[00:00:10] Speaker 02:
Okay.

[00:00:11] Speaker 02:
The next case is number 151460, AstraZeneca AB against Myline Pharmaceuticals.

[00:00:18] Speaker 02:
Mr. Clement, please continue.

[00:00:21] Speaker 04:
Thank you, Your Honors.

[00:00:21] Speaker 04:
I'm going to start, if it pleases the Court, I'm going to try to start with general jurisdiction once again and see if I get any further this time.

[00:00:27] Speaker 04:
I do think that, as was suggested in the prior argument, the other sides, I think, you know, they're only colorable argument, frankly, because I think it is so clear

[00:00:37] Speaker 04:
that the only voluntary conduct that we engaged in is doing business in Delaware.

[00:00:42] Speaker 04:
I think it is so clear after Daimler that to do less business than the substantial and continuous amount of business that Justice Ginsburg said for the court was insufficient in Daimler.

[00:00:52] Speaker 04:
And that's what's involved here.

[00:00:53] Speaker 01:
But Daimler never had the opportunity to address consent via registration, correct?

[00:00:58] Speaker 04:
Completely agree.

[00:00:59] Speaker 04:
Completely agree.

[00:01:00] Speaker 01:
California, they interpret their consent statute differently, right?

[00:01:05] Speaker 04:
Sure.

[00:01:06] Speaker 04:
But I think my submission is it cannot be true.

[00:01:10] Speaker 04:
Let's put the precedence, the Pinoyer era precedence to one side for a second.

[00:01:14] Speaker 04:
I don't see how it can possibly be true that if you were looking at this as an initial matter.

[00:01:18] Speaker 04:
that you would allow Delaware to accomplish in two steps what California could not accomplish in one step.

[00:01:23] Speaker 01:
Well, isn't there, because there's a difference between doing a consent analysis and an actual consent analysis and implied consent analysis, isn't there?

[00:01:32] Speaker 04:
And I think if you're going to do an actual consent analysis, not a fictional consent, but an actual consent, then you have to be looking at the voluntary conduct.

[00:01:40] Speaker 04:
And the voluntary conduct here was simply doing enough business in Delaware to trigger the registration requirements.

[00:01:47] Speaker 04:
And we know, I think, from Daimler that simply doing a modicum of business, what you need to do to register in Delaware is substantially less than the substantial and continuous pattern of business that the court in Daimler said was insufficient for general jurisdiction.

[00:02:02] Speaker 00:
I'm sorry.

[00:02:03] Speaker 00:
I think I'm having a hard time following your connection between amount of business and the consent question.

[00:02:10] Speaker 00:
Assume for a minute that Delaware, through its statute and state Supreme Court,

[00:02:17] Speaker 00:
had made perfectly clear that if you sign this paper, this is what you consent to, and then you sign the paper.

[00:02:25] Speaker 00:
Why is that not enough?

[00:02:29] Speaker 00:
The paper being the registration.

[00:02:31] Speaker 04:
Well, I think the question would be then, what makes you sign that piece of paper?

[00:02:40] Speaker 04:
If you just did it voluntarily, then I suppose I would agree with you.

[00:02:45] Speaker 04:
But if there's a different Delaware statute that says, and to do any business in the state, you must sign the paper, then I don't think it's voluntary.

[00:02:54] Speaker 04:
Then the only voluntary conduct is the decision to do business in the state.

[00:02:58] Speaker 04:
And that's why I think that's what you have to focus on.

[00:03:01] Speaker 04:
And I think that is exactly what you have here.

[00:03:03] Speaker 04:
Delaware says that if you want to do any business in our state, then you must register.

[00:03:09] Speaker 04:
And as part of that registration process, you must appoint

[00:03:12] Speaker 04:
an agent for service of process, which we will deem opening you up to general jurisdiction.

[00:03:16] Speaker 01:
But why, for due process purposes, is that not a voluntary act, choosing to do business in the state?

[00:03:22] Speaker 04:
It is.

[00:03:23] Speaker 04:
But it's not one that I think is consistent with the Supreme Court's due process jurisprudence, which is to say, I don't think, and this is why I don't think the unconstitutional conditions argument is really a distinct argument, I don't think consistent with minimum context and due process analysis

[00:03:40] Speaker 04:
A state can condition you doing business in the state on opening yourself up to all purpose jurisdiction.

[00:03:48] Speaker 04:
Because that's exactly what California tried to do.

[00:03:50] Speaker 04:
I mean, they didn't do it through the guise of a registration statute, but they basically said the way we interpret our long arm statute, if you do substantial continuous business in our state, then you are going to be subject to all purpose jurisdiction.

[00:04:03] Speaker 04:
We think that's consistent with due process.

[00:04:05] Speaker 04:
The Supreme Court said, no, it's not.

[00:04:07] Speaker 04:
Minimum context is the test.

[00:04:09] Speaker 04:
The minimum context test focuses, I think it's fair to say, in Justice Ginsburg's view in Daimler, is principally going to direct you to specific personal jurisdiction, but where it doesn't and where you have general purpose jurisdiction, you're going to get it in two places, where the corporation is incorporated and where its principal place of business is.

[00:04:29] Speaker 04:
And I think the only obstacle to that conclusion would be these Pinoy era cases.

[00:04:36] Speaker 04:
And with all due respect to Mr. Olson, what I imagine what Mr. Chamnagan will say, those cases, you don't have to overrule them.

[00:04:44] Speaker 04:
The Supreme Court's already done that for you in International Shoe, in Schaeffer, and in Daimler.

[00:04:50] Speaker 04:
On multiple occasions, they have told, and I think they are telling the lower courts, they're not just talking to themselves, they are saying that to the extent there are decisions from the Pinoyer era that are inconsistent with minimum contacts, international shoe analysis,

[00:05:05] Speaker 04:
They are overruled.

[00:05:08] Speaker 00:
You've read these more recently than I have.

[00:05:12] Speaker 00:
Do any of those cases in talking about contacts and so on connect to a notion of voluntariness?

[00:05:21] Speaker 00:
Yes.

[00:05:22] Speaker 00:
I think all of them, frankly.

[00:05:24] Speaker 00:
That's the crucial connection you're making.

[00:05:27] Speaker 00:
You're saying that consent, which has to be voluntary,

[00:05:31] Speaker 00:
can't really constitutionally be said to be present if what you're giving up is sufficiently unconnected to the, is disproportionate or something.

[00:05:44] Speaker 00:
None of the, what shall we call it, international shoot era cases make that connection, do they?

[00:05:53] Speaker 04:
Well, I might have missed something.

[00:05:54] Speaker 00:
I think they all do, because they all talk about- They talk about how something is not voluntary in terms of a consent.

[00:06:01] Speaker 00:
An eyes-open consent as opposed to voluntarily directing your conduct.

[00:06:10] Speaker 04:
So maybe I'm missing it.

[00:06:11] Speaker 04:
They all talk about purposeful availment, which I take to be voluntary conduct.

[00:06:16] Speaker 04:
So for the same reasons that I think that the compulsory consent that Delaware imposes is both an oxymoron and not something that gets them out of the due process problem, I also think for the exact same reasons

[00:06:29] Speaker 04:
that the statutorily mandated notification letter is not purposeful of ailment, because it wasn't voluntary.

[00:06:36] Speaker 04:
We didn't send the letter to Delaware in the AstraZeneca case, because we really liked Delaware, or we thought, you know.

[00:06:44] Speaker 00:
But was your registration voluntary?

[00:06:46] Speaker 00:
What's that?

