[00:00:00] Speaker 01: 181247 to Aaron Farmer versus I.P.C. [00:00:39] Speaker 02: Yeah. [00:00:49] Speaker 00: Settle in. [00:01:04] Speaker 01: OK. [00:01:04] Speaker 01: We're ready when you are, sir. [00:01:06] Speaker 04: May it please the court, Ashley Parrish, for Amherst [00:01:09] Speaker 04: When the commission in this case refused to investigate Ameren's claims under Section 337 of the Tariff Act, it violated a mandatory statute. [00:01:17] Speaker 03: In the Blue Briefing 20, you argue the ITC's decision is a final determination under either 1337D or F. And the statute, of course, identifies final determinations as under DEF and G. [00:01:37] Speaker 03: So are you just claiming reliance on E or G as a basis for appellate jurisdiction? [00:01:43] Speaker 04: Your Honor, we're focused on DNF. [00:01:44] Speaker 04: That's right, because the... No, no, no, no. [00:01:48] Speaker 03: I didn't ask you when you're focused. [00:01:50] Speaker 03: I said, are you just claiming reliance on... You know, we have to write these things, right? [00:01:55] Speaker 04: Right, Your Honor, we're not relying on those other provisions. [00:01:58] Speaker 04: The reason, and what I was going to say, I'm happy to address jurisdiction first, which is your honor's question. [00:02:03] Speaker 04: The strange thing about this case is that the government has conceded jurisdiction at least to the extent the court has mandamus authority. [00:02:10] Speaker 04: And of course, jurisdiction overlaps with the merits. [00:02:12] Speaker 04: And I thought what I might do, because of that, is start with the statute first. [00:02:16] Speaker 01: Well, the government's decisions on reviews of jurisdiction don't necessarily compel us to have the same view. [00:02:24] Speaker 01: So I would appreciate if you could argue jurisdiction. [00:02:27] Speaker 04: Absolutely. [00:02:27] Speaker 04: Then I will start with jurisdiction. [00:02:29] Speaker 01: OK. [00:02:30] Speaker 01: Isn't the statutory language of 1337C crystal clear? [00:02:35] Speaker 01: It says, final determinations of the commission under DEF or G of this section. [00:02:42] Speaker 01: How do you fit within DEF or G? [00:02:46] Speaker 04: So Your Honor, let me make sort of two points on that, address your question, and also explain that we have two other alternative grounds. [00:02:53] Speaker 03: And why, while you're discussing that, did you omit the reference, any reference to the limiting phrase of 1337C? [00:03:04] Speaker 03: in your opening brief. [00:03:07] Speaker 04: Well, Your Honor, I'm sorry, I don't mean to be obtuse about it, but what limiting phrase would you be referring to? [00:03:16] Speaker 04: So, I mean, it says any person adversely affected by a final determination of the Commission under subsection D, E, F, or G of this section may appeal such determination within 60 days after the termination becomes final to the United States Court of Appeals for the Federal Circuit for review in accordance with Chapter 7 of Title 5. [00:03:34] Speaker 04: And then you have to refer to D&E. [00:03:37] Speaker 04: And Your Honor, what you might be referring to is not in C, but in D, where it says in D, if the commission determines as a result of an investigation on this section that there is a violation of this section, it shall exclude from entry. [00:03:50] Speaker 04: So the D1 is exclusion of articles from entry. [00:03:53] Speaker 04: And then F is cease and desist orders. [00:03:55] Speaker 04: And our point, Your Honor, is if you take a look both at the Amgen decision and just generally, [00:04:00] Speaker 04: The idea is that commission negative determinations are also reviewable as are positive determinations. [00:04:06] Speaker 04: and the practical effect of this decision here. [00:04:09] Speaker 01: Negative determinations, for example, if they get through an investigation and they decide not to exclude articles from entry, that would be a negative determination under D. And I don't think anybody is suggesting that it's only the affirmative determinations under D, C, E, and F that are subject to review. [00:04:31] Speaker 01: But that isn't our question. [00:04:33] Speaker 04: So if your question is their argument, which is that because there's no investigation, these provisions don't apply? [00:04:39] Speaker 04: Decisions not to investigate, yes. [00:04:42] Speaker 01: That precedes any of these. [00:04:44] Speaker 01: All of these decisions in these subsections come after an investigation. [00:04:49] Speaker 01: We are clearly at step one, right? [00:04:52] Speaker 04: But Your Honor, what I would say to that, and this gets to my other points of why you have jurisdiction, is that the commission... And the question was why you left it out of your brief. [00:05:00] Speaker 04: Well, Your Honor, because for exactly the reason I'm going to explain here, which is that this is a requirement that the commission has when it issues it. [00:05:07] Speaker 04: What we did put in our brief is that the commission has a mandatory obligation to initiate an investigation. [00:05:12] Speaker 04: The commission can't divest this court of jurisdiction by avoiding that mandatory obligation and then going on ahead and saying, well, because we avoided that mandatory obligation, now the court has no authority to review. [00:05:25] Speaker 04: Congress contemplated both that this court would have [00:05:28] Speaker 04: authority to review final decisions. [00:05:29] Speaker 04: And second, that except in limited circumstances specified in the statute, that the commission would initiate an investigation and would not make these threshold judgments. [00:05:39] Speaker 01: So your answer to our question with regard to how you fit within the literal clear language of the section regarding jurisdiction is that we have to [00:05:52] Speaker 01: Even though there was no investigation here, we need to put this in the box of investigations because the ITC has violated the first section. [00:06:00] Speaker 01: So you're on it. [00:06:02] Speaker 01: OK, so let's then move on to that issue, which is what if we were to conclude, agreeing at least in part with the intervener and the government, that that section does not compel, when it says it shall investigate, [00:06:16] Speaker 01: the ITC has written gap-filling regulations to define what is a requisite complaint in a case. [00:06:24] Speaker 01: And they have the right to make that determination not foreclosed by the language of the statute. [00:06:31] Speaker 01: And what they did is say the complaint here is deficient. [00:06:34] Speaker 04: So, Gerardo, what I would say is those gap-filling regulations relate to the form and the content of the petition, like the procedural requirements. [00:06:42] Speaker 04: They don't rely [00:06:43] Speaker 04: on those regulations to say that this complaint can't go forward. [00:06:47] Speaker 04: What they rely on, and you see this in the other side's brief, is the legal conclusion that they are precluded because the FDCA is given to the exclusive authority of FDA. [00:06:56] Speaker 04: So this is not one of those regulations where they say, procedurally, you haven't complied. [00:07:00] Speaker 04: Your Honor, let me just finish the thought here, though. [00:07:02] Speaker 01: The other one. [00:07:03] Speaker 01: I don't understand. [00:07:04] Speaker 01: Can we just? [00:07:04] Speaker 01: Yeah. [00:07:05] Speaker 01: Sorry. [00:07:05] Speaker 04: Absolutely, Your Honor. [00:07:07] Speaker 04: Of course, Your Honor. [00:07:08] Speaker 01: All right. [00:07:08] Speaker 01: Can't we think about, I mean, don't they have the authority to review whether or not this is a properly filed complaint? [00:07:17] Speaker 01: And if they make the conclusion, which I understand they made here, that there's a failure to state a factually or legal cognizable claim, [00:07:25] Speaker 01: That is a failure of the complaint. [00:07:27] Speaker 01: Don't they have