[00:00:28] Speaker 02:
Okay, the next argued case is number 15, 1499, Amgen Incorporated against Sandoz Incorporated.

[00:00:36] Speaker 02:
Mr. Grubrich.

[00:00:38] Speaker 00:
Thank you, Your Honor.

[00:00:38] Speaker 00:
We will do our best to proceed with no raised voices, even though we have a very exciting question of statutory.

[00:00:44] Speaker 00:
I'd like to begin with the first of the two principal issues, which is whether the provision of the biosimilar application and related manufacturing information is mandatory.

[00:00:59] Speaker 00:
and the very first place in the statute, in the BPCIA, where that issue is addressed.

[00:01:05] Speaker 02:
So it isn't just the provision of the information, it's also the notice provisions, is it not?

[00:01:11] Speaker 02:
And whether those are mandatory, are you going to separate those?

[00:01:14] Speaker 00:
Yes, there is the notice provision with respect to the so-called Notice of Commercial Marketing.

[00:01:19] Speaker 00:
under what I'll call section 8A, subpart 8A of section 262.

[00:01:26] Speaker 00:
My intention, Your Honor, if this is acceptable, is I'll come to that in first deal with the question of whether the BLA and associated manufacturing information must be provided or whether it is optional at the discretion of the biosimilar applicant.

[00:01:41] Speaker 03:
Well, what you're going to tell us, Mr. Broombridge, is that shall means shall.

[00:01:46] Speaker 03:
In fact, it means must.

[00:01:48] Speaker 03:
And usually that is true.

[00:01:51] Speaker 03:
But this is a statute, it's a multi-faceted statute on thinking.

[00:01:55] Speaker 03:
Perhaps it's entitled to a Pulitzer Prize for Complexity or Unclarity or something.

[00:02:02] Speaker 03:
But there is an L9 provision, a default provision that says if Shell isn't complied with, then there are remedies.

[00:02:12] Speaker 03:
And why don't we consider all of this as a totality, as we must,

[00:02:16] Speaker 03:
and rely on the L9 remedy?

[00:02:20] Speaker 00:
I think we absolutely should consider the statute as a totality, Your Honor, but L9 is not a remedy.

[00:02:26] Speaker 00:
L9 taken as a whole is merely a prohibition on declaratory judgment actions under certain circumstances and the reason L9 exists is to be a gun-jumping prevention.

[00:02:39] Speaker 00:
In other words, L9A is the principal reason for it to exist, to say that with respect to certain categories of patents

[00:02:46] Speaker 00:
You cannot short-circuit the procedure that is put in place by virtue of filing a declaratory judgment action.

[00:02:55] Speaker 02:
So tell me why shall means may.

[00:02:59] Speaker 00:
In our view, your honor, shell does not mean may, shell means shall.

[00:03:03] Speaker 00:
And the first place in the statute where that appears is section 261 L1 B1.

[00:03:10] Speaker 00:
And what that section does very importantly is draw a direct connection, linkage, between the decision to use the biosimilar pathway, the K pathway, and the requirement to provide the BLA and manufacturing information.

[00:03:25] Speaker 00:
And what it says is,

[00:03:26] Speaker 00:
When a Subsection K applicant submits an application under Subsection K, such applicant shall provide access to the information required to be produced.

[00:03:37] Speaker 03:
Isn't there a provision that says one shall file a patent infringement action?

[00:03:42] Speaker 03:
And that can't mean that.

[00:03:43] Speaker 03:
I mean one doesn't have to do that.

[00:03:45] Speaker 00:
In our view, Your Honor, it does mean that, and there's very good reason for that, that part of the purpose of this regime, elaborate as it is, is to allow by a similar applicant the ability to flush out patents that are identified in the early part, the first phase of the exchange process, should it wish to do that.

