[00:00:00] Speaker 02:
at all.

[00:00:01] Speaker 02:
The next case for argument is 21-1154, Celgene Corporation versus Myelin Pharmaceutical.

[00:01:21] Speaker 02:
Before you begin, how do you pronounce your first name?

[00:01:23] Speaker 01:
Elodie, like Melody without the M. Interesting.

[00:01:26] Speaker 01:
Okay.

[00:01:26] Speaker 02:
Thank you.

[00:01:27] Speaker 02:
Please proceed.

[00:01:28] Speaker 01:
May I please support Elodie Thompson, Quinn Emanuel, or Carden Sullivan on behalf of Appellant Selging Corporation.

[00:01:35] Speaker 01:
I'd like to start with the dismissal of Mylan N.V.

[00:01:37] Speaker 01:
The complaint against Mylan N.V.

[00:01:40] Speaker 01:
should be reinstated because the district court wrongly failed to accept the allegations in the complaint as true that Mylan N.V.

[00:01:47] Speaker 04:
Can we just go to the complaint?

[00:01:49] Speaker 04:
Can you point to me the specific allegations that support that Mylan N.V.

[00:01:55] Speaker 04:
participated in the filing of this and that?

[00:01:58] Speaker 01:
The allegations in the complaint, if I could point the court to page 120 of the appendix, is that Mylan and B acted in concert with MPI and Mylan, Inc.

[00:02:12] Speaker 01:
in relation to regulatory approvals.

[00:02:15] Speaker 04:
OK, sorry.

[00:02:16] Speaker 04:
I was getting there.

[00:02:16] Speaker 04:
Where on this page, which number?

[00:02:26] Speaker 01:
It's paragraph 23.

[00:02:29] Speaker 04:
OK, but this is a very general statement.

[00:02:32] Speaker 04:
It doesn't say anything about whether they work with them on this end.

[00:02:37] Speaker 04:
Why is this enough that they generally might work with them to meet the Twombly standard that they participated with them on this end?

[00:02:46] Speaker 04:
Isn't that what's required?

[00:02:48] Speaker 01:
Well, first, that's not required at the pleading stage in this instance, because that information would not have been known at the time the complaint was filed.

[00:02:58] Speaker 01:
Exactly what Mylan Enby's role was with respect to this ANDA would be discerned in discovery.

[00:03:04] Speaker 01:
It wouldn't have necessarily been known at the time the complaint was filed, at which point you didn't know exactly who it was.

[00:03:10] Speaker 04:
But you didn't even say that you had a good fake belief that they worked with them on this ANDA.

[00:03:19] Speaker 04:
I mean, you can't just guess, right?

[00:03:21] Speaker 04:
You can't just say, well, these are a bunch of interrelated companies.

[00:03:24] Speaker 04:
We're going to guess that maybe they worked with them here.

[00:03:27] Speaker 01:
Well, it's not a guess that Mylan Enby worked with them.

[00:03:31] Speaker 01:
It's that the way the business model is, these are the entities that set the business strategy and secure the regulatory approval.

[00:03:39] Speaker 04:
Is this what you've got in terms of the complaint?

[00:03:42] Speaker 04:
Anything else?

[00:03:44] Speaker 01:
The other allegations relate to Mylan Enby directing the conduct of the subsidiary's MPI in Mylan, Inc.

[00:03:51] Speaker 01:
But of course, if this court has any... In this case?

[00:03:54] Speaker 01:
Again, no, Your Honor, not in this case in relation to this generally.

[00:03:58] Speaker 01:
But if this court has any concern about whether the allegations here meet the pleading standard, of course, the correct result would be to reverse a remand to allow for amendment of the complaint to add those allegations.

[00:04:11] Speaker 04:
Well, but the district court denied you that, right?

[00:04:15] Speaker 04:
The district court did deny... What's their standard review on that?

[00:04:18] Speaker 01:
The standard review is for abuse of discretion.

[00:04:20] Speaker 01:
However, under Third Circuit law, the reasons that the district court relied upon are an abuse of discretion because what the district court relied upon was the passage of time.

[00:04:29] Speaker 04:
Well, didn't the district court also rely on the fact that you had agreed that you would be bound by the venue issues with the other two people, the other two entities as well?

[00:04:41] Speaker 01:
That's not what the district court cited in anything related to the 2019 action here, nor, frankly, in relation to the consolidated action.

[00:04:52] Speaker 01:
The district court just said, here we are three years after the complaint has been filed.