that authority? [00:07:29] Speaker 04: So Your Honor, they do, if they're identifying procedural defaults in the complaint, like the regulations set forth, in which case they will dismiss without prejudice, and then the party has the ability to plead in order to remedy the defect. [00:07:41] Speaker 04: The problem here is not that they, so when they use the word properly filed, it's not properly filed in the sense of that somebody files a brief in this case and the clerk bumps it and says, please correct it. [00:07:52] Speaker 04: When they're saying it's not properly filed, they're relying on their legal conclusion [00:07:55] Speaker 04: which is that the FDCA, they are not allowed to investigate claims under the FDCA because FDA has authority. [00:08:01] Speaker 01: Well, when you do a failure to state a claim for legally cognizable claims, that is a legal determination. [00:08:09] Speaker 01: That's not factual. [00:08:10] Speaker 04: Exactly, you're right. [00:08:11] Speaker 04: But if that legal determination is incorrect, which is our point, then the agency has subverted the statute, which says it shall investigate based on a legal error. [00:08:20] Speaker 01: And you are allowed to- So you're saying they have that authority [00:08:23] Speaker 01: Your question isn't that they have the authority to decide not to investigate and to review the claim for its sufficiency. [00:08:34] Speaker 01: You're just saying they're wrong, and therefore we ought to have to review that. [00:08:39] Speaker 04: Your Honor, if I may be a little more specific about that, we think there are four situations where the Commission can decide not to investigate, and this is not one of them. [00:08:47] Speaker 04: The one example we're talking about is a properly filed complaint, meaning complying with the procedural requirements. [00:08:53] Speaker 04: That's a dismissal without prejudice. [00:08:55] Speaker 04: The other ones are specified in the statute 337 itself, when it involves an anti-dumping issue, or whether it involves an alleged copyright infringement. [00:09:04] Speaker 04: That's 337B. [00:09:05] Speaker 04: And then under this court's decision in Amgen, there are the Bellevue Hood reasons, which is if it's wholly insubstantial or frivolous, or if it seems like it's irrelevant, it's just there to get jurisdiction. [00:09:15] Speaker 04: Those are the only situations where the commission can decide not to proceed. [00:09:19] Speaker 04: Here the commission decided not to proceed based on a legal conclusion, which we are submitting to the court is legally wrong because it's inconsistent with the way that Palm Wonderful looks at the statute. [00:09:31] Speaker 04: And as a result, it circumvents the obligation of the agency under the statute to initiate an investigation. [00:09:38] Speaker 04: So Your Honor, let me just, if I may, just finish the thought is that even if you didn't think you had jurisdiction, [00:09:43] Speaker 04: under those two provisions under my reading, which is that the commission cannot violate the statute in order to avoid judicial review. [00:09:49] Speaker 04: You would have judicial review under 7061 of the APA, which makes the point that if an agency fails to fulfill a mandatory obligation, this court. [00:09:59] Speaker 01: Wait, doesn't that go to the district court? [00:10:01] Speaker 04: Why would that go to us? [00:10:02] Speaker 04: So Your Honor, in a situation where the DC Circuit handles this all the time with agency actions that are unlawfully withheld or delayed, [00:10:10] Speaker 04: And it's the same thing that you apply in your main daemons context, which is if the court has potential jurisdiction, meaning that Congress is assigned to this court the authority to review the final decision, if an agency fails to take a mandatory act on the way to that decision, this court also has jurisdiction to protect that jurisdiction by requiring them to take that mandatory act. [00:10:31] Speaker 04: That's an APA claim under 337. [00:10:33] Speaker 04: That's correct, Your Honor. [00:10:35] Speaker 04: And so under this statute, you could say, [00:10:37] Speaker 04: Just like the Supreme Court has talked about this recently, Your Honor, you mentioned the SAS case. [00:10:42] Speaker 04: But if there's a mandatory act that the Commission must do that is a step on the way to a decision that this Court would have authority and exclusive authority to review, like in this case, you can say to the agency, you improperly failed to investigate, and we are requiring you to open the investigation and do what Congress told you. [00:10:59] Speaker 04: And the reason you have that is because you have jurisdiction over the final determination. [00:11:02] Speaker 01: Well, that's the same argument that's made with regard to mandamus, which is that there's not. [00:11:09] Speaker 01: Yes, Your Honor. [00:11:10] Speaker 01: But I guess I'm having trouble accepting that, because I don't think it's the mandamus statute is an independent grant of statutory jurisdiction. [00:11:20] Speaker 01: So you still need a hook in the statute. [00:11:23] Speaker 04: The hook, Your Honor, the hook is 337 itself, mandamus jurisdiction. [00:11:27] Speaker 01: I'm sorry, you're talking too fast. [00:11:30] Speaker 04: The hook is in the 337 itself. [00:11:33] Speaker 04: Under maintenance jurisdiction, this court's decisions, we cite the Innatron decision, says that you have jurisdiction not only if you have actual jurisdiction, but if you have potential jurisdiction. [00:11:43] Speaker 04: And the reason for that is that you will not allow an agency or other court to avoid your jurisdiction that you would have. [00:11:50] Speaker 01: We all agree. [00:11:53] Speaker 01: kind of circular to me, because what we were talking about even on the threshold issue, there is a threshold issue about whether or not we have jurisdiction at all. [00:12:02] Speaker 01: So we would have to ask in terms of the board's decision not to institute an investigation. [00:12:08] Speaker 01: So we haven't answered that question. [00:12:10] Speaker 01: And if the question to that is yes, then we don't have to worry about mandamus or APA. [00:12:14] Speaker 01: Then we've got jurisdiction over this question. [00:12:16] Speaker 01: So why am I wrong that this is kind of a circular answer to my question? [00:12:20] Speaker 04: Because, Your Honor, the reason it's kind of circular is because the same reason that the Supreme Court in SAS talks about having jurisdiction when an agency engages in shenanigans. [00:12:30] Speaker 04: But when they mean shenanigans, they don't mean misconduct. [00:12:32] Speaker 04: They mean not doing something that the statute requires. [00:12:35] Speaker 04: It would be odd to send this to the district court because you, Congress has vested you with authority to oversee final determinations of the commission. [00:12:44] Speaker 04: We all agree, there's no dispute, that if the commission had gone through the investigation process, [00:12:48] Speaker 04: and either denied or rejected our complaint on the merits, that you would have authority. [00:12:53] Speaker 04: This is what the Amgen decision talks about, although admittedly that was after an investigation. [00:12:57] Speaker 04: And my only point is, Your Honor, is that because this court has been vested with authority to decide the final determination, if we are correct that they have a mandatory obligation to initiate the investigation, [00:13:10] Speaker 04: Their decision not to initiate the investigation doesn't shield them from judicial review. [00:13:14] Speaker 04: It's a legal error that this court can correct and then make them do the investigation that Congress required. [00:13:19] Speaker 01: What about if they had said, OK, and they had agreed with you and say, OK, it looks like the statute compels us to initiate an investigation of all cases? [00:13:27] Speaker 01: And they initiated it. [00:13:28] Speaker 01: And