[00:04:07] Speaker 00:
And there's a very good reason for that, because if the applicant, under many circumstances under which a biosignal applicant, like a traditional generic drug applicant, may face ruinous damages exposure if it launches a risk, and therefore the statutory regime gives the applicant the ability to precipitate litigation early on before it has incurred such liability.

[00:04:31] Speaker 01:
What if I agree with you then, L2 through L6,

[00:04:35] Speaker 01:
really illustrate that Congress intended the parties, the K applicants and the RPS, to come together to try to negotiate out a reasoned way of following through on patent litigation.

[00:04:50] Speaker 01:
But then when we get to L9C, the last part of subsection L, we see that Congress says that if the K applicant fails to follow through on L2, then the consequence of

[00:05:05] Speaker 01:
failing to follow that requirement is that You the patent owner can now file a patent infringement suit and that's further reinforced by 271

[00:05:15] Speaker 01:
E2CII.

[00:05:17] Speaker 00:
Well, E2CII, as we would refer to it.

[00:05:20] Speaker 00:
E2CII.

[00:05:21] Speaker 00:
I'm happy to address both of those, Your Honor.

[00:05:23] Speaker 00:
E2CII.

[00:05:24] Speaker 00:
Maybe it's best to start with E2CII, where what is going on, I think, and those are the two places in the statute that refer to what happens if the K applicant does not provide this information.

[00:05:38] Speaker 00:
So I think it would be logical to begin with Section 271 E2CII.

[00:05:45] Speaker 00:
And one thing to note here is that the two provisions that talk about what happens if the information is not provided are both ancillary provisions that follow a base case, if you will, where the information is provided.

[00:06:00] Speaker 00:
And we would suggest, Your Honor, that part of the reason for the two

[00:06:04] Speaker 00:
ancillary provisions is so that the K applicant cannot put itself in a better position by virtue of withholding the information than the position in which it would have been had it given the information.

[00:06:15] Speaker 00:
And if we look at E2C as a whole, E2C is structured so as to borrow from the Hatch-Waxman regime and to say that we are going to create an artificial act of infringement

[00:06:31] Speaker 00:
that has been the subject of very much jurisprudence before this court.

[00:06:38] Speaker 00:
For good and proper reasons, I suggest that Congress wanted to use the same artificial act of infringement, which is the submission

[00:06:45] Speaker 00:
the submission of a regulatory application to the Food and Drug Administration.

[00:06:49] Speaker 00:
Now that is going to occur some period of time typically around 80 days before the K applicant would make the decision or face the requirement to turn over the corpus of information to the reference product sponsor and therefore we have to know we have a temporal problem that the active infringement occurs

[00:07:13] Speaker 00:
before we've reached that fork in the road where the information either is or isn't provided.

[00:07:19] Speaker 00:
And what we would suggest, Your Honor, is that the reason for the structure of E2C is to say the active infringement is the submission of the regulatory application.

[00:07:31] Speaker 02:
The submission or the notice?

[00:07:33] Speaker 00:
know that this is the submission your honor that the technical act of infringement here in our view just as with Hatch-Waxman is submitting to the Food and Drug Administration the application for an abbreviated approval.

[00:07:47] Speaker 01:
But E2C2 seems to be saying something very much different than the Hatch-Waxman Act.

[00:07:54] Speaker 01:
The Hatch-Waxman Act is an act of filing the application.

[00:07:57] Speaker 01:
But here E2C2

[00:08:01] Speaker 01:
It's when the K applicant fails to follow through on its L2 obligation to turn over a copy of the biosimilar application and then any manufacturing information.

[00:08:18] Speaker 01:
At that stage where it seems like just the plain language, that is the

[00:08:24] Speaker 01:
the artificial act of infringement.

[00:08:25] Speaker 00:
No, I disagree, Your Honor.

[00:08:27] Speaker 00:
Although, to Judge Laura's point, this certainly is not the most plainly worded statute, the act of infringement, it is carefully structured so that it is the submission.