[00:04:57] Speaker 04:
But then you have hotly been contested, right?

[00:05:00] Speaker 04:
And you didn't attempt to amend.

[00:05:02] Speaker 01:
Venue has been contested, but this relates to Mylan NV, as to which venue is indisputably proper.

[00:05:09] Speaker 01:
And the district court in the decision related to the 2017 motion to dismiss for failure to state a claim in the consolidated action didn't reach the question of whether there was a failure to plead sufficient allegations as to Mylan NV.

[00:05:23] Speaker 01:
So the timing issue, which is what the district court relied upon, is really as a result of the venue discovery taking so long.

[00:05:31] Speaker 01:
It took two years, and then there you are at the end of the venue discovery period, considering a rule 12b6 motion three years after the consolidated action was filed, and a year and a half after the 2019 action was filed.

[00:05:46] Speaker 04:
During this venue discovery, did you do any discovery into whether NV

[00:05:51] Speaker 04:
actively participated or did anything that would have caused venue against it to be involved here?

[00:05:59] Speaker 01:
There was, in opposition to the motion to dismiss filed and the consolidated action, a proposed amended complaint that was filed.

[00:06:09] Speaker 01:
That's at appendix pages 30 to 2893.

[00:06:13] Speaker 01:
That includes additional allegations as to Mylan Enby's role.

[00:06:17] Speaker 01:
And so certainly when there has been no opportunity to amend a complaint, then an opportunity should be given to amend to meet the pleading standard.

[00:06:28] Speaker 01:
In addition, the request for leave to amend was before the expiration of the time at which amendment would be permitted for the 2019 action.

[00:06:37] Speaker 01:
But the reality is this was all started because instead of saying in 2017, as to Mylan NV, that doesn't relate to venue, you know, dismissed without prejudice, you may amend the complaint, the district court instead said it's denied as moot.

[00:06:54] Speaker 01:
So the timing issues really are a result of what happened in the district court and not addressing it until 2020.

[00:07:02] Speaker 01:
But I don't think the court actually needs to reach that question, because all the court needs to do is look at the decision in Valiant, in which there were almost identical allegations.

[00:07:12] Speaker 01:
And the court reversed and remanded us to the dismissal of the foreign entity there.

[00:07:16] Speaker 01:
There were, similarly as to here, all three entities were.

[00:07:21] Speaker 02:
Well, in that case, we had to remand it.

[00:07:23] Speaker 02:
The district court had never considered that issue in Valiant.

[00:07:26] Speaker 02:
Whereas here, the district court considered the issue

[00:07:29] Speaker 02:
and rejected the amendment, and we're reviewing it under an abuse of discretion.

[00:07:33] Speaker 02:
So I don't think you can walk away from Valiant and say where that sort of compels or even suggests what we should do in this context.

[00:07:42] Speaker 01:
Certainly.

[00:07:42] Speaker 01:
Well, as to the abuse of discretion standard, that does apply to the denial of leave to amend.

[00:07:47] Speaker 01:
And we think under Sir Thurkett law, there was a clear abuse of discretion.

[00:07:50] Speaker 02:
And in Valiant, as I recall, there had never been any consideration of the other issue.

[00:07:54] Speaker 02:
And that's why we demanded it.

[00:07:56] Speaker 02:
The district court had not ruled on anything related to that issue, correct?

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

[00:08:02] Speaker 01:
There had been no ruling on the Rule 12b6 motion in that case from the district court, which of course this court reviews de novo.

[00:08:09] Speaker 01:
But in looking at the allegations in Valiant, and certainly there are other cases cited in other district courts where there are identical allegations, and there was a claim that was stated.

[00:08:18] Speaker 01:
And so even if this court says, no, you must do more at that point in time when you don't know who did what in relation to the ANDA,

[00:08:27] Speaker 01:
there should at least be an opportunity for leave to amend because Celgene had had no reason to think that its allegations would be insufficient given the prior holdings and I think that this court's decision in Valiant certainly supports that.

[00:08:43] Speaker 02:
Speaking of Valiant, I mean you don't try to

[00:08:46] Speaker 02:
Are you with respect to the other entity?

[00:08:49] Speaker 02:
So are you conceiving that you lose undervaliant?

[00:08:53] Speaker 02:
You seem to try to make a distinction with a valiant in this case, but I'm not getting what the distinction is.