[00:06:47] Speaker 00:
Was your registration to do business.

[00:06:50] Speaker 00:
Maybe I'm confused.

[00:06:51] Speaker 00:
It was not voluntarily consent here by virtue of your taking the act of registering to do business with eyes open about what the consequences of that were.

[00:07:03] Speaker 04:
That act was not voluntary.

[00:07:05] Speaker 00:
OK, so let's forget about the letter, the sending of the letter.

[00:07:09] Speaker 00:
You have to establish something in Supreme Court

[00:07:12] Speaker 00:
post-Panoir era due process cases that says something about why you can characterize that eyes-open choice as involuntary.

[00:07:24] Speaker 00:
Is that right?

[00:07:28] Speaker 04:
Well, I think we're mixing.

[00:07:30] Speaker 04:
I may not just be understanding the question.

[00:07:32] Speaker 04:
I don't think there's any question that that act wasn't voluntary.

[00:07:35] Speaker 04:
So if you're asking me now, if we're past that threshold,

[00:07:39] Speaker 00:
And you're now asking me to point to the case law that says that that's... There's no question that your signing of the registration form, knowing what that meant... ...was not voluntary.

[00:07:50] Speaker 04:
That was not a voluntary act.

[00:07:51] Speaker 04:
There is a Delaware statute that says, if you do business in the state, you must register or face penalties.

[00:07:57] Speaker 00:
You can choose not to do business in the state.

[00:07:59] Speaker 00:
So how is that not voluntary?

[00:08:01] Speaker 04:
What was voluntary was our decision to do business in the state.

[00:08:04] Speaker 04:
What was not voluntary was our decision to register once we did.

[00:08:10] Speaker 00:
Oh.

[00:08:12] Speaker 00:
OK.

[00:08:12] Speaker 00:
But let's assume I want those two things to be the same thing, since you know you can't do business without registering.

[00:08:19] Speaker 00:
You then make a single choice to do business and register.

[00:08:24] Speaker 00:
You know what the consequences of that choice is.

[00:08:26] Speaker 00:
It's a voluntary choice.

[00:08:28] Speaker 00:
No?

[00:08:29] Speaker 04:
I suppose if you want to marry them up, but I think we get to impose a due process objection and say, no, that's not the way the world works.

[00:08:38] Speaker 04:
We make a voluntary decision to do business.

[00:08:40] Speaker 04:
It is a distinct decision.

[00:08:43] Speaker 04:
That's voluntary.

[00:08:44] Speaker 04:
I'll grant you that.

[00:08:44] Speaker 04:
But once we do, the state forces us to register.

[00:08:48] Speaker 04:
So I think those are distinct acts.

[00:08:50] Speaker 04:
I think the decision for them to force us to register and then have the

[00:08:56] Speaker 04:
consequence be opening us up to all-purpose jurisdiction, I think there are two complementary ways of looking at it.

[00:09:03] Speaker 04:
One is, and I suppose this might be more of almost like a facial challenge, would be to say that, you know, that's just not a condition they can impose.

[00:09:11] Speaker 04:
But I think the more natural way to look at it...

[00:09:13] Speaker 01:
This is not a facial challenge to a statute.

[00:09:16] Speaker 01:
You went into Delaware knowing what the statute was, knowing how it had been interpreted by the Supreme Court, in fact had been interpreted for many years by the Supreme Court that way, and chose to do business and register in those circumstances.

[00:09:30] Speaker 01:
You have not brought a facial challenge to the Delaware statute.

[00:09:35] Speaker 04:
You're right.

[00:09:36] Speaker 04:
And that's exactly where I was going, which is I think the more natural way to proceed in these cases

[00:09:40] Speaker 04:
and I think it's consistent with all the challenges to all the long-arm statutes out there, is you do it as applied.

[00:09:46] Speaker 04:
And you basically say, yeah, yeah, sure.

[00:09:47] Speaker 04:
You think you can extend your long-arm statute to everything, but then it's subject to the backdrop of the Constitution.

[00:09:55] Speaker 04:
You think that by virtue of us doing even a thimble full of business in Delaware, that you can then force us to register, and then you can then say the consequence of that is that we're open to a suit literally based on primary conduct that took place in Timbuktu.

[00:10:10] Speaker 04:
Now, I think the much more logical way to proceed is, whoa, you can say that if you want.

[00:10:15] Speaker 04:
And in an individual case, you will test that.

[00:10:18] Speaker 04:
And here we have a test of that.

[00:10:20] Speaker 04:
And we say, no, the consequences, the constitutional consequences of our voluntary decision to engage in some business in Delaware cannot be opening ourselves up to all purpose jurisdiction.

[00:10:36] Speaker 04:
And I think that follows directly from the Daimler decision.

[00:10:39] Speaker 04:
It's the same voluntary conduct.

[00:10:41] Speaker 04:
There, there was a decision to do some business in California.

[00:10:45] Speaker 04:
The case was decided on the premise that it was a substantial and continuous course of business in California.

[00:10:51] Speaker 04:
Yet it wasn't enough.

[00:10:53] Speaker 01:
I don't think anybody was- It wasn't enough to get the parent corporation.

[00:10:57] Speaker 04:
It wasn't enough to get either.

[00:10:59] Speaker 01:
The court- That's not what the Supreme Court said.

[00:11:01] Speaker 01:
The Supreme Court said, even if we attribute those acts, you still can't

[00:11:06] Speaker 01:
bring the parent in.

[00:11:07] Speaker 01:
But it never said we would not allow exercise of jurisdiction over Mercedes-Benz.

[00:11:13] Speaker 04:
Well, I guess I thought by the way they treated the agency thing, it would be six of one, half dozen of the other.

[00:11:17] Speaker 04:
But I don't think anything turns on that.

[00:11:19] Speaker 04:
Which is to say, I think the holding of Daimler is crystal clear that a substantial and continuous course of business in a state is not enough for all purpose jurisdiction.

[00:11:28] Speaker 02:
But you're saying never, or that you look at the facts and it may or may not be enough.

[00:11:35] Speaker 04:
I'm saying that a substantial and continuous course of business.

[00:11:38] Speaker 04:
I mean, there's a footnote in Daimler that says you may have exceptional cases.

[00:11:42] Speaker 04:
But I'm saying as a general matter, a substantial and continuous course of business is not enough for all purpose jurisdiction.

[00:11:49] Speaker 04:
And the two places that you get all purpose jurisdiction are where a corporation is incorporated or where its principal place of business is.

[00:11:56] Speaker 04:
And if in a case like this, they're both the same state, that's where you sue them.

[00:11:59] Speaker 02:
But are you saying that it's inappropriate to consider all of the relationships that we've been told

[00:12:05] Speaker 02:
should be considered ever.

[00:12:08] Speaker 02:
Or that there would be a point that would cross some sort of threshold that would open the jurisdiction.

[00:12:16] Speaker 04:
The way I read Daimler is that as to general jurisdiction- When I'm talking about Daimler, I'm talking about this case.

[00:12:21] Speaker 02:
Daimler is an extraordinary factual situation that isn't close to what we have here.

[00:12:28] Speaker 04:
But I think the teaching of Daimler for this case is that as to general jurisdiction, there really

[00:12:34] Speaker 04:
Absent the most extraordinary circumstances, there are two places that you get general jurisdiction.

[00:12:39] Speaker 04:
Principal place of business, place of incorporation.

[00:12:42] Speaker 01:
In the absence of consent.

[00:12:43] Speaker 01:
I mean, it specifically says that.