[00:08:37] Speaker 00:
And if Your Honor were to look in the middle of the body of text of both E2C1 and E2C2, we will see after a comma the words and application.

[00:08:46] Speaker 00:
and so the structure of the statute is it shall be an active infringement to submit A, B, C and then in C1 an application and in C2 an application.

[00:08:57] Speaker 00:
The only difference is that in C1 it's going to be an active infringement of a body of patents that will be defined after the exchange process has gone forward whereas in C2 that exchange won't happen because the applicant withholds the information and therefore we need to know which patents

[00:09:15] Speaker 00:
This will constitute a technical act of infringement of, and therefore it is any patent which could have been identified had the exchange process proceeded wrong.

[00:09:24] Speaker 02:
Is the technical act of infringement in Hatch-Waxman the paragraph 4 certification?

[00:09:30] Speaker 00:
No, Your Honor.

[00:09:31] Speaker 00:
I would suggest that under 271E2A, which is the relevant provision, it's the submission of the, in that case, ANDA to the Food and Drug Administration, and that the BPCA has been purposefully structured so that these provisions slot in to 271E2 to have the benefit of the same body of law.

[00:09:54] Speaker 01:
Let me understand your theory of infringement.

[00:09:56] Speaker 01:
The act of filing the K application is the act of infringement.

[00:10:01] Speaker 01:
Correct.

[00:10:01] Speaker 01:
But you won't really know which patent until a few months down the road after the patent owner submits the patent pursuant to L3?

[00:10:14] Speaker 00:
That is correct, Your Honor.

[00:10:16] Speaker 00:
And this is why we have this temporal issue.

[00:10:18] Speaker 00:
And so the act of infringement occurs before we know which patents are going to be infringed.

[00:10:23] Speaker 01:
Were there any statutes that that's the way it works?

[00:10:28] Speaker 01:
I mean, I've never seen something like that.

[00:10:30] Speaker 00:
I think this statute was purposefully written that way, and I would suggest, Your Honor, that it was done because to deal with the complexities of patenting around biologics, the fundamental difference between this regime and Hatch-Waxman, Hatch-Waxman relies on a registry, the Orange Book.

[00:10:50] Speaker 00:
that is established once and for all for everybody.

[00:10:53] Speaker 00:
This procedure invokes a kind of what I would call a bespoke identification process that says we are going to identify the body of relevant patterns.

[00:11:03] Speaker 03:
Mr. Wolf, time's moving on.

[00:11:05] Speaker 03:
I want to ask you about the notice.

[00:11:07] Speaker 03:
Certainly.

[00:11:09] Speaker 03:
Your view is that notice cannot occur until after approval of the product.

[00:11:15] Speaker 00:
Correct, Your Honor.

[00:11:16] Speaker 03:
And doesn't that add another

[00:11:18] Speaker 03:
six months to exclusivity and contradistinction to the 12-year provision?

[00:11:24] Speaker 00:
We would say no, Your Honour, because exclusivity is a term of art.

[00:11:28] Speaker 00:
in this field, exclusivity means a time in which no other application can be approved, and that is not true here.

[00:11:35] Speaker 00:
And that under the doctrine of, let's say, I believe, Justice Frankfurt called it transplantation, that when Congress takes a term that already has a meaning from one body of law and puts it into a new law, it is assumed that it brings with it, to follow the metaphor, the soil and so on.

[00:11:51] Speaker 03:
Didn't they give you notice last July?

[00:11:53] Speaker 03:
I'm sorry?

[00:11:54] Speaker 03:
Didn't they give you notice last July?

[00:11:57] Speaker 03:
except when we're approved, we will mark it.

[00:12:00] Speaker 03:
They got approval in March, and so outside of the fact that we've granted an adjunction, can't they go on the market in September?

[00:12:10] Speaker 00:
No, Your Honour, one of the things to note is that in hedging their bets, they also gave us notice after they were approved.

[00:12:18] Speaker 00:
So they have done the thing that we believe they should do, and in our view that would start the six-month clock running.