then they looked at the complaint. [00:13:30] Speaker 01: And they made a determination that they're not going to proceed any further because they think this is in the purview of the FDA and not of the ITC. [00:13:39] Speaker 04: Is that a problem? [00:13:41] Speaker 04: Yes, it would be, because then you would have the issue, and it would be a proper procedural step. [00:13:46] Speaker 04: They'd initiate the investigation. [00:13:48] Speaker 04: They would do it as the statute requires, on a hearing and after briefing. [00:13:51] Speaker 04: Then they would say, we can't because the FDCA precludes us from doing this. [00:13:55] Speaker 04: And then we would have the legal issue on the merits. [00:13:57] Speaker 04: And we would say, just like we have in our briefs, that under the statute, under Palm Wonderful, and the analysis it requires. [00:14:03] Speaker 01: But how does that come within? [00:14:07] Speaker 03: Let's go to Palm. [00:14:08] Speaker 03: Yes, Your Honor. [00:14:09] Speaker 03: In Palm, the Supreme Court described the case as not a case where a lawsuit is undermining an agency judgment. [00:14:21] Speaker 03: The complaint here goes right to the heart of the FDCA as a central component of the complaint, right? [00:14:29] Speaker 04: No, Your Honor. [00:14:31] Speaker 04: But I'm happy to explain that, but we disagree with that. [00:14:36] Speaker 03: Your complaint is that the accused products are unapproved [00:14:39] Speaker 03: new drugs directly implicating FDCA, no? [00:14:43] Speaker 04: So, Your Honor, let me agree with you that it does directly implicate FDCA. [00:14:48] Speaker 04: But my point is, and what we try to make forth in the brief, is that that isn't a question of FDA's authority. [00:14:55] Speaker 04: And I can explain to you why that's the case. [00:14:56] Speaker 03: In Palm, the Supreme Court says, again, further differentiating, unlike other types of labels regulated by the FDA, such as drug labels, [00:15:08] Speaker 03: it would appear the FDA does not pre-approve food and beverage. [00:15:12] Speaker 04: That is true here, too, Your Honor. [00:15:13] Speaker 04: The dietary supplements are not pre-approved by the FDA. [00:15:17] Speaker 04: They are decided by manufacturers on their own. [00:15:19] Speaker 04: There are, any time you want to go ahead and put a dietary supplement on the market, there is no FDA approval at all. [00:15:26] Speaker 04: And in fact, when FDA then decides later that says maybe this has been mislabeled or some misbranded under the FDCA, the FDA doesn't then take action. [00:15:35] Speaker 04: What it does is it goes to court, and it asks the court to decide the issue. [00:15:39] Speaker 04: Our point, Your Honor, is that the Congress has allowed the Commission to look at the existing state of the law, the regulations and the statutes on the FDCA, and any guidance by the FDA, and make a determination as to now whether or not, under the Tariff Act, that is farming [00:15:54] Speaker 04: of the domestic industry and applying the standards under the tariff act. [00:15:57] Speaker 01: So it's supposed to make a determination. [00:16:00] Speaker 01: I mean, the FDA has specific skills and expertise, right, to make these decisions. [00:16:05] Speaker 01: How is the ITC supposed to do that? [00:16:07] Speaker 04: No, Your Honor, with respect. [00:16:08] Speaker 04: The FDA does not have the expertise to understand the issues under the tariff act. [00:16:14] Speaker 04: No, no, no. [00:16:15] Speaker 01: Isn't the decision here about whether or not whatever it is comes under column for dietary supplements or for drugs? [00:16:23] Speaker 01: Isn't that the issue? [00:16:24] Speaker 04: That is the first part of the issue. [00:16:25] Speaker 04: And Your Honor will remember in the Allergan case, the court recognized that the FDA has exclusive authority to bring actions under the FDCA. [00:16:35] Speaker 04: But that did not stop the court from doing what courts do all the time, which is looking at the existing law, the statute, the regulations, and any FDA guidance [00:16:43] Speaker 04: and making a determination as to whether those products in that case were cosmetics or drugs. [00:16:48] Speaker 04: Our point here is that it's not a predictive judgment by the Commission as to what the agency might do or how it might change the policy. [00:16:55] Speaker 04: It's just a question on the merits as to whether we are right. [00:16:58] Speaker 04: They can look at the statute, the regulations, and decide for themselves has this been clearly said one way or the other. [00:17:05] Speaker 04: They're not asking the FDA whether or not it is true. [00:17:09] Speaker 01: They can look at the regulations and see if this has been clearly said by whom? [00:17:13] Speaker 01: By the FDA? [00:17:14] Speaker 04: By Congress and the statute, by FDA and the regulations, the law that governs. [00:17:19] Speaker 04: And the only difference is... But what if they don't find anything? [00:17:21] Speaker 04: Then we lose on the merits. [00:17:23] Speaker 03: 337A of the FDCA says, all such proceedings for the enforcement or to restrain violations of this chapter shall be by and in the name of the United States. [00:17:38] Speaker 03: phrase enforcement or restrain violations mean? [00:17:43] Speaker 04: You're on the way we interpret that, which I think is consistent with Palm Wonderful and Allergan, which means bringing a cause of action under the FDCA. [00:17:50] Speaker 04: FDA does not have litigating authority, so that statute says that the United States will bring it to enforce the FDCA. [00:17:57] Speaker 04: When you're bringing a cause of action under the Lanham Act in Palm Wonderful, even though FDA regulations were directly on point, the Supreme Court said, well, those FDA regulations are not a ceiling. [00:18:06] Speaker 04: Is it your position [00:18:08] Speaker 03: that as a matter of statutory construction, the shell language in 31337b overrides the bar on freedom enforcement. [00:18:19] Speaker 04: Your honor, our position is that under Palm Wonderful, there's two ways to look at this. [00:18:23] Speaker 04: The Supreme Court didn't decide it. [00:18:24] Speaker 04: But one is to reconcile and harmonize them. [00:18:26] Speaker 04: And the other one is to reinforce both to the utmost extent. [00:18:30] Speaker 04: Under either approach in Palm, the court says both the Lanham Act is complementary [00:18:35] Speaker 04: to the FDCA. [00:18:36] Speaker 04: That is also true here. [00:18:37] Speaker 04: Our point is that the FDCA statute requires that it be enforced, a cause of action for the FDA. [00:18:44] Speaker 04: The Tariff Act and the Lanham Act provide a private cause of action for parties. [00:18:47] Speaker 04: They don't displace each other. [00:18:49] Speaker 04: In fact, they don't even conflict, because the 337 has provisions to avoid conflict. [00:18:55] Speaker 04: Your Honor, I would be happy to answer more questions, but I also would like to reserve a little time, if I may. [00:19:00] Speaker 04: Thank you. [00:19:00] Speaker 04: Thank you very much. [00:19:06] Speaker 01: All right. [00:19:06] Speaker 01: Now we've got this unusual circumstance where you're dividing the argument not just two ways, but three ways. [00:19:13] Speaker 01: Correct. [00:19:13] Speaker 01: OK. [00:19:13] Speaker 08: So 10 minutes is the ITC time. [00:19:18] Speaker 01: And what issues do you have? [00:19:20] Speaker 01: Can you just give us a two-minute second understanding of what issue? [00:19:25] Speaker 01: Are you each covering different issues? [00:19:27] Speaker 01: Because it would be helpful to us, since we're here to ask the questions. [00:19:31] Speaker 01: to know which issues to say for which person. [00:19:33] Speaker 08: Well, I'll be very happy to answer any questions that the Commission raised in its brief. [00:19:39] Speaker 08: I believe that the United States are going to address the issue of preclusion, but