[00:12:44] Speaker 04:
Sure, but real consent.

[00:12:46] Speaker 04:
If we walked into the suit, as some other generics have, and said, oh, you're suing us here in Delaware under general jurisdiction, or you haven't really specified, well, we're happy to litigate here, that's consent.

[00:12:58] Speaker 04:
If we entered a specific agreement with them and said, we're going to litigate all our disputes in Delaware,

[00:13:04] Speaker 04:
That would be consent.

[00:13:05] Speaker 04:
Simply doing business in Delaware cannot be a basis.

[00:13:08] Speaker 00:
But it's not simply doing business.

[00:13:10] Speaker 00:
Wasn't it one of the two Justice Holmes opinions almost continues with the third sentence following the two that you just said, as there would be no doubt that if being sued you said happy to be here, that would be consent.

[00:13:23] Speaker 00:
So same thing if you

[00:13:26] Speaker 00:
say happy to be here when you enter the state by registering to do business.

[00:13:30] Speaker 00:
I mean, he expressed the court through Holmes expressly tied those two things together.

[00:13:34] Speaker 04:
Sure.

[00:13:35] Speaker 04:
In the Pinoyer era, when territorial jurisdiction was everything, so the court had to do somersaults in order to figure out how to get somebody within the territory.

[00:13:45] Speaker 04:
But the Supreme Court on repeated occasions has already said those are the fictions that were discarded in international shoe.

[00:13:53] Speaker 04:
And the Supreme Court, I don't know how they could be much clearer.

[00:13:56] Speaker 04:
International Shoe itself says that those prior Pannoyer cases, to the extent they're accurate, they can be conceptualized as minimum contacts cases.

[00:14:04] Speaker 04:
Perkins specifically says, which they think is their case, and I disagree with them.

[00:14:08] Speaker 04:
Perkins specifically says, at one point, that when you're dealing with a requirement from a state that you must get a license and an agent for process to do business in the state,

[00:14:21] Speaker 04:
that that is not conclusory, that that is not outcome determinative.

[00:14:25] Speaker 04:
Perkins says that.

[00:14:28] Speaker 00:
But wasn't that because it was not clear in advance of your appointing of the agent what the consequences would be?

[00:14:36] Speaker 04:
No.

[00:14:36] Speaker 04:
I don't think there's nothing in that part of the opinion that suggests that.

[00:14:41] Speaker 04:
And as I read that opinion, that's one sentence in context.

[00:14:44] Speaker 04:
But I think it doesn't say there's any ambiguity there.

[00:14:47] Speaker 04:
So the Perkins case, I think, is helpful to us.

[00:14:50] Speaker 04:
They want to rely on footnote 6 in the Perkins case and the fact that it cites the Pennsylvania fire case, which I think is their best case.

[00:14:59] Speaker 04:
I think that's the Holmes case you were referring to.

[00:15:01] Speaker 04:
If you look at footnote 8 of the Daimler opinion, it specifically tells people not to rely on footnote 6 of Perkins.

[00:15:10] Speaker 04:
It's the same cases.

[00:15:12] Speaker 04:
In that case, it was the Barrow case.

[00:15:15] Speaker 04:
In this case, it's a Pennsylvania fire case.

[00:15:17] Speaker 04:
It's Schaeffer against Heitner in footnote 39, where the court doesn't say that the Pinoyer-era cases are in thin ice or may be reconsidered at some point.

[00:15:26] Speaker 04:
It says they are overruled.

[00:15:28] Speaker 04:
When Justice Scalia for four justices in the Burnham case talks about the Pinoyer-era fictions, one of the fictions he specifically identifies is the idea that a corporation consents by registering and appointing an agent of process.

[00:15:44] Speaker 04:
And he says those fictions were done away with international shoot.

[00:15:49] Speaker 04:
This is not a case, whatever you think about Sheridan-Lehman and the reluctance of lower courts to overrule the Supreme Court decisions for them, the Supreme Court has done the overruling.

[00:15:59] Speaker 00:
And it's told courts... I think we're just going to retrace our steps, but what is fictional about

[00:16:08] Speaker 00:
signing the registration on the assumption that you knew exactly what that meant, as opposed to just appointing an agent.

[00:16:18] Speaker 00:
And then it's easy to see how one can say, it's a fiction to say, oh, that means you consented to something that you actually didn't have staring you in the face.

[00:16:27] Speaker 00:
But here, I don't think you dispute.

[00:16:30] Speaker 00:
You have the Delaware Supreme Court decision saying, this is what this means, and you sign it anyway.

[00:16:36] Speaker 04:
That's not fictional.

[00:16:37] Speaker 04:
What is fictional is that that is voluntary consent.

[00:16:40] Speaker 04:
If you put a gun to my head, I will sign anything you want me to.

[00:16:44] Speaker 04:
And you can say, well, you consented to it.

[00:16:47] Speaker 04:
You signed.

[00:16:48] Speaker 04:
But the fact that you had a gun to my head made it not voluntary consent.

[00:16:52] Speaker 04:
And I think what matters when it comes to waiving constitutional rights is voluntary consent, not having a state law that says that you must register under these circumstances.

[00:17:04] Speaker 04:
And what gave rise to the registration obligation, and you're right, we're retracing our steps, but what gave rise to it was exactly what Daimler said is not sufficient for general purpose jurisdiction.

[00:17:14] Speaker 02:
Let's hear from the other side.

[00:17:15] Speaker 02:
Thank you, Your Honor.

[00:17:17] Speaker 02:
We'll save you a little time.

[00:17:18] Speaker 02:
Mr. Shanmugam.

[00:17:20] Speaker 03:
Thank you, Judge Newman.

[00:17:20] Speaker 03:
Kenneth Shanmugam of Williams and Connolly for Appellee AstraZeneca.

[00:17:24] Speaker 03:
May it please the Court, in these cases, MyLand is really seeking to upend the subtle understanding

[00:17:29] Speaker 03:
The brand-name drug manufacturers may bring consolidated patent infringement actions against generic manufacturers in a single jurisdiction, such as Delaware, as long as the exercise of jurisdiction is fair and reasonable.

[00:17:41] Speaker 03:
Now, I'd like to start, if I may, with the first of the two bases for jurisdiction here, specific jurisdiction, both because that was the first basis in our briefs in this case, but also because I think that that's really the only issue that this Court

[00:17:53] Speaker 03:
needs to resolve in order to dispose of the case if it decides to do so in our favor.

[00:17:58] Speaker 01:
When you say it's a settled understanding that's being upset, it's not settled in the courts.

[00:18:04] Speaker 01:
I mean, parties have been doing it, but that doesn't mean that there's ever been an opinion that analyzed it from a jurisdictional standpoint.

[00:18:11] Speaker 03:
Not from this court, to be sure.

[00:18:12] Speaker 03:
I think the lower courts overwhelmingly have held that there is personal jurisdiction.

[00:18:16] Speaker 03:
And quite frankly, the issue had not really been

[00:18:19] Speaker 03:
litigated all that often prior to Daimler and, quite frankly, prior to Mylon raising this issue in a number of different cases.

[00:18:26] Speaker 03:
Well, let me sort of start with specific jurisdiction, because again, I think that that's the narrower of the two potential grounds here.

[00:18:31] Speaker 03:
I think it's important to underscore at the outset that specific jurisdiction, unlike general jurisdiction, is a claim-specific inquiry.

[00:18:38] Speaker 03:
In fact, you can have specific jurisdiction over some claims in a case and not others.

[00:18:42] Speaker 03:
And therefore, it really is essential to take a look at the claimant issue.

