[00:00:00] Speaker 04:
The case is number 19-2402, Valley and Pharmaceuticals against Myland Pharmaceuticals.

[00:00:08] Speaker 04:
Mr. Steinbler.

[00:00:09] Speaker 01:
Thank you, Judge Newman, and may it please the Court.

[00:00:12] Speaker 01:
The District Court erred in ruling that venue was improper under 1400B because the act of infringement defined in 271E2 is a nationwide act that occurs in every district in the country, including New Jersey.

[00:00:27] Speaker 01:
That can be seen in two ways, which I'll address.

[00:00:31] Speaker 01:
The first is that the Hatch-Waxman Act artificially treats the post-approval acts of making, using, and selling the ANDA product as having been committed pre-approval with the submission of the ANDA.

[00:00:44] Speaker 01:
And of course, those acts will occur nationwide.

[00:00:47] Speaker 04:
The second.

[00:00:47] Speaker 04:
Well, Mr. Sander, just to clear the air for a start, is there any question about personal jurisdiction in New Jersey?

[00:00:57] Speaker 01:
No.

[00:00:57] Speaker 04:
For any of the subsidiaries or however it's treated?

[00:01:06] Speaker 01:
There has been no issue raised at the personal jurisdiction.

[00:01:11] Speaker 04:
Okay.

[00:01:11] Speaker 04:
So it's agreed that personal jurisdiction is available?

[00:01:15] Speaker 01:
There has been no contest to personal jurisdiction.

[00:01:18] Speaker 01:
So the only thing that's been addressed is venue.

[00:01:22] Speaker 01:
Okay.

[00:01:22] Speaker 03:
Well, then personal jurisdiction is waivable if not raised in a motion, correct?

[00:01:27] Speaker 03:
In a Rule 12 motion?

[00:01:29] Speaker 01:
Right, and it was not.

[00:01:31] Speaker 01:
OK.

[00:01:32] Speaker 01:
So again, I've got these two points to address.

[00:01:34] Speaker 01:
The first is about the Hatch-Waxman Act artificially treating these post-approval acts of selling the product as having been committed pre-approval.

[00:01:43] Speaker 01:
The second is that the act of infringement occurs nationwide because the ANDA is purposely directed nationwide.

[00:01:51] Speaker 01:
So as to the first.

[00:01:53] Speaker 01:
Hatch-Waxman artificially treats those future acts as having been committed with the submission of the ANDA.

[00:02:00] Speaker 01:
That, of course, is precisely the subject matter that courts adjudicate in Hatch-Waxman cases.

[00:02:06] Speaker 02:
How do you get to that?

[00:02:08] Speaker 02:
I mean, when the Supreme Court said that 271E2 creates an artificial act of infringement, it was simply referring to the act of infringement that 271E2

[00:02:23] Speaker 02:
defines as an act of infringement, which is a submission.

[00:02:26] Speaker 02:
And the submission that occurs at time one, that doesn't say that this time one act of infringement, namely the submission, is treating the yet to occur but hoped for future acts as having occurred at time one.

[00:02:49] Speaker 01:
Let me give two answers to that.

[00:02:51] Speaker 01:
The first is that 271E2, as we know, provides a grant of jurisdiction for courts to adjudicate whether the antiproduct would infringe if it was approved and marketed.

[00:03:04] Speaker 01:
And as we know, that's a hypothetical analysis.

[00:03:07] Speaker 01:
And my submission is that it's conceptually treating those commercial manufacturer use and sale of the product as having occurred with the submission.

[00:03:16] Speaker 01:
How do we know that?

[00:03:18] Speaker 01:
We know that because the text of the statute says so.

[00:03:22] Speaker 01:
When a court does this hypothetical infringement analysis under 271E2, if it finds the patent is valid and infringed, the remedies provision of 271E4

[00:03:35] Speaker 01:
states that the ANDA product can't be approved until the expiration of the patent, which, quote, has been infringed.

[00:03:44] Speaker 03:
Well, Council, even under that theory, isn't it possible that what they're talking about in terms of the has been infringed is the fact that normally infringing acts, which would include all the activity leading up to the ANDA, are deemed non-infringing

[00:04:04] Speaker 03:
by statute, and so then by the filing, those infringing acts are basically revived as past infringement.

[00:04:16] Speaker 01:
But that's not the act of infringement that is adjudicated in Hatch-Waxman cases under 271E2.

[00:04:23] Speaker 01:
The acts of infringement that are adjudicated in Hatch-Waxman cases under 271E2 is whether the commercial manufacturer, use, and sale of the product would infringe a valid patent.

[00:04:38] Speaker 01:
The statutes treating infringement by making, using, and selling the end of product, which is what courts adjudicate in Hatch-Waxman cases,

[00:04:46] Speaker 01:
as having happened in the past.