[00:09:02] Speaker 01:
Yes, Your Honor, if the court is referring to distinguishing Valiant on whether an act of infringement has occurred in the district, there certainly is a very big distinguishing factor, which is the paragraph 4 certification that was sent to Celgene in New Jersey.

[00:09:21] Speaker 01:
In Valiant, the entities that sued, the plaintiffs, were located in Ireland, Japan, and Delaware, but the lawsuit was brought in New Jersey.

[00:09:32] Speaker 01:
That's not the case here, where Celgene is located in New Jersey, which means that the paragraph 4 certification, notice of which must be provided to the NDA holder and the patent holder, had to be sent to Celgene in New Jersey.

[00:09:47] Speaker 01:
So that's a clear distinguishing factor between Valiant and what happened here.

[00:09:52] Speaker 04:
Even though all the and a preparation and everything like that took place in new in West Virginia, let's just assume that's true.

[00:09:59] Speaker 04:
I don't know if you just beat that or not.

[00:10:01] Speaker 04:
Just sending notice that that's required to the company and its other home in another state where let's assume my line has no basis at all is enough to establish a venue and Patney's home district.

[00:10:15] Speaker 01:
It's enough to indicate that an act of infringement has occurred in that district.

[00:10:20] Speaker 01:
And that's because under the ANDA framework, the submission must include proof not only that the notice of the paragraph 4 certification was sent to Celgene in New Jersey, but that it was received by Celgene in New Jersey.

[00:10:35] Speaker 05:
Why is it that the submission of the ANDA

[00:10:39] Speaker 05:
under the statute necessarily includes the act of sending the notice letter to the patent owner.

[00:10:47] Speaker 05:
My understanding of the statute and the regulations is the submission of an ANDA, including the certification, is completely separate from and a precursor to the ultimate transmission of the notification letter to the patent owner.

[00:11:03] Speaker 05:
Is there something in the statute or the regs

[00:11:06] Speaker 05:
that shows me that the transmission of the notification letter is a necessary act and component of submitting an ANDA to the FDA.

[00:11:18] Speaker 01:
Yes, and it is that the ANDA application has to be amended to include proof that Celgene was notified in New Jersey.

[00:11:27] Speaker 05:
I understand that there's a rule that talks about amending the ANDA.

[00:11:33] Speaker 05:
Still, there's the act of submission.

[00:11:36] Speaker 05:
The use of submit, submitting, submission throughout the statute and regs seems to be contemplating a particular thing that is a precursor to the notification letter itself.

[00:11:51] Speaker 05:
You have to do a certification.

[00:11:53] Speaker 05:
The certification is a promise.

[00:11:55] Speaker 05:
Included in that is a promise that you will send a notification letter.

[00:11:59] Speaker 05:
But certification doesn't include proof that you actually did send the notification letter, as I understand the requirements for certification, paragraph four certification.

[00:12:13] Speaker 05:
Can you write about that?

[00:12:14] Speaker 01:
My understanding is that under 21 CFR 314.95E, there has to be an amendment filed with the ANDA application as part of the submission.

[00:12:25] Speaker 01:
Not only that the paragraph for notice letter was received by Celgene, but it requires supplementation with proof of delivery, essentially.

[00:12:36] Speaker 05:
And I guess what I'm wondering is why isn't it that submission is different from amendment?

[00:12:43] Speaker 05:
You prepare your ANDA, you submit your ANDA, and then including the certification, and then after you submit the

[00:12:51] Speaker 05:
the ANDA, you send a notification letter to the patent owner.

[00:12:56] Speaker 05:
And then you then give the FDA proof of sending that notification letter through an amendment.

[00:13:07] Speaker 05:
But that's separate and apart from the actual submission itself.

[00:13:11] Speaker 01:
So I think the court, looking at the structure of both the statute and the regulations, can see all the parts that must be in the ANDA submission.

[00:13:20] Speaker 01:
And for it to be an act of infringement, it has to include the paragraph four certification.

[00:13:24] Speaker 01:
And for the 45-day clock to trigger for the filing of that infringement suit, there has to be notice provided to the patent holder, the NDA filer, and an amendment to that, and a submission with proof that that notice has been received.

[00:13:44] Speaker 05:
And so it's because when you look at the- To trigger the window for the patent holder to file a lawsuit.

[00:13:50] Speaker 05:
not only do you have to receive the notification letter but the ANDA applicant also has to amend the ANDA application?

[00:14:00] Speaker 01:
The 45 days triggers from when the notice was received but the FDA has to receive proof as part of the ANDA submission

[00:14:08] Speaker 01:
that the applicant complied with the requirements.

