[00:00:30] Speaker 03:
Their final case this morning is number 16-2179, Amgen, Inc.

[00:00:33] Speaker 03:
vs. Haspera, Inc., Mr. Colmbridge.

[00:00:39] Speaker 02:
Good morning, Your Honors and let please the Court.

[00:00:41] Speaker 02:
I would like to begin by stating that in our view, the central issue in this appeal is what did this Court decide in the Sandoz case when it said that after bringing an infringement action,

[00:00:58] Speaker 02:
the so-called reference product sponsor can access the required information through discovery.

[00:01:03] Speaker 03:
Well, it seemed to say that you could do it by bringing a suit for an artificial act of infringement, which is not what you've done.

[00:01:14] Speaker 02:
I disagree with that, Your Honor.

[00:01:16] Speaker 02:
I think we did bring a suit for asserting two causes of action under Section 271A and one under Section 271E2C.

[00:01:25] Speaker 02:
But what the

[00:01:28] Speaker 03:
statute seems to say is the artificial act of infringement in this case would be to the cell patent, which is not a patent on which you've sued.

[00:01:43] Speaker 02:
We don't agree with that, Your Honor.

[00:01:45] Speaker 02:
That's what the statute says.

[00:01:46] Speaker 02:
In other words, what we think that what the statute says is there's an artificial act of infringement with respect to potentially many patents.

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Once you bring a lawsuit

[00:01:56] Speaker 02:
on any one of those, you can then access the corpus of information that is defined by subsection L2A and thereafter act accordingly.

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And we think that's what this court held in Sandoz.

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And the reason for that is because if we look at how the issue arose in Sandoz, Amgen argued, well, it cannot be the case that the biosimilar applicant is allowed to withhold this information because the result would

[00:02:25] Speaker 02:
a situation in which infringement could effectively be concealed forever.

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Sandoz came back and said, that's not so.

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You could get that information in discovery, so it would be, in essence, no harm, no foul.

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And we understand that is what the court meant when it referred to the so-called required information.

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It's a set of information that's defined in the statute, and it's not defined by reference to any patent.

[00:02:52] Speaker 03:
But that seems to be different from what

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I thought your answer was in response to my question.

[00:02:59] Speaker 03:
Is it not the case that under the original Amgen opinion, that if you're going to sue to get this information, you have to bring a suit alleging an artificial act of infringement under C2I?

[00:03:19] Speaker 02:
Your Honor, I don't believe that it's necessary that you

[00:03:24] Speaker 02:
bring a suit under that particular subsection I think it's necessary to bring a suit but if you but in on the facts of this case MGen did bring a suit under 271E2C1 or at least under E2C.

[00:03:39] Speaker 02:
Right, but it didn't bring an action under E2C2.

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It did not denominate the action in the original complaint as being under E2C2.

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It's denominated as being under E2C.

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which may be ecumenical as to whether it's under C1 or C2.

[00:04:01] Speaker 01:
And in our view, Your Honor, though, the question here is... Just curious, is there anything that's preventing you right now from filing another complaint under 271E2C2 for any patents that you have that relate to manufacturing the biological product?

[00:04:19] Speaker 02:
Yes, Your Honor, and what's preventing bringing such a suit is that

[00:04:23] Speaker 02:
We can't tell whether there's infringement.

[00:04:27] Speaker 02:
And as we understand the entire statutory regime that would apply here and would apply to any lawsuit, there has to be a reasonable basis to meet rule 11 and put that patent in play.

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And so if you're a company like Amgen that owns literally hundreds of potentially applicable patents, you can't just pluck out one or, for that matter, dozens of them and say, I'm planning to bring a lawsuit.

[00:04:50] Speaker 02:
And my rule 11 basis for bringing the lawsuit is that I cannot exclude the possibility, defendant, that you infringed.

[00:04:56] Speaker 02:
Wait, wait, wait.

[00:04:57] Speaker 03:
That doesn't make sense.

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Because if the purpose of the statute here is to allow, when the information is applied, that you be able to get it through a suit for an artificial act of infringement, it doesn't look as though the rule 11 standard would apply to such an action

[00:05:17] Speaker 03:
on the theory that you didn't know that the patent was infringed.

[00:05:24] Speaker 02:
I think our view of the law, Your Honor, would be that the rule of 11 standard does apply and that indeed the reason why the statute prescribes this information exchange and then uses the term for many of its operative provisions as to which the reference product sponsor has formed a belief

[00:05:45] Speaker 02:
a reasonable belief that a claim of infringement could be asserted, that what's embedded in that reasonable belief language is that there has been an analysis, a comparison between the accused instrumentality and a patent claim that has resulted in a belief, an objectively reasonable belief, that there is infringement and that that's a precondition to bringing suit.