[00:04:49] Speaker 01:
And the second point here, Judge, is that the 271 Act II, E2 Act of infringement is not ever been narrowly limited just to the physical act of submitting the ANDA.

[00:05:01] Speaker 01:
The court made that point crystal clear in Glaxo v. Nova Farm, where it said the patentee's burden of proving ultimate infringement is not met by the filing of the ANDA.

[00:05:13] Speaker 01:
And of course, that's true.

[00:05:14] Speaker 01:
The act of infringement that courts have been adjudicating for 30 years in ANDA cases is whether the proposed acts of making, using, and selling the ANDA product would infringe the patent.

[00:05:24] Speaker 01:
The court has consistently held that it is wrong to view the physical act of filing an ANDA as the totality of the act of infringement defined by 271E2.

[00:05:34] Speaker 01:
And of course that's- Let me ask you this, counsel.

[00:05:37] Speaker 03:
So you're conceding that we have to find

[00:05:43] Speaker 03:
something that constitutes past infringement under 1400B?

[00:05:51] Speaker 01:
There's no question.

[00:05:52] Speaker 01:
The 1400B and what it means, it requires a completed act of infringement.

[00:05:58] Speaker 01:
That completed act of infringement is the submission of the ANDA.

[00:06:02] Speaker 01:
The only question that is open here, the question to be decided, is what does that include and where does it occur?

[00:06:09] Speaker 01:
And the 271-E2 text itself says the act of infringement is not just a physical act of submitting it, it's submitting it for the purpose of seeking to engage in those acts.

[00:06:24] Speaker 01:
So that's precisely why the Supreme Court described 271-E2 and E of Dalili as an artificial act of infringement, because it artificially treats those future acts, making, using, and selling the product as having occurred

[00:06:39] Speaker 01:
nuke pro-tunque with the submission of the ANDA.

[00:06:42] Speaker 02:
The problem I have with that is that it seems to me that it's just a very, very strained way of talking to say that things that haven't yet happened are treated as having happened.

[00:06:58] Speaker 02:
There's a perfectly straightforward way of understanding why the E2 act of infringement is artificial because it's really quite unlike

[00:07:08] Speaker 02:
every other act of infringement in 271.

[00:07:12] Speaker 02:
It doesn't involve making, selling, offering, using, etc.

[00:07:17] Speaker 02:
But that still doesn't mean, even with the fact that that act goes a long way toward promising a future act, it doesn't mean that the future act is passed.

[00:07:30] Speaker 01:
But the act of infringement that's actually litigated in Hatch-Waxman cases

[00:07:35] Speaker 01:
includes those future acts of making, using, and selling the product.

[00:07:39] Speaker 01:
And there's no reason to construe 271E2 differently for venue than it is for infringement in every Hatch-Waxman cases.

[00:07:49] Speaker 01:
But that's point one.

[00:07:50] Speaker 01:
There's a separate point.

[00:07:52] Speaker 02:
Can I just double check?

[00:07:53] Speaker 02:
And I spent some time looking for this, and I guess I haven't found it, so maybe you have found it.

[00:07:59] Speaker 02:
That is, I was looking for, taking as a given, which has been the law for, I guess, 35 years or something, that the subject matter of the Hatch-Waxman case is whether there would be infringement if the ANDA approval comes forward and the product was marketed.

[00:08:24] Speaker 02:
Is there some specific language in

[00:08:28] Speaker 02:
the statute that says that judging the hypothetical acts, what would happen if all this goes forward, is treated as having occurred some past tense type language referring to the hypothetical.

[00:08:49] Speaker 02:
I was not able to find any.

[00:08:51] Speaker 01:
So, as I said,

[00:08:53] Speaker 01:
The 271E4 Remedy Section says, if you adjudicate what is adjudicated in Hatch-Waxman cases, this very subject matter that you described, Judge, then you can't get approved until the patent expires that, quote, has been infringed.

[00:09:12] Speaker 01:
That's past tense, has been infringed.

[00:09:17] Speaker 01:
The whole notion here.

[00:09:18] Speaker 02:
Right, but the problem with that language is that it refers to the expiration of the patent that has been infringed under paragraph 2C, which just refers back to the filing definition, doesn't it?

[00:09:35] Speaker 01:
But the 271E2 doesn't just refer to the filing definition and has never been understood to just be the physical act of submitting the ANDA.

[00:09:44] Speaker 01:
271E2 has this purpose language.

[00:09:46] Speaker 01:
It's submitting an ANDA for the purpose of seeking approval to engage in these acts.

[00:09:53] Speaker 01:
That's the connection.

[00:09:54] Speaker 01:
That's the connection.

