[00:00:00] Speaker 04:
Our next case for argument is 24-2009, Regeneron Pharmaceuticals v. Miley.

[00:00:10] Speaker 08:
May it please the court, Sean Van Horn, on behalf of the appellant Formicon AG.

[00:00:15] Speaker 08:
So the question today is, why is a German biotech company from the suburbs of Munich facing a suit in the Northern District of West Virginia?

[00:00:22] Speaker 08:
And we posit because our opponents have misread this court's precedent in the Accorda case.

[00:00:28] Speaker 08:
And I first want to address the court's recent order on Rule 4K2.

[00:00:34] Speaker 08:
Rule 4K2, not the overextension of a court, is the proper lens for determining personal jurisdiction over a foreign defendant, such as our client, Formicon.

[00:00:43] Speaker 08:
But as we proved below, it does not apply, because Washington state has personal jurisdiction over Formicon, which negates the application here.

[00:00:52] Speaker 08:
So as an initial matter, the generon forfeited the 4K2 basis of personal jurisdiction below.

[00:00:58] Speaker 08:
Formicon addressed it in its opening brief, its motion to dismiss.

[00:01:01] Speaker 08:
That's at Appendix 26094.

[00:01:04] Speaker 08:
Regeneron then failed to address it in its response to that motion to dismiss on personal jurisdiction at 26121.

[00:01:11] Speaker 08:
In Formicon's reply brief on the motion to dismiss, it noted that they had conceded.

[00:01:17] Speaker 04:
OK, well, so let's not talk about waiver, because you're the only one talking about personal jurisdiction.

[00:01:23] Speaker 04:
And there was no waiver in the other case where they didn't talk about personal jurisdiction, right?

[00:01:29] Speaker 04:
They disputed under 4K2 and the other one.

[00:01:33] Speaker 08:
You're saying that in the Samson case, they dispute jurisdiction.

[00:01:35] Speaker 08:
OK.

[00:01:36] Speaker 04:
Since you all have divided it up, and I respected not asking him all the personal jurisdiction questions, I'm putting them to you, can you skip over waiver?

[00:01:44] Speaker 04:
Of course.

[00:01:45] Speaker 08:
My apologies.

[00:01:46] Speaker 08:
I thought the order had only been entered regarding 4K2 and the Formicon case, so that's why I was addressing it for us.

[00:01:52] Speaker 08:
But let me just address it factually with respect to Formicon.

[00:01:54] Speaker 08:
So yes, we agree 4K2 is an appropriate lens.

[00:01:57] Speaker 08:
We have a foreign defendant.

[00:01:59] Speaker 08:
who's being sued.

[00:02:00] Speaker 08:
And so 482 would be an appropriate way to look.

[00:02:02] Speaker 08:
The first requirement under 482 is that there would be no state in which there would lie personal jurisdiction.

[00:02:08] Speaker 08:
So in the briefing on the motion to dismiss, we address that.

[00:02:10] Speaker 04:
And there are cases that say a company can't just assert, well, I can be sued in this case as a litigation strategy to get around the plaintiff's choice of forum in lieu of their own.

[00:02:22] Speaker 04:
And I assume you're going to tell me that's not what happened here.

[00:02:25] Speaker 08:
Yes, of course.

[00:02:25] Speaker 08:
That's exactly not what happened.

[00:02:27] Speaker 08:
So the Inray Stingray case that was cited in the court's order is not relevant here.

[00:02:32] Speaker 08:
There was no unilateral post-suit conduct that we alleged.

[00:02:35] Speaker 08:
The conduct in the state of Washington began five years before the lawsuit was filed.

[00:02:40] Speaker 04:
It's your contract with the manufacturer.

[00:02:42] Speaker 08:
Yes, at appendix 14707.

[00:02:45] Speaker 08:
In our motion, Formicon's response to the motion for PI, we had actually used it as a prior use.

[00:02:50] Speaker 04:
If that's the case, then there's personal jurisdiction over you, not just in Washington, but also in California, correct?

[00:02:57] Speaker 08:
This was not below.

[00:02:59] Speaker 08:
There is evidence of contact with the state of California.

[00:03:02] Speaker 04:
No, it's actually in your 26118 paragraph 6.

[00:03:07] Speaker 04:
Uh, paragraph five is where you talk about your contract with biologic.

[00:03:11] Speaker 04:
Paragraph six use identical language for your contract with, uh, another company.

[00:03:16] Speaker 04:
I think they might be confidential, so I'm not going to say the name.

[00:03:19] Speaker 04:
Paragraph seven is where you talk about a contract you have with another company who is going to do some packaging and labeling and that's in Delaware.

[00:03:27] Speaker 04:
So you precisely and identically what you allege your contacts are

[00:03:33] Speaker 04:
with Washington State are also precisely identifi- identically alleged with regard to California and Delaware.

[00:03:40] Speaker 04:
Am I correct in that?

[00:03:41] Speaker 08:
You're correct factually.

[00:03:43] Speaker 08:
Those are things that are in the fact record.

[00:03:44] Speaker 08:
We agree in highlighting those.

[00:03:46] Speaker 04:
So just to be clear, so if your view is personal jurisdiction exists over us in Washington by virtue of this contract we have, then personal jurisdiction also exists over you in California and Delaware by virtue of the other contracts you have, all of which are itemized one by one in your answer.

[00:04:02] Speaker 08:
So that I don't agree with, because we only conceded jurisdiction in Washington.

[00:04:06] Speaker 08:
There are contacts.

[00:04:07] Speaker 04:
It's not relevant to me what you conceded.

[00:04:10] Speaker 04:
Your concession, you have minimum.