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And in fact, that as this court noted in Apotex, the very artificial act of infringement

[00:06:14] Speaker 02:
where the information is withheld.

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In other words, E2C2 is defined by reference to that reasonable belief.

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Those are the patterns as to which there is infringement.

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The artificial active infringement applies.

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But we should have to take account of the fact that the whole purpose of C2 is to allow you to sue for an artificial active infringement if the information necessary to make a determination

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infringement has not been supplied.

[00:06:47] Speaker 02:
With utmost respect, I don't read it that way.

[00:06:49] Speaker 02:
I certainly agree that the purpose of E2C, and indeed all of E2, is to facilitate suits based on an artificial act of infringement.

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I do not read, Amgen does not read E2C as saying that it is in some way animated by a separate desire or standard to bring suit to get information.

[00:07:11] Speaker 02:
But it says that.

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It says that the applicant for the application fails to provide the application and information required, which is this situation, isn't it?

[00:07:21] Speaker 03:
Well, what it says, Your Honor, is that this situation?

[00:07:25] Speaker 02:
In our view, yes, it is this situation, at least with respect to these patents.

[00:07:29] Speaker 01:
So perhaps out of an abundance of caution, without any court ruling and commenting on the scope of Rule 11's applicability to this unique context,

[00:07:42] Speaker 01:
you chose not to file under E2C2 for any of your cell culture medium claims.

[00:07:48] Speaker 01:
But nevertheless, it seems like once you've exhausted your efforts to try to reasonably acquire and investigate a possible claim for your manufacturing patents and you haven't been able to succeed through the L2-3 process, then you

[00:08:10] Speaker 01:
you know, appear to have a reasonable basis for now filing a claim for your cell culture patents under E2C2.

[00:08:20] Speaker 02:
Our view, Your Honor, is that we do not, because we couldn't plead that.

[00:08:23] Speaker 02:
Let's assume, for example, that there are dozens or maybe even hundreds of possibly implicated patents.

[00:08:29] Speaker 02:
What would that complaint look like?

[00:08:31] Speaker 02:
It would be an immense document saying, here's a patent I own.

[00:08:35] Speaker 02:
I've asked for information about this.

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I haven't got the information.

[00:08:37] Speaker 02:
Therefore, I think they infringe it.

[00:08:39] Speaker 02:
that we, in our view, that can't possibly be what the statute requires or is meant to impose.

[00:08:46] Speaker 03:
Well, how come either the statute contemplates some suit on an irrelevant patent is given the route to get the information that wasn't supplied?

[00:08:57] Speaker 03:
How do you read C2 as allowing that to happen?

[00:09:00] Speaker 02:
Because, Your Honor, the definition of the information is not based on any patent.

[00:09:05] Speaker 02:
and therefore it's equally relevant to any patent that's asserted if one is looking at it in that fashion.

[00:09:10] Speaker 02:
I think part of the problem with saying you have to sue on the patent to which this would be relevant is that the patent owner will never know which that is.

[00:09:22] Speaker 02:
As a practical matter, there can be a large number of them.

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And there's always the risk that you missed some that were important.

[00:09:29] Speaker 02:
And the way the statute deals with that is it doesn't say the information is defined by relevance to patents.

[00:09:35] Speaker 02:
It says in L2A, the information is the application that was submitted to the Food and Drug Administration, the entire thing.

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And such other information, that describes the processes used to manufacture the product.

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And so that is entirely independent of any patents.

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And because the corpus of information is defined that way, once the lawsuit begins, if it's to be accessible in discovery, in our view, the whole corpus of information should be accessible in discovery.

[00:10:04] Speaker 02:
regardless of what patent or patents have been put in play.

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And that's how we think that the statute makes much more sense that way, and that what can happen if it's viewed that way and that entire corpus of information is then disclosed.

[00:10:17] Speaker 02:
At that stage, the evaluation to form a reasonable belief as to whether a claim of infringement can reasonably be asserted can take place, and the entire process can move forward.

[00:10:31] Speaker 02:
as was contemplated by the statute, and that way we come back to this place where the end result isn't different.

[00:10:37] Speaker 02:
There might be a slight temporal change, but the end result isn't different than what would have happened had the procedures of the statute been followed.

[00:10:46] Speaker 02:
If we go the other route and we say you have to make a decision, perhaps even a guess, as to which of your many patents may be relevant and sue on those patents, and you only get then information that is relevant to the ones that you've sued on.

[00:11:01] Speaker 02:
that it ends up creating a situation in which you can miss patents, in which you may never learn of an infringement.

[00:11:08] Speaker 02:
And it's grossly inefficient, because it's essentially saying, pull the trigger on lots of things, and then we'll figure out which ones matter afterwards.