[00:14:12] Speaker 01:
And that's because under the statute, the act of submitting is only infringing if it includes a paragraph for certification.

[00:14:24] Speaker 01:
And the 45-day clock for triggering the infringement action is related back to when the notice was sent.

[00:14:33] Speaker 05:
Do you have anything other than that one regulation that calls for amending the ANDA?

[00:14:38] Speaker 05:
that includes proof of documentation that you sent the notification letter that, in your view, requires us to understand a submission, quote unquote, of an ANDA to necessarily include proof of providing notice to the patent owner.

[00:15:00] Speaker 01:
The statute itself requires that the notice be sent.

[00:15:06] Speaker 01:
So it's the statute and the regulation.

[00:15:08] Speaker 05:
I understand that, but that doesn't necessarily mean that it's part of the submission.

[00:15:15] Speaker 01:
Well, the submission, again, if it has to be filed with the FDA, then it is submitted.

[00:15:23] Speaker 01:
And if the court is looking at a temporal aspect of it, then the FDA will require additional information in connection with an ANJA as a general matter.

[00:15:32] Speaker 01:
And it's necessary for the FDA to

[00:15:35] Speaker 01:
consider that ANDA to have all of the required materials filed.

[00:15:40] Speaker 01:
And so there's nothing that says there's only one day on which the submission is complete.

[00:15:45] Speaker 01:
Of course if there are amendments to the submission that must be filed with the FDA,

[00:15:50] Speaker 01:
that necessarily includes them within a submission.

[00:15:55] Speaker 01:
Submit is not contrary to what Mylan has argued.

[00:15:58] Speaker 04:
But isn't it all still being submitted from West Virginia?

[00:16:02] Speaker 04:
The fact that it's sent out and then ultimately received somewhere else doesn't somehow broaden where the submission is occurring, which is what we in the ANDA cases consider as the act of infringement.

[00:16:14] Speaker 04:
Otherwise, I guess you're saying Congress somehow implicitly amended the venue statute in any cases to allow claims to be made in the Patent East Home District, even if the generic manufacturer and producer had no connection whatsoever to that.

[00:16:35] Speaker 04:
That would be inconsistent with general patent venue rules, wouldn't it?

[00:16:41] Speaker 01:
certainly it is unique and it is unique in terms of patent venue because really the infringement that you're looking... Well, it's the same venue statute though, right?

[00:16:56] Speaker 04:
It's not a different venue statute.

[00:16:58] Speaker 01:
It's what we have argued that Section 1391 could apply for and actions.

[00:17:05] Speaker 02:
But that's a thing we don't buy into that.

[00:17:06] Speaker 01:
But assuming that the court doesn't buy into that argument, yes, it is the same venue statute.

[00:17:12] Speaker 01:
And while the patent venue statute must be narrowly construed, the Hatch-Waxman Act does not need to be narrowly construed.

[00:17:18] Speaker 02:
Well, you know, if you look at Valiant, I mean, there is a footnote where the court

[00:17:21] Speaker 02:
kind of acknowledges, we're not purporting to resolve every single possible question about what's in the preparation of submission.

[00:17:29] Speaker 02:
But the case does say, in Hatch-Waxman cases, venue is proper only in those districts that are sufficiently related to the end of submission, in those districts where acts occurred that would suffice to categorize those taking them as a submitter under 271E.

[00:17:47] Speaker 02:
So I guess I'm having the same problem that it appears Judge Chen is having.

[00:17:51] Speaker 02:
establishing the connection between what you're saying is part and parcel of the submission of the ANDA.

[00:17:57] Speaker 02:
I'm just not seeing it.

[00:18:00] Speaker 02:
So you want to try again?

[00:18:01] Speaker 01:
Sure.

[00:18:03] Speaker 01:
So the reason that the Paragraph 4 certification and notice provided to the patent holder and the ANDA filer, sorry, the NDA filer, which in this case is Celgene,

[00:18:14] Speaker 01:
is part of the ANDA submission is because without that paragraph four certification there is no infringement and without notice provided to the patent holder, the NDA filer, the clock doesn't start for the infringement action.

[00:18:30] Speaker 01:
That notice provided to the patent holder says

[00:18:34] Speaker 01:
Here are the patents that are implicated.

[00:18:36] Speaker 01:
Here are the reasons why they're invalid or not infringed.

[00:18:43] Speaker 01:
And that is what triggers the filing.