[00:18:44] Speaker 03:
And of course, the claimant issue here

[00:18:46] Speaker 03:
is a claim for the so-called artificial act of infringement under Section 271E2.

[00:18:51] Speaker 03:
And I think that the language of that provision is actually quite instructive.

[00:18:55] Speaker 03:
The language of that provision says, and I'm quoting, that it shall be an act of infringement to submit A, an application for a drug claimed in a patent, and I'm going to omit some of the irrelevant language here, if the purpose of such submission is to obtain approval to engage in the sale of a drug claimed in a patent before the expiration of such patent.

[00:19:14] Speaker 03:
And I think what that really tells us is that what Congress did here is to define an intentional act of patent infringement.

[00:19:20] Speaker 03:
And I'll come back to the Article III implications of that in a minute.

[00:19:24] Speaker 03:
And that act causes injury wherever the generic manufacturer seeks approval to market and sell its competing product.

[00:19:32] Speaker 01:
But where does the act occur?

[00:19:34] Speaker 01:
Regardless of where it causes injury, let's start with where it occurs.

[00:19:38] Speaker 03:
Well, so I think it is certainly true that the ANDA is prepared somewhere, and it is then transmitted to the FDA.

[00:19:45] Speaker 03:
And again, we know from Zeneca that the mere act of transmission to the FDA does not constitute a cognizable contact.

[00:19:53] Speaker 03:
But I think that the critical point, Judge O'Malley, and you had raised this in the earlier arguments, is that under the Calder versus Jones framework, the framework that governs personal jurisdiction when you're dealing with intentional torts, the analysis doesn't simply focus on where

[00:20:07] Speaker 03:
the act takes place in isolation.

[00:20:09] Speaker 03:
It focuses on where the act is directed or aimed.

[00:20:14] Speaker 03:
And again, our point here is that the act is directed or aimed essentially everywhere where the patent holder has rights.

[00:20:22] Speaker 03:
And to get back to the Article III implications of this, which I think tie into this point,

[00:20:26] Speaker 00:
I don't think that this is a case where Congress... Is that everywhere where the patent holder has rights or everywhere where the applicant plans to market to sell the drugs?

[00:20:35] Speaker 03:
And everywhere that the applicant, and I should have added this important point, and everywhere where the applicant is attacking those rights.

[00:20:42] Speaker 03:
And so just to be clear, our argument doesn't depend

[00:20:46] Speaker 00:
on where the... You changed the word, I think, because you had some thought in the middle of your sentence.

[00:20:52] Speaker 00:
Attacking those rights is different from selling something that will take sales away from the one who has the rights.

[00:20:59] Speaker 03:
I think it's sort of a fine conceptual distinction.

[00:21:02] Speaker 00:
But the injury in fact is not fine and conceptual.

[00:21:04] Speaker 00:
It's real.

[00:21:05] Speaker 03:
Well, and just to be clear about what the injury is here.

[00:21:08] Speaker 03:
I think that the injury here, as Judge O'Malley suggested implicitly in one of her questions,

[00:21:14] Speaker 03:
is an immediate injury to the value of our patent rights, because those rights are being called into question by the filing of the ANDA with the paragraph four certification.

[00:21:24] Speaker 03:
So in other words, this is not a Spokio-type case in which it is Congress sort of creating the Article III injury by statute.

[00:21:33] Speaker 00:
Why do they have a stake in the resolution of validity of your patents?

[00:21:40] Speaker 03:
Well, for the simple reason that they are the ones

[00:21:43] Speaker 03:
calling the validity of the Pats into question.

[00:21:45] Speaker 03:
And you are right.

[00:21:45] Speaker 03:
Their stake, they obviously want to, they as the defendant in the case that we're now bringing, obviously want to market and sell the competing product.

[00:21:56] Speaker 03:
And Judge Toronto, to get back to one of your other questions, I think it is certainly true that an ANDA applicant doesn't ordinarily, and certainly based on our knowledge, doesn't ever sort of say in an ANDA application, we're going to sell this product in particular locations.

[00:22:12] Speaker 03:
But I think it's implicit in the statutory scheme that what the applicant... I just want to clarify that.

[00:22:17] Speaker 00:
Doesn't the applicant say, we plan to sell the thing that we're seeking approval for?

[00:22:23] Speaker 03:
Not in hyperbole, but I think that's implicit in the statutory scheme, right?

[00:22:26] Speaker 03:
Because what they're seeking from the FDA is nationwide approval.

[00:22:31] Speaker 03:
And so the reason why I think this fine distinction is important is because our argument here doesn't turn on the reality of where or even whether

[00:22:41] Speaker 03:
Mylan is going to sell its competing product, though I would note parenthetically that, I mean, look, there can't really be any serious doubt that if they get approval, they're going to sell the drug nationwide and sell it through established distribution channels, presumably including into Delaware.

[00:22:55] Speaker 03:
Our argument turns on the nature of the act of infringement.

[00:22:59] Speaker 03:
And again, what they're seeking is nationwide approval.

[00:23:02] Speaker 01:
This is where I sort of understood you were drawing a distinction between the arguments you're making and the arguments that were being made on behalf of Porter, is that as I understood your reliance on Calder, your view is that it doesn't matter where they're going to sell, just the mere fact that they've asked for approval and that the

[00:23:24] Speaker 01:
Article III injury is much akin to the analysis we would do if, in fact, Mylon brought a DJ action seeking to invalidate your patent for purposes of whether or not there is enough threat.

[00:23:40] Speaker 03:
Yes.

[00:23:40] Speaker 03:
And just to be clear, I don't think that there's really any daylight between our position and the position that Mr. Olson was articulating when he was up here a little while ago.

[00:23:47] Speaker 03:
We certainly think that the fact that the sales are, in fact, going to take place

[00:23:51] Speaker 03:
nationwide tends to confirm that there's nothing inequitable about nationwide jurisdiction.

[00:23:56] Speaker 03:
And we, as does Accorda, have a fallback argument here that there are additional Delaware-related contacts here.

[00:24:04] Speaker 01:
But frankly, we think that- But your Calder analysis really turns on the fact that once there is an act of infringement, then you have the effects analysis and that it is akin to defamation

[00:24:21] Speaker 03:
That is absolutely correct.

[00:24:23] Speaker 03:
And just to be clear, we think that that is the appropriate way in which to resolve this case.

[00:24:28] Speaker 03:
And of course, this court's decision in this case is going to have implications not just for our two cases with their specific fact patterns, but to all of the other cases out there arising under the Hatch-Waxman Act.

[00:24:38] Speaker 03:
We think the correct analysis here is that there are effectively nationwide contacts, again, subject to the limitation, that the exercise of jurisdiction must be fair and reasonable.

[00:24:49] Speaker 03:
And importantly, that analysis under the Supreme Court's decision in Burger King takes into account factors such as the burden to the defendant.

[00:24:55] Speaker 01:
But do we have to find that there would be jurisdiction in every single state in which they sought approval?

[00:25:01] Speaker 01:
Because if we're trying to say, is this Walden or is this Calder,

[00:25:05] Speaker 01:
then wouldn't you have to have the overlay of the effects as well?

[00:25:11] Speaker 01:
I mean, the effects are relevant to the jurisdictional analysis, either way.

[00:25:19] Speaker 01:
But what the Supreme Court said in Walden is you need more than just effects.

[00:25:22] Speaker 01:
Correct.

[00:25:23] Speaker 01:
But you need them nonetheless.

[00:25:25] Speaker 03:
Right.