[00:11:15] Speaker 02:
It would be much better, and we think this is exactly what the statute was intended for, to say, get the information, make the comparison with the accused instrumentality, and then assert your claims of infringement.

[00:11:26] Speaker 02:
And that's viewed that way, then,

[00:11:31] Speaker 02:
We get that corpus of information, and we simply do after the lawsuit what the statute, had it been followed, would have required before the lawsuit.

[00:11:39] Speaker 02:
How do you square that with the statutory language?

[00:11:44] Speaker 02:
Again, Your Honor, in our view, as I'm sure the Court is aware, our view of the statutory language is that compliance with L2A is actually mandatory, but of course the Court held to the contrary in Sandoz.

[00:11:58] Speaker 02:
And so in our view, the statutory language says the information is required.

[00:12:04] Speaker 02:
It doesn't mince its words.

[00:12:05] Speaker 02:
It says in at least three places, this information is required.

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And the required is what this court is talking about.

[00:12:13] Speaker 03:
How does the statute allow you to get under the Amgen decision, which is binding on this panel for the moment?

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How do you fit yourself

[00:12:27] Speaker 03:
under the statutory language.

[00:12:28] Speaker 03:
How is this suit that you brought, a suit that's covered by C2?

[00:12:36] Speaker 02:
Well, the complaint avers an active infringement under C2, Your Honor, not of one of these patents, not of the so-called cell culture patents, but of one of the two patents that has been asserted in the underlying lawsuit.

[00:12:51] Speaker 03:
So you read C2 as allowing you to claim an artificial active infringement

[00:12:56] Speaker 03:
with respect to any patent?

[00:12:59] Speaker 02:
No, I think the way we read it is this is a situation where some but less than all of the required information was disclosed.

[00:13:06] Speaker 02:
That information was sufficient for Amgen to form a belief that a claim of infringement could reasonably be asserted as to three patents, two of which were then included in the underlying lawsuit.

[00:13:19] Speaker 02:
And so there was an artificial act of infringement of those two patents by virtue of Fospero having submitted

[00:13:26] Speaker 02:
its application to the FDA, and thus trigger the 271E2C.

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And thus, mGen can bring an action for those.

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And this is how we read the Sandoz decision.

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We have a patent, or in this case, two patents that we can sue on.

[00:13:42] Speaker 02:
Having sued on them, we then are in court and can get what the statute characterizes as the information required under L2A.

[00:13:51] Speaker 00:
So you're saying that there's an ancillary discovery proceeding, which is implicit,

[00:13:56] Speaker 00:
in the structure of the statute that enables you by suing on patents one and two to obtain information about patents four and five that should have been turned over in the L2.

[00:14:08] Speaker 02:
That's right, Your Honor.

[00:14:09] Speaker 02:
And to focus on that a little further, it's because that second round of information isn't defined by virtue of being relevant to patents four and five.

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It's defined by virtue of being a set of information about the product.

[00:14:22] Speaker 02:
and that that's what is required.

[00:14:24] Speaker 00:
Well, but the only reason you're seeking it is because of its potential pertinence to four and five.

[00:14:29] Speaker 02:
In this case, that's certainly true, Your Honor, yes.

[00:14:32] Speaker 03:
Could you address the appealability question?

[00:14:34] Speaker 02:
Absolutely, Your Honor, I'd be happy to.

[00:14:36] Speaker 02:
So in our view, we meet the requirements of the collateral order doctrine.

[00:14:41] Speaker 02:
I'll talk about those first, and then we can come to mandamus.

[00:14:45] Speaker 03:
Both under mandamus and the collateral order doctrine, you've got to show that you don't have an adequate rendering

[00:14:51] Speaker 03:
why can't you wait until the final judgment?

[00:14:55] Speaker 03:
Why can't you wait until there's a final judgment and appeal?

[00:14:59] Speaker 03:
Why isn't that satisfactory?

[00:15:00] Speaker 02:
Because, and I think there's agreement on this, Your Honor, one of the rights that the BPCIA gives to a patent holder or a reference product sponsor such as Amgen is the right to have the patent issues resolved before by a similar market entry.

[00:15:16] Speaker 02:
And I think that there's no dispute about this, certainly in the red brief at page five,

[00:15:21] Speaker 02:
It states that that is one of the purposes of the statute.

[00:15:24] Speaker 02:
This court commented on that in the Apotex case.

[00:15:29] Speaker 02:
And there's very good reasons why that would be so.

[00:15:31] Speaker 01:
But to be fair, the statute also contemplates there will be times where you as the reference product sponsor will be collecting damages for sales of the biosimilar product out in the commercial marketplace.

[00:15:45] Speaker 01:
That's 271E4.