[00:04:15] Speaker 04:
In order for there to be personal jurisdiction, you need to have minimum contacts.

[00:04:19] Speaker 04:
We're not in the stingray world.

[00:04:21] Speaker 04:
We both agree.

[00:04:22] Speaker 04:
Agreed.

[00:04:22] Speaker 04:
So you've got to have minimum contacts.

[00:04:24] Speaker 04:
What you allege exists against you in Washington, you identically allege.

[00:04:29] Speaker 04:
from California and Delaware.

[00:04:31] Speaker 08:
I disagree that it's identical.

[00:04:33] Speaker 04:
Let's look at the document.

[00:04:37] Speaker 04:
26118.

[00:04:39] Speaker 04:
I think I have the wrong appendix.

[00:04:49] Speaker 04:
uh... uh... uh... uh... uh... uh... uh... uh... uh... uh... uh... uh... uh... uh... uh... uh... uh... uh... uh... uh... uh... uh... uh... uh... uh... uh... uh... uh... uh...

[00:05:16] Speaker 04:
I assume that's probably what it is, right?

[00:05:18] Speaker 04:
OK.

[00:05:19] Speaker 04:
OK.

[00:05:19] Speaker 08:
I'll concede that.

[00:05:21] Speaker 01:
All right.

[00:05:25] Speaker 04:
So and then you also have an agreement with somebody else in looks like Pennsylvania.

[00:05:31] Speaker 08:
Correct.

[00:05:33] Speaker 08:
Those are correct.

[00:05:33] Speaker 04:
So those are all places where personal jurisdiction exists over you.

[00:05:38] Speaker 08:
What I take issue with is whether we reach the legal conclusion that there's personal jurisdiction there.

[00:05:44] Speaker 08:
Whether that is a sufficient minimum context is an evaluation that no one has done yet.

[00:05:48] Speaker 08:
There are contacts with those states.

[00:05:49] Speaker 08:
Do they rise to the level of creating personal jurisdiction in those states?

[00:05:52] Speaker 08:
I do not know.

[00:05:53] Speaker 04:
OK, but your allegation with regard to Washington is identical to your allegations in terms of the amount of contact you have for each of those other states.

[00:06:03] Speaker 04:
So if you want me to accept that there are minimum contacts with your company in Washington based on what you've alleged

[00:06:13] Speaker 04:
that how are there not minimum contacts with your company in the other places.

[00:06:17] Speaker 08:
So respectfully, the type of contact with Washington is far more substantial than the context in those other states.

[00:06:23] Speaker 04:
OK, well, then distinguish.

[00:06:25] Speaker 04:
So all I have to go on is what you have here.

[00:06:27] Speaker 04:
Correct.

[00:06:28] Speaker 04:
There's nothing else.

[00:06:29] Speaker 08:
Well, I'm going to cite you to the motion to dismiss brief at 26111 in the appendix.

[00:06:36] Speaker 08:
where we discuss the substantial evidence that is located in Bobble, Washington.

[00:06:39] Speaker 08:
So that's where the contract manufacturer, that's where the allegedly infringing product has been made and will be made going forward.

[00:06:47] Speaker 08:
So to the extent that there will be contacts with a state in the United States, not only will there be contact with that state, there already has been.

[00:06:55] Speaker 08:
There's ongoing contact there.

[00:06:57] Speaker 08:
That is very different than, for example, having a supplier.

[00:06:59] Speaker 04:
You want me to look at 26111?

[00:07:01] Speaker 08:
Correct.

[00:07:02] Speaker 08:
That's our motion to dismiss.

[00:07:03] Speaker 04:
Right.

[00:07:03] Speaker 04:
I'm at 26111.

[00:07:04] Speaker 04:
What is it you want me to look at?

[00:07:06] Speaker 04:
Why don't you read to me what it is that you're talking about?

[00:07:17] Speaker 04:
Because what I'm looking at is about convenience.

[00:07:19] Speaker 08:
So we talked about the non-party witnesses who are located at the contract manufacturer near Seattle, Washington.

[00:07:23] Speaker 04:
This is about convenience.

[00:07:25] Speaker 08:
Right, so these were facts that were put in the, we were also arguing to transfer the case to Washington state.

[00:07:31] Speaker 04:
But convenience is not personal jurisdiction.

[00:07:33] Speaker 08:
Correct, but it's highlighting the contacts and the nature of the contacts with that state, which are very different than just having a contract with the supplier.

[00:07:40] Speaker 08:
They put together a manufacturing facility in Washington that will produce the allegedly infringing product.

[00:07:46] Speaker 08:
And that organization is responsible to do the manufacturing, which includes putting together the cell cultures and cell culture media for that manufacturer.

[00:07:55] Speaker 04:
They're going to do the manufacturing in Washington.

[00:07:57] Speaker 04:
But you say that you have this other company, and I won't say the name just in case it's confidential, but that is in Delaware with headquarters in Pennsylvania that's going to do all of the final packaging and labeling for all of your orders.

[00:08:12] Speaker 08:
That's correct.

[00:08:14] Speaker 04:
All you've told me so far is you've got a company that you hired that's going to do manufacturing.

[00:08:19] Speaker 04:
That's the only thing that's in this record.

[00:08:20] Speaker 08:
No, no.

[00:08:20] Speaker 08:
They're doing the manufacturing.

[00:08:22] Speaker 08:
They've been producing it, the batch records that support the PLA.

[00:08:25] Speaker 04:
So do you think your minimum contacts is the fact that they're actually already doing it or the minimum contacts is the fact that you have a contract with them to do it?

[00:08:31] Speaker 08:
So I think both of those would create minimum contacts.

[00:08:34] Speaker 04:
Well, if both of them have minimum contracts and you already have a contract with a packager, why isn't that a minimum contact?

