52] Speaker 02: And that's that they lack tentative approval. [00:23:55] Speaker 02: And we think that makes this case different than all of the other prior cases. [00:24:00] Speaker 02: And it has two very important jurisdictional. [00:24:02] Speaker 05: Can I ask you a technical and maybe picayune thing? [00:24:06] Speaker 05: Am I right that there was a kind of oops moment in your brief when you quoted the statute with ellipses and put tentative approval before language? [00:24:19] Speaker 05: That you rearranged pieces of the statute in your quote [00:24:22] Speaker 05: without calling attention to that fact? [00:24:26] Speaker 02: Your Honor, I don't remember rearranging the words, but what I think you're pointing out is that there are two different sections in the forfeiture triggers. [00:24:34] Speaker 02: One that refers to a judgment, a declaratory judgment action that is brought by another applicant. [00:24:42] Speaker 02: And then the provision that actually lays out the various things that can trigger the forfeiture in an action that is brought by [00:24:49] Speaker 02: another applicant, and those things include a court decision of invalidity or non-infringement by, quote unquote, any other applicant, which other applicant has obtained tentative approval. [00:25:04] Speaker 02: And so there is both the brought by clause, which I think you're correct, proceeds, it's in the precatory section to the enumerated sub-provisions, and then there is the has obtained, [00:25:15] Speaker 02: that follows that, and I think the statutory citation you might be looking for, it's subsection J5, capital D, little i, Roman one, and that's the precatory language that has the brought by, and then it's in little bb, and I think capital AA, that has obtained tentative approval. [00:25:37] Speaker 02: So we read those two sections together, that the action must be brought by, [00:25:42] Speaker 02: any other applicant which other applicant has obtained tentative approval? [00:25:47] Speaker 05: Suppose I were to read the statute not to require the statute not to require tentative approval at the outset of the declaratory judgment action. [00:26:02] Speaker 05: And indeed, even if this one were dismissed and they got tentative approval, I don't know, in May of 2016, [00:26:11] Speaker 05: They bring their DJ action. [00:26:12] Speaker 05: And I think the litigation over the non-intringement is over the next day, basically, because there's nothing to litigate. [00:26:21] Speaker 05: And an appeal would either be frivolous or maybe summarily affirmed. [00:26:27] Speaker 05: Do you agree with Daichi's answer that regardless of all of that, they cannot bring this suit because you simply have a right [00:26:38] Speaker 05: to this exclusivity period, and even if they have tentative approval, they cannot bring the challenge, the almost self-evidently meritorious challenge as to the 703. [00:26:54] Speaker 02: Yes, Your Honor, I agree with that. [00:26:55] Speaker 02: And I'd like to add two things to that. [00:26:58] Speaker 02: One, in those circumstances, we'd be on all fours with Janssen. [00:27:02] Speaker 02: Janssen's rationale would control, because Apotex chose not to challenge both of the listed patents [00:27:08] Speaker 02: there's no jurisdiction over the case, even if they had tentative approval. [00:27:12] Speaker 02: With respect to the tentative approval point, there are really two things that I'd like to emphasize here. [00:27:18] Speaker 02: The first is that there's a time of filing rule for federal jurisdiction, so that if you subsequently meet whatever condition is required to secure federal jurisdiction, your case can't be revived. [00:27:33] Speaker 02: The jurisdiction needs to exist from the outset. [00:27:35] Speaker 05: So why would it make any difference if this suit went away and the minute they got 10 approval, they bring a new suit? [00:27:42] Speaker 02: Perhaps they could refile. [00:27:44] Speaker 02: But remember, we have 75 days to launch after the final judgment. [00:27:49] Speaker 05: That's why I picked May 2016. [00:27:51] Speaker 05: Sure. [00:27:52] Speaker 02: So if it's May 2016, perhaps at that point they could refile. [00:27:57] Speaker 02: More on that