[00:15:47] Speaker 01:
So it's not set up in such a way that

[00:15:51] Speaker 01:
The statute enacted by Congress absolutely commands that all potential patent infringement suits will be filed and resolved before any biosimilar actually hits the market.

[00:16:04] Speaker 02:
That's correct, Your Honor, but I think that as we read the statute, recognizing that there are disparate views here, it's set up so that the reference product sponsor can get into court and ask for a resolution before there is biosimilar market entry.

[00:16:19] Speaker 02:
And that's, in fact, the purpose of the 180 days of L8B.

[00:16:23] Speaker 02:
The court may say, I disagree.

[00:16:26] Speaker 02:
You're not entitled to that.

[00:16:28] Speaker 02:
They can come on the market and that'll be a damages case.

[00:16:31] Speaker 02:
But the reference product sponsor has the ability to get there first.

[00:16:35] Speaker 02:
Now, the damages provisions of the remedy part would be 271E4.

[00:16:40] Speaker 02:
The reference product sponsor could accidentally or deliberately fail to bring suit when it is supposed to.

[00:16:47] Speaker 02:
and then it may be cabins to a royalty remedy.

[00:16:50] Speaker 02:
But again, that's within the power of the reference product sponsor.

[00:16:54] Speaker 02:
And there are very good reasons, as this court, for example, commented or quoted from the legislative history in the Apotex case, saying, by way of example, that it's a very different proposition to go to a district court and say, please stop this infringing product from coming on the market, as opposed to going and saying,

[00:17:17] Speaker 02:
there's an infringing product on the market, please take it off the market.

[00:17:21] Speaker 02:
And that courts may be reluctant to do the latter, but more willing to do the former.

[00:17:26] Speaker 02:
So what we have is a statutory regime that was very carefully crafted to give the patent holder the ability to get into court before biosimilar market entry.

[00:17:38] Speaker 02:
Now, on the facts of this case, why do I raise this?

[00:17:40] Speaker 02:
Because to Judge Doug's question, why is this not adequately appealable

[00:17:45] Speaker 02:
are following the judgment on the merits, because as we make that, we work the time period in this.

[00:17:51] Speaker 02:
The earliest we think that this court could be addressing, could be giving us a decision on the question that brings us here today, if we waited until the final judgment is probably 2019.

[00:18:02] Speaker 02:
And we think it's highly likely, or at least likely, that Hospera will have entered the markets before that.

[00:18:10] Speaker 02:
And therefore, the right to have an adjudication

[00:18:14] Speaker 02:
if you wish, before biosimilar market entry will have been gone forever.

[00:18:20] Speaker 02:
And one, I don't want to be hyperbolic, but one can analogize that, say, to the case law about immunity from suit.

[00:18:28] Speaker 02:
That it's not, in those cases, one could say, why is it a problem?

[00:18:31] Speaker 02:
You know, if you lose at the end, we'll just say you were immune and that, you know, you will have prevailed.

[00:18:37] Speaker 02:
But here, part of the right that the reference product sponsor has is, if it chooses, the ability to have a resolution, to go to a court and ask for a resolution before generic market entry.

[00:18:47] Speaker 02:
And that will be irrevocably lost to us, we believe.

[00:18:49] Speaker 00:
It seems to be a bit of a stretch to say that the right not to have to face suit, which is the immunity issue, is the same as the right not to have to face competition, which is your issue.

[00:19:00] Speaker 02:
I don't think it's a right not to have to face competition.

[00:19:02] Speaker 02:
It's a right to be able to go to court and say, court, I should not have to face competition.

[00:19:07] Speaker 02:
Now those are subtly different, but importantly different.

[00:19:11] Speaker 00:
It's subtle enough to elude me.

[00:19:13] Speaker 02:
Well, I think the way the statute is set up, and this was the purpose of, for example, the 180 days in our view, to say there has to be a time before the generic is on the market, when the patent holder or reference product sponsor can go into court and say, please don't allow them to enter the market, give me a preliminary injunction.

[00:19:36] Speaker 02:
because there will be an infringement if they enter the market, and then we'll have a set of consequences that are untoward.

[00:19:42] Speaker 02:
I think we're out of time.

[00:19:45] Speaker 03:
Apologize, Your Honor.

[00:19:48] Speaker 03:
You are asking the questions.

[00:19:50] Speaker 03:
Mr. Maloro?

[00:19:56] Speaker 04:
Thank you, Your Honor.

[00:19:57] Speaker 04:
May it please the Court, the fundamental problem with merits of the appeal here

[00:20:03] Speaker 04:
is that the BPCIA does not alter Rule 26 of the Federal Rules of Civil Procedure.

[00:20:09] Speaker 04:
That's above and beyond and distinct from the jurisdictional issues.

[00:20:13] Speaker 03:
But what about the theory that somehow this comes within C2?