[00:25:26] Speaker 03:
Well, which is to say that you are focusing on the defendant's conduct and where the effects of the conduct are felt.

[00:25:32] Speaker 03:
And sure, effects are insufficient.

[00:25:34] Speaker 03:
And the reason why we think that Walden is not the applicable framework here, and we really think that Walden is an exception to Calder rather than vice versa, but however you doctrinally slice it, the reason we think that Walden is irrelevant is that here you have conduct.

[00:25:48] Speaker 03:
that is purposefully targeted not only at Delaware, but everywhere.

[00:25:51] Speaker 03:
Again, it's targeted everywhere that we have patent rights and where they are seeking approval to market and sell a competing product.

[00:26:00] Speaker 02:
And at one point- Are you saying that the issue before us goes beyond this particular case?

[00:26:05] Speaker 02:
Well- Or whether they were properly sued in Delaware?

[00:26:08] Speaker 02:
Well, Judge Newman, I think this- Are there lines to be drawn if we are saying that they need to be drawn?

[00:26:14] Speaker 03:
This court, Judge Newman, certainly could say that there are sufficient contacts idiosyncratic to these two cases to support the exercise of jurisdiction in Delaware.

[00:26:23] Speaker 03:
And in particular, in our case, because the notice letters, which were, after all, integral to the entire scheme, were actually sent to an AstraZeneca affiliate in Delaware.

[00:26:32] Speaker 03:
But of course, there are lots of these cases in which Mylon is raising this objection.

[00:26:36] Speaker 03:
And I think it would be important for this court to provide guidance to the lower courts, not least because what we're really talking about is the question

[00:26:43] Speaker 03:
You know, what are the contacts at issue in cases of this variety?

[00:26:46] Speaker 03:
And again, we think that the principal relevant conduct here is purposely targeting our patent rights everywhere and seeking approval to market a competing product everywhere.

[00:26:57] Speaker 03:
And that makes us no different from defamation.

[00:26:58] Speaker 03:
And the one other thing I would say on this issue.

[00:27:01] Speaker 01:
When you say everywhere, so that means that the suit could be brought in any state

[00:27:07] Speaker 01:
that it didn't matter that you were incorporated in Delaware?

[00:27:11] Speaker 03:
Yes, but subject to the important limitation that the exercise of jurisdiction has to be fair and reasonable.

[00:27:15] Speaker 03:
And so if we decided to bring suit in Alaska, I think Mylan could colorably argue that it would be very burdensome to have to litigate there.

[00:27:23] Speaker 03:
And you would engage in the usual analysis, taking into account the multiplicity of Burger King factors as to whether or not the exercise of jurisdiction is appropriate there.

[00:27:33] Speaker 03:
I want to say just two other quick things on specific jurisdiction and then turn my remaining time to general jurisdiction.

[00:27:38] Speaker 03:
Mr. Clement said at the outset of his argument that the fact that our position on specific jurisdiction could give rise to nationwide jurisdiction gave him pause.

[00:27:46] Speaker 03:
But I would respectfully submit that there's actually nothing odd about that.

[00:27:50] Speaker 03:
As Mr. Olson said during his argument, of course, once a product is brought to market,

[00:27:55] Speaker 03:
it happens all the time that there is effectively nationwide jurisdiction.

[00:27:58] Speaker 03:
And so if I market a smartphone and sell it nationwide and Apple thinks that I'm infringing their patent rights, of course there's nationwide jurisdiction.

[00:28:06] Speaker 03:
And in fact, as this court will be aware, there are a number of federal statutes that effectively, affirmatively confer nationwide jurisdiction, such as the securities laws and Civil Rico and the Sherman Act, which by virtue of their nationwide service of process provisions, effectively give rise to nationwide personal jurisdiction.

[00:28:24] Speaker 03:
I think on the flip side with regard to Hatch-Waxman, sure, it's true that Hatch-Waxman itself does not contain an express jurisdictional provision.

[00:28:32] Speaker 03:
But I think our position, and not Mylon's incredibly stingy position under which you would simply, quote unquote, often have jurisdiction where the and it is prepared, whatever that means, I think that our position is much more consistent with Congress's intent.

[00:28:46] Speaker 03:
Because in the Hatch-Waxman Act, Congress wanted these cases to be resolved in an expeditious fashion, and indeed,

[00:28:54] Speaker 03:
Although Mr. Clement relies on the House report to the Hatch-Waxman Act, I think the best evidence of Congress's intent comes in section 299 of Title 35, a provision that was added in the America Invents Act.

[00:29:08] Speaker 03:
That's the provision that, of course, cut back on consolidated proceedings against multiple defendants in an effort to control problems with non-practicing entities, but which specifically carved out Hatch-Waxman cases from the requirements for obtaining consolidation.

[00:29:23] Speaker 03:
And I think that that's the best affirmative evidence that Congress wanted these proceedings to be resolved in a consolidated fashion, again, consistent with Congress's intent.

[00:29:31] Speaker 01:
But why wouldn't 1407 be good enough for that purpose?

[00:29:35] Speaker 03:
Well, because I think that it would create incredible complications by virtue of the operation of the 30-month stay provision.

[00:29:43] Speaker 03:
As our brief and the amicus briefs point out, the MBL process, of course, introduces inevitable delay.

[00:29:49] Speaker 03:
And in addition, you have the problem that would arise because, of course, these cases, if they're tried,

[00:29:53] Speaker 03:
are going to have to be tried in the various jurisdictions in which they were initially brought.

[00:29:57] Speaker 03:
And you have the very real problem of the potential for inconsistent judgments and, of course, the implications of those inconsistent judgments for both the 30-month state provision and for this court's orderly review.

[00:30:09] Speaker 01:
Yeah, but the judge, I mean, maybe this is going too far afield, but the MDL judge, since these are bench trials, could be cross-designated as a judge in all the other jurisdictions.

[00:30:22] Speaker 03:
I think that would require the consent of the parties or at least some creative activity on the part of the district courts in order to facilitate that.

[00:30:31] Speaker 01:
Well, no, it's not that.

[00:30:32] Speaker 01:
I mean, having been an MDL judge and have been designated in other districts for purposes of trying cases, you simply have to go through the appropriate processes in order to get our committee on the multi-district

[00:30:46] Speaker 01:
litigation to designate you.

[00:30:48] Speaker 01:
That's it.

[00:30:48] Speaker 03:
Yeah.

[00:30:48] Speaker 03:
Well, but as Your Honor will know, the very fact of designating an MDL judge itself typically takes a period of some months.

[00:30:56] Speaker 03:
And again, I think that Congress's priority in the Hatch-Waxman Act was on the efficient resolution of these cases.

[00:31:01] Speaker 03:
And again, I think the best evidence of Congress's intent on this score is not a House report, a piece of legislative history, but rather Section 299, which seems expressly to contemplate consolidated proceedings.

[00:31:13] Speaker 03:
Since I have a minute left, I want to say just a word about general jurisdiction, if I may.

[00:31:17] Speaker 03:
I think that this is not simply a case in which this court is bound by the Supreme Court's prior jurisprudence.

[00:31:23] Speaker 03:
This is a case in which there is simply no indication that the Supreme Court today would deviate from those earlier Supreme Court cases.

[00:31:30] Speaker 03:
On the issue of consent, I think that it is sufficient here that Mylon voluntarily chose to do business in Delaware.

[00:31:37] Speaker 03:
But I think it is also true that in 2010, for whatever reason,

[00:31:41] Speaker 03:
Mylon took the additional voluntary step of electing to register in Delaware, when it could have simply chosen instead.

