[00:00:01] Speaker 03: Good morning, everyone. [00:00:02] Speaker 03: Good morning. [00:00:03] Speaker 03: You seated? [00:00:04] Speaker 03: All right. [00:00:05] Speaker 03: The first case this morning is number 151456, a court of therapeutics against Mylan Pharmaceuticals. [00:00:13] Speaker 03: Mr. Clement, please proceed. [00:00:16] Speaker 03: We appreciate the first two cases overlap. [00:00:18] Speaker 03: We'll take them as they come. [00:00:21] Speaker 02: Thank you, Your Honor. [00:00:21] Speaker 02: It may please the Court. [00:00:23] Speaker 02: There are, as you indicate, two related cases today, and there are also two important issues presented by those cases, one of general jurisdiction [00:00:31] Speaker 02: and one of specific personal jurisdiction. [00:00:33] Speaker 02: With the court's indulgence, I'll start with the first of those two issues. [00:00:37] Speaker 01: The Supreme Court, in its Daimler opinion, is- Can you start with the specific jurisdiction, just to reflect at least the way I'm thinking about this case? [00:00:46] Speaker 01: Sure. [00:00:46] Speaker 01: So the reason there's a case of controversy in this artificial act of infringement, I want you to tell me why what I'm thinking is incorrect. [00:00:56] Speaker 01: is that Congress has reasonably determined that the filing of an and application has a close enough causal connection to the only thing that will actually harm the pioneer drug company, which is the actual ultimate competition. [00:01:10] Speaker 01: You undisputedly plan to compete directly or indirectly in Delaware. [00:01:18] Speaker 01: Why isn't that enough? [00:01:19] Speaker 02: Well, it's not enough, Your Honor, I think, because plans, future intents are not enough to support [00:01:26] Speaker 02: specific personal jurisdiction right now. [00:01:28] Speaker 01: Why not? [00:01:29] Speaker 01: I mean, it seems to me either they're not enough for there to be an Article III case of controversy, or they're enough to support specific personal jurisdiction. [00:01:38] Speaker 02: I don't think that follows, Your Honor. [00:01:40] Speaker 02: And I think that if your logic actually were correct, there wouldn't be any need for Congress to create the artificial act of infringement that is the filing of the paragraph. [00:01:50] Speaker 01: That seems to me to be not true. [00:01:52] Speaker 01: And one aspect of Congress's power [00:01:55] Speaker 01: to create a case of controversy that wouldn't otherwise exist has to do not with the injury and fact element, but with the attenuation of the cause of chain. [00:02:06] Speaker 01: That's what the Supreme Court said in the Massachusetts EPA case. [00:02:09] Speaker 01: We've said that I think a couple of times recently in Apotex and [00:02:13] Speaker 01: and earlier Sandow's case, Congress can, in fact, take a causal chain that might otherwise be too attenuated and say, no, this is close enough. [00:02:23] Speaker 01: Why isn't that what Congress has done here so that Mylan, by filing an and application, has sufficiently announced its intent to compete in Delaware? [00:02:37] Speaker 02: Well, I don't think that's what it's done. [00:02:38] Speaker 02: It certainly hasn't announced any greater intent to compete in Delaware [00:02:43] Speaker 02: than in any other jurisdiction in the country. [00:02:45] Speaker 01: So why isn't there a specific jurisdiction anywhere? [00:02:48] Speaker 02: Well, I think that's a sufficiently jarring conclusion right there to make me at least have some pause to think that there's actually specific personal jurisdiction in all 50 states. [00:02:59] Speaker 04: And I also think with all... Isn't it true though, even if you could argue that the act of infringement, because you've sought approval to act in every single state, [00:03:11] Speaker 04: that wouldn't necessarily translate to specific jurisdiction in every state, because you still have the overlay of the reasonableness analysis that has to be done. [00:03:20] Speaker 02: Well, I mean, I suppose that's true. [00:03:23] Speaker 02: But I guess what I'd like to say is I think the logic of this argument, first of all, you've got to get over the minimum contact specific availment sort of prong before you even get to substantial justice in fair play. [00:03:37] Speaker 02: And so I think the problem is if there is jurisdiction in any jurisdiction because of the act of filing the ANDA, it would logically be in Maryland. [00:03:48] Speaker 02: Now, this court's Zeneca decision is an obstacle to that, to be sure, and I'm happy to talk about that. [00:03:52] Speaker 02: But we haven't purposefully availed ourselves of Delaware at all. [00:03:56] Speaker 02: And with all due respect to your honor, I think there is a problem with the analysis that you're parsing it true, because I mean, [00:04:04] Speaker 02: obviously have thought about this and you put it in terms of intent to compete. [00:04:08] Speaker 02: But that's certainly not the way my friends on the other side talk about it. [00:04:11] Speaker 02: I think they talk about it the way you would more logically talk about it with all due respect, which is they talk about this future act of infringement that will take place in Delaware. [00:04:21] Speaker 02: But of course, the whole design of the Hatch-Waxman Acts is actually to prevent there from being an infringing sale in Delaware. [00:04:28] Speaker 01: And if there is an infringing sale in Delaware in the future, then... I assume you don't doubt that one can sustain specific personal jurisdiction on the basis of a planned act, something that has not yet occurred as long as it is sufficiently planned and directed to the place. [00:04:51] Speaker 01: That is, you can have injunctive actions to prevent harm [00:04:55] Speaker 01: that is going to be directed into the state, right? [00:04:58] Speaker 01: Specific personal jurisdiction isn't limited to retrospective relief for already occurring. [00:05:04] Speaker 02: I would certainly concede that, Your Honor, but I don't think there's any support for the proposition that purely future acts that may or may not take place. [00:05:13] Speaker 02: And it's also worth taking into account here that once you file the paragraph four certification and the ANDA, there are a lot of different [00:05:21] Speaker 02: off-ramps, if you will, that may prevent a generic company from ever marketing the drug in any state, let alone a specific state. [00:05:29] Speaker 01: Can you explain why there's a case or controversy in the absence of a sufficient likely connection to the future competition? [00:05:40] Speaker 01: I mean, you get an FDA approval. [00:05:41] Speaker 01: It makes nothing happen. [00:05:44] Speaker 01: It doesn't affect them one bit unless there's an actual likelihood that you're going to use it, right? [00:05:51] Speaker 02: Well, I think, I'm not sure that's right, which is to say, I think that once we call into question the validity of the patent, that there may be enough there to get you over the Article III minimum without regard to contemplating how that is going to be implemented in a marketed [00:06:12] Speaker 02: product, because if we get the invalidation of their patent, I think they've suffered an injury. [00:06:16] Speaker 01: I'm sorry, but you don't get an invalidation unless you get into court. [00:06:19] Speaker 01: So what is it that gets you into court? [00:06:21] Speaker 01: There must be a case of controversy. [00:06:24] Speaker 01: You must be threatening an injury in fact. [00:06:27] Speaker 01: And I guess I'm having a hard time understanding what that is other than the competition that you will bring to bear once you use the approval. [00:06:41] Speaker 02: I think it's the threat to their patent. [00:06:43] Speaker 02: I think that's sufficient to get you over the minimum Article III hump. [00:06:47] Speaker 04: Is it your position that Hatch-Waxman, by creating this artificial act of infringement, that that provision is simply giving rise to a cause of action as opposed to an actual act of infringement? [00:07:04] Speaker 