[00:08:40] Speaker 08:
It's not identical to the basis of personal jurisdiction in those other states, is what I'm taking issue with.

[00:08:45] Speaker 08:
So there are a whole series of contacts with the state of Washington where you set up a CMO years ago, you create the batch records, you sell cultures, you have people go there.

[00:08:53] Speaker 08:
None of that is in this record.

[00:08:55] Speaker 04:
None of it is in this record.

[00:08:56] Speaker 08:
uh... welcome the only minimum contact you've alleged is the fact that you have a contract with the manufacturer but uh... well i think we say right there that the manufacturing the the product in the state of washington where i just cited you uh... and i think we also have the declares that they're manufacturing it

[00:09:14] Speaker 04:
And how does that impact your contact with them?

[00:09:17] Speaker 04:
Your contact is your contract with them to manufacture it.

[00:09:21] Speaker 04:
Now they're manufacturing it.

[00:09:22] Speaker 04:
You also have a contract with people to package it and label it.

[00:09:25] Speaker 04:
And then you got another contract with somebody else to do something else.

[00:09:28] Speaker 04:
I can't remember everything.

[00:09:29] Speaker 04:
Let's see.

[00:09:29] Speaker 04:
You've got, oh, commercial.

[00:09:31] Speaker 04:
Let's see.

[00:09:31] Speaker 04:
You contracted with somebody in California to do something.

[00:09:35] Speaker 04:
somebody in Delaware to package and label it.

[00:09:39] Speaker 04:
You've got all these contracts.

[00:09:40] Speaker 04:
You will let you one after the other in your answer.

[00:09:43] Speaker 08:
So we're not disputing those contacts.

[00:09:46] Speaker 08:
Obviously, none of them are with the state of West Virginia, which is the relevant point as far as we're concerned.

[00:09:52] Speaker 08:
So we only need to prove under 4K2 that there was one jurisdiction, at least, where there was personal jurisdiction.

[00:09:59] Speaker 08:
We put forward Washington state.

[00:10:00] Speaker 08:
Yes, there are contacts in other states.

[00:10:02] Speaker 08:
So 4K2 would have been satisfied.

[00:10:04] Speaker 08:
That's presumably why they dropped it at the motion to dismiss.

[00:10:07] Speaker 08:
So that's why they ultimately went all in on the Accorda case as a means to get around 4K2.

[00:10:13] Speaker 08:
And so our dispute, as I started with at its core, is about how far you can read the Accorda case if you're going to sidestep the other bases.

[00:10:20] Speaker 01:
One other question that's not Accorda.

[00:10:25] Speaker 01:
So there's an MDL.

[00:10:27] Speaker 01:
There was an MDL order in place at the time of this preliminary injunction.

[00:10:34] Speaker 01:
part of the preliminaries that can still be done by the MDL court.

[00:10:40] Speaker 01:
Why is there actually a dispute here?

[00:10:42] Speaker 01:
If this went, got refiled elsewhere, they'd have to transfer it right back here?

[00:10:49] Speaker 08:
Right.

[00:10:49] Speaker 08:
So ultimately, if there's no jurisdiction, I mean, the precedent has been clear looking at the Steele case by the Supreme Court.

[00:10:56] Speaker 08:
A court that doesn't have personal jurisdiction cannot issue a preliminary injunction.

[00:11:00] Speaker 08:
Now, they, after the case is properly dismissed for lack of personal jurisdiction, try to seek a new preliminary injunction.

[00:11:06] Speaker 08:
And indeed, if they come back to the MDL in a roundabout way,

[00:11:11] Speaker 08:
We don't believe they would have a basis to get a new preliminary injunction.

[00:11:14] Speaker 08:
The facts on the ground have changed substantially with the launch of Amgen's product, which this court permitted several weeks ago.

[00:11:20] Speaker 08:
And so irreparable harm will be a different calculation.

[00:11:23] Speaker 08:
In addition, Regeneron themselves pointed out below that under 35 USC 271 E6B, that if this case is dismissed, they will not be able to seek anything other than a reasonable royalty, in which case there will be a consequence for having filed it in a place that had no personal jurisdiction.

[00:11:40] Speaker 01:
I guess I haven't looked into this enough to understand this.

[00:11:47] Speaker 01:
Your position is that in MDL cases, that those cases cannot be referred by the MDL panel to a federal district court in a forum that would not itself have personal jurisdiction.

[00:12:09] Speaker 08:
No, we don't take issue with that here.

[00:12:11] Speaker 01:
We did argue to the JP&L that that was, yeah.

[00:12:14] Speaker 01:
Then I think I misunderstood what you were saying when you immediately jumped to steel company as a response to the scenario in which you get sued in the state of Washington and the next day it gets

[00:12:27] Speaker 01:
transferred under the MDL order back to West Virginia.

[00:12:30] Speaker 08:
Yeah, the MDL's jurisdiction would be predicated on personal jurisdiction in the transferring court.

[00:12:35] Speaker 08:
So here, Washington, for example.

[00:12:37] Speaker 01:
So I guess I return to my question.

[00:12:41] Speaker 01:
So it would be a new case file.

[00:12:42] Speaker 01:
This judge could issue this same injunction

[00:12:47] Speaker 01:
by virtue of having it under the MDL order rather than having it as an initial matter?

[00:12:53] Speaker 08:
No.

[00:12:53] Speaker 08:
He would have two problems with issuing a new preliminary injunction.

[00:12:55] Speaker 08:
There would be a new case filed in the state of Washington that gets transferred, presuming that happens.

[00:13:00] Speaker 08:
And in that case, the new preliminary injunction would have to be on a new basis, not the basis of the old injunction.