[00:31:48] Speaker 01:
Well, the voluntary step was so that it wouldn't be a violation of Delaware law.

[00:31:51] Speaker 03:
But as Judge O'Malley, you pointed out earlier, it would have simply had to endure relatively modest consequences, including a $500 fine if it had refused to do so.

[00:32:00] Speaker 03:
But I think that I'm content to rest on the fact that its decision to do business in Delaware

[00:32:06] Speaker 03:
was itself a voluntary act.

[00:32:08] Speaker 03:
And that is really all that is required.

[00:32:10] Speaker 01:
And I think if you would expect a responsible corporation to say, I'm going to comply with the law, regardless of what the penalties are.

[00:32:16] Speaker 03:
Well, I can't speak to why Mylon decided to register in 2010.

[00:32:20] Speaker 03:
I am not aware of any dramatic change in Mylon's business model that took place then.

[00:32:25] Speaker 03:
I assume that Mylon was doing business before 2010, much as it was doing when it decided to register.

[00:32:30] Speaker 03:
But I think that the critical fact for purposes of this discussion is that not only do we have

[00:32:36] Speaker 03:
the pre-international shoes Supreme Court decisions.

[00:32:39] Speaker 03:
We have a litany of subsequent Supreme Court decisions that not only cite Pennsylvania fire insurance and other cases in that line, but that draw the distinction between actual consent and implied or fictitious consent in exactly the way that we're drawing it, and that put this type of consent on the actual consent side of the line.

[00:32:58] Speaker 03:
And the two cases I would point this Court to, which are cited in the briefs but may be lost in the shuffle, are first the Oberding case,

[00:33:05] Speaker 03:
which was the case involving the question of whether a driver impliedly consented to Kentucky jurisdiction and therefore to venue by driving through the state.

[00:33:15] Speaker 03:
And that's 346 US at 340 to 342.

[00:33:18] Speaker 03:
And then second and critically, the Insurance Corporation of Ireland case at 456 US at 704.

[00:33:24] Speaker 03:
And to be sure, as Mylon points out in its reply brief, that case catalogs a number of different types of cases in which there could be consent.

[00:33:32] Speaker 03:
Cases in which a party voluntarily agrees to the jurisdiction of a particular court, for example.

[00:33:38] Speaker 03:
But in the one category of cases that Mylan conspicuously omits, pages 9 to 10 of its reply brief, it says that the court has upheld state procedures which find constructive consent in the voluntary use of certain state procedures.

[00:33:51] Speaker 03:
And of course, that's precisely what's going on in cases such as Pennsylvania fire insurance.

[00:33:55] Speaker 03:
And if I could, with the court's leave, just say one word about the two kind of collateral issues that are floating around with regard to general jurisdiction.

[00:34:02] Speaker 03:
First, the unconstitutional conditions argument, and then the commerce clause argument.

[00:34:07] Speaker 03:
Judge Toronto, I also, like Mr. Clement, really don't think that there's a lot of daylight between the straight up question of constitutionality and the application of the unconstitutional conditions doctrine here.

[00:34:17] Speaker 03:
But it's perhaps for a slightly different reason.

[00:34:20] Speaker 03:
I think all of these

[00:34:21] Speaker 03:
personal jurisdictions.

[00:34:23] Speaker 00:
I'm not sure which way the absence of daylight cuts here.

[00:34:26] Speaker 03:
I think it probably cuts in our favor for the reason I'm about to say and in a minute Mr. Clement can disagree with me.

[00:34:32] Speaker 03:
I think it cuts in our favor because I think that the Supreme Court has made clear and it's clearest in Insurance Corporation of Ireland that the reason that we have this doctrine, the reason we have a due process limitation on personal jurisdiction is because of individualized considerations of fair notice.

[00:34:51] Speaker 03:
And so I think in a case in which a party is consenting, the party is on fair notice of the implications of its action.

[00:35:00] Speaker 03:
And so the due process interest, in some sense, has therefore been served.

[00:35:04] Speaker 03:
And I think it is also true, as Mr. Olson pointed out, that in addition to the fact that any separate alliance on the unconstitutional conditions doctrine here has been plainly waived, the Supreme Court's decision in Narbo, I think, really sort of essentially deals with an unconstitutional conditions style argument.

[00:35:21] Speaker 03:
Because in Nirbo, of course, the Supreme Court distinguished cases such as Pennsylvania fire insurance from the Southern Pacific case, the primary case on which Mylon's amicus relies, in which you had a state saying, if you consent to do business here, you're going to lose your right to remove cases to federal court.

[00:35:40] Speaker 03:
And the court said that statute is invalid, whereas the statute at issue in Pennsylvania fire insurance is valid.

[00:35:46] Speaker 03:
And while the Supreme Court back then

[00:35:48] Speaker 03:
wasn't really talking as explicitly in terms of unconstitutional conditions because that doctrine was a relative babe at the time in constitutional law.

[00:36:00] Speaker 03:
I think that that decision essentially rejects that style of argument.

[00:36:03] Speaker 01:
What about that?

[00:36:05] Speaker 01:
Clement's point that that's because at the time, the Supreme Court was talking more about the dormant commerce clause issues and not really focusing on the due process.

[00:36:13] Speaker 03:
Well, I think that that's true with regard to Bendix.

[00:36:16] Speaker 03:
And I do want to say a word about the commerce clause.

[00:36:18] Speaker 03:
I think that is also an argument that has not been raised by Mylon here.

[00:36:23] Speaker 03:
And I heard Mr. Clement to essentially concede that the thrust of his challenge here is a due process claim rather than a commerce claim.

[00:36:29] Speaker 03:
And I really think that a commerce clause challenge

[00:36:31] Speaker 03:
would really be appropriately brought as a facial challenge to the Delaware statute.

[00:36:37] Speaker 03:
But I think interestingly, Judge O'Malley, if you take a look at the Sternberg case, which is, after all, the Delaware Supreme Court case that construed the Delaware statutes as providing for consent by registration, Justice Holland, in his opinion for that court, addressed, and I think addressed quite learnedly,

[00:36:52] Speaker 03:
the Dormant Commerce Clause argument.

[00:36:54] Speaker 03:
And said that the burden was not undue and distinguished the Bendix case, which is a case that neither Mylon nor its amici rely on, but which I think is really sort of the closest case.

[00:37:07] Speaker 03:
It distinguished that case on the grounds that the burden was not as substantial.

[00:37:11] Speaker 03:
And I really do think that the question of whether or not this statute is consistent with the Commerce Clause

[00:37:18] Speaker 03:
would be governed by Pike versus Bruce Church balancing.

[00:37:20] Speaker 03:
And in addition to the fact that the burden is relatively slight, I think Delaware's interest in having a statute of this variety is simply in putting out-of-state corporations on the same footing as in-state corporations would be on, including subjecting them to the jurisdiction of the court if, say, the contacts are insufficient to give rise to specific jurisdiction.

[00:37:41] Speaker 03:
And so if you had a company, for instance, that put a product into the stream of commerce and, unlike Milan, did not use

[00:37:47] Speaker 03:
established distribution channels.

[00:37:49] Speaker 03:
That company might be able to argue that there's no specific jurisdiction over a product liability suit, but the effect of their consent would be to subject them nevertheless to the jurisdiction of the Delaware courts if their product ended up injuring a Delaware consumer.

[00:38:02] Speaker 01:
So I don't think there's any...