[00:18:45] Speaker 02:
What the court said, our court said, was in those districts where acts occurred that would suffice to categorize those taking them as a submitter under 271E.

[00:18:58] Speaker 02:
Do you think that makes them a submitter?

[00:19:01] Speaker 01:
Well, in this instance, MPI sent the notice letter to Celgene in New Jersey.

[00:19:08] Speaker 01:
And so it's an act directed at New Jersey that MPI took in relation to the ANDA submission.

[00:19:13] Speaker 02:
And that makes Celgene a submitter?

[00:19:16] Speaker 01:
It doesn't make Celgene a submitter, but it's an action that the submitter took, Mylan generally here, directed at New Jersey.

[00:19:26] Speaker 01:
And we do have this argument, the empire material argument, which indicates that when a venue statute says

[00:19:34] Speaker 01:
we look to where an act has been committed or has occurred, we look to where it's directed, where its effects will be felt.

[00:19:41] Speaker 01:
And there's no question here because we know the infringement action is directed at Celgene or the infringement is directed at Celgene in New Jersey because for the Orange Book patents they're required to list

[00:19:53] Speaker 01:
who the patent holder is, the NDA filer, and the address at which the representative can be contacted to provide the paragraph for a notification.

[00:20:02] Speaker 02:
So you're not saying that the cell gene was the submitter?

[00:20:05] Speaker 02:
No, Your Honor.

[00:20:07] Speaker 02:
Okay.

[00:20:07] Speaker 02:
We're way out of time, so we'll restore some rebuttal and let's hear from the other side.

[00:20:12] Speaker 01:
Thank you, Your Honor.

[00:20:46] Speaker 00:
Good afternoon, Your Honors.

[00:20:47] Speaker 00:
May it please the Court.

[00:20:48] Speaker 00:
The District Court in this case issued a detailed 43-page opinion dismissing all three entities at issue in this case.

[00:20:56] Speaker 00:
Two for lack of venue and one for failure to state a claim.

[00:21:00] Speaker 00:
That detailed opinion set forth precisely the evidence of record regarding venue and the pleading allegations regarding failure to state a claim that warrant dismissal.

[00:21:11] Speaker 00:
That decision should be affirmed.

[00:21:12] Speaker 00:
Start with the first question that I heard from Your Honor regarding what specifically in the complaint are they standing on.

[00:21:18] Speaker 00:
And it's paragraph 23 on appendix 120.

[00:21:22] Speaker 00:
What I heard was that, yes, this allegation is nonspecific, problem number one.

[00:21:28] Speaker 00:
What I didn't hear was it's also conclusory.

[00:21:30] Speaker 00:
That's problem number two.

[00:21:32] Speaker 00:
What my friend on the other side said was that this allegation was not a guess.

[00:21:37] Speaker 00:
Well, if it's not a guess, then where are the facts that back up that they actually worked in concert together?

[00:21:42] Speaker 02:
Well, what about the court's dismissal of this and her not allowing them to amend?

[00:21:47] Speaker 00:
So that was in the first case.

[00:21:49] Speaker 00:
And so this appeals from the second case, so I'm going to start in the first case.

[00:21:52] Speaker 00:
So by stipulation, it's the record and the resolution from the first case that applies in the second case.

[00:21:58] Speaker 00:
In the first case,

[00:21:59] Speaker 00:
They requested, they didn't file a motion.

[00:22:01] Speaker 00:
That was pointed out by the district court.

[00:22:02] Speaker 00:
They requested leave to amend in their opposition brief.

[00:22:05] Speaker 00:
And in doing so, they made that request two years after the court deadline to file an amended pleading, or to file a motion to request an amended pleading.

[00:22:14] Speaker 00:
And we were also a handful of months away from trial at that point.

[00:22:17] Speaker 00:
The district court said that they're well past their deadline, and that ship on amendment has long since sailed because of it.

[00:22:24] Speaker 00:
The district court also pointed out that the same complaints that we had regarding the sufficiency of the complaint

[00:22:29] Speaker 00:
were filed in 2017.

[00:22:31] Speaker 00:
They were on notice of our problems with the sufficiency of their complaint.

[00:22:36] Speaker 00:
If you compare our first motion and our second motion, they're virtually the same when it comes to 12b6 because the complaint hadn't changed.

[00:22:42] Speaker 00:
So they had plenty of time before the court deadline to file an admitted pleading.

[00:22:48] Speaker 00:
They chose not to.