I also prepared some remarks on that. [00:19:48] Speaker 08: I am not sure what interveners plan to address today. [00:19:54] Speaker 01: Let me start off with just one kind of off-topic question, because I didn't understand it. [00:20:00] Speaker 01: It goes to the FDA, so maybe it's justice that should answer this. [00:20:04] Speaker 01: I didn't quite understand what position the government was taking in terms of talking about, well, the FDA six months from now or sometime in the future might do guidelines. [00:20:14] Speaker 01: Do you know what I'm saying? [00:20:15] Speaker 01: It was in the FDA letter that it submitted, and it's here. [00:20:20] Speaker 01: What are we supposed to do with that? [00:20:22] Speaker 01: Does that suggest that in other circumstances the FDA may have issued firm guidance and therefore we'd be in a different position and the ITC could go ahead because we had firm guidance? [00:20:34] Speaker 08: That's correct. [00:20:35] Speaker 01: If the tribunal doesn't have to... So it's not that the ITC doesn't have the authority to do it and it's only the FDA? [00:20:42] Speaker 01: It's only in instances where the FDA hasn't given us guidance that the ITC cannot act? [00:20:50] Speaker 08: Well, in the instances where the tribunal has to interpret or apply the FDCA in the first instance, then those claims are precluded. [00:20:59] Speaker 08: But there are instances where the FDA has already spoken, in which case the tribunal wouldn't have to engage in interpreting the FDCA. [00:21:09] Speaker 08: They would just have to adjudicate the false representations under the Lanham Act claim. [00:21:14] Speaker 08: I can give you some examples. [00:21:15] Speaker 08: For example, there is a district court case that directly spoke to that issue. [00:21:19] Speaker 08: It's the GHP case that said that if the plaintiff chooses to go to the FDA and have them declare their competitors' products unlawfully marketed as drugs, then they can come back [00:21:36] Speaker 08: to the district court. [00:21:38] Speaker 01: Oh, sure. [00:21:38] Speaker 01: I mean, in this case, if they had gotten the FDA to look at their drug, I thought you were talking about something more general. [00:21:45] Speaker 01: And I don't know enough about the FDA. [00:21:48] Speaker 01: I thought you were contemplating the FDA coming up with some future guidance. [00:21:53] Speaker 01: And I don't know what that guidance would be, if they have a listing of drugs of what falls under the drug category and what falls under dietary supplements. [00:22:02] Speaker 08: Yes, for example, the commission [00:22:05] Speaker 08: has, in some instances, instituted investigations when the issue turned on FDA approval status. [00:22:13] Speaker 08: And so that's an issue that has already been determined by the FDA. [00:22:18] Speaker 08: Whether something is FDA approved or not doesn't require interpretation of the FDCA. [00:22:25] Speaker 03: Were you able to identify any alleged history that bears on what constitutes an appealable final determination? [00:22:37] Speaker 08: legislative history in the statute. [00:22:41] Speaker 08: There is a statutory language that provides for congressional oversight of pre-institution decisions. [00:22:53] Speaker 03: I'm asking about legislature. [00:22:55] Speaker 08: Yeah, legislative history I am not aware of any that addresses specifically whether [00:23:02] Speaker 08: Suppose your question goes to whether pre-institution decisions are are appealable or not. [00:23:10] Speaker 08: The statute is silent and the legislative history to my understanding is that it's silent as well as to whether those decisions are appealable or not. [00:23:18] Speaker 08: But there is a statutory language that says that those decisions are subject to congressional oversight. [00:23:24] Speaker 01: My understanding is that your position is that we do have jurisdiction, but it's not mandamus. [00:23:32] Speaker 01: My understanding of the All Writs Act is that it's not an independent grant of statutory jurisdiction. [00:23:41] Speaker 01: So if you're saying we don't have jurisdiction under the statute, how can we have mandamus jurisdiction? [00:23:50] Speaker 08: There is a mandamus jurisdiction when there is prospective jurisdiction or potential jurisdiction, when the order or the decision frustrates the jurisdiction. [00:24:00] Speaker 01: But if there's prospective jurisdiction? [00:24:03] Speaker 08: Yes, because if it was. [00:24:04] Speaker 01: But you're telling us, what is the prospective jurisdiction? [00:24:07] Speaker 01: You're saying that the board, the ITC, cannot act here because it's within the purview of the FDA. [00:24:15] Speaker 01: So what does the prospective jurisdiction look like? [00:24:19] Speaker 08: In general, [00:24:20] Speaker 08: if the ITC conducts an investigation, those cases then are within the exclusive jurisdiction of the federal circuit of this court. [00:24:30] Speaker 08: And the case law, while not directly on point, states that when there is prospective jurisdiction, then the mandamus jurisdiction may also be present for when an order frustrates the court's jurisdiction. [00:24:46] Speaker 01: I guess, tell me in this case what the prospective jurisdiction looks like. [00:24:51] Speaker 01: I mean, you decided that you don't have jurisdiction because it's within the purview of the FDA. [00:24:58] Speaker 01: What does prospective jurisdiction look like? [00:25:01] Speaker 01: You're telling us you don't have jurisdiction today. [00:25:04] Speaker 08: You don't have appellate jurisdiction. [00:25:05] Speaker 08: You may review under the clear abuse of discretion standard. [00:25:09] Speaker 08: And this is consistent with the syntax case, where a similar decision by the commission [00:25:16] Speaker 08: declining to institute an investigation was reviewed by mandamus. [00:25:21] Speaker 07: If you're wrong about you lacking jurisdiction, then you would have had to go forward with an investigation, right? [00:25:30] Speaker 08: If we are wrong with respect to the jurisdiction? [00:25:33] Speaker 07: With respect to the FDA preemption, basically, on the merits. [00:25:39] Speaker 07: If you're wrong about the merits, then the statute would require you to do an investigation. [00:25:45] Speaker 08: That's been the commission's interpretation that when it's presented with a properly filed complaint, that it would institute an investigation. [00:25:55] Speaker 07: And the properly filed... And we would have jurisdiction over the final decision as a result of that investigation. [00:26:01] Speaker 08: That is for exclusive jurisdiction. [00:26:02] Speaker 08: That is correct. [00:26:03] Speaker 08: And I just wanted to address that properly filed, this court's predecessor in syntax and in union have both interpreted that to mean [00:26:13] Speaker 08: not procedurally deficient complaint, but a complaint that lacks sufficient allegations to support the asserted claims. [00:26:22] Speaker 08: So it is not true, as appellants have argued here, that the Commission only has authority to reject procedurally deficient complaints. [00:26:33] Speaker 08: I also wanted to address a point that the appellant made, that in this case the Commission has unlawfully [00:26:41] Speaker 08: delayed or unreasonably delayed its decision. [00:26:45] Speaker 08: That concerns section 7061 of the APA. [00:26:50] Speaker 08: And that section, the Supreme Court, has said that it can only force or compel a court or a tribunal to act on a ministerial act or a nondiscretionary act, or it can compel the tribunal to act, but it cannot direct [00:27:09] Speaker 08: the tribunal on how to act. [00:27:12] Speaker 08: And in this case, the commission has acted. [00:27:14] Speaker 08: The commission declined to institute. [00:27:15] Speaker 08: But what's going on here is that appellants are not satisfied with the way that the commission acted. [00:27:21] Speaker 08: But