02: It's a bit metaphysical, I guess, which is to say it's a highly artificial act of infringement. [00:07:10] Speaker 02: It is, I think, necessitated by Congress's reality that just by filing it, we haven't actually threatened a future sale in all 50 states. [00:07:19] Speaker 02: I think if that were the case, you wouldn't even need to treat the paragraph four filing as this artificial act of infringement. [00:07:26] Speaker 02: You just contemplate the [00:07:29] Speaker 02: thousands of infringement actions that could eventually be contemplated. [00:07:33] Speaker 04: I don't think that's the way anybody's ever thought of the filing of the- Of course you need the artificial act of infringement because the whole point of Hatch-Waxman is to allow a resolution before the actual commercial sale, right? [00:07:51] Speaker 02: Exactly, Your Honor. [00:07:52] Speaker 04: Exactly. [00:07:53] Speaker 04: But the problem is they had to do that because they protected all the prior activity that would have been subject to an infringement action. [00:08:01] Speaker 02: Absolutely. [00:08:02] Speaker 02: And they want to encourage generics, not discourage them. [00:08:06] Speaker 02: So they don't want to put them in the position that by doing the contemplation and the actions that would be necessary in advance of the paragraph 4 certification, that they then are in a position where they've already infringed. [00:08:18] Speaker 03: You're not presenting [00:08:20] Speaker 03: the case, which would really be, I think, unique in the Hatch-Waxman litigation, that there is not an act of infringement, whether you call it artificial or statutory or anything else. [00:08:33] Speaker 03: Hatch-Waxman provides this is an act of infringement. [00:08:37] Speaker 03: You have an obligation to file suit within a relatively short period of time or else school's out. [00:08:44] Speaker 03: And so it seems to me that what I hear you saying is that despite what [00:08:50] Speaker 03: I think is undisputed that there is an act of infringement. [00:08:54] Speaker 03: There is neither specific nor general jurisdiction in Delaware. [00:09:02] Speaker 02: Absolutely, Judge Newman. [00:09:03] Speaker 02: That is our humble point. [00:09:05] Speaker 02: I'm trying to be responsive to Judge Toronto's line of questioning, but I do think when we file the paragraph for certification, I do not think the right way to think about that is that that is in any way directed at Delaware. [00:09:21] Speaker 03: Why should the forum be chosen any differently in this case? [00:09:28] Speaker 03: You aren't disputing that there'd be jurisdiction in the state of incorporation. [00:09:33] Speaker 02: No, there's clearly jurisdiction in West Virginia, which is where my client is incorporated. [00:09:38] Speaker 03: And that one should disregard acts or at least the consideration of acts that otherwise could very well be relevant to [00:09:52] Speaker 03: Specific jurisdiction? [00:09:55] Speaker 02: Well, we're not asking for a special rule. [00:09:57] Speaker 02: We just don't think there are any other specific acts directed at Delaware that are jurisdictionally relevant. [00:10:05] Speaker 04: But it's your position that there is no specific jurisdiction anywhere, correct? [00:10:10] Speaker 02: No, I don't think that actually follows, Your Honor. [00:10:12] Speaker 02: I think actually, I mean, I think the logical place where there also could be specific personal jurisdiction is where the ANDA is prepared. [00:10:21] Speaker 04: How could that be when those acts are protected by statute from claims of infringement? [00:10:27] Speaker 02: Well, I still think they are protected, but I still think they are jurisdictionally relevant acts. [00:10:33] Speaker 02: So I think if, for example, Mylan has its headquarters is in West Virginia, but it has offices in Pennsylvania. [00:10:40] Speaker 02: If it, contrary to the facts of this case, had prepared the ANDA in Pennsylvania, I think there might be a good argument that there would be specific personal jurisdiction [00:10:50] Speaker 02: over my client in Pennsylvania. [00:10:53] Speaker 04: Here, I don't take issue that there is a- So you think all the pre-filing activity would be relevant jurisdictionally, even if not enough to create a cause of action? [00:11:05] Speaker 02: Yeah, I think that's right. [00:11:05] Speaker 02: Even immunized activity, I think, can be relevant for specific personal jurisdiction. [00:11:11] Speaker 02: So even if you want to think about it in the strongest form, that those pre-filing acts are immunized from liability, I think they're still relevant [00:11:18] Speaker 02: for the specific personal jurisdiction analysis. [00:11:21] Speaker 04: And does it remain your view that Mallin was right in Zeneca to argue that there is no active infringement in the state of Maryland? [00:11:30] Speaker 02: I do think that's right. [00:11:31] Speaker 02: I think that's right for reasons that are kind of unique to the fact that there's a federal facility there, and it's sort of a happenstance that the FDA is located in Maryland. [00:11:42] Speaker 02: Of course, if the other side's right, and if Judge Toronto's theory is right, [00:11:46] Speaker 02: then the Zeneca decision's actually wrong, or at least just missed the obvious reason why there actually is specific personal jurisdiction, or at least minimum contacts with Maryland, which is, under their theory, their specific personal jurisdiction in all 50 states. [00:12:00] Speaker 01: Can I ask you, I guess, a non-legal question? [00:12:05] Speaker 01: Either in your own ANDA filings, or more generally under FDA regulations or whatnot, does an ANDA applicant [00:12:14] Speaker 01: declare in any way an intent to use the approval being sought to enter a market? [00:12:24] Speaker 02: I'm not a hundred percent sure. [00:12:26] Speaker 02: I'll try to get you an answer to that, but I'm not a hundred percent sure. [00:12:29] Speaker 02: It's not obvious to me why that's a statutory requirement, but I don't want to give you an answer that I'm not prepared to give. [00:12:35] Speaker 04: I understand that these circumstances are unique because of the structure of Hatch-Waxman, but do you have any [00:12:41] Speaker 04: I didn't see any cases cited for the proposition that exempt acts can be jurisdictionally relevant. [00:12:50] Speaker 02: I don't know that the question had specifically come up. [00:12:53] Speaker 02: I didn't really view it as a part of my friends on the other side's argument. [00:12:57] Speaker 02: So I don't know that we've really specifically looked into the question in that way. [00:13:00] Speaker 02: I really don't see any reason why that wouldn't be true. [00:13:05] Speaker 02: And I've looked at a lot of personal jurisdiction cases. [00:13:09] Speaker 02: And there's just nothing in those cases that suggests that whether your act is itself immune or exempt, that somehow that makes it jurisdictionally irrelevant. [00:13:19] Speaker 02: I mean, I think what the court's case is, and particularly if we're talking about specific personal jurisdiction after Walden make clear, is that it's the defendant's contacts with the forum that matter. [00:13:32] Speaker 02: And that's why in answer to Judge Newman's question, I don't view us as asking for any special rule here whatsoever. [00:13:39] Speaker 02: The logic of the district court opinions here is that because we provided the statutorily required notification to companies that are headquartered in Delaware, that somehow we therefore should have known that we would be liable to suit in Delaware. [00:13:55] Speaker 03: Well, then those weren't there. [00:13:56] Speaker 03: Only conditions. [00:13:57] Speaker 03: We'll hear from Mr. Olson. [00:13:59] Speaker 03: But I think he will tell us that there are many contacts with Delaware that ought to provide specific jurisdiction. [00:14:08] Speaker 02: Well, Judge Newman, I'll listen for those as well, because what matters is not just contacts with Delaware, but they are the