[00:20:18] Speaker 03:
Because that seems to be the heart of the question.

[00:20:20] Speaker 04:
The cause of action that was pled was a cause of action for infringement of a patent which was close to but not quite expired.

[00:20:28] Speaker 04:
And the complaint just denominated it under C. But it's actually a C1 complaint.

[00:20:33] Speaker 04:
because that patent was listed on the 3A list that Amgen provided during the so-called patent dance.

[00:20:41] Speaker 04:
It is a patent that falls squarely under C1.

[00:20:44] Speaker 04:
They just said C. And this is not a C2 case.

[00:20:49] Speaker 04:
Even if it were a C2 case, the infringement is the infringement of this so-called isoform patent.

[00:20:58] Speaker 03:
I guess what they're arguing is that if you bring suit

[00:21:03] Speaker 03:
under the product patent under C2, that's permissible because there's an artificial infringement of the product patent.

[00:21:12] Speaker 03:
That would seem to be what they're saying.

[00:21:14] Speaker 04:
I think that does kind of capture what they're saying.

[00:21:17] Speaker 04:
There are two problems with that.

[00:21:19] Speaker 04:
One, that's not what happened here.

[00:21:21] Speaker 04:
They sued under C1.

[00:21:23] Speaker 04:
They just didn't say that.

[00:21:24] Speaker 04:
But secondly, even if they sued under C2,

[00:21:28] Speaker 04:
for the product patent, which I don't think C2 would fit, but even if you called it a C2 suit, Rule 26 still says that discovery is governed by the claims and defenses.

[00:21:40] Speaker 04:
And the claim is for infringement of product patents.

[00:21:43] Speaker 03:
I don't understand your rule.

[00:21:44] Speaker 03:
I don't understand that Rule 26 argument.

[00:21:46] Speaker 03:
If, in fact, it's an artificial act of infringement not to supply the information with respect to the product patent, we don't have to worry about Rule 26 because the statute tells us

[00:21:58] Speaker 03:
that the information is relevant, because that's the very basis for the suit.

[00:22:03] Speaker 04:
The information will be relevant only to the patents asserted under the so-called artificial act of infringement.

[00:22:10] Speaker 04:
And therefore, rule 26 says the claim is for infringement of the product patent.

[00:22:15] Speaker 03:
But for an artificial, they say, for an artificial act of infringement of the product patent.

[00:22:21] Speaker 03:
That the failure to supply the information is an artificial act of infringement of the product patent.

[00:22:27] Speaker 03:
and not just the cell patent.

[00:22:29] Speaker 03:
That's what they said.

[00:22:31] Speaker 04:
Maybe we're not making myself clear as to which patents we're talking about.

[00:22:35] Speaker 04:
It's 298 is the patent they sued on under C. That's the product that, right?

[00:22:41] Speaker 04:
Yes, it's related to ISO forms of the product.

[00:22:45] Speaker 04:
The cell patents, the 349, they did not sue under C. Right.

[00:22:50] Speaker 04:
So 298, they brought a lawsuit.

[00:22:52] Speaker 04:
That patent was listed on the 3A list.

[00:22:54] Speaker 04:
Therefore, that's a C1 suit that they brought.

[00:22:58] Speaker 04:
They just put C in the complaint, but it's a C-1 suit because that's the provision of C that governs that act of infringement.

[00:23:05] Speaker 00:
So if you were counseling Amgen at the beginning of this process, what would you suggest they do?

[00:23:12] Speaker 00:
Apparently, you would say, don't go the discovery route.

[00:23:16] Speaker 00:
What route should they have followed?

[00:23:18] Speaker 04:
Well, Amgen had options that they chose not to take advantage of.

[00:23:23] Speaker 00:
What would be the best options for a party in Amgen's position

[00:23:27] Speaker 00:
other than the rule 26 option that they elected.

[00:23:30] Speaker 04:
Well, Amgen could have, if they thought they had a patent that this information that they're seeking was somehow relevant to, they could have listed that patent on their 3A list.

[00:23:42] Speaker 04:
And indeed, they had a duty to list that patent.

[00:23:45] Speaker 04:
Only if they reasonably had believed that it was infringed, right?

[00:23:49] Speaker 04:
That a claim of patent infringement could be asserted.

[00:23:52] Speaker 00:
Right.

[00:23:52] Speaker 00:
But are you suggesting they should guess and that that would be good enough to be a reasonable belief?

[00:23:58] Speaker 00:
Because Mr. Boone was just telling us they had no basis beyond guessing.

[00:24:03] Speaker 04:
It would be more than a guess if they looked at a patent and thought that patent was infringed and there was one piece of information that they couldn't definitively tell yet whether it was infringed.