that is not actionable under that section of the APA. [00:27:30] Speaker 03: In Amgen, which your opposing counsel raised, we held that even though the ITC labeled the issue as jurisdictional [00:27:40] Speaker 03: its dismissal was intrinsically a final decision on the merits. [00:27:45] Speaker 03: Why is it incorrect to characterize the decision not to institute, in this case, as intrinsically a final determination, not to issue either an exclusion or a cease and desist order? [00:27:59] Speaker 08: We explained in the commission's brief that the decision here was not a decision on the merits because we have not, the commission has not decided whether these products are [00:28:10] Speaker 08: are drugs or dietary supplements. [00:28:12] Speaker 08: The commission has stated that the predicate finding by the FDA is missing here, and so the complainant has failed to properly plead the Lanham Act claim. [00:28:26] Speaker 08: In Amgen, the court reached the merits of the issue. [00:28:29] Speaker 08: The court found that the claim was not a process claim, and so it determinatively found that the complainant could not proceed on that patent. [00:28:40] Speaker 08: The other argument that the commission made in its brief is that this is a decision without prejudice. [00:28:47] Speaker 08: There is precedent that we cited that when you defer to the agency to make a determination in the first place, it's not even permissible to dismiss based with prejudice. [00:28:59] Speaker 08: So there is precedent from this court in Block versus ITC where when the decision is without prejudice, then it's neither a final determination [00:29:10] Speaker 08: nor the equivalent of a final determination and in block versus international. [00:29:15] Speaker 01: I don't understand. [00:29:16] Speaker 01: What you said here was they can't come in. [00:29:19] Speaker 01: We don't have authority to review it because this is under the purview of the FDA and not under the ITC. [00:29:27] Speaker 01: What's not dispositive? [00:29:29] Speaker 01: I mean, I don't want to use the word final because you don't want to use the word final. [00:29:32] Speaker 01: What's not dispositive about that? [00:29:36] Speaker 01: in terms of telling them, don't come back, guys, because we're not going to initiate an investigation. [00:29:42] Speaker 08: They can come back if they have the predicate finding from the FDA. [00:29:47] Speaker 07: Well, if that's your position, I don't understand why you're conceding mandamus jurisdiction. [00:29:52] Speaker 07: It seems to me that what you're suggesting is that this is a non-reviewable decision, that the way for them to go about getting relief from you is to first go to the FDA [00:30:03] Speaker 07: and get a determination that these products are drugs, and then come to you and say they're being improperly labeled as supplements. [00:30:14] Speaker 07: But why would you concede mandamus jurisdiction if you think that there's a route that they can do it properly and then invoke your jurisdiction under 337? [00:30:23] Speaker 08: Well, we are bound by precedent. [00:30:26] Speaker 08: And given that in syntax, this court's predecessor agreed to [00:30:33] Speaker 08: review the decision to not to institute based on mandamus, we are bound by precedent and so that is the reason we did not dispute mandamus jurisdiction in this case. [00:30:47] Speaker 01: I see that my time is up if you have further questions. [00:31:03] Speaker 01: Good morning. [00:31:04] Speaker 01: Good morning, Your Honor. [00:31:07] Speaker 01: You agree that if we lack jurisdiction, it also applies to mandates, right? [00:31:13] Speaker 05: We do, Your Honor. [00:31:15] Speaker 05: It may help to take a look at the Dominion case that we cited, where it's very similar, where the first court in St. [00:31:23] Speaker 05: Jude says there is no appellate jurisdiction, which we think is clear from the statute when there's no investigation. [00:31:28] Speaker 05: And because there's no appellate jurisdiction, [00:31:31] Speaker 05: then the mandamus, as Your Honour has noted, under the Oral Rights Act, the mandamus doesn't reach to help get to jurisdiction because there is no jurisdiction. [00:31:39] Speaker 01: So then why do we move to the statutory construction issue of shall investigate? [00:31:44] Speaker 01: Why isn't that as clear as it gets in terms of compelling the ITC to initiate an investigation in every complaint? [00:31:51] Speaker 05: Well, Your Honour, if the statute just said shall, then that would be much harder for us. [00:31:58] Speaker 05: But there's a key word, which is [00:32:00] Speaker 05: upon its initiative. [00:32:01] Speaker 05: The same word shall modifies both on complaint and upon its initiative. [00:32:05] Speaker 01: I'm sorry. [00:32:06] Speaker 01: I, for one, don't buy that. [00:32:08] Speaker 01: Upon its own initiative is talking about something else. [00:32:12] Speaker 01: My read of that section is shall initiate an investigation based on a complaint, sort of full stop, or on its own initiative. [00:32:22] Speaker 01: I think the only way to have any clarity in that statement is to divide the two up, right? [00:32:27] Speaker 05: with respect to you, I don't know, because if you put the period in, then you have half a sentence. [00:32:33] Speaker 01: So how does it mean shall investigate a complaint on its own initiative, or shall investigate an alleged violation on its own initiative? [00:32:44] Speaker 05: So what Congress did here, and the legislative history helped, actually, is that you shall as may, not as must. [00:32:51] Speaker 05: If you go to the way this statute was written originally. [00:32:54] Speaker 01: Well, you can tell the Supreme Court that chow means may or not must. [00:32:57] Speaker 01: But I'm a little scared to try to do so. [00:33:00] Speaker 05: So I understand. [00:33:01] Speaker 05: And the SAS opinion that Judge Wallach brought up, I think, is quite helpful on that. [00:33:05] Speaker 05: Because the relevant word is chow. [00:33:07] Speaker 05: And they compare it to a statute where it may have said the director could, quote, start proceedings on his initiative. [00:33:16] Speaker 05: And that's a slip up six. [00:33:17] Speaker 05: So the Supreme Court definitely understands that you read the entire statute [00:33:22] Speaker 05: That statute did not have the word upon its initiative. [00:33:26] Speaker 05: So what Congress did when they replaced the word authorize with shall, they made clear it was a non-substantive decision. [00:33:32] Speaker 05: 1974 Senate report, not just somebody talking on the floor, a key Senate report, section 3 through 7B1 of the act would continue as it was originally enacted to authorize. [00:33:44] Speaker 05: House report was the same way. [00:33:46] Speaker 05: You go back to 1984, where you have regulations from the ITC saying that they have discretion. [00:33:52] Speaker 05: So the idea that it's a shall in the sense you want to start it with, I know you may at first read like that, but when you look at upon its initiative, that shall has to modify that. [00:34:02] Speaker 05: And of course, if it reads shall that they have to do on every complaint, then as the bar has been talking about, many more complaints will start being investigated by the ITC. [00:34:13] Speaker 01: Well, that depends. [00:34:14] Speaker 01: That depends if shall can be modified by that gap-filling exercise in the regulations so that the IDC gets to define what a complaint is. [00:34:25] Speaker 01: And the argument becomes, in this instance, they determine that this was not a legally cognizable claim. [00:34:32] Speaker 01: And therefore, it didn't come within the complaint language. [00:34:35] Speaker 05: Yeah, no, and that's right, Your Honor. [00:34:37] Speaker 05: That's a different argument. [00:34:38] Speaker 05: That's a different argument. [00:34:40] Speaker 05: With permission, I'd like to shift to that