[00:22:49] Speaker 00:
Rather, they chose to file this request, which again was not a motion.

[00:22:52] Speaker 00:
only in opposition to the motion that we renewed later in 2020.

[00:22:58] Speaker 00:
So the court properly denied them leave to amend.

[00:23:02] Speaker 00:
Now, the stipulation that was agreed to by the parties says that the final resolution of the first case applies fully to the second case.

[00:23:10] Speaker 00:
So that resolution by stipulation applies to the second case.

[00:23:15] Speaker 00:
That's what they stipulated to.

[00:23:17] Speaker 00:
That's why, in force and effect, they were denied leave to amend in the second case.

[00:23:22] Speaker 00:
uh... in resolving the twelve six it appears that the district court relied on some discovery for any purposes in making the decision i need to start thinking that this group that your honor what we did in our motions we submitted documents that were integral to the complaints in other words an extra from the end and the notice letter itself those documents were integral to the complaint because they were referred to expressly in the allegations of the complaints under third circuit law i believe it's the burlington co case it says

[00:23:51] Speaker 00:
you can do that.

[00:23:53] Speaker 00:
A movement under 12b6 is entitled to do that because the plaintiff has notice of those documents because they're specifically referred to in the complaint.

[00:24:01] Speaker 00:
So the district court correctly considered those documents in connection with a rule 12b6 motion.

[00:24:06] Speaker 00:
Selden does not dispute that point.

[00:24:08] Speaker 00:
and dismissed the allegation that this group allegation that Mylan submitted the ANDA, the group allegation being Mylan was a short form for three separate entities, dismissed that group allegation as to Mylan and V because those documents show that MPI and MPI alone submitted the ANDA.

[00:24:33] Speaker 05:
In a theoretical world, I know it might not be

[00:24:37] Speaker 05:
possible under what we know under the facts of this case.

[00:24:40] Speaker 05:
But what could and should have Celgene done to get over a 12b6 motion with this complaint with respect to Mylan and V?

[00:24:51] Speaker 00:
Your Honor, with regard to Mylan and V, there's nothing they could do.

[00:24:55] Speaker 00:
And that's because we actually submitted affidavits on this that the court did not consider a connection with the 12b6, but in connection with the venue, rather, because it was also a live issue in the venue portion of the motion.

[00:25:05] Speaker 00:
that Milan V had nothing to do with the preparation of the ANDA, nothing to do with the submission of the ANDA, nothing to do with the eventual future distribution or sale of the ANDA.

[00:25:15] Speaker 00:
So there was nothing they could do.

[00:25:17] Speaker 04:
But in a hypothetical world where they might have had something to do, what would they have done?

[00:25:22] Speaker 04:
They would have asked for venue discovery and more promptly moved to amend the complaint?

[00:25:27] Speaker 04:
If they had found out evidence that showed the foreign entity had

[00:25:32] Speaker 04:
participated in it actually somehow.

[00:25:35] Speaker 00:
Strictly speaking, it wouldn't be venue because we're talking about 12b6 here, but some sort of general discovery regarding who did what in connection with the ANDA.

[00:25:42] Speaker 00:
And indeed, that's what the parties did do for three years leading up to our renewed motion.

[00:25:46] Speaker 00:
So they had plenty of opportunity to find that evidence, and nothing that they found rebutted the affidavit that we submitted on for the venue portion that said Mylan and Vee was not connected to the end in terms of its preparation, submission, or any future plans for it.

[00:26:04] Speaker 02:
Can I just ask a side question related to the evidence, which is just that there's a lot of stuff marked confidential in the briefs and in the appendix.

[00:26:13] Speaker 02:
And it's not intuitively obvious to me why some of that stuff is confidential.

[00:26:18] Speaker 02:
And that includes some of it's about Mylan employees and what they were doing in New Jersey.

[00:26:23] Speaker 02:
And there's a lot of other stuff that's very general information about Mylan's corporate structure.

[00:26:30] Speaker 02:
Do you know what I'm talking about, Andy?

[00:26:32] Speaker 02:
Is that stuff necessarily?

[00:26:35] Speaker 02:
I mean, we've got to write an opinion in this case, presumably.

[00:26:38] Speaker 02:
Do you adhere to those confidentiality markings here, or are you prepared

[00:26:43] Speaker 00:
disavow them uh... so with respect to my employees because we're talking about their residences we were very concerned about employee confidential information that their residences are their personal homes

[00:26:55] Speaker 02:
as you can see from the briefing, they have nothing to do with my... Okay, so they come up with addresses and names of employees.