[00:13:06] Speaker 08:
The facts have changed considerably.

[00:13:08] Speaker 08:
And in addition, as Vergeneron pointed out in their own brief, that under 35 USC 271 E6B, they would not be allowed to seek injunctive relief because under the BPCIA, if the case is dismissed, you can only get a reasonable royalty.

[00:13:24] Speaker 08:
So they argue that would be a reason to reject a dismissal for personal jurisdiction and only do transfer.

[00:13:29] Speaker 08:
But I posit here that the case law is clear that you have to dismiss the case if it lacks personal jurisdiction.

[00:13:34] Speaker 08:
They made the error in the strategic decision to file in West Virginia with no context.

[00:13:38] Speaker 08:
And as a result, they shouldn't be rewarded, essentially, to be sent back and essentially get a redo to file in the right place and then just fix it and patch it over.

[00:13:48] Speaker 08:
The case should be dismissed outright for lack of personal jurisdiction.

[00:13:53] Speaker 08:
And, you know, as I said, I mean, none of the, you know, just addressing a quarter briefly, none of the facts that animate a quarter are present here.

[00:14:00] Speaker 08:
There is no distribution network on the ground.

[00:14:03] Speaker 08:
We've made very clear that another company called Clinga Biopharm is responsible for hiring.

[00:14:07] Speaker 04:
But you all just, you just don't, you never at any point address the one sentence in a quarter that they have just hammered over and over again.

[00:14:14] Speaker 04:
And so I sure as heck hope that you mooted it before you came in today, because they hammered the sentence over and over and over again, and you never addressed it.

[00:14:22] Speaker 04:
And the sentence in the court is, and even if Mylon does not sell drugs directly to Delaware, it has a network of independent wholesalers and distributors with which it contracts to market the drugs in Delaware.

[00:14:34] Speaker 04:
Such directing of sales into Delaware is sufficient for minimum contacts.

[00:14:38] Speaker 08:
So we have a separate company that does the... You can't hide that way.

[00:14:43] Speaker 04:
We're not gonna play a shell game here.

[00:14:45] Speaker 08:
Yep.

[00:14:46] Speaker 08:
So under Corda, they have... There is no distribution network at all in the state.

[00:14:54] Speaker 08:
We didn't have a distributor in place, and that's clearly in our brief, that we won't have any

[00:15:02] Speaker 08:
Let me just give you the specific.

[00:15:04] Speaker 04:
Is your client saying it has no intention to have its product sold in the state of West Virginia?

[00:15:09] Speaker 08:
The client has intent to sell in the United States, but they've not targeted the state of West Virginia by putting a distribution network in West Virginia.

[00:15:16] Speaker 01:
There's no distributor.

[00:15:18] Speaker 01:
The phrase have not targeted, I think this is self-evident to you, can mean two quite different things for these purposes.

[00:15:27] Speaker 01:
That is, you haven't selected West Virginia

[00:15:30] Speaker 01:
as a place to distribute to the exclusion of anybody else, which I don't think you're saying and is implausible.

[00:15:41] Speaker 01:
And if that's all you're saying, why does that make any difference?

[00:15:44] Speaker 08:
So I would just say to our reply brief at three where we point out that another party will have to engage a distributor.

[00:15:51] Speaker 01:
Right, but that's the chill game point.

[00:15:54] Speaker 08:
The reason it doesn't make a difference is because, of course, everybody filing to get approval to sell intends generally to sell in the United States.

[00:16:00] Speaker 08:
Under their reading of a quota, the mere fact that you hope to sell one day in the United States means you could be sued in any jurisdiction in the United States at the choice of reference product sponsor in any federal court in any state.

[00:16:11] Speaker 08:
because you hope to sell one day in the United States.

[00:16:13] Speaker 08:
And that can't possibly be right.

[00:16:15] Speaker 01:
Hope to is not the same thing as an intent and plan and enter into contracts that haven't quite been implemented yet because it only takes another two days and let's wait.

[00:16:26] Speaker 08:
The key language is targeting a particular state form.

[00:16:29] Speaker 08:
There's no evidence of any targeting of West Virginia.

[00:16:31] Speaker 08:
There's undoubtedly an intent to sell in the United States.

[00:16:34] Speaker 08:
But you have to target a particular state under personal jurisdiction law.

[00:16:37] Speaker 04:
How do you have to target a particular state so much as you just have

[00:16:41] Speaker 04:
sell in all of them or sell in the state?

[00:16:44] Speaker 08:
Well, there's no even guarantee.

[00:16:45] Speaker 08:
Many biosimilars companies don't get off the ground and don't end up selling in all the states.

[00:16:49] Speaker 08:
I mean, you can look at examples like Hispira and Adalumimab from AbbVie.

[00:16:54] Speaker 08:
Many of those companies have never even managed to launch despite an intent to sell.

[00:16:58] Speaker 08:
So using some

[00:16:59] Speaker 08:
future potential sale in a state is a hook for jurisdiction when there's no evidence of current efforts to target that state as is required by purposeful availment and by Respectfully the accorded case where there were all those facts that Delaware was they filed in Delaware They registered with the pharmacy board they had distributors in place in Delaware

[00:17:17] Speaker 08:
Those are all examples of actual facts on the ground that you painted the target, the state of Delaware, to intend to launch the product there.

[00:17:25] Speaker 08:
If those facts existed for West Virginia, we wouldn't be here.

[00:17:28] Speaker 08:
But none of those facts exist.

[00:17:29] Speaker 08:
There's no evidence of any, quote, planned marketing in the state of West Virginia.

[00:17:33] Speaker 08:
There's just evidence general to the United States that they will eventually engage a distributor in Germany.