argument. [00:34:43] Speaker 05: I mean, the ITC's authority to interpret key phrases under the Tariff Act is longstanding. [00:34:50] Speaker 05: As Your Honor mentioned, they are not the FDA. [00:34:54] Speaker 05: And the FDA, in this context, quote, is charged with the administration of the FDCA, says the ITC. [00:35:00] Speaker 05: And of course, the FDA approves new drugs. [00:35:02] Speaker 05: regulates proper labeling, misbranding, truthful labeling. [00:35:06] Speaker 05: I mean, you can go on and on. [00:35:07] Speaker 05: They were key to the dietary supplement. [00:35:08] Speaker 01: So you agree with your friend that this is just a matter of timing. [00:35:12] Speaker 01: It's not that the ITC can't act. [00:35:14] Speaker 01: It's that they can only act once the FDA has given some clarity to the analysis. [00:35:23] Speaker 05: So with the United States, as you will hear from shortly, that if an FDCA violation is a necessary element of the complaint, [00:35:32] Speaker 05: then it is barred. [00:35:34] Speaker 05: And what was not in POM, it was not close to a necessary element. [00:35:38] Speaker 05: And I think if you look at the sites to update their complaint, both the Tariff Act here and the Lanham Act here, their complaint requires finding of a violation. [00:35:47] Speaker 05: It's a necessary element of the cause of action. [00:35:50] Speaker 05: And so that is not something that the ITC should be looking at. [00:35:55] Speaker 01: But how does that get cured? [00:35:57] Speaker 01: They have to run down to the FDA and get the FDA to initiate [00:36:01] Speaker 01: proceeding or to declare this a drug, and then they can come back to the IDC. [00:36:07] Speaker 05: Well, it's barred, Your Honor, as the FDCA. [00:36:10] Speaker 07: Even if the FDA says this is a drug, and they continue to try to bring it in marked as a supplement? [00:36:18] Speaker 05: The statute could not be clearer, as you'll hear in 12 seconds, Your Honor, that the private bar in the FDCA, the bar on private rights of action is so clear. [00:36:27] Speaker 05: It's only the United States that can address a violation of the FDCA. [00:36:31] Speaker 05: And that is a decision that Congress made. [00:36:32] Speaker 01: So what was your friend from the ITC telling us? [00:36:35] Speaker 01: Wasn't she giving us a different answer to that question? [00:36:38] Speaker 05: So I will try. [00:36:39] Speaker 05: But obviously, it's not our position. [00:36:41] Speaker 05: But I think someday they see if it's an FDA violation, they may have some enforcement authority. [00:36:47] Speaker 05: But that's not what we've been saying and not what the United States has been saying. [00:36:52] Speaker 05: If there's a cause of action that depends on the FDCA, it is barred. [00:36:55] Speaker 05: And that makes a lot of sense, given what we're talking here, which is it's the FDA's role and not the role of the ITC. [00:37:02] Speaker 02: I am once again reminded of Kogo saying, we have met the enemy and he is us. [00:37:08] Speaker 05: Well, I do. [00:37:09] Speaker 05: If I could have just five seconds. [00:37:10] Speaker 05: I know you see a lot. [00:37:10] Speaker 05: Can I just ask one more question? [00:37:12] Speaker 07: I just want to ask you about the jurisdiction. [00:37:14] Speaker 07: If we agree with you on jurisdiction, and also that there's no man-damaged jurisdiction, where would they go to get this issue reviewed by the court about whether the ITC has this authority or not? [00:37:32] Speaker 07: I mean, you think it's clear from the statute that this type of fundamental legal question was Congress intended to preclude review altogether? [00:37:44] Speaker 05: What is the question, Your Honor? [00:37:45] Speaker 05: If it's an FDCA claim, it's not? [00:37:48] Speaker 07: The question whether the ITC can initiate an investigation when it involves an FDCA claim, yes. [00:37:57] Speaker 01: Do they have an APA cause of action or something? [00:38:02] Speaker 05: I'm not in a position to speculate, Your Honor, on how they can. [00:38:07] Speaker 07: But I'm sure you well know that there's a strong presumption of judicial review. [00:38:13] Speaker 07: And to overcome that, Congress has to speak very explicitly. [00:38:18] Speaker 07: And I don't think we see anything in this statute that suggests judicial review of this question is barred altogether. [00:38:25] Speaker 07: It may not be that we're the right forum, but there must be some forum to [00:38:31] Speaker 07: contest the ITC's assertion that it lacks authority. [00:38:36] Speaker 05: So the timing is key. [00:38:39] Speaker 05: What we have here is the agency not doing anything, which really, as you know, I get all that. [00:38:45] Speaker 07: But is it an APA action? [00:38:47] Speaker 07: Is it the agency is failing to properly exercise its authority? [00:38:54] Speaker 07: This can't be the type of unreviewable agency action [00:38:59] Speaker 07: that is precluded in any, either in this statute or in the APA, it just doesn't seem to me like it's altogether unreviewable. [00:39:10] Speaker 05: As you're referring, Your Honor, the APA, of course, plays an important role in guiding agency action. [00:39:16] Speaker 05: And so if they had an argument, then they could run it. [00:39:20] Speaker 05: So I don't want to be coming across as suggesting otherwise. [00:39:23] Speaker 05: I did have one final point, Your Honor. [00:39:25] Speaker 07: I mean, you do see a problem here that if we [00:39:29] Speaker 07: If we proclaim that we lack jurisdiction, I would think that we'd want to at least be assured somewhat that there's jurisdiction somewhere. [00:39:37] Speaker 07: Because I don't think we want to imply that this is an unreviewable question. [00:39:43] Speaker 05: So I think on that one, the way you phrased it there, we may disagree. [00:39:47] Speaker 05: I mean, Congress made a decision here about who should be reviewing the ITC and when. [00:39:52] Speaker 05: And Congress gets reports about the ITC's action, and Congress is entitled [00:39:58] Speaker 05: to monitor this. [00:39:59] Speaker 05: If there's something extreme, Your Honor, which I think is what you're applying, that then down the road maybe there will be an IPA action. [00:40:05] Speaker 05: But the thing that strikes me about this case is that there is no disagreement among the executive branch. [00:40:10] Speaker 05: We have the FDA saying they would like to investigate. [00:40:13] Speaker 05: We have the ITC saying, we agree, a better place to investigate. [00:40:16] Speaker 05: The ITC does IP work. [00:40:18] Speaker 05: doesn't do FDA work. [00:40:19] Speaker 01: FDA is saying we would like to investigate this question? [00:40:24] Speaker 05: The fundamental core question. [00:40:26] Speaker 05: That's why you have a six-page letter detailing why the legal question, the interpretation of the FDCA is something they want to do. [00:40:34] Speaker 05: There will be problems with the executive branch if one agency is doing something [00:40:38] Speaker 05: and the other agency is doing it later. [00:40:40] Speaker 01: Can I ask you one more question about this jurisdictional thing and whether or not we agree with, even assuming we would agree with you that the statute is quite clear in terms of our jurisdiction applying only to those subsections. [00:40:53] Speaker 01: We're also compelled to follow our precedent and our precedent of Amgen [00:40:59] Speaker 01: seems quite clear. [00:41:01] Speaker 01: And your friend tried to describe some daylight in terms of what was going on. [00:41:06] Speaker 01: I'm not seeing the daylight between our case and Amgen and what the court pronounced in Amgen. [00:41:12] Speaker 05: So in Amgen, Your Honor, there was a 188 page decision by the ALJ. [00:41:19] Speaker 05: No matter what words you use to describe that. [00:41:21] Speaker 01: Yeah, but the commission undid that. [00:41:23] Speaker 01: So we're at a different point in