[00:24:15] Speaker 04:
Remember, they got 700,000 pages of information

[00:24:19] Speaker 01:
They got a complete identity.

[00:24:22] Speaker 01:
Let's do a hypothetical now.

[00:24:24] Speaker 01:
Let's say that a K applicant hands over the application.

[00:24:30] Speaker 01:
And the application gives lots of information about the product, the biosimilar product, but gives no information about how to manufacture that biosimilar product.

[00:24:41] Speaker 01:
And the K applicant refuses to hand over any manufacturing information along with the application.

[00:24:48] Speaker 01:
under L2A.

[00:24:49] Speaker 01:
So now we know that there has been a violation of that mandate by Congress in L2A.

[00:24:58] Speaker 01:
So under those circumstances, it seems like it would be really shooting in the dark for the RPS to list any of its manufacturing patents when it's identifying patents beyond the biologic product patented claims.

[00:25:18] Speaker 04:
It seems as if there was a violation of 2A, then there are options to bring suit on patents that could be listed under 3A under C2.

[00:25:31] Speaker 01:
Right.

[00:25:32] Speaker 01:
And so I guess you're saying then that the RPS, the reference product sponsor, could file a lawsuit under E2C2 and necessarily would have to be guessing somewhat about which

[00:25:46] Speaker 01:
patents it identified in its complaint.

[00:25:49] Speaker 01:
But upon filing that very complaint, the reference product sponsor in the context of the situation shouldn't be subjected to rule 11 sanctions.

[00:25:59] Speaker 01:
And in fact, there ought to be discovery produced by the K applicant in such a litigation to actually reveal the manufacturing processes for the biosimilar product.

[00:26:14] Speaker 01:
Is that a fair way of

[00:26:16] Speaker 01:
explaining how the mechanism should go?

[00:26:19] Speaker 04:
Presumably, if there's an absence of information that makes the assertion of the patent reasonable, then there should be a situation where Rule 11 ought not to be a concern.

[00:26:31] Speaker 04:
If they essentially didn't get the information under circumstances where they should have, they had a patent assertion that would be reasonable.

[00:26:39] Speaker 04:
It's not dissimilar in some ways from the Roche case cited in the party's papers,

[00:26:44] Speaker 04:
where information was asked for, it wasn't given, a suit was filed.

[00:26:48] Speaker 01:
And if all that's true, then there shouldn't be anything that stops Amgen from filing another complaint, say, tomorrow under E2C2 and identifying some cell culture patents and alleging that there has been a patent infringement of those cell culture patents, which would then

[00:27:08] Speaker 01:
trigger the discovery process.

[00:27:10] Speaker 04:
Well here we have a dispute between the parties as to whether 2A was complied with.

[00:27:14] Speaker 04:
Our view is they would be barred.

[00:27:16] Speaker 01:
There would be a dispute in district court and then I guess unfortunately a district court judge would have to decide whether in fact Aspera violated L2A.

[00:27:27] Speaker 01:
But then if the district court concluded that yes, there was manufacturing information that needed to be submitted under the L2, L3 process and wasn't

[00:27:37] Speaker 01:
handed over, then under those circumstances, Amgen should be able to pursue this E2C2 complaint.

[00:27:46] Speaker 04:
I'm not sure I would agree with that, Your Honor, in the sense that... Well, why wouldn't they?

[00:27:49] Speaker 04:
Because Haspera, having opted in to the 2A disclosures, opted into the patent dance.

[00:27:55] Speaker 01:
But you opted in only in a very partial minimal way under this theory of the fact pattern, where they only complied halfway.

[00:28:06] Speaker 04:
I would submit that they have complied 100% and the volume of information... Right, but we're in my theoretical world right now.

[00:28:14] Speaker 01:
In your theoretical world... You violated L2A by not satisfying the manufacturing information requirement.

[00:28:24] Speaker 04:
So under that circumstance... The patent should then be listed and you should go through the patent dance because the patent dance then is designed to crystallize the issues.

[00:28:34] Speaker 04:
So if you opt into 2A.

[00:28:36] Speaker 01:
But I would agree that you should go through the patent dance and list patents under L3A in accordance with the actual information that the biosimilar provided under L2A.

[00:28:51] Speaker 01:
But for those very important pieces of information that it did not submit, then it seems like the RPS is at a loss on what to do next.

[00:29:01] Speaker 04:
No, I would submit that what the RPS has to do is list the patents that, in your hypothetical world, you're saying they might sue on under C2.

[00:29:11] Speaker 03:
I don't understand that, because C2 assumes that the patents haven't been listed.

[00:29:16] Speaker 03:
And it seems to say that there's an artificial act of infringement.

[00:29:22] Speaker 04:
And that's because C2 applies to the situations where you have an opt-out.