[00:17:38] Speaker 04:
To the entire United States.

[00:17:39] Speaker 08:
To the entire United States.

[00:17:41] Speaker 04:
Well, isn't, I mean, maybe not everyone thinks so, but I think West Virginia is part of the United States.

[00:17:46] Speaker 08:
Well, yes.

[00:17:46] Speaker 08:
It's almost heaven, but there are no country roads that lead from Munich to it.

[00:17:51] Speaker 08:
So as a result, we don't think it's appropriate.

[00:17:54] Speaker 02:
That was really well done.

[00:17:56] Speaker 04:
I mean, how much did you practice that?

[00:17:58] Speaker 04:
It's the first line that I... And just out of curiosity, how many people told you, please don't say that?

[00:18:05] Speaker 04:
There have to be people when you were moved to think, don't do it.

[00:18:08] Speaker 04:
Just don't do it.

[00:18:10] Speaker 02:
I mean, I liked it.

[00:18:10] Speaker 02:
I thought it was great.

[00:18:11] Speaker 02:
So you went on that one.

[00:18:13] Speaker 08:
What was in the mood, but I know you went rogue on that one, okay?

[00:18:19] Speaker 08:
We're over time I Like talking personal jurisdiction, I can answer more questions.

[00:18:26] Speaker 08:
Thank you

[00:18:37] Speaker 07:
I don't have any jokes that good.

[00:18:40] Speaker 04:
Well, if you call me Mountain Mama, you're out of here.

[00:18:43] Speaker 07:
It's the last thing I'll do, I promise you.

[00:18:47] Speaker 07:
If I may start where my opponent ended, which is with Accorda.

[00:18:51] Speaker 07:
I obviously don't have the camaraderie to presume what the court meant by Accorda.

[00:18:54] Speaker 07:
But I can say that afterwards, Valiant read Accorda to conclusively establish that future acts can confer jurisdiction in a case of 271E.

[00:19:06] Speaker 07:
There's been no dispute here today that those future acts- I'm sorry.

[00:19:10] Speaker 00:
What's planned for future acts?

[00:19:11] Speaker 00:
Indeed.

[00:19:11] Speaker 00:
Those planned at the time.

[00:19:13] Speaker 07:
Yes, planned and the court in a court of said that by virtue of having filed an abbreviated application with FDA that as an economic reality indicates reliably a plan to market in the United States.

[00:19:28] Speaker 07:
There's no dispute that there's a plan to market here in the United States.

[00:19:32] Speaker 04:
And there's really like no evidence for example that

[00:19:36] Speaker 04:
I see in this case that suggests, well, sometimes when people have these plans, they only market in certain states, right?

[00:19:42] Speaker 04:
Like, I mean, it seems to me almost, I'm not going to take judicial notice of it, but almost something I could take judicial notice of, that when you get this approval, you sell a generic, you sell it everywhere.

[00:19:52] Speaker 07:
That's right.

[00:19:53] Speaker 07:
And you don't need to take judicial notice.

[00:19:54] Speaker 07:
We deposed, as part of jurisdictional discovery, their corporate representative.

[00:19:57] Speaker 07:
You can look.

[00:19:58] Speaker 07:
It's a 2, 6, 2, 5, 8 through 16.

[00:20:01] Speaker 07:
We say, where is this going to be sold?

[00:20:03] Speaker 07:
And he says, in the United States, we refer to a map that's at 26377, as you will not be surprised to hear.

[00:20:10] Speaker 07:
It's the United States as a whole.

[00:20:12] Speaker 07:
It doesn't black out West Virginia or any other state.

[00:20:14] Speaker 07:
One could imagine a scenario in which one intends to contract with a regional distributor only and say, I'm only going to market my drug in New York or wherever it is.

[00:20:24] Speaker 01:
Or it might be illegal in a particular state.

[00:20:25] Speaker 07:
Right.

[00:20:27] Speaker 07:
Sure, that's, I suppose, a possibility.

[00:20:29] Speaker 07:
There are scenarios like that that one can contemplate.

[00:20:32] Speaker 07:
This is not one of them, I would submit.

[00:20:35] Speaker 06:
Does Accordia require you to have plans to distribute in the forum state?

[00:20:39] Speaker 06:
I think plans to distribute anywhere are sufficient, or everywhere are sufficient.

[00:20:43] Speaker 06:
Not specifically to the forum state?

[00:20:45] Speaker 06:
No.

[00:20:46] Speaker 07:
I think it says repeatedly in Accordia that they have plans to distribute their product in Delaware and elsewhere, or Delaware

[00:20:54] Speaker 07:
and other places in the United States.

[00:20:56] Speaker 07:
So that page five, I think actually they crystallized the dispute quite nicely at page five of the reply brief.

[00:21:02] Speaker 07:
And they say the dispute between the parties is whether there needs to be specific activity planned for West Virginia per se, West Virginia as opposed to everywhere else, or whether it's enough to have plans to market nationwide.

[00:21:15] Speaker 04:
And what the court said in a quarter is that- So just let me clarify, because I think that you maybe didn't say it as precisely as I think you meant to.

[00:21:23] Speaker 04:
They do have plans to do this in West Virginia.

[00:21:26] Speaker 07:
Absolutely.

[00:21:27] Speaker 04:
They have plans to do it everywhere.

[00:21:28] Speaker 04:
West Virginia is part of everywhere.

[00:21:29] Speaker 07:
You said it better than I did.

[00:21:31] Speaker 07:
Absolutely.

[00:21:31] Speaker 07:
That's exactly the point.

[00:21:32] Speaker 07:
And the court said in a court, if the plans already had been in place, if this weren't a 271E action, but instead were a 271A action, and they actually sold everywhere, there would be no doubt, the court said, that there would be jurisdiction in Delaware as in every other state.