defendant's litigation-related contacts with Delaware. [00:14:18] Speaker 02: And that's what's missing in this case, because they're located in Delaware. [00:14:23] Speaker 02: In this case, we filed the statutorily required notification letter in New York, but to a Delaware corporation. [00:14:30] Speaker 02: So they're located in Delaware. [00:14:32] Speaker 02: They have some ongoing suits against other generics in Delaware. [00:14:36] Speaker 02: But again, that's their contacts, not our contacts. [00:14:39] Speaker 02: And then with respect to Delaware more generally, I'm not here to tell you that, at least through distributors, that we do no business in Delaware. [00:14:47] Speaker 02: But that's not suit-related contact. [00:14:49] Speaker 02: And so with respect to suit-related contacts of the defendant in Delaware, I dare say they come pretty close to the null set. [00:14:57] Speaker 03: But doesn't that take us back to cases like Beverly Hills Fan and many of the general cases that look to the specific facts? [00:15:06] Speaker 03: of the particular relationship with the forum and then the fairness of suit in that forum and the specific situation? [00:15:17] Speaker 02: Absolutely, Your Honor. [00:15:18] Speaker 02: But in Beverly Hills fan, you actually had the company was selling the product in Virginia at the time, the alleged, the relevant product in Virginia. [00:15:28] Speaker 02: That's not happening here. [00:15:30] Speaker 02: The other thing, at least as I read the court's opinion, that was really driving the analysis in the Beverly Hills case [00:15:36] Speaker 02: is that there was no other obvious forum for that litigation. [00:15:40] Speaker 02: And that is not a problem we have here. [00:15:42] Speaker 02: There is a pending suit in West Virginia. [00:15:44] Speaker 02: We admit to personal jurisdiction in West Virginia, but that's where the suit should be brought. [00:15:49] Speaker 03: What I'm really trying to think through is the uniqueness of Hatch-Waxman and its artificial premises and whether, in fact, or we know that since that relates to the entire structure of [00:16:06] Speaker 03: present, future infringement, that we do need to look at how future plans might affect jurisdiction? [00:16:16] Speaker 02: Well, two things, Your Honor. [00:16:18] Speaker 02: One is that, and I think this would be common ground among all the parties, I mean, Congress and the Hatch-Waxman can't have, can't trump the defendant's personal jurisdiction's rights. [00:16:29] Speaker 02: So even if it would be convenient in Hatch-Waxman litigation [00:16:33] Speaker 02: to continue the status quo ante, which was general jurisdiction cases being filed in Delaware. [00:16:38] Speaker 02: Even if that's convenient, that can't trump my client's rights. [00:16:41] Speaker 02: But second, and I think most important, Congress thought about this, at least if you look to legislative history. [00:16:47] Speaker 02: And in the House report that's at page 10 of the generic pharma brief, Congress had a solution in mind to this, which is you'd use the normal means of consolidating litigation and multi-district litigation [00:17:01] Speaker 02: to deal with these problems. [00:17:02] Speaker 02: There's nothing so unique about Hatch-Waxman. [00:17:04] Speaker 04: The committee report talked about that, but there's nothing in the statute that says that that's the only mechanism. [00:17:09] Speaker 02: No, I agree. [00:17:11] Speaker 02: But to those that look to committee reports, that committee report is much more directly on point than anything on the other side of this case. [00:17:20] Speaker 02: And it does seem to me quite telling that Congress, when it thought about this, didn't say, well, of course we're going to have a super court somewhere. [00:17:27] Speaker 02: And by the way, if you're going to have a super court somewhere, I think more logically, it would be Maryland, not Delaware. [00:17:32] Speaker 02: I mean, why Delaware? [00:17:35] Speaker 04: Let me ask you this. [00:17:36] Speaker 04: In response to Judge Toronto, you said that the case of controversy is created because you've attacked the validity of the patent by the filing. [00:17:46] Speaker 04: Now, why isn't that akin to the defamation that occurs in Calder and that you would apply the effects test? [00:17:54] Speaker 04: Why doesn't that put you closer to Calder than it does to Walton? [00:17:57] Speaker 02: Well, I really think after Walden, Calder is the exception and Calder is the general rule. [00:18:04] Speaker 02: And as I read the court's Calder, rather read the court's Walden decision, what is so relevant there about the defamation tort at issue in Calder is that it is actually an element of the tort that there be third party injury. [00:18:17] Speaker 04: But in Walden, there was just fortuitous [00:18:21] Speaker 04: connection between the plaintiff and the defendant in another state that gave rise to the tort. [00:18:26] Speaker 04: Here, much like Calder, you knew full well who you were directing your paragraph for certification to. [00:18:35] Speaker 02: With all due respect, Your Honor, I think that is exactly the analysis that the Supreme Court rejected in the Walden case. [00:18:43] Speaker 02: Because remember, the Walden case, there were multiple claims. [00:18:47] Speaker 02: But the claim that the Ninth Circuit let go forward [00:18:50] Speaker 02: was not the claim for the unlawful seizure of the money in the airport in Georgia, where the connection to Nevada was quite fortuitous. [00:18:58] Speaker 02: The claim that the Ninth Circuit allowed to go forward was the claim about the false affidavit that they alleged that the officer put in once the individuals were already back in Nevada. [00:19:09] Speaker 02: And the arguments, if you look at the footnotes in Justice Thomas's decision, the arguments that the plaintiffs made in Walden are exactly the same arguments. [00:19:19] Speaker 02: that my friends on the other side are making here. [00:19:21] Speaker 02: They said, well, you had somebody who was in Nevada. [00:19:24] Speaker 02: The alleged tortfeasor knew they were in Nevada. [00:19:27] Speaker 02: And by putting in the false affidavit, they were knowingly targeting somebody who was resident there. [00:19:32] Speaker 02: And the court, I think, cannot be more emphatic that it is not the plaintiff's connection with the forum that matters. [00:19:40] Speaker 02: What matters are the defendants, my clients, litigation-related contacts with the forum. [00:19:46] Speaker 02: And those are what are just simply absent in this case. [00:19:49] Speaker 02: And to be sure, they're absent in part because of the nature of the Hatch-Waxman Act. [00:19:55] Speaker 02: I'll grant you that. [00:19:56] Speaker 02: And that might be a source of concern if there were no form for this litigation. [00:20:00] Speaker 02: But there's a perfectly rational and available form for this litigation, which is West Virginia, where I think there's both specific and general jurisdiction vis-a-vis my client. [00:20:10] Speaker 02: I see I'm over my time. [00:20:11] Speaker 03: Let's hear from the other side, and we'll work out the timing. [00:20:15] Speaker 03: Mr. Olson. [00:20:19] Speaker 00: Thank you, Your Honors. [00:20:20] Speaker 00: May it please the Court. [00:20:22] Speaker 00: I will turn to the specific jurisdiction point, although I would plan to turn to the general jurisdiction point, time permitting. [00:20:30] Speaker 00: Congress decided in this statute that there was a clear, present, immediate infringement. [00:20:38] Speaker 00: Congress passed a law that says that the ANDA itself and the paragraph four certification [00:20:45] Speaker 00: constitutes infringement. [00:20:46] Speaker 00: I know the court and the Supreme Court used the word artificial, but the Congress used the word infringement. [00:20:52] Speaker 00: That triggered immediate, present harm. [00:20:56] Speaker 04: But why shouldn't we just look at that provision of the Hatch-Waxman Act as creating the cause of