[00:12:25] Speaker 00:
But in our view, the only reasonable reading of the statute is that the notice must be given after the product is approved by FDA.

[00:12:35] Speaker 00:
And there are several reasons for that, which I'm happy to address.

[00:12:40] Speaker 00:
First is the choice of language in L8A itself, where in contradistinction to the rest of subsection L, it uses the term licensed as opposed to the product, which is the subject of the K application.

[00:12:51] Speaker 02:
Also, to try and simplify the argument, then, you think that your position is that there must be notice at both stages.

[00:13:03] Speaker 00:
Correct, Your Honor.

[00:13:05] Speaker 02:
And that shall is mandatory.

[00:13:08] Speaker 02:
Correct, Your Honor.

[00:13:10] Speaker 02:
And that, and this is really where the district court took the position that you're arguing with, as I understand it, that the district court says, all right, but if they don't,

[00:13:21] Speaker 02:
give you the information.

[00:13:23] Speaker 02:
You didn't say if they don't give you the notice.

[00:13:26] Speaker 02:
You said if they don't give you the information then you can sue them.

[00:13:30] Speaker 00:
The district court said that and the district court also said that following the logic that while the statute prescribes in L9 some consequence that flows then all of this is optional and in the district court's view of the world they could not provide the application.

[00:13:46] Speaker 00:
not provide the notice.

[00:13:48] Speaker 00:
And the first thing that we as the reference product sponsor might learn is the day that they launch the product.

[00:13:54] Speaker 03:
What if we agree with you that shall means shall?

[00:13:58] Speaker 03:
What happens next?

[00:13:59] Speaker 03:
Do they have to go back to the beginning of the exchange process?

[00:14:02] Speaker 00:
In this case, Your Honor, what we want is to be put in the position that we should have been in had the statute been followed.

[00:14:10] Speaker 00:
And what we would suggest is that the right way to accomplish that, should this court agree with us on the interpretation of the statute,

[00:14:15] Speaker 00:
is to reverse the judgements against us on our claims and sentences, counterclaims below, and then

[00:14:24] Speaker 00:
clarify what the statute means and then send the case back to the district court for it to fashion a remedy that will put us in the position where we would have been.

[00:14:31] Speaker 00:
We're not asking for a windfall here, but we are asking ultimately what MGen wants.

[00:14:36] Speaker 03:
You're not asking for a windfall, but you've had exclusivity for over 20 years.

[00:14:42] Speaker 00:
Well, I respectfully disagree with that, but for those 20 years anyone that wanted to... And we still have our use patent left, right?

[00:14:48] Speaker 00:
We have a use patent that covers one of the indications.

[00:14:52] Speaker 00:
one of several indications and we have we believe two method of making patents that are relevant here that we expect to enforce in further proceedings below but one of the things they do want to point out on the notice provision that there's only one place in the statute

[00:15:08] Speaker 00:
that talks about commercial marketing and approval together.

[00:15:14] Speaker 00:
And that is Section K6, which deals with exclusivity for the first biosimilar applicant.

[00:15:21] Speaker 00:
This would be a cognate, if you will, of the 180-day exclusivity that generics can get under that requirement.

[00:15:27] Speaker 00:
And it says, if no L6 lawsuit is filed,

[00:15:32] Speaker 00:
then the exclusivity for the biosimilar is the shorter of one year from first commercial marketing or 18 months from approval.

[00:15:45] Speaker 02:
Just a gap in my understanding.

[00:15:49] Speaker 02:
This is marketing exclusivity not exclusivity of access to the Amgen data.

[00:15:57] Speaker 00:
The exclusivity in case 6 is exclusivity for the biosimilar applicant as against subsequent biosimilar applicants.

[00:16:06] Speaker 02:
What kind of exclusivity?

[00:16:08] Speaker 02:
Marketing exclusivity of approval?