[00:09:55] Speaker 01:
The statute, if you understand the statute as a whole, it's artificially treating those acts as having occurred with the ANDA.

[00:10:03] Speaker 01:
That's what's being adjudicated in Hatch Wexman cases.

[00:10:06] Speaker 01:
But there's a separate ground.

[00:10:09] Speaker 01:
There's a separate ground that you can think about this as to why it's a nationwide act, which is because it is purposefully directed

[00:10:16] Speaker 01:
nationwide.

[00:10:18] Speaker 01:
That's what the court held in Accorda.

[00:10:20] Speaker 01:
And ANDA is purposely directed to every district.

[00:10:23] Speaker 03:
But that purposely directed language relates to personal jurisdiction, right?

[00:10:28] Speaker 03:
Not to venue.

[00:10:31] Speaker 01:
It was decided in the context of personal jurisdiction.

[00:10:37] Speaker 01:
But I would also note that in Accorda, in the concurring opinion,

[00:10:42] Speaker 01:
Judge O'Malley writes, the act of infringement, which the Supreme Court has called highly artificial, is nonetheless a defined and very real act of infringement that takes place wherever the antifiler seeks to market its product.

[00:10:57] Speaker 01:
That's footnote two.

[00:10:59] Speaker 01:
Now, this court has interpreted other acts of infringement, sale and offer for sale, as occurring where they are purposefully directed.

[00:11:09] Speaker 01:
That's the Transocean and North American Phillips cases, among others.

[00:11:13] Speaker 01:
In Transocean, the court held that a contract for sale is a sale and that it occurs at the location of the anticipated future performance specified in the contract.

[00:11:25] Speaker 01:
A contract for sale that called for delivery and performance in the US is a sale that occurs in the US.

[00:11:32] Speaker 01:
Transocean also held that an offer for sale occurs at the location of the proposed future sale.

[00:11:39] Speaker 01:
The focus, the court said, should not be on the location of the offer, but rather on the location of the future sale that would occur.

[00:11:47] Speaker 01:
In North American Phillips, the court said a sale has both a physical and a conceptual dimension.

[00:11:54] Speaker 01:
And it held, therefore, that a sale occurs in multiple places, including at the location of the buyer to which the sale is directed.

[00:12:03] Speaker 03:
That same analysis... So you're saying the filing of an ANDA is akin to an offer for sale?

[00:12:09] Speaker 01:
I'm saying the filing of an ANDA is akin to a sale.

[00:12:15] Speaker 01:
It's akin to a contract for sale.

[00:12:20] Speaker 01:
It's akin to an offer for sale.

[00:12:22] Speaker 01:
It's purposely directed and should be understood to occur where it's purposely directed.

[00:12:27] Speaker 01:
The submission of the ANDA has both the physical and this conceptual dimension.

[00:12:36] Speaker 01:
It's not just the mechanical act, the physical act of submitting an ANDA.

[00:12:43] Speaker 01:
And I would submit that following this court's precedent in a quarter, Transocean and North American Phillips, the filing of an ANDA is an act of infringement that occurs nationwide where it's purposefully directed just like a sale, just like a contract for sale, just like an offer for sale.

[00:13:00] Speaker 01:
And that should dispose of this question.

[00:13:02] Speaker 01:
Now one last quick point.

[00:13:04] Speaker 01:
Construing 271E2 active infringement to just the physical location from which the NDA is submitted would have serious practical consequences.

[00:13:15] Speaker 01:
It would make it impossible in many Hatch-Waxman cases to have all of the defendants consolidated in one court.

[00:13:21] Speaker 01:
Ours is a case of one.

[00:13:22] Speaker 03:
Well, not impossible.

[00:13:23] Speaker 03:
You'd have to use 1407, right?

[00:13:25] Speaker 01:
But 1407 still has trials in separate courts.

[00:13:30] Speaker 01:
And that's a problem.

[00:13:34] Speaker 01:
We had 19 defendants in our case, which is not untypical, all in New Jersey.

[00:13:39] Speaker 01:
And now, because of the district court's ruling, we've got some cases consolidated in New Jersey, a separate case with the Milan defendants in West Virginia.

[00:13:48] Speaker 01:
We have two discovery schedules, two claim construction proceedings, two separate trials in two different courts, all for the same patents and the same reference product.

[00:13:57] Speaker 03:
You've been here long in West Virginia, aren't you?

[00:14:00] Speaker 01:
Just say that one more time, please.

[00:14:01] Speaker 03:
I said, aren't you pretty far along in West Virginia before Judge Keeley?

[00:14:05] Speaker 01:
We have not gotten to clan construction yet.

[00:14:11] Speaker 01:
But Congress has shown its intention to have the opposite result.