action? [00:21:04] Speaker 04: In other words, creating the artificial case of controversy, but not creating jurisdictionally relevant conduct. [00:21:14] Speaker 00: I don't think there is such a thing as artificial case or controversy. [00:21:17] Speaker 00: There is a case or controversy because Congress decided that filing the ANDA and the paragraph four certification in and of itself constitutes infringement. [00:21:28] Speaker 01: I don't understand that. [00:21:30] Speaker 01: You said there's a case of controversy, including an injury in fact, the most fundamental requirement of Article III, simply because Congress put a label of infringement on something somebody did? [00:21:43] Speaker 00: Congress determines under the Constitution what constitutes infringement of a patent. [00:21:49] Speaker 01: Infringement is not an Article III word. [00:21:53] Speaker 01: What's the injury in fact? [00:21:55] Speaker 00: The injury is a threat to [00:21:58] Speaker 00: the validity of the patent held by my clients, the jeopardy that it puts it in, that patents are put in as a result of the ANDA process that takes place. [00:22:12] Speaker 01: Congress called this... What state does Mylan have? [00:22:16] Speaker 01: in that question unless Mylan plans to take sales away from you. [00:22:22] Speaker 00: And that's exactly what Mylan plans to do. [00:22:25] Speaker 00: That is why the ANDA is filed. [00:22:27] Speaker 00: That's why the paragraph four certification is. [00:22:30] Speaker 00: That's why the Supreme Court called this a provocation to litigation. [00:22:34] Speaker 00: It is a clear, present, right now infringement. [00:22:38] Speaker 00: The act of infringement, whether there are sales or not, the act of infringement threatens [00:22:46] Speaker 00: what Mylan owns in Delaware and other places where Mylan intends to sell this product. [00:22:54] Speaker 00: It's announced in intention. [00:22:55] Speaker 01: Do you know by the way, can I just ask you the same question I asked Mr. Clement, is there some aspect of Mylan's filing or every ANDA applicant's filing that says we intend to use the approval once you give it to us? [00:23:13] Speaker 01: to market a drug. [00:23:14] Speaker 00: Well, that is the announced intention. [00:23:16] Speaker 00: That's the only reason why you would file the ANDA. [00:23:18] Speaker 00: That's the purpose for it. [00:23:20] Speaker 01: I'm trying to ask a very specific question. [00:23:22] Speaker 01: Do they declare that in the hand of filing or someplace else? [00:23:29] Speaker 00: Not in so many words. [00:23:30] Speaker 00: It doesn't say we intend to do this and we'll do it no matter what. [00:23:33] Speaker 01: It seems awfully intuitive that that's why you would go to the trouble. [00:23:37] Speaker 01: I'm just asking a very specific question. [00:23:38] Speaker 00: No. [00:23:38] Speaker 00: And I'm answering that question by saying that's the whole purpose of the statutory scheme, to put this in play, to cause an immediate present threat. [00:23:47] Speaker 00: Now, in addition, of course, what Mylan has done is not only threatened to market the products in Delaware or other states, it is also registered to do business in Delaware. [00:24:03] Speaker 00: It is registered to sell, manufacture, and distribute products in Delaware. [00:24:09] Speaker 00: It is licensed to do business by the pharmacy board in Delaware. [00:24:14] Speaker 00: It is engaged in litigation in Delaware in some 50 cases. [00:24:18] Speaker 04: That all goes to the fairness issue. [00:24:21] Speaker 04: But I think that Mr. Clement would argue to you that you're missing the middle piece here, which is the acts related to the cause of action that occur in the state. [00:24:33] Speaker 04: So you have to say that either the act of infringement occurs within the state of Delaware or that we are allowed to look at [00:24:44] Speaker 04: at potential future acts for purposes of establishing jurisdiction. [00:24:50] Speaker 00: And I submit both is true. [00:24:51] Speaker 00: Because the Congress itself decided that the infringement takes place when the ANDA and the paragraph four certification take place. [00:24:59] Speaker 00: What is an infringement? [00:25:00] Speaker 00: It's an invasion of someone else's rights. [00:25:04] Speaker 00: That invasion takes place, just like in the Calder case or in the Keaton case, where the defendant is going to be hurt, where the plaintiff is going to be hurt. [00:25:13] Speaker 00: will be hurt, is hurt by the publication, is hurt by the infringement. [00:25:17] Speaker 04: The infringement occurs where the plaintiff is going to be hurt? [00:25:20] Speaker 04: Is that what you said? [00:25:20] Speaker 00: The infringement is an invasion of the rights of the plaintiff. [00:25:26] Speaker 00: The plaintiff is in Delaware. [00:25:28] Speaker 00: The plaintiff is in other states as well. [00:25:30] Speaker 00: But the plaintiff is in Delaware. [00:25:32] Speaker 00: If you're going to infringe someone's patent, you're threatening their rights. [00:25:38] Speaker 00: You're undermining their rights. [00:25:40] Speaker 00: And you're doing that where that [00:25:42] Speaker 04: So are you saying that in a normal circumstance, say I'm a regional seller and I only sell in two or three states, that if I sell an infringing product in those states, that you then consume me in your home, if it's in a different state, just because that's where you own the patent? [00:26:03] Speaker 00: It may well be that under certain subject to the fair and reasonable limitation, [00:26:08] Speaker 00: that that's damage done to the owner of the product. [00:26:12] Speaker 00: And I think that's entirely consistent. [00:26:16] Speaker 00: But there are all these other factors that we've cited that's in the briefs. [00:26:20] Speaker 00: It's not just intending infringing sales. [00:26:23] Speaker 00: It's registration at due business. [00:26:26] Speaker 00: It's registration with the pharmacy board. [00:26:29] Speaker 00: It's past sales. [00:26:30] Speaker 00: It's litigation as a plaintiff and a defendant in Delaware. [00:26:34] Speaker 00: The purpose of the Hatch-Waxman Act is to facilitate [00:26:37] Speaker 00: this very litigation because the patent owner is hurt by the process itself. [00:26:43] Speaker 04: So the purpose of the Hatch-Waxman Act is to give rise to litigation that can occur before the sales happen, right? [00:26:51] Speaker 04: Yes. [00:26:52] Speaker 04: But there's nothing in the Hatch-Waxman Act that says where the litigation is supposed to occur. [00:26:57] Speaker 00: That's correct. [00:26:58] Speaker 00: It does not say that, but it does say that the process creates an infringement when it is initiated by the defendant. [00:27:07] Speaker 00: Let me turn momentarily, while I still have time, to the general jurisdiction point, because I think it's very fundamental. [00:27:15] Speaker 00: In 2010, Mylan chose to register to manufacture, distribute, and sell pharmaceuticals in Delaware, knowing full well that 22 years earlier, the Delaware Supreme Court clearly and unambiguously held that doing so [00:27:35] Speaker 00: doing what Midland did in 2010 would constitute consent to jurisdiction, general jurisdiction in Delaware. [00:27:45] Speaker 00: The United States Supreme Court has held that such content is voluntary, constitutional, and effective to waive objections to general jurisdiction. [00:27:57] Speaker 01: There is no... Can I ask you this question, which maybe bears, or at least you argue about this, [00:28:05] Speaker 01: in addressing, I guess it's the chamber's argument about unconstitutional conditions. [00:28:10] Speaker 01: And I think both you and I guess AstraZeneca have what seem to me to be all of one sentence that gets at the point, which says, well, of course, Delaware has a strong interest in [00:28:27] Speaker 01: saying if you want to do business in our state, you must consent to be sued in our state on causes of action having nothing to do with our state. [00:28:39] Speaker 01: It's a sentence. [00:28:40] Speaker 01: It's a nice assertion. [00:28:41] Speaker 00: Tell me why that's... Well, in the first place, this is an argument that was not raised by... I understand that. [00:28:46] Speaker 00: And under this court's jurisdiction in the Amoco case, [00:28:50] Speaker 00: If it's not briefed in the opening brief, it is waived. [00:28:53] Speaker 01: Tell me why Delaware actually has an interest in saying, if you want to do business here, you have to be suable on causes of action that don't concern us. [00:29:02] Speaker 00: Well, I might say, first of all, I will answer that question. [00:29:05] Speaker 00: But first of all, the Supreme Court of the United States has already answered this in the Nearbow case. [00:29:10] Speaker 00: It says this is in the nature of a contractual relationship. [00:29:14] Speaker 00: In order to do business here and to have access to our courts, [00:29:18] Speaker 00: You must consent to jurisdiction in our courts so that you not only have the right to participate and bring cases in our courts, but you have the responsibility and burden to be responsive in those courts to citizens bringing cases here. [00:29:33] Speaker 00: In the Neurbo case, the Supreme Court said that's a contractual type relationship. [00:29:38] Speaker 00: It is a voluntary decision by the party doing business. [00:29:42] Speaker 01: And it is constitutional. [00:29:45] Speaker 01: I think I understand the Supreme Court's [00:29:47] Speaker 01: due process cases on this point. [00:29:50] Speaker 01: Do you think that there's any daylight between that analysis and an unconstitutional conditions analysis? [00:29:57] Speaker 00: No, because this is not... My colleague here would have raised that point had he thought that this was an unconstitutional condition point. [00:30:09] Speaker 00: He didn't raise it. [00:30:10] Speaker 00: He didn't brief it. [00:30:11] Speaker 00: It's in one sentence in a footnote in the reply brief. [00:30:14] Speaker 00: The Supreme Court has already decided in that connection, in the connection of registration to do business as consent to general jurisdiction in the nearbow case that it was constitutional, that is a precedent that's binding on this court. [00:30:28] Speaker 04: How is that different though than the fact that the state of Ohio was not allowed to say that as a condition of doing business in Ohio, [00:30:36] Speaker 04: you either have to consent to jurisdiction or you have to waive the running of the statute of limitations. [00:30:43] Speaker 04: And the Supreme Court said that was an undue burden on commerce. [00:30:46] Speaker 00: Yes, but this is a different situation. [00:30:49] Speaker 00: This is directly related and tied to the fact that you're being given the opportunity to participate in the courts of the state of Delaware. [00:30:59] Speaker 00: You do not have to register to do business. [00:31:02] Speaker 00: You do not have to do business in Delaware. [00:31:05] Speaker 00: Once you do, you do not have to register to do business in Delaware. [00:31:09] Speaker 00: There are consequences. [00:31:10] Speaker 00: And my colleague points this out in his brief. [00:31:13] Speaker 00: He says that you're going to provide an incentive for corporations not to do business in particular states or not to register to do business in particular states. [00:31:22] Speaker 00: It's right in the brief. [00:31:24] Speaker 00: So there's a voluntary choice here. [00:31:26] Speaker 00: You're entering commerce in the state of Delaware. [00:31:29] Speaker 00: A part of that bargain, as the United States Supreme Court put it in the NIRBO, [00:31:35] Speaker 00: Part of that bargain is your consent then to the burdens and making yourself available to suit. [00:31:41] Speaker 00: You're using our courts to bring suits. [00:31:43] Speaker 00: You're going to have to be responsive to people who bring suits against you in our courts. [00:31:48] Speaker 00: That's a reasonable transaction. [00:31:50] Speaker 00: That doesn't have anything to do with the statute of limitations or the removal case that is also mentioned in the briefs. [00:31:57] Speaker 00: This is a reasonable relationship. [00:31:59] Speaker 00: It's a reasonable exchange. [00:32:01] Speaker 00: The Supreme Court has already found that. [00:32:03] Speaker 00: The Supreme Court has also said in a number of cases that the right to personal jurisdiction is a right of personal liberty, and it is waivable. [00:32:15] Speaker 00: That's not contested. [00:32:17] Speaker 00: And then the Robert Mitchell Furniture case. [00:32:22] Speaker 04: If this is so important and so basic a principle, why is it that in Daimler they didn't begin with the question of whether or not Mercedes-Benz was [00:32:32] Speaker 04: registered to do business in California. [00:32:34] Speaker 00: The Deimer case specifically refers to the Perkins case and the Goodyear case as cases, as those cases said, where there was not consent to do business. [00:32:44] Speaker 00: The Deimer case was focusing, and it was briefed and argued. [00:32:48] Speaker 00: The only reference in the argument in the Deimer case was a question by Justice Ginsburg saying, well, of course, you can always consent to jurisdiction. [00:32:57] Speaker 00: And the government attorney, Deputy Solicitor General Needler said, yes, of course. [00:33:02] Speaker 00: That was the only reference in that case at all. [00:33:05] Speaker 00: The Supreme Court in Daimler specifically said, I can't remember the page number, but it specifically said, referring to the Perkins case and the Goodyear case, that those were cases where there had not been consent to jurisdiction. [00:33:19] Speaker 00: And the fact is that the Goodyear case is the very first case cited in the Daimler case [00:33:25] Speaker 00: And as Justice Ginsburg knew what she was talking about, she referred to the Goodyear case something like 15 times. [00:33:32] Speaker 00: I went through this yesterday. [00:33:33] Speaker 00: 15 times in the course of her opinion. [00:33:36] Speaker 00: She knew that Goodyear was a case where there had not been consent. [00:33:40] Speaker 00: And then that case and the Daimler case refers to the Perkins case as a textbook case of general jurisdiction and minimal contacts where there had not been consent to jurisdiction. [00:33:52] Speaker 00: So we have a syllogism in a sense. [00:33:55] Speaker 00: There's no question that this is a personal right, that no question it may be waived. [00:34:01] Speaker 00: There's no question what Delaware law was very clear. [00:34:04] Speaker 00: The Robert Mitchell case makes clear that if the state makes it clear in a statute or by construction, then it is something that's clear, ambiguous, and available to Milan to consider. [00:34:18] Speaker 00: 22 years after that decision, knowing that the decision had been made, knowing that this was a waivable right, it went ahead and waived those rights and petitioned, signed up to do business in Delaware, knowing all of those things. [00:34:33] Speaker 00: So there was really no question about it. [00:34:36] Speaker 00: The cases by the United States Supreme Court that says that this is constitutional and constitutes consent to general jurisdiction cannot be overturned by this court. [00:34:47] Speaker 00: Even if you were inclined to do so, I can't imagine that you would be. [00:34:51] Speaker 00: But those are binding on this court. [00:34:54] Speaker 00: Mr. Clement, in his brief, says those are holdings of the United States Supreme Court. [00:34:59] Speaker 00: Because he calls them discredited or archaic, it doesn't mean that they are not the law of the United States Supreme Court. [00:35:08] Speaker 00: That constitutes general jurisdiction, in addition to the strong points that support specific jurisdiction in these cases [00:35:16] Speaker 00: because of the way Hatch-Waxman Act is set up. [00:35:19] Speaker 03: So to be clear, to focus is your primary argument that by consenting to suit in Delaware, that that is a critical aspect