[00:21:47] Speaker 07:
So we're dealing with sort of the fiction of 271E, where

[00:21:50] Speaker 07:
The acts for which we're seeking redress have not yet occurred.

[00:21:53] Speaker 07:
We have an artificial act of infringement under 271E, the filing of the BLA.

[00:21:58] Speaker 07:
And we're seeking redress for those future acts that will occur everywhere, including in West Virginia.

[00:22:03] Speaker 07:
So we think it's clear under ACORDA, and courts have applied ACORDA uniformly.

[00:22:08] Speaker 07:
We cite the Apicor case.

[00:22:09] Speaker 07:
We cite the Millennium case out of Delaware, where courts without the other

[00:22:14] Speaker 07:
Facts that Formicon points to without the registration, et cetera, have simply read a quota for the proposition that where you file an application to sell everywhere and you intend to sell everywhere, you're subject to jurisdiction everywhere.

[00:22:26] Speaker 07:
I actually think it's clear here.

[00:22:27] Speaker 04:
Do you agree that you cannot prevail under 4K2, though, because they do have personal jurisdiction by virtue of having these contracts?

[00:22:35] Speaker 07:
I don't agree with that, Your Honor.

[00:22:37] Speaker 04:
Well, you gave it up below.

[00:22:38] Speaker 04:
You gave it up.

[00:22:39] Speaker 07:
No, we didn't give it up below.

[00:22:40] Speaker 07:
We were not permitted to invoke 4K2 below because a precondition for invocation of 4K2 is service of process.

[00:22:47] Speaker 07:
We had not yet served process.

[00:22:49] Speaker 07:
And so we were not permitted to invoke 4K2.

[00:22:52] Speaker 07:
Since then, our motion for alternative service has been granted by the district court.

[00:22:56] Speaker 07:
That happened at the end of September.

[00:22:58] Speaker 07:
We served the complaint in October, about a month and a half ago.

[00:23:02] Speaker 07:
So we now could invoke 4K2.

[00:23:04] Speaker 07:
None of the facts that Your Honor was discussing with the opposing counsel have been developed with respect to whether one contract or another is sufficient to confer jurisdiction.

[00:23:13] Speaker 07:
I'd submit it's not.

[00:23:14] Speaker 07:
Their prior manufacturing to which he referred is not infringing conduct.

[00:23:19] Speaker 07:
That's all safe harbor.

[00:23:20] Speaker 07:
We're not seeking redress for any of that.

[00:23:23] Speaker 07:
The act of infringement for which we're seeking redress is their 271E filing of their ABLA.

[00:23:29] Speaker 07:
And after their product is approved, they will sell everywhere.

[00:23:33] Speaker 07:
They may manufacture in Washington.

[00:23:35] Speaker 07:
But right now, if there's not jurisdiction under a quarter for their planned future acts, if that's somehow not good enough, then it's not good enough to say that we plan to manufacture in Seattle or plan to do something else in San Diego or plan to do something else in Wilmington, Delaware.

[00:23:51] Speaker 07:
It's either enough under a quarter to have future conduct, and it is.

[00:23:55] Speaker 04:
Well, because they're not claiming that personal jurisdiction

[00:23:58] Speaker 04:
lies against them under a quota in Washington.

[00:24:01] Speaker 04:
They're claiming personal jurisdiction lies in Washington because they have minimum contacts by virtue of the contract that they have established for manufacturing the goods.

[00:24:13] Speaker 07:
But that hasn't happened yet in any infringing way.

[00:24:15] Speaker 07:
There's no connection to the infringement.

[00:24:18] Speaker 07:
The infringement here is the filing of their application.

[00:24:20] Speaker 07:
And the act, again, for which we're seeking redress is the future conduct.

[00:24:24] Speaker 07:
That past manufacturing that happened in Washington, we're not asking for damages.

[00:24:31] Speaker 07:
We didn't file a claim of 271A infringement saying you infringed in Washington.

[00:24:35] Speaker 04:
Well, aren't they intending to manufacture in Washington?

[00:24:38] Speaker 04:
Isn't that part of the same planned acts that you're talking about?

[00:24:42] Speaker 07:
I agree, but they're no more intending to manufacture in Washington than they are to sell in West Virginia and Delaware and Michigan.

[00:24:48] Speaker 01:
What about, I guess, thinking of an intermediate case or a third case between what they manufactured for the purpose of getting the FDA approval and the future manufacturing?

[00:25:01] Speaker 01:
The third case is

[00:25:02] Speaker 01:
Right now, they are manufacturing to stockpile for selling.

[00:25:07] Speaker 01:
So they're actually doing it right now, not for the purpose of getting FDA approval.

[00:25:14] Speaker 01:
And it is actually right now.

[00:25:16] Speaker 01:
So it's not even future.

[00:25:18] Speaker 07:
Well, first of all, I don't understand that to be the fact.

[00:25:20] Speaker 07:
But in that hypothetical- I just made it up.

[00:25:22] Speaker 07:
You made it up.

[00:25:23] Speaker 07:
In that hypothetical, Your Honor, I don't think we have- He's been peeking in the windows.

[00:25:28] Speaker 07:
Thank you, please.

[00:25:29] Speaker 07:
Thanks for telling me.

[00:25:30] Speaker 07:
Maybe we'll do something about that.

[00:25:31] Speaker 07:
But the point is that we haven't done anything about it.

[00:25:33] Speaker 07:
I think that could be a minimum contact for some future claim of infringement that we have not brought.