[00:14:15] Speaker 01:
In the America Invents Act, Congress exempted Hatch-Waxman cases from the new rules prohibiting consolidation of patent cases.

[00:14:23] Speaker 01:
Congress made clear that Hatch-Waxman cases are a unique category.

[00:14:28] Speaker 01:
They should be able to be consolidated in one court.

[00:14:30] Speaker 01:
And that cuts against the notion that Congress intended to limit venue in Hatch-Waxman cases to just the district where the generic company decides to have somebody press a button to submit the end in.

[00:14:42] Speaker 01:
Because if the generic can pick and choose venue that way, it makes it much more likely that you'll have Hatch-Waxman cases splintered in different courts, like we have in our case.

[00:14:53] Speaker 01:
Congress showed the opposite intention in the AIA, and 271E2 should be interpreted in that light.

[00:15:02] Speaker 01:
So I'll stop here unless the court has additional questions reserved the rest of my time.

[00:15:08] Speaker 01:
And I'd like to rest on our papers.

[00:15:10] Speaker 01:
I think it's sufficient for this other question on appeal regarding the district court's dismissal of the foreign defendant.

[00:15:17] Speaker 04:
And we'll see.

[00:15:18] Speaker 04:
So any more questions for counsel at this point?

[00:15:21] Speaker 04:
Judge O'Malley?

[00:15:22] Speaker 04:
No, thank you.

[00:15:23] Speaker 04:
No, thanks.

[00:15:24] Speaker 04:
All right, then we'll hear from Mr. Johnson.

[00:15:28] Speaker 00:
Thank you, Your Honor, and may it please the Court.

[00:15:31] Speaker 00:
This is a straightforward case under Blackletter rules of statutory interpretation.

[00:15:35] Speaker 00:
The key statutory phrase is has committed acts of infringement.

[00:15:40] Speaker 00:
It's undisputed that has committed, looking backward in time, to completed acts.

[00:15:45] Speaker 00:
We heard it today, and it's in both their opening and reply briefs.

[00:15:48] Speaker 00:
It's undisputed that the only completed act of infringement alleged here

[00:15:52] Speaker 00:
is submission of the ANDA, an actual physical act with a place.

[00:15:57] Speaker 00:
And it's undisputed that that place is not New Jersey.

[00:16:00] Speaker 00:
It was prepared and sent from West Virginia to Maryland.

[00:16:03] Speaker 00:
So what does Valiant say?

[00:16:04] Speaker 00:
It says submission of an ANDA is a nationwide act.

[00:16:08] Speaker 00:
But look at the intellectual gymnastics you have to buy to get there.

[00:16:12] Speaker 00:
This is actual language straight from their brief.

[00:16:14] Speaker 00:
Congress intended to treat the proposed acts of making, using, and selling the drug as having already been committed

[00:16:21] Speaker 00:
even though they have not yet actually occurred.

[00:16:25] Speaker 00:
The infringement that will occur is treated as having already occurred.

[00:16:29] Speaker 00:
The acts of infringement the defendant has committed include the future acts that the antifiler will take, contemplated acts, plans acts.

[00:16:37] Speaker 00:
We're told to look at the conceptual acts rather than the physical acts.

[00:16:42] Speaker 00:
As Judge Torano's question suggested, that is a very strained reading of 1400B.

[00:16:48] Speaker 00:
Valiant is asking you to treat the future as the past.

[00:16:52] Speaker 00:
But that's not how Congress wrote the statute.

[00:16:54] Speaker 00:
And this court and the Supreme Court have both repeatedly affirmed that it should be interpreted according to its terms.

[00:17:00] Speaker 00:
ZTE called it an intentionally narrow statute.

[00:17:04] Speaker 03:
Well, aren't we supposed to interpret both of these statutes together?

[00:17:08] Speaker 03:
I mean, shouldn't we assume that Congress

[00:17:11] Speaker 03:
when it set up the Hatch-Waxman scenario was attempting to define past acts of infringement broadly?

[00:17:23] Speaker 00:
Of course, Judge O'Malley.

[00:17:25] Speaker 00:
You have to read acts of infringement as well as has committed.

[00:17:29] Speaker 00:
But they're seeking to divorce the acts of infringement idea from the verb tense language of 1400B.

[00:17:35] Speaker 00:
And there's nothing anomalous about the result below, particularly when 271E2 is read in light of 271E1, and I think your question got at that a bit.

[00:17:46] Speaker 00:
Congress obviously wanted to get generic drugs into the market fast, so it created a safe harbor for pre-launch activities that might otherwise infringe, like R&D or manufacturing.

[00:17:56] Speaker 00:
but it also wanted to speed up the litigation, so it treated the submission of the ANDA as an act of infringement, as a substitute for the pre-launch activities that are covered by the safe harbor.