in the total environment of the interactions and relations with Delaware that solves the jurisdictional issue. [00:35:41] Speaker 00: Well, my primary point are, too, Your Honor, that there is unequivocal consent to jurisdiction. [00:35:49] Speaker 00: That should end it. [00:35:50] Speaker 00: Yes, that's unequivocal. [00:35:51] Speaker 00: And then with respect to specific jurisdiction, that is a factor that comes into the court's consideration with respect to whether there is litigation-related conduct by Mylan in Delaware. [00:36:06] Speaker 00: The invasion of the rights of a Delaware citizen [00:36:11] Speaker 00: where Milan has announced its intention to do something. [00:36:15] Speaker 00: The simple announcement under HMAD Act is an infringement of the rights of this company. [00:36:21] Speaker 00: Milan has been doing business in Delaware for a long period of time and has participated in the Delaware court. [00:36:28] Speaker 00: All of those support specific jurisdiction in this case. [00:36:32] Speaker 00: So there are two points. [00:36:33] Speaker 00: It is clear that there is general jurisdiction. [00:36:36] Speaker 00: But it is also clear that there is specific jurisdiction in the context of this case with this plan. [00:36:41] Speaker 04: Before you sit down, let me just ask your view with respect to our Zeneca decision. [00:36:47] Speaker 04: First of all, what precedential impact can those two opinions have? [00:36:53] Speaker 04: What is the holding that is other than the fact that in that case, there wasn't jurisdiction over Milan and Maryland? [00:37:01] Speaker 00: Well, I think that it's presidential only with respect to the fact that the peculiar facts of the case, the government office in Maryland and the issue that was also involved about petitioning the government and so forth. [00:37:14] Speaker 00: That case is certainly not precedent here, because the facts are completely different. [00:37:19] Speaker 00: We're talking about different circumstances. [00:37:22] Speaker 00: So that case is not precedent. [00:37:24] Speaker 04: But would you agree that if your theory that the act of infringement occurs in any state in which the approval is sought, that that would have meant that there was jurisdiction and merit? [00:37:37] Speaker 00: I think that the court, as I read the opinion, distinguished because the fact that it occurred in Maryland, but in the context almost like an enclave, because it was the FDA's headquarters and that's where it had to be filed there. [00:37:51] Speaker 04: Well, that was one judge. [00:37:52] Speaker 04: Yes. [00:37:52] Speaker 04: And then there was another judge that said there was no act that occurred. [00:37:56] Speaker 04: occurred in Maryland. [00:37:57] Speaker 04: There couldn't be personal jurisdiction. [00:37:59] Speaker 04: Then the third judge just dissented without saying what. [00:38:01] Speaker 00: OK. [00:38:02] Speaker 00: That's another reason why I think it's not a precedent with respect to what we're talking about here today. [00:38:08] Speaker 00: It's not clear what would have decided. [00:38:10] Speaker 00: There are a number of different potential grounds with respect to it. [00:38:14] Speaker 00: But the act of infringement, like the act of libel in the Calder case or the act of libel in the Keaton case, emanates out, does immediate damage to the person [00:38:26] Speaker 00: whose rights are being infringed, and that supports specific jurisdiction in those venues. [00:38:32] Speaker 03: I think there's another aspect that I've found troubling and confusing from the beginning. [00:38:39] Speaker 03: In Hatch-Waxman, we've been talking about an artificial act of infringement. [00:38:44] Speaker 03: That really was not the premise of Hatch-Waxman. [00:38:48] Speaker 03: In Hatch-Waxman, what the generic was doing had already been established as an act of infringement. [00:38:56] Speaker 03: Patch Waxman said, no, preparing for the end, you can do it, although it infringes according to precedent, would infringe and does infringe. [00:39:09] Speaker 03: And as compensation for that, also you can join the issue of validity before the patent, before you are ready to market so that you aren't stuck with [00:39:24] Speaker 03: four years in the courts before you can practice your end. [00:39:28] Speaker 03: Now these are different kinds set of premises than what we have come to be talking about. [00:39:35] Speaker 03: We've been talking about the notice that is given after the paragraph for certification as generating the opportunity to state an artificial aspect of infringement. [00:39:53] Speaker 03: now to proceed, and then we're sort of involved with how complex, how complete are the relationships. [00:40:03] Speaker 03: It seems to me that we're generating a house of cards which really has nothing to do with the issues, which again takes us back to the specific facts of the extent of the relationship. [00:40:19] Speaker 03: Again, I mentioned Beverly Hills fan earlier. [00:40:23] Speaker 03: because it was a patent case, and therefore brought out all of the aspects of practice and distribution, where it was manufactured, I think was overseas, and all the rest of it. [00:40:36] Speaker 03: So where does that leave us? [00:40:39] Speaker 03: Does it leave us, as I had always thought, with the question of simply looking at the extent of the contacts, and again, [00:40:50] Speaker 03: where there is fairness, where there is due process, where there are sufficient contacts, without all of the other things we've been debating? [00:40:59] Speaker 00: Yes. [00:40:59] Speaker 00: Well, I think my answer to that would be, in the first place, that elides the general jurisdiction point where there's been a waiver and registration. [00:41:07] Speaker 00: But I think it's fair to say that Hatch-Waxman, in a sense, by taking these acts of infringement, the preparation, the testing, the trials, and that sort of thing, that would have been acts of infringement, saying, [00:41:19] Speaker 00: No, we're going to allow those to take place. [00:41:22] Speaker 00: The bargain is that then when you're ready to do this, when you intend to move forward, those acts of infringement become right and material. [00:41:32] Speaker 00: When you file the ANDA and the paragraphs for certification, you're bundling all that together. [00:41:37] Speaker 00: And that then is the act of infringement that those other acts would have been. [00:41:42] Speaker 00: And then that is what you're doing. [00:41:43] Speaker 04: And why doesn't that support Mr. Clement's argument that then what you do is you look backward to where those acts [00:41:49] Speaker 04: of infringement actually occurred for jurisdictional purposes. [00:41:51] Speaker 00: Because what I'm saying and what I think is a reasonable inference to be drawn from the statute itself and the picture that it presents is the act of infringement is doing damage to the patent holder. [00:42:08] Speaker 00: The act of infringement by announcing this intention, and there shouldn't be any doubt that that's why [00:42:15] Speaker 00: You don't have to say that, Judge Toronto, that I'm going to intend to do these things, because you wouldn't be filing the ANDA if you did not intend to do it. [00:42:24] Speaker 00: And everything in the history of Mylon and the facts of this case support the proposition that that intent was real, the threat was real, and the damage was done by the filing of the ANDA, which is an act of infringement which hurts the patent holder where the patent holder lives and where the patent holder's products are going to be infringed. [00:42:43] Speaker 00: if the process plays itself out the way Mylon intends to play itself out. [00:42:49] Speaker 03: Well, that suit, that paragraph 4 certification was not put into the statute to benefit the patent holder. [00:42:56] Speaker 03: It was put into the statute to benefit the generic so that this, the issues, the threshold issues, the validity issues could be resolved while the patent is still pending. [00:43:08] Speaker 