[00:25:38] Speaker 07:
If we saw they were stockpiling and committing acts of infringement that were not safe harbored under 271E1 and say, that's an act of infringement under 271A, I think we would have to file an amended complaint and say, you are now committing infringement.

[00:25:51] Speaker 07:
We want damages for those acts of infringement.

[00:25:54] Speaker 07:
And then we would be saying,

[00:25:56] Speaker 07:
The act of infringement for which we seek redress is that manufacture in Seattle.

[00:26:00] Speaker 07:
And I think we would then, of course, have personal jurisdiction in Seattle.

[00:26:04] Speaker 07:
But that's not the fact.

[00:26:05] Speaker 07:
That's not the claim that we've brought.

[00:26:07] Speaker 07:
Those aren't the facts.

[00:26:08] Speaker 07:
And so what we have now is a 271E case.

[00:26:11] Speaker 07:
And as I said, those are all about future acts.

[00:26:14] Speaker 01:
Just help me understand this.

[00:26:15] Speaker 01:
You said you completed service by a mechanism different from 4K.

[00:26:23] Speaker 07:
Yes, we filed a motion for alternative service.

[00:26:26] Speaker 07:
That was granted by the court on September 30th.

[00:26:30] Speaker 07:
So we completed that service on October 16th, 2024, a month and a half ago.

[00:26:38] Speaker 01:
to is restrictive in the sense that if its circumstances are present, that that's the only way you can get personal jurisdiction.

[00:26:50] Speaker 07:
Oh, no.

[00:26:51] Speaker 07:
I don't understand it that way at all.

[00:26:53] Speaker 07:
Agrees that there's jurisdiction under a quarter.

[00:26:56] Speaker 07:
I don't think one gets to 4k to view 4k to is some alternative in a way stopgap mechanism to use the term that stingray used to have jurisdiction in an instance where one otherwise wouldn't under form k1 I would observe one other thing which I think is your is your argument.

[00:27:12] Speaker 04:
Wait a minute is your argument because a quarter establishes a category that constitutes minimum contacts and

[00:27:22] Speaker 07:
Then under 4K1, we have jurisdiction.

[00:27:24] Speaker 07:
Our argument, let me try to put it as clearly as I can, is that we win under a quota.

[00:27:28] Speaker 05:
And it's got to be.

[00:27:29] Speaker 05:
That much you got good.

[00:27:30] Speaker 07:
And then if we win under a quota, then 4K2 is something that the court never has to look at at all.

[00:27:36] Speaker 07:
If, for whatever reason, the court disagrees with us and that there's not jurisdiction under a court, then the court could look to 4K2.

[00:27:45] Speaker 07:
I would agree that that has not been developed below.

[00:27:48] Speaker 07:
We haven't addressed that.

[00:27:49] Speaker 07:
The district court has not addressed that in the first instance.

[00:27:53] Speaker 07:
dismisses our Accorda argument, I think it would require the court to say that these future acts are not sufficient to confer jurisdiction.

[00:28:02] Speaker 07:
And if that's the case, then it's hard for me to see how it would be the case that the future contemplated act of manufacturing in Washington state somehow confers jurisdiction, where the future contemplated act of selling in Wisconsin or West Virginia somehow does not.

[00:28:19] Speaker 07:
And so I would then say that 4K2 would permit jurisdiction in that instance because they would not have anywhere where there's jurisdiction if there's no jurisdiction under a court.

[00:28:33] Speaker 07:
And so 4K2 would apply to confer jurisdiction.

[00:28:36] Speaker 07:
I do want to comment before I sit down about the implications of what would happen

[00:28:40] Speaker 07:
if the court for some reason decided that there were not jurisdiction, because opposing counsel suggested that the correct thing to do in that instance would be to dismiss the case.

[00:28:50] Speaker 07:
I don't think that's correct.

[00:28:51] Speaker 07:
Under the Hightower case out of the Federal Circuit just last month, and other cases from the Fourth Circuit,

[00:28:59] Speaker 07:
The proper avenue at that point would be transfer under 1631 to Washington state or wherever there was jurisdiction, not dismissal.

[00:29:09] Speaker 07:
Dismissal is inappropriate because it wouldn't be in the interest of justice.

[00:29:13] Speaker 07:
What they're trying to set up is a dismissal that would have draconian consequences under 271E and would restrict our remedies under a lawsuit.

[00:29:21] Speaker 07:
They're not dismissal and then refiling in Washington state.

[00:29:24] Speaker 07:
That's not necessary.

[00:29:25] Speaker 07:
That's not permitted under either federal circuit law or fourth circuit law.

[00:29:29] Speaker 07:
In that instance, transfer under 1631 would be the right mechanism.

[00:29:33] Speaker 04:
Isn't that especially true in circumstances where

[00:29:37] Speaker 04:
In advance of this lawsuit, it would be virtually impossible for you to have known to have sued them in Washington.

[00:29:43] Speaker 07:
Exactly right.

[00:29:44] Speaker 04:
Until you gained the answer or the motion or whatever it was that I was quoting.

[00:29:50] Speaker 04:
How do you know?

[00:29:50] Speaker 04:
How do you know where they have all their contracts?

[00:29:52] Speaker 07:
That's absolutely true in the ANDA context.

[00:29:54] Speaker 07:
It's sometimes true in the ABLA context.

[00:29:56] Speaker 07:
There's a patent dances, your honor knows, where there's an information exchange and the ABLA can be

[00:30:01] Speaker 07:
Produced before the litigation but as your honor knows under the Amgen Sandoff case from the Supreme Court That's not required for a biosimilar applicant to produce to the reference product sponsor the ABLA So there could be a scenario where we have no idea where we could sue hope so just to be clear Is this your sort of way of telling you actually did know about Washington?