in a moment. [00:27:58] Speaker 02: And then you might be in that hypothetical. [00:28:00] Speaker 02: But I want to highlight that the jurisdictional defect that exists today, the jurisdictional defect that existed the day the suit was filed, would not be cured by them subsequently obtaining tentative approval. [00:28:12] Speaker 02: That needs to be fixed independently. [00:28:15] Speaker 02: The second thing that I want to say is a little bit different. [00:28:18] Speaker 02: You were positing, I think, a situation in which you, and I know it's just a question, not what you were saying, but if the statute were... Posit is not a bad word, sure. [00:28:28] Speaker 02: You are positing an interpretation of the statute, which I think proceeds from the premise that the statute is ambiguous. [00:28:35] Speaker 02: The statute could require tentative approval to exist at the outset, the initial filing, or it could simply be read as requiring tentative approval to be obtained at some point later in time prior to the entry of judgment. [00:28:49] Speaker 02: That ultimately is an issue that the FDA is going to have to resolve. [00:28:53] Speaker 02: And so it introduces another layer of uncertainty into the statutory interpretation here. [00:28:59] Speaker 03: Don't we have to decide that now? [00:29:01] Speaker 02: I don't think that you have to decide that right now, Your Honor. [00:29:04] Speaker 03: I think the fact that it's... Assume we decide that Janssen isn't dispositive. [00:29:09] Speaker 03: Assume we decide that all the prior case laws are a bit like a square peg being jammed in a round hole. [00:29:17] Speaker 03: And there's nothing in those other cases behind us. [00:29:21] Speaker 03: And we're just looking at this press. [00:29:24] Speaker 02: I don't think that you need to decide that right now. [00:29:27] Speaker 02: And I have to say, I'm not sure what the effect of you deciding that right now is. [00:29:31] Speaker 02: Under Chevron, and there's a Supreme Court decision that deals with these issues called Brandex Internet Services, which was decided a few years ago, federal agencies that have authority to interpret their organic statute, which is the FDA interpreting the FDCA, [00:29:47] Speaker 02: are allowed to revisit questions de novo, even if a court gets to the question first and a pint on it. [00:29:54] Speaker 03: In what kind of context is the FDA going to decide whether or not to receive tentative approval means before or after bringing the suit? [00:30:02] Speaker 02: Well, if this case were to proceed, if Apotex were to get the judgment it requests, then there would be a question in front of the FDA about what the consequence of that decision is. [00:30:12] Speaker 02: My clients certainly would take the position that because they didn't have tentative approval of the time that judgment was entered, the statute isn't triggered. [00:30:20] Speaker 02: My clients also would have another argument, which we raise toward the end of our brief. [00:30:25] Speaker 02: which is based on the Teva versus Sebelius precedent, which you all referenced earlier in the argument. [00:30:34] Speaker 03: The FDA clearly is not going to trigger the 2003 and then the forfeiture proceedings until tentative approval is obtained. [00:30:43] Speaker 02: That's correct. [00:30:44] Speaker 02: And the agency also typically doesn't resolve exclusivity issues until a subsequent applicant is actually prepared to launch its product. [00:30:52] Speaker 02: So it would await the tentative approval. [00:30:54] Speaker 03: The point is it doesn't have to go back to the FDA. [00:30:57] Speaker 03: If it gets jurisdiction here and they get the automatic decision, then they just sit there and fold their hands. [00:31:05] Speaker 03: And they say, if my line can't get to the market in 75 days, the passage of time alone takes care of what they need. [00:31:13] Speaker 02: And your honor, I expect. [00:31:16] Speaker 03: So why does the FDA have to be involved again? [00:31:20] Speaker 02: Well, I think my clients would raise the statutory arguments that they've made in this case before the agency, and if they don't approve them, we retain a right to 180-day exclusivity. [00:31:29] Speaker 02: And I was saying a moment ago, we think the Teva versus Sebelius case from the D.C. [00:31:33] Speaker 02: Circuit is very important, because that case said a brand manufacturer [00:31:37] Speaker 02: can't cause the first filer to lose its exclusivity by disclaiming or delisting a patent or ceasing to pay the maintenance fees. [00:31:46] Speaker 02: And so our view is this is really a contrived, a ginned up lawsuit to evade the Teva versus Sebelius case. [00:31:53] Speaker 02: What Apotex is saying is, well, we understand that Daiichi's disclaimer can't get rid of the exclusivity that Mylan currently enjoys, but we're now gonna gin up a court decision that says what everybody on earth knows. [00:32:06] Speaker 02: which is that the Daiichi patent has been disclaimed, it can't be asserted. [00:32:10] Speaker 02: And because it's not just Daiichi having disclaimed it, but a court saying that Daiichi just claimed it, we can get around that case. [00:32:18] Speaker 02: And the consequence of that, of course, is to pervert the statutory reward that Congress delivered to clients who take the initiative like Mylan and open up the market six years early. [00:32:29] Speaker 02: Again, if Mylan hadn't filed its paragraph four to the 703 patent, [00:32:34] Speaker 02: no generic could enter until 2022. [00:32:38] Speaker 02: Because of Mylan's actions, the market opens in 2016. [00:32:42] Speaker 02: APOTEX can enter if they ever get tentative approval. [00:32:46] Speaker 05: So if you had not filed the paragraph for certification, why should we assume that Daiichi would not, in October 2016, have disclaimed [00:33:04] Speaker 05: or just decided not to sue anybody making a generic. [00:33:13] Speaker 05: Perhaps they wouldn't have, Your Honor, and in every case... So how do we know that your filing of that paragraph four certification moved the entry point back? [00:33:26] Speaker 05: eight or nine years or whatever it was, six years or whatever it was. [00:33:29] Speaker 02: Your honor, nobody can know for certain what Daiichi was thinking, but the timing of this, which was a patent that had been listed for years in the Orange Book being disclaimed upon receipt of Mylan's paragraph four certification suggests a causal link. [00:33:45] Speaker 02: But regardless of whether it was a causal link in fact or in theory, it's exactly what Congress wanted to encourage. [00:33:53] Speaker 02: If you're a generic and you stick your neck out at the risk of a patent infringement litigation to challenge a patent and you open the market up early, your reward is six months of exclusivity. [00:34:03] Speaker 02: And here the trade-off is six months of exclusivity for six years of early generic competition. [00:34:10] Speaker 02: And I'd respectfully submit, I see my red light is on, that it would turn the statute upside down to take away Milam's reward for having achieved so much for consumers. [00:34:18] Speaker 05: Thank you. [00:34:19] Speaker 02: Thank you, Your Honors. [00:34:29] Speaker 04: Aaron, let me just address Mr. Chomsky's last point there. [00:34:34] Speaker 04: It's a fundamental misunderstanding of what this 180-day exclusivity is post-MMA amendments, okay? [00:34:40] Speaker 04: It is no longer a statutory entitlement. [00:34:42] Speaker 04: It is no longer just a reward for being the first to get your papers on file. [00:34:46] Speaker 04: We cited some legislative history that makes that abundantly clear. [00:34:50] Speaker 04: What it's a reward for is actually getting your product to market, and they haven't gotten their product to market. [00:34:56] Speaker 04: And the consequence of not getting your product to market [00:34:58] Speaker 04: is that you're subject to these potential forfeitures. [00:35:02] Speaker 04: People who can't, generics that can't get their products to market are subject to forfeiture. [00:35:06] Speaker 05: Because the ultimate purpose here- They can't get their product to market now. [00:35:10] Speaker 04: Right. [00:35:10] Speaker 05: Okay. [00:35:11] Speaker 05: So can you address the argument that Mylan just made that this is in substance, if not technically, [00:35:23] Speaker 05: contrary to what the DC Circuit held in Sebelius. [00:35:27] Speaker 05: This