[00:18:07] Speaker 00:
You don't need to view the message.

[00:18:08] Speaker 03:
What's your response to the 271E4 argument, which is that once the court issues an order, that if they find

[00:18:23] Speaker 03:
that the patent is valid and infringed, then even though no actual sale has occurred, they deem it to be infringed and they deem the generic to be an infringer.

[00:18:38] Speaker 00:
Your Honor, the remedies language of 271E4 strongly supports our position and I would direct the court to subparagraph C, which says the following.

[00:18:46] Speaker 00:
Damages or other monetary relief may be awarded against an infringer

[00:18:51] Speaker 00:
only if there has been commercial manufacture, use, offer to sell, or sale.

[00:18:56] Speaker 00:
So the remedy provision of the act says those things are not treated as having occurred.

[00:19:02] Speaker 00:
Yes, there's a hypothetical aspect of this.

[00:19:04] Speaker 00:
Of course, you're asking whether the product described in the ANDA would infringe if marketed.

[00:19:09] Speaker 00:
But Mr. Steinler keeps saying it's akin to a sale.

[00:19:14] Speaker 00:
It's really much more akin to the pre-launch activities that are covered by the safe harbor.

[00:19:18] Speaker 04:
And if a non-

[00:19:21] Speaker 04:
to the general assumption that the remedy is that the FDA in such case will not approve the product for sale rather than proceeding for a specific ruling on sale and the details of sale and infringement.

[00:19:46] Speaker 00:
No, of course, Your Honor, the plaintiff, in that case, if they prevail, they get injunctive relief and it prevents the approval until the expiration of the patent.

[00:19:55] Speaker 00:
But if you're asking Congress to find the act of infringement in this context as the submission of the ANDA,

[00:20:02] Speaker 00:
And the purpose language of the statute, I would note, is not as broad as they're characterizing it to be.

[00:20:09] Speaker 00:
It says, if the purpose of such submission is to obtain approval to engage in commercial manufacturer user sale.

[00:20:16] Speaker 00:
So the purpose is actually a limiting condition, but the act of infringement is the submission of the ANDA.

[00:20:24] Speaker 00:
There's no requirement that one have the purpose of selling in any particular market, let alone nationwide.

[00:20:31] Speaker 00:
Obviously, if there were no purpose to sell anywhere, then there probably wouldn't be enough of a dispute to support Article III jurisdiction.

[00:20:38] Speaker 00:
But the statute, their assumption is that, well, you have to have nationwide sales to support Article III jurisdiction, and that's just not the case.

[00:20:47] Speaker 03:
Let me ask you this.

[00:20:48] Speaker 03:
Assuming that we agree with you,

[00:20:52] Speaker 03:
up to a point that it's the ANDA that triggers the infringement.

[00:21:00] Speaker 03:
Does that include sweeping in any location where any pre-filing activity which would have been infringing occurs?

[00:21:13] Speaker 00:
No, Your Honor.

[00:21:13] Speaker 00:
I think, and if I could explain it this way, I think you've got a spectrum of what the active submission could include potentially.

[00:21:20] Speaker 00:
At one end of the spectrum, I would say it's clear that it cannot include anything that's described in 271E1.

[00:21:27] Speaker 00:
And that refers to uses reasonably related to the development and submission of the ANDA.

[00:21:34] Speaker 00:
So we know that that's part of the safe harbor.

[00:21:37] Speaker 00:
At the other end of the spectrum, the submission

[00:21:39] Speaker 00:
the act of tendering or presenting the ANDA to the FDA, I think, is considered the act of infringement.

[00:21:47] Speaker 03:
Now, some courts... So why isn't Maryland the only jurisdiction that these cases could be heard?

[00:21:52] Speaker 00:
Well, I think, Your Honor, we don't dispute, Your Honor, that the submission, it went from West Virginia to Maryland and that the submission occurred in Maryland.

[00:22:01] Speaker 00:
But there's no dispute that nothing happened in New Jersey.

[00:22:05] Speaker 00:
And there's no dispute that all the preparation activities

[00:22:08] Speaker 00:
And so forth happened in West Virginia, which is not an arbitrarily chosen place.

[00:22:14] Speaker 00:
It's been Milan's headquarters since 1961.

[00:22:16] Speaker 03:
So indulge me.

[00:22:18] Speaker 03:
So under your theory, what would be all the possible places where the filing occurs other than Maryland?

[00:22:27] Speaker 00:
So what I was getting to, Your Honor, is in between the 271E1 stuff that's clearly not the active infringement and the submission is stuff

[00:22:36] Speaker 00:
related to the preparation of the submission.