time, but it's still to the same end, which is the court said we don't have any authority to be here. [00:41:30] Speaker 05: Yes, but the relevant statutory words, as Your Honor has been emphasizing, is as a result of an investigation. [00:41:35] Speaker 05: When you have an ALJ with an 188-page report, it's really intrinsically on merits determination. [00:41:42] Speaker 01: Yeah, but the statute, no. [00:41:44] Speaker 01: The statutory provision we're talking about doesn't say as a result of an investigation. [00:41:49] Speaker 01: It says a final determination of the commission under subsection D, E, F, and G. So what was Amgen under? [00:41:57] Speaker 05: But Your Honor, when you look at the D through all those provisions, they all either necessarily or by implication assume an investigation. [00:42:05] Speaker 05: So if you start with D, they all say as a result of an investigation. [00:42:11] Speaker 01: So you're saying Amgen came within these. [00:42:14] Speaker 01: And Amgen was just telling us that the opposite of this is the not doing it was also within our jurisdiction. [00:42:21] Speaker 05: In Amgen, I think it's fair to say there was a result of investigation. [00:42:24] Speaker 05: And so that's why there was jurisdiction. [00:42:27] Speaker 05: While here, it's impossible to say there's an investigation because nothing was done except the ruling. [00:42:36] Speaker 01: Thank you. [00:42:37] Speaker ?: Thank you. [00:42:45] Speaker 06: Good morning, and may it please the court. [00:42:47] Speaker 06: Joe Busa on behalf of the United States as amicus. [00:42:50] Speaker 06: We have participated only on the question, the merits of the preclusion question. [00:42:54] Speaker 06: And so I thought it might be most fruitful to start with, Chief Judge Prost, your question about. [00:42:59] Speaker 03: Where are the intervenors? [00:43:00] Speaker 03: I'm sorry. [00:43:01] Speaker 03: I apologize, Your Honor. [00:43:02] Speaker 06: That was my previous. [00:43:05] Speaker 06: So Chief Judge Prost, I thought it might be most helpful. [00:43:08] Speaker 03: Where are the foreign companies? [00:43:10] Speaker 03: Are they not here? [00:43:14] Speaker 05: We represent all the intervenors. [00:43:15] Speaker 06: Oh, OK. [00:43:18] Speaker 06: So you asked if there was guidance forthcoming from FDA on the specific question presented by the regulatory classification of these articles. [00:43:27] Speaker 06: And the answer is no. [00:43:28] Speaker 06: FDA has not made a decision about whether these articles are unapproved new drugs or rather dietary supplements. [00:43:35] Speaker 06: And there is no guidance forthcoming on that specific question. [00:43:38] Speaker 06: I think what you might be remembering is references to draft guidance that FDA has been developing for some years about what does and doesn't constitute a new dietary ingredient that is still in draft form. [00:43:51] Speaker 06: I don't think it is imminently entering final status, although I'm not sure about that. [00:43:56] Speaker 06: But what's crucial is that is general guidance about what counts as a new dietary ingredient. [00:44:03] Speaker 06: that guidance has not been issued. [00:44:05] Speaker 06: It wouldn't specifically resolve the question presented about these articles and whether they are or are not dietary supplements within the meaning of the FDCA. [00:44:14] Speaker 01: So all the guidance people have talked to us about future guidance in the briefs and so forth would not change the position that you would have us take in this case with regard to IDC's authority. [00:44:24] Speaker 06: I don't think so, Your Honor, no. [00:44:26] Speaker 06: And that's because that guidance. [00:44:27] Speaker 01: Don't you think the implication of what was told to us in the briefs or in the letter suggested otherwise? [00:44:32] Speaker 01: And wasn't there a suggestion this morning that, well, yeah, this is denied without prejudice, because when the FDA comes up with sufficient clarity or guidance, we can just do this over? [00:44:45] Speaker 01: There was a suggestion that not that this is imminent, but this is more or less likely to happen. [00:44:51] Speaker 06: I don't know, sir. [00:44:52] Speaker 06: I do believe that the guidance about what constitutes a new dietary ingredient is forthcoming. [00:44:57] Speaker 06: We'll lead the FDA to make a rule. [00:45:01] Speaker 06: Not necessarily with respect to these articles, the guidance is going to help industry figure out whether what they have is a new dietary ingredient or not. [00:45:08] Speaker 01: Well, is the guidance going to be specific enough so that if they file a new complaint with the ITC, the ITC is going to say, yes, we have the authority to review it because we can apply the FDA guidance? [00:45:21] Speaker 01: Or are you going to be here again saying, no, no, no, no, no, this is only within the purview of the FDA? [00:45:26] Speaker 06: Your Honor, the answer is no, they will not be able to hear that further case. [00:45:32] Speaker 06: And that's because [00:45:34] Speaker 06: It takes difficult scientific and technical judgments as well as deep knowledge of the FDC and its regulations to apply even that helpful guidance about new dietary ingredients to any given article and determine whether that article constitutes a dietary supplement or an unapproved new drug. [00:45:52] Speaker 06: That determination is something FDA takes very seriously and it's not possible for [00:45:59] Speaker 06: a non-specialist tribunal to make those kinds of difficult determinations. [00:46:03] Speaker 06: Indeed, that's why Congress assigned to FDA and to FDA alone the ability to enforce the FDCA. [00:46:11] Speaker 06: That's Section 21 U.S.C. [00:46:12] Speaker 06: 337A, Your Honor, which you asked my opposing counsel about. [00:46:17] Speaker 06: And we think the best construction of what it means to bring a proceeding for the enforcement of the FDCA, it's pretty clear right here. [00:46:26] Speaker 06: If you read their complaint from back to front, [00:46:29] Speaker 06: They allege FDCA violations, pages and pages and pages of them. [00:46:34] Speaker 01: So your view is that we don't have jurisdiction, but also we don't have mandamus jurisdiction, because mandamus jurisdiction is not an independent grant of statutory jurisdiction. [00:46:47] Speaker 06: Your Honor, the United States, as amicus, has not taken a position on the judicial reviewability, finality, or mandamus issues presented. [00:46:54] Speaker 06: And that's because of the unique situation arising here, where you have the Commission with independent litigating authority, but you also have deep equities by a coordinate agency inside the federal government. [00:47:07] Speaker 06: We intervene to protect those broader United States interests, and so we have not taken a position on the jurisdiction reviewability issues. [00:47:15] Speaker 06: We've simply argued that should you reach the merits of the preclusion issue here, you should conclude, along with unanimous determination of the other courts of appeals on this subject, that invoking a cause of action under some other statute simply to enforce the FDCA one straight into. [00:47:33] Speaker 07: Does the FDA have the authority to go to a district court and have these kind of articles excluded from importation because they violate the FDA? [00:47:45] Speaker 06: Indeed, Your Honor. [00:47:46] Speaker 06: So it's not just to clarify. [00:47:48] Speaker 06: I don't think they would have to go to the district court. [00:47:50] Speaker 06: I believe there is administrative proceeding in front of the FDA to determine whether, in which the importers participate. [00:47:57] Speaker 06: And they can determine, look, are these articles in violation of the FDCA? [00:48:02] Speaker 06: And then FDA is able to work in conjunction with the customs at the ports of entry into the United States to exclude. [00:48:10] Speaker 03: To what court is