is giving legal effect through a district court judgment that's there for the asking, if only there's jurisdiction, to the equivalent of Daichi's delisting. [00:35:44] Speaker 04: Yes, sir. [00:35:45] Speaker 04: And it's really the same point. [00:35:46] Speaker 04: In other words, the incentive structure for what brands are able to do. [00:35:49] Speaker 05: Sebelius is post-MMA. [00:35:51] Speaker 05: Post-MMA, correct. [00:35:53] Speaker 05: How is this different from what the DC Circuit held was contemplated by the MMA? [00:36:02] Speaker 04: Sure. [00:36:02] Speaker 04: The district court said that a brand company cannot deprive the first generic of its exclusivity. [00:36:09] Speaker 04: But we're not the brand company. [00:36:11] Speaker 04: What we're doing is we're now operating under the statutes that's actually written for us, other applicants, other generic applicants, that creates basically a pathway for us [00:36:23] Speaker 04: to challenge those patents and to get these judgments. [00:36:27] Speaker 04: So the incentive structure there and what Congress is really looking to do is not just to reward one generic over another generic. [00:36:33] Speaker 04: The real point of all this is to get these products in the hands of consumers as soon as possible because of the tremendous drop in price and the benefit that the consumers get. [00:36:42] Speaker 04: Okay? [00:36:42] Speaker 04: So what's going to happen is if there's one generic on the market, the price drops a little bit. [00:36:48] Speaker 04: But if you have multiple generic competition, which is what MMA Mets are really looking for, [00:36:52] Speaker 04: the price is going to drop 40%. [00:36:54] Speaker 04: Okay, so that takes benefits financially for sure, but the public benefits a lot more because these prices are going to drop. [00:37:00] Speaker 04: And that's the real point of these MMA amendments. [00:37:04] Speaker 04: And in the legislative history, we cited to Senator Schumer and, you know, at 15746. [00:37:10] Speaker 05: If you had written a paragraph [00:37:17] Speaker 05: for certification to cover both of the patents, 599 and 703. [00:37:21] Speaker 05: What would have happened? [00:37:25] Speaker 04: So we would be in litigation most likely over the 599 patent. [00:37:29] Speaker 04: But there's no guarantee we would have won that litigation in time for it to matter anyway. [00:37:33] Speaker 05: And suppose you filed a declaratory judgment action because they didn't sue you. [00:37:40] Speaker 05: They didn't take the initiative of doing that. [00:37:44] Speaker 05: And in that action, [00:37:46] Speaker 05: the district judge said, do you have anything to tell us that the earlier litigation on the 599 didn't fully consider and you say no. [00:37:56] Speaker 05: And the district judge says, well, I'm going to follow that judgment. [00:38:01] Speaker 05: Infringed, not invalid. [00:38:04] Speaker 05: And I think I heard counsel for Daiichi say that might present a quite different situation under the [00:38:15] Speaker 05: forfeiture provisions because you would have put in play all of the patents as opposed to only some. [00:38:21] Speaker 05: Can you address that? [00:38:24] Speaker 05: Including correcting what I just said, I thought I heard. [00:38:27] Speaker 04: So that is, I think, trying to apply some of the logic for Janssen and the fact that Janssen said you had to sort of attack both patents. [00:38:36] Speaker 04: But the distinction here is that the 599 patent is no longer a basis for Mylan's exclusivity. [00:38:43] Speaker 04: And what the Davies and Oveon case says in the other case, and even the statute itself, forfeiture provisions is all that we have to attack is the patent that is the basis for the exclusivity to cause the forfeiture. [00:38:54] Speaker 04: And that patent right now is only the 703 patent. [00:38:59] Speaker 04: If I could move on to just address more fully the ripeness issue that Judge Clevenger raised. [00:39:06] Speaker 04: In our briefs, we cited two district court decisions that have expressly addressed that issue. [00:39:12] Speaker 04: and they expressly found that having tenant approval was not a prerequisite for us moving forward with this