[00:22:38] Speaker 00:
At least one district court, the Galderma case in the Northern District of Texas, has said that the submission includes that preparation.

[00:22:46] Speaker 00:
I'm not sure that's the most natural reading of the statute.

[00:22:48] Speaker 00:
I think the more natural reading of the statute is that the submission is where it's sent, whether that's via US mail or electronically and where it's received.

[00:23:00] Speaker 00:
You could analogize it to mail or wire fraud.

[00:23:03] Speaker 00:
I think some courts have held that

[00:23:04] Speaker 00:
that that occurs where it's sent and where it's received.

[00:23:07] Speaker 00:
But it's not, you know, every conceivable place in interstate commerce.

[00:23:12] Speaker 00:
And here, it's undisputed that nothing happened in New Jersey.

[00:23:16] Speaker 03:
So, you know, you could... Well, help me understand because I don't, you know, obviously I don't work in the pharmaceutical field.

[00:23:23] Speaker 03:
But so, when, under Galderma, if they're

[00:23:29] Speaker 03:
there could potentially be, obviously the court thought there could potentially be more than one place where it's prepared.

[00:23:37] Speaker 03:
So what goes into the preparation of the ANDA?

[00:23:41] Speaker 00:
Well, so it's clearly, it can't be interpreted to be the R&D and the manufacturer and the bioequivalence work and things like that because that's covered by the Safe Harbor.

[00:23:53] Speaker 00:
I think of the preparation as, you know, essentially the preparing of the paperwork as opposed to simply

[00:23:59] Speaker 00:
the hitting send or putting it in the mail.

[00:24:02] Speaker 00:
You don't need to decide that issue in this case because it's undisputed that everything here happened in West Virginia and nothing happened in New Jersey.

[00:24:11] Speaker 00:
But in theory, the submission could potentially extend to the preparatory activities in the paperwork, filling out the forms, et cetera.

[00:24:22] Speaker 02:
Can I ask you this question?

[00:24:24] Speaker 02:
So Hatch Maxman's been around for, what, three and a half

[00:24:28] Speaker 02:
decades.

[00:24:29] Speaker 02:
Why has this venue question not arisen in all that time?

[00:24:35] Speaker 00:
Well, I think the principal reason, Your Honor, is because now the focus is on the second prong of 1400B after T.C.

[00:24:42] Speaker 00:
Heartland.

[00:24:43] Speaker 00:
As you know, T.C.

[00:24:45] Speaker 00:
Heartland overruled V.E.

[00:24:46] Speaker 00:
Holdings, which said you could have venue any place there was personal jurisdiction over the defendant.

[00:24:54] Speaker 00:
Now that that's not the law and resides

[00:24:57] Speaker 00:
under the first prong of 1400B means the place of incorporation, then obviously now there's a reason that there's a focus more on the second prong, both on the regular and established place of business piece and on the active infringement piece.

[00:25:14] Speaker 00:
But to come back to my point about 271E1, and it's really much more akin to look at the filing of the ANDA as akin to pre-launch activities, if the plaintiff in a non-Hatch-Waxman case

[00:25:26] Speaker 00:
sued to stop R&D or manufacturer, they would not be able to come into court and say, oh, well, we think the defendant is going to sell in these other states, so there's venue there.

[00:25:39] Speaker 00:
The act of infringement would simply be the manufacturer or the R&D.

[00:25:43] Speaker 00:
And so the and the submission is really quite analogous to that.

[00:25:46] Speaker 00:
There's nothing at all unusual about it.

[00:25:50] Speaker 00:
Now, Mr. Steinler has spoken as well about the Trans Ocean and North American Phillips cases

[00:25:56] Speaker 00:
which were not mentioned in the opening brief.

[00:25:58] Speaker 00:
I would suggest those arguments are forfeited, but regardless, they don't carry the day.

[00:26:04] Speaker 00:
The North American Phillips case is a personal jurisdiction case involving sales.

[00:26:09] Speaker 00:
As the courts aware, personal jurisdiction is ultimately about the fairness of being hailed into court in a given state.

[00:26:15] Speaker 00:
It's judge-made law.

[00:26:17] Speaker 00:
It's somewhat subjective to determine, is it ultimately fair to have the defendant being sued here?

[00:26:23] Speaker 00:
But it's most importantly, and the court in the quarter specifically acknowledged this, it's not constrained by the specific statutory language of the venue statute.

[00:26:32] Speaker 00:
And the Supreme Court and the Federal Circuit, this court, have both repeatedly held that 1400B does not get a liberal construction.

[00:26:41] Speaker 00:
The idea of conceptual acts of infringement is foreign to the idea of venue.