[00:27:00] Speaker 00:
That's correct, that's correct.

[00:27:01] Speaker 00:
Okay, fair enough.

[00:27:01] Speaker 00:
Things like their, some of their webpages from LinkedIn, whatever else, those are all public, we don't have a problem with those, but specific to the residents as we did, we were concerned about that.

[00:27:10] Speaker 00:
If we stepped too far, Your Honor, I apologize for that, but we were just trying to maintain their confidence.

[00:27:14] Speaker 02:
And what about Mylands Corporate Structure?

[00:27:17] Speaker 00:
Mylands Corporate Structure, is there a specific reference, Your Honor?

[00:27:20] Speaker 02:
No, I don't have one.

[00:27:22] Speaker 00:
okay i i i i will see generally i think the concern is that that the information that had to do with a lot of the server person with financial information regarding these these entities and how they interrelate to each other and so we were concerned because none of that stuff is public and it's frankly uh... the disclosure financial information is not public is something that clinton's let me move you to i think maybe we were going which was the second portion of the discussion here about what acts are related to submission

[00:27:50] Speaker 02:
undervaluant and whether the acts that your friend here described were sufficiently related to submission.

[00:27:58] Speaker 00:
Sure, and so I believe the only activity that my friend pointed out was the submission, I apologize, the sending of the paragraph or notice letter to Selging.

[00:28:08] Speaker 00:
And I want to respond to Judge Chen's question, which had to do with, is it actually part of 271E2?

[00:28:14] Speaker 00:
And it's not.

[00:28:15] Speaker 00:
A cause of action under 271E2 is complete upon submission of the ANDA.

[00:28:21] Speaker 05:
The notice that- And the other side's argument is you don't have a complete submission of an ANDA until you amend the ANDA with proof of sending the notice letter.

[00:28:31] Speaker 00:
So it is required in the Hatch-Waxman statute that you tell the FDA that you complied with the statute by sending notice.

[00:28:37] Speaker 00:
It is not part of 271E2.

[00:28:40] Speaker 00:
And the example I'll raise is that when you send a notice letter to the brand, before they sue you, they don't ask you, oh, did you let the FDA know about the notice letter?

[00:28:47] Speaker 00:
And that's because the cause of action for infringement under 271E2 is complete upon the submission of the ANDA.

[00:28:55] Speaker 00:
Whatever is sent regarding the notice letter confirmation, whatever else, that's not part of a complete act of infringement.

[00:29:01] Speaker 00:
As Your Honor pointed out, it is the submission

[00:29:03] Speaker 00:
It's electronically submitted to when the button is pushed.

[00:29:06] Speaker 00:
That is the act of infringement.

[00:29:08] Speaker 05:
But the and applicant has to amend the application under FDA's rules to include proof of

[00:29:19] Speaker 00:
The notification confirmation must be provided to the FDA regarding the sending of those.

[00:29:24] Speaker 05:
Yeah through an amendment of the submission which then raises a question of well then When is the submission truly complete?

[00:29:33] Speaker 05:
We know that requirement apparently is to do this kind of amendment So is that amendment part of the submission or does it come completely after the submission?

[00:29:44] Speaker 05:
That's really the question.

[00:29:45] Speaker 05:
I'm trying to figure

[00:29:46] Speaker 00:
In the context of 271E2, it comes, in terms of the timeline, it's after the submission.

[00:29:52] Speaker 00:
It is something that occurs after the submission.

[00:29:53] Speaker 05:
Because why?

[00:29:54] Speaker 05:
If the FDA rules require the ANDA applicant to amend its ANDA application?

[00:30:01] Speaker 00:
Because the cause of action of infringement is complete upon submission of that original ANDA.

[00:30:07] Speaker 00:
We can be sued immediately, right then and there.

[00:30:10] Speaker 00:
There's no need for this extra step of, please let us know that you confirm the FDA the notice that are perceived.

[00:30:15] Speaker 00:
and another point i thought their time for filing a suit is triggered upon receipt of the notification of the notification letter not of the submission of of the paperwork to the f d a regarding confirmation of the notice letter was sent and at the point on the notice letter the theory here is that the sending of a notice letter to address in new jersey somehow makes new jersey relevant to the submission itself we think that turns fourteen hundred be on its head

[00:30:41] Speaker 00:
because what they're saying is that an office building operated by the plaintiff is irrelevant to the venue statute.