that appealed? [00:48:12] Speaker 06: CIT? [00:48:13] Speaker 06: I'm not 100% sure about that, Your Honor, but I do understand that my understanding is that there is APA review of those exclusion or determinations. [00:48:23] Speaker 06: Just in a very similar way to if FDA were to seek to enforce and seek an injunction or criminal liability or civil forfeiture, the FDA would work with DOJ to institute those proceedings by and on behalf of the United States in a district court, and that court would be able to review those determinations. [00:48:42] Speaker 06: Congress has created a specific, highly reticulated and detailed regime to govern these specific articles. [00:48:48] Speaker 06: That is why this regime displaces the application of the Tariff Act [00:48:52] Speaker 06: that Amarin seeks to invoke here. [00:48:55] Speaker 06: And it would upset Congress's decided judgment in reserving exclusive enforcement authority to the FDA to allow private parties like Amarin to come to the Commission or to district courts around the country, circumvent FDA's procedure, and try to obtain enforcement of the FDCA they could not obtain by going to the agency charged with the administration of this statute. [00:49:21] Speaker 03: Surely, eventually, there must be appeals and determinations of excludability, FDA determinations. [00:49:32] Speaker 06: I believe that's correct. [00:49:33] Speaker 06: If FDA comes to a determination on its own enforcement authority that items coming into the country violate the FDCA, FDA then can institute an enforcement action. [00:49:44] Speaker 06: In that case, exclusion of those items from entry into the country, working with the customers. [00:49:50] Speaker 01: So what did your friend have done, precisely? [00:49:52] Speaker 01: trying to get the end he's seeking here. [00:49:54] Speaker 06: Well, that's exactly the crucial point, Your Honor. [00:49:56] Speaker 06: They can come to FDA, and they can tell FDA, we think that our competitors' items are violating the FDCA. [00:50:04] Speaker 06: They're unapproved new drugs. [00:50:05] Speaker 06: We want you to exclude them. [00:50:06] Speaker 06: If the FDA agrees, one, this is an enforcement priority under the statute. [00:50:11] Speaker 01: Is the FDA required to do an investigation on every case? [00:50:15] Speaker 06: Oh, no. [00:50:15] Speaker 06: I don't believe so, Your Honor. [00:50:16] Speaker 06: And that's because Congress reserved exclusively to the FDA the ability to determine [00:50:22] Speaker 06: Look, we have limited resources. [00:50:24] Speaker 06: There are many things the FDA could be pursuing around the country. [00:50:28] Speaker 06: Is this the most important? [00:50:29] Speaker 06: That is a decision that Congress assigned to the FDA, the expert decision makers in this issue. [00:50:35] Speaker 06: Ameren would have you open that exclusivity up with the necessary consequence that there would be cases all around the country in district courts on Lanham Act claims that would force non-expert decision makers to make these very difficult judgments and divide the agency's attention. [00:50:53] Speaker 06: and the agency and Congress made very clear in 21 USC 337A that that was not appropriate. [00:50:59] Speaker 06: Thank you very much. [00:51:07] Speaker 04: Your honors, I'd like to make three points that I think could be helpful to the court. [00:51:10] Speaker 04: Judge Hughes, your question to the Commission's counsel outlines the jurisdictional analysis and I'd like to cite your case that echoes I think your question. [00:51:17] Speaker 04: This is the DC circuit at 750 [00:51:20] Speaker 04: F second, 70, and then 76 to 79. [00:51:23] Speaker 04: That's a Judge Edwards decision. [00:51:25] Speaker 04: That case, the question was, well, the APA doesn't confer you an independent. [00:51:29] Speaker 04: What's the name of it? [00:51:31] Speaker 04: It's Telecoms Research and Action Center versus FCC. [00:51:35] Speaker 04: And what the court says there is that the APA itself does not confer an independent basis of jurisdiction. [00:51:41] Speaker 04: But the court says that when the Court of Appeals ability to review on the merits may be defeated by an agency that fails to resolve disputes, [00:51:48] Speaker 04: A circuit court may resolve claims of unreasonable delay in order to protect its future jurisdiction, and it explains what it means by that, which is that the jurisdiction comes to this court to require the agency action that leads to the potential jurisdiction down the road. [00:52:02] Speaker 04: Second, Judge Prost, your question about the shell means shell. [00:52:07] Speaker 04: All I would suggest to the court is, in addition to looking at that initial language, you read on in Section B, because it specifically not only says that the agency shell, [00:52:16] Speaker 04: institute an investigation upon complaint, it then gives two exceptions. [00:52:20] Speaker 04: In the context of the anti-dumping laws and in copyright infringement, the agency may not when it's wholly dependent on that, and it may in the context of when it's in part. [00:52:30] Speaker 04: So the Congress specifically carved out exceptions where the agency would have discretion. [00:52:34] Speaker 04: This is not one of those. [00:52:35] Speaker 04: Finally, Your Honor, there are requests that you carve out a new exception, a new exception for the FDCA. [00:52:41] Speaker 04: isn't consistent with the analysis of POM Wonderful or the recognition in Allergan that terms in the FDC are not something special. [00:52:48] Speaker 04: The analysis that POM requires is, is there a conflict? [00:52:51] Speaker 04: Your Honor, the government, the attorney from the SG's office tries to create the conflict, but he is just wrong about the scheme. [00:52:58] Speaker 04: FDA does not pre-approve these things. [00:53:00] Speaker 04: These decisions are made by manufacturers every day. [00:53:03] Speaker 04: FDA does not get to decide whether they come in or not. [00:53:06] Speaker 04: They go to a court, and a court has to look at what the law is at the time to decide whether FDA is right or wrong. [00:53:12] Speaker 04: There is nothing that prevents Congress from doing what it did here, which is requiring the Commission to take a look at whether or not these things are or are not, in fact, dietary supplements. [00:53:22] Speaker 04: That's not a difficult decision, but in any event, it's a merits decision. [00:53:26] Speaker 04: If we cannot prove that we're right about this, that the law is clear, then the Commission rules against us on the merits, and you have a full record to review. [00:53:34] Speaker 04: The problem with this case, Your Honor, is that 337A says that the commission and under the ITC is supposed to be, quote, in addition to any other provision of law. [00:53:43] Speaker 04: The FDCA is another provision of law. [00:53:46] Speaker 04: This remedy is in addition. [00:53:48] Speaker 04: It provides us a private right of action. [00:53:49] Speaker 04: We have been thrown out of the commission. [00:53:51] Speaker 04: There is no remedy for us to address the violations of 337 and the Lanham Act. [00:53:56] Speaker 04: FDA does not have authority over the Lanham Act for the 337. [00:54:00] Speaker 04: We would ask the court only to do this, which is to remand to the commission to do what Congress required. [00:54:06] Speaker 04: The legislative branch here trumps the executive branch. [00:54:09] Speaker 04: It directed the commission to initiate an investigation. [00:54:11] Speaker 04: We would be very grateful if the court would direct the commission to do that and address our claims on the merits. [00:54:17] Speaker 04: Thank you for your time. [00:54:18] Speaker 04: I'm very grateful. [00:54:19] Speaker 01: Thank you. [00:54:20] Speaker 01: We thank all the clients and the cases submitted. [00:54:22] Speaker 01: That concludes our proceeding for this morning. [00:54:26] Speaker ?: All right.