00: Yes, but it seems to me that it's put into effect [00:43:12] Speaker 00: so that this statutory scheme can take place. [00:43:16] Speaker 00: And as the Supreme Court put it, as the statute says, it's the act of infringement itself. [00:43:24] Speaker 00: But it's also the provocation of litigation. [00:43:27] Speaker 00: I think that's the words of the United States Supreme Court. [00:43:32] Speaker 00: It announces that you better do something. [00:43:35] Speaker 00: You better file a lawsuit. [00:43:37] Speaker 00: You are being provoked because this is about to take place and you better defend yourself because if you don't defend yourself, these bad things are going to come to fruition. [00:43:47] Speaker 00: And those are going to be damaging. [00:43:49] Speaker 00: Those are going to be damaging where you've been selling your patented products and where you live and where you do business. [00:43:57] Speaker 03: So how does that affect where you consume? [00:44:01] Speaker 00: It affects where you can sue in the sense that what I've been saying is that the injury that you caused, the infringement, it is not infringement. [00:44:11] Speaker 00: Infringement is not something that happens in a vacuum. [00:44:15] Speaker 00: It is actual harm itself. [00:44:17] Speaker 00: And it's harm to whom? [00:44:19] Speaker 00: It's harm to the patent holder. [00:44:22] Speaker 00: It's immediate harm, and Judge Taranto put his finger on this right at the beginning. [00:44:27] Speaker 00: If it isn't, we have an Article III issue about someone bringing suits where there are threats and what the court might require in terms of concrete immediate tangible injury and so forth. [00:44:39] Speaker 00: Congress has already decided that for us. [00:44:41] Speaker 00: This is damage occurring right when those statutory events take place. [00:44:47] Speaker 00: And how do they play themselves out? [00:44:49] Speaker 00: They play themselves out in an invitation to come into court to get this resolved. [00:44:55] Speaker 00: And we submit that over and above or beyond the general litigation issue, which we general jurisdiction issue, which we think is pretty clear cut, this triggers a responsibility to take some action by the patent holder. [00:45:11] Speaker 00: And where is the patent holder hurt? [00:45:13] Speaker 00: Where the patent holder lives? [00:45:14] Speaker 00: Where the patent holder has been successfully selling patented products? [00:45:19] Speaker 00: which the infringer or the generic wishes to intrude upon. [00:45:24] Speaker 01: And that last bit is everywhere on the assumption that Mylan will in fact direct its products. [00:45:33] Speaker 00: There's nothing wrong with that because as you point out, when they actually do start selling the product, those cases can be brought in those venues, in those jurisdictions. [00:45:43] Speaker 00: Okay. [00:45:43] Speaker 03: Thank you, Mr. Olson. [00:45:47] Speaker 03: Let's see. [00:45:48] Speaker 03: Mr. Clinton, you have some rebuttal time. [00:45:51] Speaker 03: And then the next case, do you want to put those in one after the other? [00:45:58] Speaker 02: Sure. [00:45:58] Speaker 02: But it would probably be helpful to me just yet to know when they're going to switch at the table behind me and that sort of thing. [00:46:05] Speaker 02: I'm cognizant that I have some additional time. [00:46:08] Speaker 02: I would like to make three points in rebuttal if I could. [00:46:11] Speaker 02: The first is to just try to elaborate on an answer to a question to Judge O'Malley, which is, [00:46:16] Speaker 02: As I had a moment to reflect there, I really am quite confident, though I haven't been able to do any legal research while I sat there, that immunized conduct can give rise to personal jurisdiction. [00:46:27] Speaker 02: And to give you just a for instance, imagine that the plaintiff in Walden had sued not just the law enforcement agent, but the prosecutor who was involved in the preparation of the allegedly false affidavit, and assume that Walden, as to that suit, actually brought it in the right forum [00:46:44] Speaker 02: and filed the suit against the prosecutor in Georgia. [00:46:48] Speaker 02: Now, I don't have any doubt that the prosecutor would enjoy absolute immunity, and that suit would get dismissed on the merits based on an absolute immunity defense in a heartbeat. [00:46:57] Speaker 02: But I also have no doubt that there would be personal jurisdiction over the prosecutor for purposes of that suit, even though the relevant conduct was immunized. [00:47:05] Speaker 02: And that may be the way to think about this, which is to say that the reason there's not an Article III problem is because but four-hatch Waxman [00:47:12] Speaker 02: The very acts of preparing the ANDA would be an act of infringement that would give rise to Article 3 injury and the way that Hatchman waxed it. [00:47:21] Speaker 01: You can imagine I'm still not, I don't think I've heard an answer to the question. [00:47:28] Speaker 01: What injury in fact is there to them from your filing an ANDA on the assumption that you don't plan to use it? [00:47:41] Speaker 02: Well, on the assumption that we don't plan to use it. [00:47:45] Speaker 01: Yeah, so you're not going to sell. [00:47:46] Speaker 01: You think, like a lot of people with patents, you want a FDA certificate on the wall. [00:47:52] Speaker 02: No, but I mean, suppose I'm just planning on manufacturing it. [00:47:56] Speaker 02: And I'm planning on leaving the selling and the distribution entirely to other people. [00:48:01] Speaker 02: I still want the ANDA. [00:48:03] Speaker 02: My manufacturing activity, which may take place entirely in one state, [00:48:08] Speaker 02: is more than enough, I think, to give rise to an Article 3 injury. [00:48:14] Speaker 02: And I don't think then the right way to think about this is that once you have the end of filing, you have to then sort of predict exactly where we're going to end up filing. [00:48:25] Speaker 02: I mean, you know, you could have a generic company that for idiosyncratic reasons... But it doesn't seem to be very difficult here. [00:48:30] Speaker 01: I mean, you agree that [00:48:33] Speaker 01: You're doing this because you want to use the ANDA and you have a widespread distribution network, but in particular as to Delaware, you will direct your product into Delaware. [00:48:46] Speaker 02: Well, only if we prevail in the litigation and at that point the sales that we make won't even be infringing sales. [00:48:53] Speaker 02: And we haven't even sort of talked about this, but part of the conundrum I'm having is they seem to think the problem here is the ANDA anticipates infringing sales in all 50 states. [00:49:02] Speaker 02: But the one thing this whole process does is make it almost entirely unlikely there will be any infringing sales. [00:49:09] Speaker 02: If the allegations of their complaint are correct. [00:49:11] Speaker 01: Injury in fact here comes from the sales. [00:49:15] Speaker 01: With all due respect, I don't think that's right. [00:49:17] Speaker 02: What else is this? [00:49:18] Speaker 02: It would come from the moment we manufactured. [00:49:21] Speaker 02: They have an infringement case. [00:49:24] Speaker 02: And of course, you don't manufacture just to stockpile. [00:49:27] Speaker 01: How are they harmed? [00:49:29] Speaker 02: They are harmed because you are infringing their patent. [00:49:32] Speaker 01: I don't get what that is other than a set of words. [00:49:38] Speaker 01: What do they lose unless you sell or arrange with others to sell a product that causes them loss of sales? [00:49:47] Speaker 02: They lose their right to exclude that is inherent in the patent. [00:49:53] Speaker 02: It's your job to give me hypotheticals, but I assume, put Hatch-Wax on the side. [00:49:58] Speaker 02: I assume if I have a patent, [00:50:00] Speaker 02: And I see somebody else, my business competitor, start manufacturing. [00:50:05] Speaker 02: And that manufacturer swears on a stack