[00:30:22] Speaker 07:
We have received their ABLA We didn't know that they thought Washington would be a place where those personal jurisdiction We didn't know that whether

[00:30:30] Speaker 07:
California was, I still don't know whether they think California is, but I think as a general proposition, we wouldn't typically know where there's jurisdiction and where there's not.

[00:30:39] Speaker 07:
In the end of context, there's virtually no information exchange before students, so you're throwing darts at a dartboard in their scenario.

[00:30:46] Speaker 07:
I would submit that all that is gone under a court.

[00:30:49] Speaker 07:
A court has brought order to chaos and has been applied very simply by district courts to confer jurisdiction since it was authored and issued years ago.

[00:31:00] Speaker 07:
And I don't think there's any reason to disagree.

[00:31:01] Speaker 04:
I judge Toronto.

[00:31:03] Speaker 05:
You said it, not me.

[00:31:08] Speaker 05:
so i i i i i i i i i i i i i i i i i i i i i

[00:31:23] Speaker 07:
suggested if there were a transfer under 1631 to Washington or California or anywhere else, then automatically the case would immediately be transferred back to West Virginia per the MDL order.

[00:31:35] Speaker 07:
They could have but did not appeal the MDL order.

[00:31:38] Speaker 07:
So it would automatically be transferred to West Virginia.

[00:31:41] Speaker 07:
And the court in West Virginia under FMC and longstanding law has the ability as an MDL court to enjoin a party.

[00:31:48] Speaker 07:
So this is just, as we said in our brief, kind of a merry-go-round that leads nowhere.

[00:31:53] Speaker 01:
And if circumstances have changed, they can always get a revision even in this one.

[00:31:58] Speaker 07:
Absolutely.

[00:31:59] Speaker 07:
As I suggested a moment ago, Rule 65 permits, when there are changed circumstances, to go back and say, we want relief from the injunction of the district court.

[00:32:07] Speaker 07:
But again, that's all in a scenario where the court disagrees with us on jurisdiction.

[00:32:12] Speaker 07:
I just wanted to clarify that the proper avenue at that point is transfer under 1631, not a draconian dismissal that would have severe consequences with respect to the relief we could potentially seek.

[00:32:23] Speaker 07:
If Your Honors have any further questions on personal jurisdiction or double patenting, or otherwise, I'm happy to entertain them.

[00:32:30] Speaker 07:
Otherwise, I'll sit down.

[00:32:35] Speaker 07:
Thank you, Your Honor.

[00:32:43] Speaker 08:
You have a minute or two.

[00:32:44] Speaker 04:
Oh yeah.

[00:32:46] Speaker 04:
Sorry.

[00:32:47] Speaker 04:
Yes.

[00:32:48] Speaker 08:
Yeah.

[00:32:49] Speaker 08:
So I just want to address a few points.

[00:32:50] Speaker 08:
So the fundamental problem of expanding a quarter to just rely on general plans to market in the United States without particularly targeting a state but not exempting that state affirmatively.

[00:33:00] Speaker 08:
I think it takes us out of line with Supreme Court precedent on personal jurisdiction, which requires purposeful availment.

[00:33:06] Speaker 08:
I mean, even in the internet context, there's got to be some evidence that you tried to go after a particular state.

[00:33:11] Speaker 08:
And a court is very clear in anchoring itself.

[00:33:14] Speaker 08:
And I agree quite articulate on this point that you must connect directly to the forum.

[00:33:18] Speaker 08:
You register with the pharmacy board in that state.

[00:33:20] Speaker 08:
You have a distributor on the ground in that state.

[00:33:22] Speaker 08:
They're all connected to Delaware.

[00:33:24] Speaker 08:
There are no such facts here for West Virginia, none.

[00:33:27] Speaker 08:
And so the effect of this is a slippery slope.

[00:33:29] Speaker 08:
There is nothing to stop a future case from beginning in a federal court in Saipan or Alaska or Puerto Rico or wherever they choose to bring it if there is a general plan to market in the United States.

[00:33:41] Speaker 08:
And that's a real problem from a due process standpoint.

[00:33:44] Speaker 08:
You can look at worldwide Volkswagen, which says that defendants should be able to plan their corporate activities so they can fairly know where they're likely to be sued.

[00:33:52] Speaker 08:
What do you do as a biosimilar?

[00:33:55] Speaker 01:
Worldwide Volkswagen.

[00:33:56] Speaker 01:
very long time but that was the the manufacturer sold the car at that point in in New Jersey was it some place and then the car just went somewhere else so it

[00:34:10] Speaker 01:
There was no plan or set of contractual relationships with a sale activity outside the initiative.

[00:34:21] Speaker 08:
The situation here is actually worse.

[00:34:22] Speaker 08:
It's just as bad or worse than the stream of commerce.

[00:34:24] Speaker 08:
Because the plan to sell a car, knowing that it will end up in any particular state, like you're talking about in worldwide Volkswagen, is not dissimilar from the case of planning to sell biosimilar products throughout the United States.

[00:34:36] Speaker 08:
The fact that, who knows whether West Virginia will ever make the planned marketing targeting campaign eventually when there is a distributor in place.

[00:34:43] Speaker 08:
Maybe it will, maybe it won't.

[00:34:44] Speaker 08:
It's not carved out.

[00:34:46] Speaker 08:
But you have to have facts that tether to the particular forum.

[00:34:49] Speaker 08:
Otherwise, there's no way for the defendant to plan where they could be sued.

[00:34:52] Speaker 08:
They have to be prepared to be sued in any jurisdiction.

[00:34:56] Speaker 04:
OK.

[00:34:57] Speaker 04:
Thank both counsels.

[00:34:58] Speaker 04:
This case is taken under submission.