[00:29:27] Speaker 04:
Essentially, you have a non-compliance with 2AM, the Sandoz case, for example.

[00:29:31] Speaker 03:
Okay, but under Judge Chin's hypothetical, there's a violation of L2A.

[00:29:37] Speaker 03:
The necessary information wasn't supplied.

[00:29:40] Speaker 03:
The remedy, as I understand it, you say, has to be under C2, right?

[00:29:47] Speaker 04:
Well, at the end of the patent dance information... Well, there's no patent dance if it hasn't been listed.

[00:29:55] Speaker 03:
Well, it should be listed.

[00:29:57] Speaker 01:
I guess that's what I keep circling back to.

[00:29:59] Speaker 03:
C2 highlights that it wasn't listed.

[00:30:01] Speaker 01:
It wasn't listed because the information wasn't handed over under L2A.

[00:30:06] Speaker 01:
That's the theoretical construct we've created here for purposes of this argument.

[00:30:12] Speaker 04:
If there's absolutely no way to have a compliance with 2A because there was one piece of paper submitted that said I want to market a biosimilar version of product X and no more detail was provided, if that's the hypothetical,

[00:30:33] Speaker 04:
It still would be possible for Amgen to list the patents that it thinks might be infringed, including manufacturing patents.

[00:30:40] Speaker 04:
And Amgen's view is, well, that would put a burden on the subsection K applicant to have to respond to a lot of patents.

[00:30:48] Speaker 03:
That's saying that they have to list the patents.

[00:30:49] Speaker 03:
They're saying that we get to sue for artificial active infringement under C2.

[00:30:55] Speaker 03:
And that seems to be what the original Amgen decision said.

[00:31:00] Speaker 03:
And C2 assumes

[00:31:02] Speaker 03:
that the patents weren't listed, but could have been if the correct information had been support.

[00:31:09] Speaker 04:
And I guess I would have two responses.

[00:31:10] Speaker 04:
One is they should list if you're in the patent dance.

[00:31:13] Speaker 04:
But if they don't, and they sue under C2, and they sue for infringement of patents where they say they didn't get information, there was a complete failure under 2A, they now have a claim, a cause of action, for infringement of these manufacturing patents.

[00:31:28] Speaker 04:
And under Rule 26, discovery would presumably be appropriate.

[00:31:32] Speaker 04:
for obtaining information as to those claims that are now in a lawsuit that is properly before district court.

[00:31:41] Speaker 01:
So that goes back to, I guess, my initial question.

[00:31:44] Speaker 01:
There isn't anything stopping Amgen from filing that E2C2 complaint today for its manufacturing patents that relate to cell cultures.

[00:31:58] Speaker 01:
There would be a debate over whether or not there was a

[00:32:01] Speaker 01:
violation on your side of the L2A requirement of handing over manufacturing information, and the district court would then have to decide whether or not there was a violation of L2A.

[00:32:13] Speaker 01:
But if there was, if the district court does conclude there was a violation of L2A, then I don't see, unless you tell me differently, any reason why Amgen couldn't go forward on that E2C2 complaint.

[00:32:28] Speaker 04:
I guess accepting the premise that

[00:32:32] Speaker 04:
Listing patents under 3A is not required, and a suit under C2 is permitted.

[00:32:41] Speaker 04:
Once you get into a C2 suit, then you can get the discovery.

[00:32:46] Speaker 04:
But if you opt into the patent dance, unlike the Sandoz case, and you provide information, and at the edges, there is a patent that the RPS thinks

[00:32:59] Speaker 04:
is infringed, but they don't have 100% certainty because there's a piece of information that they don't think they can glean from the 700,000 pages they got.

[00:33:10] Speaker 04:
They should list that patent and then go through the patent dance because the next thing that happens is that the Subsection K applicant provides contentions.

[00:33:19] Speaker 03:
Well, how can you say that when C2 contemplates that we're going to have an artificial active infringer when the patent wasn't listed?

[00:33:27] Speaker 04:
In cases where 2A is violated.

[00:33:29] Speaker 00:
Which is the whole hypothetical we've been discussing for the last 10 minutes.

[00:33:33] Speaker 04:
Well, I guess 2A is not violated where you opt into the patent dance.

[00:33:39] Speaker 00:
You mean you think as long as you produce something, unlike Sandoz, and you don't say just drop dead, I'm not coming forward with anything, then you've opted into the patent dance and you get treated as if you had completely complied with L2?

[00:33:55] Speaker 04:
Yes, if you make a good faith

[00:34:00] Speaker 04:
proffer of your information under 2A, if there's a dispute over whether or not a piece of information is required or not, that patent should be listed and you should go through the patent dance.