of Bibles that they're just manufacturing. [00:50:10] Speaker 02: It's just something they do out of, it's like a hobby of theirs. [00:50:13] Speaker 02: They're not going to sell to anybody. [00:50:15] Speaker 02: I would think to an absolute certainty that I have Article III standing as the patent holder to enjoin them. [00:50:22] Speaker 02: Because the very act of manufacturing in violation of my patent is an Article III injury. [00:50:29] Speaker 02: You may disagree with me, but I think I'm right about that. [00:50:32] Speaker 04: Paragraph 4 certification contains an assertion that the patent's invalid. [00:50:38] Speaker 04: Yes. [00:50:38] Speaker 04: And I assume that any respectable corporation would have to list that as a material event for purposes of their SEC filings, right? [00:50:47] Speaker 04: Because it would arguably impact the value of those property rights. [00:50:53] Speaker 02: I mean, I think that's right. [00:50:55] Speaker 02: I mean, I don't want to pass myself off as an expert on, you know, [00:50:59] Speaker 02: 10K filings. [00:50:59] Speaker 02: But that seems right to me. [00:51:02] Speaker 02: It seems even more right that regardless of the security disclosures, there is an injury in fact for Article III purposes that takes place at the point of the declaration of invalidity or the point of manufacture. [00:51:14] Speaker 02: And I don't think it's right that absent a contemplated future sale, that there is no Article III injury. [00:51:21] Speaker 02: And therefore, you have to trace down where the sale may take place. [00:51:24] Speaker 02: So that was really the first point. [00:51:25] Speaker 02: The second point I wanted to make was just simply [00:51:29] Speaker 02: You know, as I predicted, I think Mr. Olson I think moved on to general jurisdiction quite quickly because I do think he has a problem. [00:51:36] Speaker 02: I listened to what he said in terms of the litigation related contacts that the defendant has with Delaware. [00:51:43] Speaker 02: And what I heard was the registration to do business and the litigation in the forum. [00:51:48] Speaker 02: Those are the two other things I heard besides the fact that we sent the statutorily required letter to New York to a company that was based in Delaware. [00:51:55] Speaker 02: Now, neither of those two things is litigation-related contact. [00:52:00] Speaker 02: We registered to do business, but that is not the way, and, you know, I don't think there are allegations in this. [00:52:06] Speaker 02: I mean, in theory, you could get into jurisdictional discovery on this point, but I don't think it's really disputed. [00:52:12] Speaker 02: The registration to do business there is not what gives rise to the injury here. [00:52:16] Speaker 02: I doubt that if we ever got to the point of distributing this product there, it would really be through the activities that we registered for. [00:52:24] Speaker 02: But that's a question that if you really wanted to, you could get into. [00:52:26] Speaker 01: But do you see any daylight between the due process consent analysis and an unconstitutional conditions analysis? [00:52:35] Speaker 02: No, I don't, which is why I don't think we've waived anything. [00:52:38] Speaker 02: I just think they're two sides of the same coin. [00:52:40] Speaker 02: They're two ways of looking at the same issue. [00:52:43] Speaker 02: So if I just mentioned, because I want to get to general jurisdiction, I did want to get on the table. [00:52:47] Speaker 02: But the other thing that they point to is litigation that we've initiated in Delaware. [00:52:52] Speaker 02: Again, I can't think of anything that's less related to this litigation, which is the test under specific personal jurisdiction. [00:52:59] Speaker 02: And I would add that what you really have in terms of our initiated litigation is four suits, each one of which at least one of the defendants was a Delaware corporation. [00:53:10] Speaker 02: So all it shows is that we know what personal jurisdiction is, and we know where to sue people, which is where they're at home. [00:53:16] Speaker 02: You sue corporations where they're at home, at least if you're relying on general jurisdiction. [00:53:20] Speaker 02: To bring me to that. [00:53:21] Speaker 02: I'm going to get a chance to say more about this, but the one thing I really do think it's important to recognize is that this whole issue doesn't get away just by a clever misuse of the word consent. [00:53:34] Speaker 02: Because of course we concede, and of course Justice Ginsburg in her decision in Daimler concedes, and of course Goodyear concedes that somebody can still consent to jurisdiction. [00:53:46] Speaker 02: So the cases talk about the situation where the only situation that's relevant for specific [00:53:51] Speaker 02: or a general jurisdiction question is when you have a defendant who has not consented. [00:53:57] Speaker 02: But consent, and at various points both other parties make this clear, consent is a voluntary concept. [00:54:05] Speaker 02: And the only thing voluntary that my client has done is engage in the modicum of business that is necessary for you to then be required by Delaware to register and then be required to appoint an agent for service of process. [00:54:19] Speaker 04: But given that the penalties are so [00:54:22] Speaker 04: minimal in Delaware as opposed to what the Supreme Court was looking at in Bendix. [00:54:29] Speaker 04: You certainly had the option to not consent. [00:54:33] Speaker 02: Well, I don't think we did if we wanted to be in compliance with Delaware law. [00:54:38] Speaker 02: Delaware law does not say register or not. [00:54:42] Speaker 02: If you decide not to register, that's totally fine. [00:54:44] Speaker 02: You just have to pay $500 as you go. [00:54:47] Speaker 02: That's not the way the statute's written. [00:54:48] Speaker 02: The statute is written is if you do business in Delaware, [00:54:51] Speaker 02: You must register. [00:54:53] Speaker 02: And then, of course, it deals with the consequences of registering and the consequences of not registering. [00:54:58] Speaker 02: And with all due respect, I don't think the analysis here turns on whether the penalty for not registering is $500 or $500 million. [00:55:08] Speaker 02: I mean, I don't think either way it is an obligatory statutory requirement that we register. [00:55:14] Speaker 04: And so I think... If that's the case, though, why is it that in Bendix's case, the Supreme Court didn't just simply say, you can't ever force anyone to register, as opposed to saying, let's look at the level of the burden that's imposed by the registration requirement? [00:55:30] Speaker 02: Because in that case, they had a dormant commerce clause challenge teed up for them and not a due process clause challenge. [00:55:36] Speaker 02: I mean, I'll sort of grant you that sort of the premise of that case is, [00:55:40] Speaker 02: Well, there are real consequences if you register, but they didn't have an attack on that. [00:55:47] Speaker 02: So I really think that's your answer there. [00:55:50] Speaker 02: And I think there is a reason there, which is I think it was easier to conceptualize. [00:55:55] Speaker 02: You read those opinions. [00:55:57] Speaker 02: I think the court thought it was doing pike balancing, but I think it's easier to conceptualize what was going on there as being facially discriminatory compared to the situation that you have here. [00:56:07] Speaker 02: I think you could try to make a commerce clause violation here. [00:56:10] Speaker 02: But we've really focused the court's attention on the due process clause. [00:56:14] Speaker 02: The other aspect of this, of course, is what to do with the Pinoyer era Supreme Court cases. [00:56:18] Speaker 02: But I'm happy to talk about that in the second case, if it pleases the court. [00:56:22] Speaker 03: Let's close out this case. [00:56:24] Speaker 03: Thank you. [00:56:24] Speaker 03: Thank you both. [00:56:27] Speaker 03: Number 151456 is taken under submission.