[00:26:46] Speaker 00:
And it's not as though this is a case where

[00:26:49] Speaker 00:
where there is no venue anywhere and you have to turn to some sort of concept like that to find venue somewhere.

[00:26:56] Speaker 00:
The Transocean case was not a venue case either.

[00:27:00] Speaker 00:
It wasn't even a, nor was it a 271E case.

[00:27:02] Speaker 00:
It was an offer to sell or sale case and the court simply read within the United States to modify sell, not offer.

[00:27:10] Speaker 00:
Nothing in the case suggests that sales are a nationwide act.

[00:27:14] Speaker 00:
To the extent it talks about sales, it talks about the place of performance.

[00:27:17] Speaker 00:
But this is not a sales case.

[00:27:19] Speaker 00:
This is a 271E2 case and all of those future activities are not before the court and the language of 271E2 does not permit them, notice 1400B permit them to be before the court.

[00:27:33] Speaker 02:
Do you agree on the sort of practical point that was made that the most efficient form of consolidation which has been taking place for decades is now

[00:27:49] Speaker 02:
very much limited in its availability if you were to win here, because you would have only pre-trial consolidation.

[00:28:00] Speaker 00:
I don't agree that it's as stark as they presented.

[00:28:06] Speaker 00:
Yes, admittedly, consolidation and joiner can be a bit more challenging with this, but it's undisputed and this court's decision in EMC holds that

[00:28:15] Speaker 00:
you have to have proper venue to join or consolidate.

[00:28:18] Speaker 00:
Those are independent requirements.

[00:28:20] Speaker 00:
And I would note that Milans made every effort to coordinate deadlines and events with the defendants that are consolidated in the District of New Jersey.

[00:28:28] Speaker 00:
As Judge O'Malley's question indicated, there's still the potential to use 1407.

[00:28:34] Speaker 00:
But regardless, the fact that there might be an independent venue requirement and consolidation might become a slightly higher hurdle

[00:28:44] Speaker 00:
doesn't allow rewriting the second prong of 1400B to look forward in time when Congress used a verb tense that looked backward in time.

[00:28:59] Speaker 00:
I'm happy to take any further questions.

[00:29:01] Speaker 00:
The only thing I would say on the alternative ground is that I would direct the court to paragraph 29 of their complaint, which specifically alleges

[00:29:13] Speaker 00:
that it was myelin pharmaceuticals that submitted, and in this case, there's nothing that would overcome the presumption of corporate separateness to pull in MLL or even MI.

[00:29:27] Speaker 03:
Yeah, that's a good point.

[00:29:28] Speaker 03:
Let me ask you about that.

[00:29:29] Speaker 03:
The problem is that how can the judge, I mean, did the judge really decide that question?

[00:29:38] Speaker 00:
I think the judge did decide that he didn't spell out all the steps in his reasoning, unfortunately.

[00:29:44] Speaker 00:
But the findings about the record are in the opinion.

[00:29:48] Speaker 00:
If you look at pages five to six, he says that the plaintiffs here can't show that these other corporate defendants were involved in this.

[00:30:01] Speaker 00:
And that is, of course, the basis for this argument.

[00:30:05] Speaker 03:
But how do you make that determination?

[00:30:08] Speaker 03:
on a 12B motion that relates to venue.

[00:30:11] Speaker 00:
Well, I would start with paragraph 29, which is on page 153 of the appendix, which says, this is the only paragraph of the complaint that addresses Myland's infringing and a submission.

[00:30:21] Speaker 00:
It says, upon information and belief, Myland Pharmaceuticals filed their cause to be filed with the FDA and a number 212064.

[00:30:30] Speaker 00:
Now, there are some what I would consider not plausible and conclusory allegations that kind of lump all three defendants together.

[00:30:38] Speaker 00:
But the record is undisputed that only MPI submitted the ANDA.

[00:30:44] Speaker 00:
And to the extent that you're wondering, well, did they get to dispute that?

[00:30:47] Speaker 00:
I mean, that's the very provision of the affidavit that matters for venue purposes.

[00:30:51] Speaker 00:
So I think it's clear that they had both an opportunity and an obligation to rebut it if it weren't true.

[00:31:00] Speaker 04:
OK, any more questions for Mr. Johnson?

[00:31:03] Speaker 03:
No.

[00:31:05] Speaker 04:
Thank you, Your Honors.

[00:31:06] Speaker 00:
We urge the court to affirm.

[00:31:08] Speaker 04:
Okay, thank you.

[00:31:10] Speaker 04:
Mr. Sander, you have three minutes to rebuttal.

[00:31:13] Speaker 01:
Thank you, Your Honor.

[00:31:14] Speaker 01:
Let me just make three quick points.

[00:31:17] Speaker 01:
The first is with respect to this question of whether we should be considering pre-launch activities.