action. [00:39:21] Speaker 03: Without a whole lot of discussion. [00:39:23] Speaker 04: Well, they had some discussion. [00:39:24] Speaker 04: I mean, the rationale I think made sense. [00:39:27] Speaker 04: First is that our and is fixed right now. [00:39:29] Speaker 04: The product, there's no dispute about what our product is. [00:39:31] Speaker 04: And don't forget, this is a patent infringement action at the end of the day. [00:39:34] Speaker 04: What's being decided here is do we infringe this patent or not? [00:39:39] Speaker 04: But the second point, which is I think the really most important point, [00:39:41] Speaker 04: is the practicalities of the situation, the timing issue. [00:39:44] Speaker 04: Even though this seems like a relatively simple thing, the fact is we brought our case in 2012. [00:39:49] Speaker 04: We're now in 2015. [00:39:51] Speaker 04: It takes a while even for issues like this to percolate through the court structure. [00:39:55] Speaker 04: And what Congress wanted to have happen is they wanted early resolution of these patent disputes. [00:40:00] Speaker 04: And they didn't want to have a bottleneck where we had to wait for 10 of approval before we bring it, because frankly, there's not enough time to get everything done [00:40:09] Speaker 04: And of course, under the new statute, as Mr. Connie points out, we not only need to support each other. [00:40:14] Speaker 05: At least in this case, if you're right about how trivially easy the patent merits litigation will be, where is the timing issue? [00:40:26] Speaker 05: Why not wait until you have tentative approval? [00:40:30] Speaker 05: I think you agree there's no forfeiture. [00:40:33] Speaker 05: Correct. [00:40:33] Speaker 05: So why not wait until you've got tentative approval? [00:40:37] Speaker 05: have your papers ready, refile, ask for, I don't know, PRO, emergency relief, or something like that. [00:40:47] Speaker 05: They will have nothing to say in response to it, I gather. [00:40:50] Speaker 05: I forget what else I was going to say, but I mean, a disclaimed patent can't be infringed. [00:40:55] Speaker 05: I gather everybody is in agreement with that. [00:40:59] Speaker 05: And then you've got your forfeiture, don't you? [00:41:02] Speaker 04: Well, again, [00:41:04] Speaker 04: FDA will ultimately have to give us the approval. [00:41:07] Speaker 04: Okay. [00:41:08] Speaker 04: And as Mr. Chomsky pointed out, he's not going to sit still while the FDA gives us this approval. [00:41:13] Speaker 04: He's going to bring an action against the FDA to try to delay this as long as possible so that he could run the clock out on us and that, you know, they're going to get to market. [00:41:21] Speaker 03: Well, he's going to bring these less enforced surveillance. [00:41:24] Speaker 04: Exactly. [00:41:25] Speaker 04: That's exactly what's going to happen in this community. [00:41:26] Speaker 04: Yet another battle. [00:41:28] Speaker 04: And so why stop us from getting the judgment that we're definitely entitled to? [00:41:31] Speaker 04: The one thing that is certain right now [00:41:32] Speaker 04: is that if we don't get this judgment, we're not going to be eligible to get to market on day one. [00:41:36] Speaker 04: That is the one certainty that we have. [00:41:43] Speaker 03: Why you can't bring his, you can't do this under civilian suit at the FDA until the FDA does something, right? [00:41:52] Speaker 03: That's correct. [00:41:52] Speaker 03: There has to be an act. [00:41:53] Speaker 03: So what's the FDA act, and it's going to be writing them down your approval? [00:41:58] Speaker 04: So we'll be granted tentative approval and at that point they will bring a citizens petition most likely or an action in the district of DC to try to join the FDA for improving us. [00:42:11] Speaker 04: That's gonna be the next phase of this litigation because there is so much at stake, which frankly just proves the point of why we should go forward here, that there are adverse interests, this is really significant and we need to get this judgment and move forward. [00:42:25] Speaker 04: That's what we're asking for here. [00:42:28] Speaker 04: No further questions. [00:42:30] Speaker 05: Thank you very much.