[00:38:05] Speaker 01:
I mean, do you think that it's relevant at all that at the time these cases were first decided, that there were very few corporations that were doing business in every single state in the union?

[00:38:17] Speaker 01:
I mean, that was a situation where you chose a few states to do business in, and so that it made more sense to allow the states this kind of flexibility.

[00:38:26] Speaker 03:
Well, of course, the irony, Judge O'Malley, is that international shoe, far from

[00:38:32] Speaker 03:
narrowing the scope of jurisdiction actually broadened it in part to respond to the economic realities that people were increasingly moving nationwide and corporations were increasingly doing business nationwide.

[00:38:43] Speaker 03:
And International Shoe really added this notion of minimum contacts to the jurisdictional mix to afford a mechanism for providing jurisdiction over out-of-state corporations.

[00:38:55] Speaker 03:
And Mr. Clement makes the argument, particularly in his brief, that this is somehow going to gut the rule of Daimler.

[00:39:01] Speaker 03:
But I think that the practical reality is that notwithstanding the fact that Pennsylvania fire insurance is soon going to be celebrating its 100th anniversary as a Supreme Court decision, we have not seen a flood of state statutes requiring consent as a condition of registration.

[00:39:20] Speaker 03:
I think that I'm aware of only seven states where the state statutes have definitively been construed in that fashion.

[00:39:26] Speaker 03:
There are, if anything, a greater number of state statutes

[00:39:29] Speaker 03:
that have expressly been construed to go in the other direction.

[00:39:33] Speaker 03:
Now, of course, even if there were such a flood of cases, I don't think that that's any reason to think that the earlier Supreme Court decisions should not be followed.

[00:39:41] Speaker 03:
And indeed, even Daimler itself, as Mr. Olson pointed out, preserved consent as an alternative basis for general jurisdiction.

[00:39:49] Speaker 03:
And I would note parenthetically in response to one of your earlier questions, Judge O'Malley, that California is a state that does not have

[00:39:57] Speaker 03:
a jurisdiction by registration statute, the California courts have definitively construed the registration statute not to permit that.

[00:40:06] Speaker 03:
So that issue was not on the table.

[00:40:08] Speaker 03:
But even in Daimler itself, the court was careful to make clear that consent remained an alternative basis for jurisdiction.

[00:40:15] Speaker 01:
Was your response to the argument that there's a difference between consent and coerced consent?

[00:40:21] Speaker 03:
Well, I don't think that even the Warren court would have viewed this consent as involuntary.

[00:40:25] Speaker 03:
I mean, with all due respect,

[00:40:26] Speaker 03:
But this was an express act of registration, and again, of course, a voluntary act to do business in the first place.

[00:40:35] Speaker 03:
And at a minimum, where the state statute requires a separate affirmative volitional act that is directly related to jurisdiction, whether that act is registration or the designation of an agent.

[00:40:48] Speaker 03:
I think this clearly falls on the actual consent side of the law.

[00:40:51] Speaker 00:
And I think you may have said something

[00:40:55] Speaker 00:
quickly in passing a few minutes ago.

[00:40:58] Speaker 00:
But what exactly is Delaware's interest in saying, if you want to do business here, you must subject yourself to our courts for matters that have nothing to do with our state?

[00:41:09] Speaker 03:
Well, I think in fairness, first, that, Judge Stronto, you could have a case in which you simply don't have sufficient minimum contacts to give rise to specific jurisdiction.

[00:41:21] Speaker 03:
But yet the state could very much have an interest in providing a remedy for

[00:41:25] Speaker 03:
in-state residents.

[00:41:27] Speaker 00:
And so, you know, a case would be a case in which, you know, a... A general jurisdiction, which is what Sternberg says you consent to, can be a, what's the language, entirely transitory cause of action.

[00:41:41] Speaker 00:
The plaintiffs don't have to come from Delaware.

[00:41:43] Speaker 00:
The defendant doesn't have to come from Delaware.

[00:41:45] Speaker 00:
The action that, the conduct at issue doesn't have to have anything to do with Delaware.

[00:41:50] Speaker 00:
What is Delaware's interest?

[00:41:51] Speaker 03:
It certainly is true that the statute might sweep somewhat more broadly.

[00:41:56] Speaker 03:
And so it does provide a remedy potentially for out-of-state residents as well as for in-state residents.

[00:42:02] Speaker 00:
So what's Delaware's interest in doing that?

[00:42:04] Speaker 03:
Well, I think that Delaware's interest may not justify the entire sweep of the statute.

[00:42:08] Speaker 03:
But I think that at a minimum, it is appropriate for Delaware to make the legislative judgment to say, essentially, we are going to put out-of-state corporations on a level jurisdictional footing.

[00:42:18] Speaker 03:
within state corporations.

[00:42:19] Speaker 03:
And that's all that this consent does.

[00:42:21] Speaker 03:
And of course, that's precisely what the consent at issue in cases such as Pennsylvania Fire Insurance and Robert Mitchell Furniture did.

[00:42:29] Speaker 03:
Of course, the whole point of the consents there was that they gave rise to general jurisdiction.

[00:42:35] Speaker 03:
And the Supreme Court said that there's nothing problematic about that.

[00:42:38] Speaker 03:
And my point, I think, was simply in response to Judge O'Malley's question about how a court would look at a commerce clause challenge.

[00:42:44] Speaker 03:
That, thankfully, is not one of the issues before the court here.

[00:42:47] Speaker 03:
We think that this court can affirm the decisions of the lower courts in these two cases solely on the basis of specific jurisdiction.

[00:42:55] Speaker 03:
But at a minimum, the court ought to address the issue of specific jurisdiction.

[00:42:59] Speaker 03:
And it certainly would be appropriate, if the court chose to, to go on and address the issue of general jurisdiction as well.

[00:43:04] Speaker 03:
But our primary argument on specific jurisdiction, our argument that what a generic manufacturer is seeking to do here, is to essentially declare nationwide war on the rights of a brand name manufacturer.

[00:43:15] Speaker 03:
That is a sufficient basis for resolving these cases.

[00:43:18] Speaker 03:
It would provide for contacts nationwide, but again, subject to the important limitation that the exercise of jurisdiction in any particular case must be fair and reasonable.

[00:43:28] Speaker 03:
And on that basis, we would submit affirmance should be required.

[00:43:31] Speaker 02:
Can I ask one more question?

[00:43:32] Speaker 01:
One more, and we need to wrap it up.

[00:43:34] Speaker 01:
OK.

[00:43:34] Speaker 01:
With respect to the issue of specific jurisdiction, there seems to be a little bit of a

[00:43:44] Speaker 01:
divergence in terms of the two arguments that perhaps you both make, and that is that we can look at expressed desires to engage in future conduct as to that prong of the argument

[00:44:01] Speaker 01:
it seems that the only cases you cite are contractual cases, where there's a contractual obligation to engage in future conduct.

[00:44:11] Speaker 01:
Here, even though they're seeking approval to sell, they may never sell in certain of those jurisdictions.

[00:44:19] Speaker 01:
Isn't that a distinction, at least as to that prong of your argument, rather than the prong that says the harm is occurring because of the pall on the patent?

[00:44:27] Speaker 03:
Well, I don't think there's really any sort of daylight there, but I think you've sort of fairly characterized our argument, which is to say that our argument does not depend on where the sales are ultimately going to take place.

[00:44:40] Speaker 03:
It turns on what it is that the generic manufacturer is seeking approval to do.

[00:44:46] Speaker 03:
And the generic manufacturer is seeking nationwide approval.