[00:31:24] Speaker 01:
Pre-launch activities are not what's litigated in Hatch-Waxman cases.

[00:31:29] Speaker 01:
As Judge Toronto had said, the subject matter that's litigated in Hatch-Waxman cases under the 271E2 grant of jurisdiction is whether making, using, and selling the product post-approval would infringe a valid patent.

[00:31:44] Speaker 01:
And it is our submission that we should be interpreting that act of infringement consistently for infringement and for venue and for personal jurisdiction as well.

[00:31:56] Speaker 01:
That's point one.

[00:31:57] Speaker 01:
Point two, with respect to the damages provision of 271E4C, that only happens in the unusual case if the ANDA has been approved and the generic has launched.

[00:32:11] Speaker 01:
In the normal case, there's never going to be an actual active infringement.

[00:32:16] Speaker 01:
There will never be damages.

[00:32:18] Speaker 01:
And the principle issues are governed by the 271E4A

[00:32:25] Speaker 01:
and the other provisions that I mentioned, which refer to the infringement in the past tense.

[00:32:30] Speaker 01:
And then lastly, quickly, with respect to this issue about the foreign defendant, the foreign defendant is alleged in the complaint to have been a submitter.

[00:32:46] Speaker 01:
And as I think was rightly pointed out, there is no analysis.

[00:32:51] Speaker 01:
The court below said, we understand venue is proper in every judicial district over a foreign defendant, but then dismissed without any explanation.

[00:33:04] Speaker 01:
And the complaint allegation needs to be accepted as true.

[00:33:09] Speaker 02:
Can I just ask that, even though this is obviously very much the tail

[00:33:16] Speaker 02:
on this case.

[00:33:18] Speaker 02:
So Mylan made a motion to dismiss for lack of venue and included in that motion was also a 12b6 motion to dismiss both the foreign Mylan entity and the Pennsylvania Mylan entity on the ground that the only cause of action here is a cause of action for the active infringement, namely the antifiling, and neither the Pennsylvania nor the Indian entity did that.

[00:33:46] Speaker 02:
had nothing to do with that and and the question and and and i think that they can see that uh... the foreign entity could not properly be be dismissed for lack of venue the question is could it be dismissed because it is clear on the face of the complaint that m l l did not commit bad act of infringement i understand the complaint there are two things one paragraph twenty nine among the three milan entities

[00:34:14] Speaker 02:
The one that's submitted is myelin pharmaceuticals.

[00:34:17] Speaker 02:
That's paragraph 29.

[00:34:18] Speaker 02:
And then you have eight versions of the generic allegation, one for each complaint, that says myelin, which is a term that on the opening page of the complaint you say is going to hereafter be referred to the three entities collectively submitted or caused to be submitted the ANDA.

[00:34:39] Speaker 02:
It seems to me quite literally true to say that collectively

[00:34:43] Speaker 02:
um... myelin submitted it if the myelin pharmaceuticals did why did why does that not mean that on the face of the complaint there is no allegation the indian entity submitted the uh... uh... submitted and therefore committed an active infringement which is relevant only to two seventy one e two uh... satisfying two seventy one e two had nothing to do with that

[00:35:11] Speaker 01:
The short answer is that by defining Milan to be all three of those entities, the complaint is alleging that all three of those entities were submitted on its face.

[00:35:23] Speaker 01:
And that's not something that can be addressed in a rule.

[00:35:26] Speaker 01:
It has to be assumed to be true for purposes of a Rule 12 motion, and it cannot be addressed in a Rule 12 motion.

[00:35:35] Speaker 03:
So there are conflicting allegations in the complaint, and we're supposed to

[00:35:41] Speaker 03:
ignore one of them and just focus on the other one?

[00:35:48] Speaker 01:
I don't think they're conflicting, Your Honor.

[00:35:50] Speaker 01:
I think they're supplementary to each other.

[00:35:53] Speaker 01:
That is to say, it may well be true that the American company pressed the button to submit it, but this court's jurisprudence on who is a submitter and involved in the preparation of that is what the allegation is here, that the Indian entity was involved as a submitter.

[00:36:14] Speaker 01:
So I don't think those are inconsistent.

[00:36:16] Speaker 01:
I think those complement each other.

[00:36:21] Speaker 04:
Any more questions?

[00:36:26] Speaker 02:
Not for me, thanks.

[00:36:28] Speaker 04:
All right, thank you.

[00:36:29] Speaker 04:
Thanks to counsel for both sides.

[00:36:31] Speaker 04:
The case is taken under submission.

[00:36:33] Speaker 04:
That concludes the argued cases for this panel for this morning.

[00:36:41] Speaker 00:
The Honorable Court is adjourned from day to day.