[00:30:47] Speaker 00:
But the venue statute is quite specific.

[00:30:49] Speaker 00:
It's focused on defendants and defendants only, their place of incorporation, where they committed acts of infringement, where they have regularly established places of business.

[00:30:59] Speaker 00:
It is not focused on the plaintiff at all.

[00:31:02] Speaker 00:
So this argument is legally incorrect because it reads language into the statute that's not there, or it

[00:31:10] Speaker 00:
broadly construes that language, which is not consistent with Supreme Court instruction, that the venue statute is to be narrowly construed.

[00:31:31] Speaker 00:
Unless there are any further questions, I will see the remainder of my time.

[00:31:36] Speaker 00:
Thank you.

[00:31:43] Speaker 02:
Mr. Thompson.

[00:31:52] Speaker 02:
We'll restore three minutes, everybody.

[00:31:58] Speaker 01:
I'll start with the amendment of the claim as to Mylan N.V.

[00:32:02] Speaker 01:
And first, I want to say that my friend on the other side was incorrect that the trial was imminent on appendix page 48.

[00:32:09] Speaker 01:
I'm sorry.

[00:32:10] Speaker 02:
I didn't hear you.

[00:32:10] Speaker 02:
Your friend was correct that what?

[00:32:12] Speaker 01:
Incorrect that trial was imminent.

[00:32:14] Speaker 01:
On page 48 of the appendix, the court denies Seldenes' opposition argument that the improper venue motion was forfeited because it wasn't brought in a timely manner.

[00:32:29] Speaker 01:
And it does so in part because it says no trial is imminent.

[00:32:32] Speaker 01:
It's incongruous to say this motion for improper venue isn't too late, but it's too late to amend a complaint as to Mylan NB, which the court won't address until we address the improper venue motion.

[00:32:46] Speaker 01:
But I would also just point out that under the abuse of discretion standards, since this court applies Third Circuit law, the court should look to Alvin v. Suzuki, which is 839 F.

[00:32:56] Speaker 01:
3rd, 242.

[00:32:58] Speaker 01:
It's a 2016 decision.

[00:33:00] Speaker 01:
It says that denial of a leave to amend based on a case management

[00:33:06] Speaker 01:
The relevance of case management order is an abuse of discretion.

[00:33:11] Speaker 01:
That's what happened here.

[00:33:12] Speaker 01:
That's the reason that the motion for leave to amend was denied, and that's an abuse of discretion.

[00:33:17] Speaker 01:
Finally, while we think that the arguments related to the 12D summary judgment motion are entirely improper, I did want to pick up on your questions, Judge Pros, concerning the information under seal and the length of discovery, of venue discovery.

[00:33:34] Speaker 01:
If the court would look to pages 2401 to 2405 of the appendix, they will see that it took two years nearly for Mylan to reveal its corporate structure and the overlap between officers and directors.

[00:33:49] Speaker 01:
And as the court pointed out, that information is under seal now.

[00:33:53] Speaker 01:
And while that's not relevant to assessing a Rule 12b6 motion, I do think that it's relevant to this court's consideration of what additional facts

[00:34:00] Speaker 01:
Celgene could have pleaded at the time it filed the complaint because all of that information about the interactions between the myelin entities, myelin keeps it very closely guarded.

[00:34:13] Speaker 01:
I will turn very briefly to the act of infringement.

[00:34:17] Speaker 01:
One, in deciding the act of infringement that occurred here, that's under the Hatch-Waxman Act.

[00:34:22] Speaker 01:
And so there's no constraint to narrowly construe the Hatch-Waxman Act.

[00:34:26] Speaker 01:
then the Act of Infringement should really comport with the purpose of the Hatch-Waxman Act.

[00:34:34] Speaker 01:
This court in Valiant said that acts of infringement are those sufficiently related to the ANDA submission.

[00:34:40] Speaker 01:
So it's not when was the button pressed to submit, but what is sufficiently related to that submission.

[00:34:46] Speaker 01:
And here the notice letter sent to Celgene in New Jersey is sufficiently related to the ANDA submission.

[00:34:56] Speaker 02:
Thank you.

[00:34:56] Speaker 02:
We thank both sides, and the case is concluded.

[00:34:58] Speaker 02:
That concludes our proceeding for this morning.

[00:35:01] Speaker 03:
Thank you.

[00:35:02] Speaker 03:
All rise.

[00:35:04] Speaker 03:
The honorable court is adjourned until tomorrow morning at 10 o'clock AM.