[00:44:50] Speaker 03:
And under the framework of Calder versus Jones, which is the framework that governs intentional torts,

[00:44:56] Speaker 03:
we think that this is no different from a case involving, say, defamation.

[00:45:00] Speaker 03:
Now, yes, it is true that by virtue of the nature of the tort in a defamation case, in both the Calder case and the Keaton case, you had the nationwide publication of the defamatory material.

[00:45:13] Speaker 03:
And in the Keaton case, you had jurisdiction, even in a jurisdiction where the plaintiff was not resident, by virtue of that nationwide publication.

[00:45:22] Speaker 03:
But here, again, the act in question is this nationwide declaration of war.

[00:45:26] Speaker 03:
It is the fact that the generic manufacturer is calling into question the brand name manufacturers or the pioneer drug company's rights, wherever those rights are held, and wherever the generic manufacturer is seeking approval to sell the product.

[00:45:40] Speaker 03:
And so that's why there may seem to be a slight disconnect here.

[00:45:43] Speaker 03:
Of course, the result in either case is the same.

[00:45:47] Speaker 03:
If you look to ultimate sales, we certainly think that there can't really be any serious doubt

[00:45:51] Speaker 03:
that the ultimate sales here are going to take place nationwide.

[00:45:54] Speaker 03:
But again, because this is a claim-specific inquiry, we think you have to focus on what it is that the generic is seeking to do.

[00:46:00] Speaker 03:
And what the generic is seeking to do under Section 271E2 is approval to market and sell a drug that is claimed in a patent before the expiration of the patent.

[00:46:10] Speaker 03:
And that causes nationwide injury.

[00:46:12] Speaker 03:
And that certainly suffices to establish nationwide context.

[00:46:15] Speaker 03:
Again, with the important caveat that where the exercise of jurisdiction would not be fair and reasonable,

[00:46:20] Speaker 03:
And we really don't think Mylon can make an argument to the contrary here.

[00:46:25] Speaker 03:
There may be some limitation on jurisdiction.

[00:46:29] Speaker 02:
Thank you.

[00:46:30] Speaker 02:
Thank you, Your Honors.

[00:46:33] Speaker 02:
Well, no, Mr. Klenick, you have three minutes.

[00:46:37] Speaker 02:
Thank you.

[00:46:37] Speaker 02:
I'm getting tired.

[00:46:39] Speaker 04:
I would just indulge you for three points, if I may.

[00:46:41] Speaker 04:
First of all, my friend on the other side came perilously close to implying that the Insurance Corporation of Ireland case actually

[00:46:48] Speaker 04:
positively cited Pennsylvania fire in its language about taking advantage of certain state procedures as being a way to waive jurisdiction.

[00:46:56] Speaker 04:
That decision does not... What about a tinker to tailor to chance kind of remedy?

[00:47:02] Speaker 04:
But importantly, it doesn't cite Pennsylvania fire for that proposition.

[00:47:05] Speaker 00:
What does he say?

[00:47:08] Speaker 04:
Well, what the court cites for that proposition is a case that basically says

[00:47:14] Speaker 04:
that if you file a complaint and then you open yourself up to a counterclaim.

[00:47:20] Speaker 04:
So that's the kind of state procedures they're talking about.

[00:47:22] Speaker 04:
They're talking about the state courts, which is a classic sort of personal jurisdiction waiver.

[00:47:26] Speaker 04:
So really, in terms of citing Pennsylvania Fire Post International Shoe, what the other side has is Olberding, which is a venue case, and they have footnote six of the Perkins case.

[00:47:39] Speaker 04:
Well, the Perkins text says that a consent statute is not conclusory.

[00:47:44] Speaker 04:
And footnote 18 of Daimler says, don't rely on footnote 6 of Perkins.

[00:47:51] Speaker 04:
And the last point on that is just the court could not have been clear, and it's a plurality opinion to be sure, but in Burnham, they specifically said that these kind of old consent statutes are the fictions that International Shoe did away with.

[00:48:05] Speaker 04:
So the second point I'd like to make is that

[00:48:08] Speaker 04:
I mean, my friend on the other side said that filing an ANDA in a paragraph 4 certification is the equivalent of declaring nationwide war on the patent.

[00:48:18] Speaker 04:
Now, that doesn't seem to be the way that Congress thought about this at all.

[00:48:21] Speaker 04:
They thought it was a mechanism to provide some litigation over the issue.

[00:48:26] Speaker 04:
And I think it's actually interesting to contemplate what happens if the shoe's on the other foot.

[00:48:31] Speaker 04:
I mean, if Mylan were to bring a declaratory judgment action about the validity of this patent,

[00:48:37] Speaker 04:
I wouldn't think we could file it in West Virginia just because we thought that was a convenient place to file the suit.

[00:48:43] Speaker 04:
And in fact, the Hatch-Waxman Act itself specifically has a provision that contemplates what happens and where to file a suit if in the relatively unusual event that the patentee does not bring their own declaratory judgment action, and it says that the generic and defiler can bring it in the patentee's principal place of business.

[00:49:03] Speaker 00:
In the absence of that provision, why do you doubt that you could bring that in West Virginia?

[00:49:08] Speaker 00:
If they sell their drug in West Virginia and you're challenging the validity of the patent that would exclude you from West Virginia?

[00:49:14] Speaker 04:
I don't think the fact that they're selling a product that we think is backed by an invalid patent gives us a basis to sue them in West Virginia.

[00:49:24] Speaker 04:
Because we don't have a patent in everything that's covered by an invalid patent.

[00:49:31] Speaker 04:
It works in reverse, and I think logically we would sue them in their home state, and they should sue us logically in our home state.

[00:49:37] Speaker 04:
The point I'd like to finish with is my friend on the other side began by talking about the settled practice of having these cases litigated in Delaware.

[00:49:44] Speaker 04:
Well, sure there was a settled practice, but it's unambiguous that the settled practice was based on general jurisdiction.

[00:49:51] Speaker 04:
It wasn't based on a consent theory.

[00:49:53] Speaker 04:
It wasn't based on a specific personal jurisdiction theory.

[00:49:56] Speaker 04:
It was based on the pre-Daimler theory that if you did a decent amount of business,

[00:50:00] Speaker 04:
You were there for all purpose jurisdiction.

[00:50:02] Speaker 04:
And both of the district courts that you're reviewing today correctly recognize that Daimler was a game changer for that, that Mylan was not at home in Delaware.

[00:50:12] Speaker 04:
And this court, the other side, doesn't even take issue with that.

[00:50:16] Speaker 04:
So their submission is that, lo and behold, business as usual.

[00:50:21] Speaker 04:
Nothing really changes because of Daimler, because we can also hook Mylan and other companies on this consent theory.

[00:50:28] Speaker 04:
or we can hook them on specific personal jurisdiction.

[00:50:31] Speaker 04:
And with respect, neither of them makes sense.

[00:50:33] Speaker 04:
Pennsylvania Fire is going to celebrate its 100th birthday because it is a Pinoy era case that has been long overruled by the Supreme Court.

[00:50:41] Speaker 04:
And with respect to specific jurisdiction, I simply do not think there is specific jurisdiction in every state in the nation by virtue of filing an ANDA in Maryland.

[00:50:53] Speaker 04:
If that were the case, then this court was profoundly misguided

[00:50:56] Speaker 04:
And it's an iniquity decision, and I don't think that was the case.

[00:50:58] Speaker 02:
Thank you for your indulgence.

[00:51:00] Speaker 02:
Thank you, Mr. Clement.

[00:51:02] Speaker 02:
The case is taken under submission.