[00:34:13] Speaker 04:
If that doesn't happen and it is legitimate to file a C2 suit, then discovery would be appropriate under the C2 suit cause of action for patent infringement of those patents that are asserted.

[00:34:27] Speaker 04:
You want to say a couple words about appealability?

[00:34:29] Speaker 04:
Yes.

[00:34:30] Speaker 04:
Thank you, Your Honor.

[00:34:31] Speaker 04:
As to the collateral order doctrine and the all writs, two things.

[00:34:38] Speaker 04:
This is effectively reviewable on appeal.

[00:34:41] Speaker 04:
The courts have made clear that even rights that are central to the system that are not adjudicated through an interlocutory appeal, those can be reviewed effectively afterwards.

[00:34:54] Speaker 04:
In this court, we have the quantum case where privilege issues

[00:35:00] Speaker 04:
were deemed to be not appealable under collateral order, cannot, compelling testimony, Richardson, disqualification of counsel.

[00:35:10] Speaker 04:
And as far as I can tell, there's not been any motion to compel discovery, a denial of a motion to compel where privileges weren't, where immunities weren't involved, where a court has ever said that was reviewable under the collateral order doctrine.

[00:35:24] Speaker 04:
And I think the same principle applies under Paul Ritz.

[00:35:28] Speaker 04:
Also, the issues are intertwined with the merits of the case.

[00:35:32] Speaker 04:
The Rule 26 standard is claims and defenses.

[00:35:37] Speaker 04:
And so under those circumstances, these issues on discovery are wrapped into the merits of the case.

[00:35:44] Speaker 04:
In fact, that's exactly what Judge Andrew's decision was based on, that there was no relevance of the information to the patents that were asserted in the case.

[00:35:56] Speaker 03:
OK.

[00:35:57] Speaker 03:
Thank you, Mr.

[00:35:58] Speaker 03:
Thank you, Your Honor.

[00:36:05] Speaker 02:
I'll just address two points.

[00:36:08] Speaker 02:
On the question of listing under L3A, we think very much that the listing requirement has to be triggered by a reasonable belief, and therefore it cannot be, what I understand to be, a spurious position that if you lack information, you are therefore required to list.

[00:36:27] Speaker 02:
This is very important because if there is indeed such a listing requirement, the consequence of failing to list a patent that should have been listed is that it can never ever be asserted.

[00:36:37] Speaker 02:
And so there is part of the reason why this dispute is going on is because biosimilar makers have a very powerful reason to want to expand the 3A listing requirement because whenever they can say a patent should have been listed and was not,

[00:36:51] Speaker 02:
there is in essence a sixty-day statute of limitations and it can never be asserted.

[00:36:54] Speaker 00:
But your defense is a reasonable belief defense.

[00:36:57] Speaker 02:
That's exactly right, Your Honor, but I really want to highlight why we're having this argument because there's a very important consequence that flows from it.

[00:37:05] Speaker 02:
The other piece to Judge Chen's hypothetical where what if I give you some but less than all of the information required under two-way?

[00:37:13] Speaker 02:
I think we have a fundamental difference.

[00:37:16] Speaker 02:
Amgen's view is that's a two-way violation if you give less

[00:37:20] Speaker 02:
significantly less than all.

[00:37:21] Speaker 02:
Yes, there could be disputes around the periphery, but if you say, I will give you the application, but I refuse to give you the manufacturing information, it's a violation.

[00:37:30] Speaker 02:
I think Hosbira's view is, if I come and give you something meaningful, then I've sort of burst that bubble, and there's no violation, and we're operating in a situation where L2A was complied with.

[00:37:43] Speaker 02:
And so I think that's a fundamental difference, a divergence of view between the parties.

[00:37:47] Speaker 02:
Lastly, with respect to the artificial active infringement, in the situation like Judge Chin's hypothetical, it's our view that you could, the way the statute is written, you could in fact have an artificial active infringement under both sections.

[00:38:04] Speaker 02:
If you give me some information and I can list the patent, there's an artificial act under C1.

[00:38:11] Speaker 02:
But if you've likewise violated the statute, there would still be an artificial active infringement, even of the same patent.

[00:38:17] Speaker 02:
under C2.

[00:38:18] Speaker 02:
And that's the reason why the careful wording of C2 talks about a patent that could be identified.

[00:38:25] Speaker 02:
It's intending to embrace both those that were listed and those that could not be listed.

[00:38:31] Speaker 02:
Thank you, Mr. Gingrich.

[00:38:32] Speaker 03:
Thank both counsel for the pieces submitted.

[00:38:34] Speaker 03:
That concludes our session for this morning.

[00:38:37] Speaker 01:
All rise.

[00:38:38] Speaker 01:
The honorable court is adjourned until tomorrow morning at 10 o'clock a.m.