[00:16:11] Speaker 02:
by the FDA or exclusivity of access to the data?

[00:16:16] Speaker 00:
Exclusivity of approval by the FDA.

[00:16:18] Speaker 03:
In other words, K6 says that when certain requirements are met, the FDA shall not approve another... Your access to the data through the FDA is inherent in this statute.

[00:16:29] Speaker 03:
That's not in question.

[00:16:30] Speaker 00:
Our access is the reference product sponsor.

[00:16:33] Speaker 00:
Their access to the data is inherent in the statute as long as they comply with the statute.

[00:16:44] Speaker 00:
Our fundamental problem

[00:16:46] Speaker 00:
is that what Sandoz has done in our view is to come in and say, we'd like to follow the pieces of the BPCAA that we think benefit us, but we'd like to not follow the pieces that we don't like.

[00:16:57] Speaker 00:
And in our view, you can't do that.

[00:17:00] Speaker 00:
This is what the 262L1B1 says.

[00:17:03] Speaker 00:
You can either follow the whole process or you can choose to go under the A pathway and file your own application.

[00:17:11] Speaker 00:
Don't invoke

[00:17:13] Speaker 00:
the K pathway at all, and you can get on the market.

[00:17:16] Speaker 00:
And others have done that, Your Honour.

[00:17:18] Speaker 00:
For example, Teva has done that.

[00:17:19] Speaker 00:
that there's already another competitor in this space.

[00:17:22] Speaker 00:
So to say that we enjoyed twenty-four years of exclusivity isn't correct.

[00:17:26] Speaker 00:
That people are free to come on the market.

[00:17:30] Speaker 03:
I know you've ran a lot more than twelve.

[00:17:32] Speaker 00:
Well, that's certainly true, Your Honor, but I see that I'm woefully over my time.

[00:17:38] Speaker 01:
I'm sorry, I've got another question.

[00:17:40] Speaker 01:
I don't see anything in subsection L that links up

[00:17:46] Speaker 01:
All of these requirements do all these information exchanges with the approval process.

[00:17:54] Speaker 01:
The approval process, I read that, is all about subsection K. Subsection K

[00:18:01] Speaker 01:
that provides all the requirements the applicant must meet in order to get approval for its biosimilar.

[00:18:07] Speaker 01:
And L is really just about regulating patent litigation.

[00:18:14] Speaker 01:
I feel like ultimately part of your case rests on reading subsection L as being hooked into

[00:18:26] Speaker 01:
you know, if the requirements aren't met then therefore they can't be approved.

[00:18:31] Speaker 00:
I don't think we would say there can't be approvals.

[00:18:33] Speaker 00:
We certainly do say that they are joined together and where they're joined together is 262L1B1 which says when a Subsection K applicant submits a Subsection K application it shall provide the information required under L2 which in turn triggers the cascade of events that get run through Subsection L and therefore we would say there's not a prohibition here, again unlike Hatch-Waxman, we're not looking at a situation where

[00:19:02] Speaker 00:
The statute specifically says, FDA, you're not allowed to approve this.

[00:19:08] Speaker 00:
But the beginning point is joined directly together, to yoke together by 262L1B1.

[00:19:16] Speaker 00:
And what that is saying is, if you want to invoke the benefits of the K-pathway and enjoy abbreviated approval and the market position that comes with being a biosimilar,

[00:19:27] Speaker 00:
then you must provide the information and begin the cascade of events that runs through subsection L. And if you don't want to, you don't have to, but that's your choice to make.

[00:19:37] Speaker 00:
That's where the point of connection is, Your Honour.

[00:19:39] Speaker 00:
And what I would just like to also point out with respect to the notice is that if we do look at K6, which is the only place where notice of commercial marketing and approval are used together, approximately,

[00:19:51] Speaker 00:
The statute says those two things, one would occur at 12 months and one at 18 months.

[00:19:57] Speaker 00:
You can't read that without thinking that first commercial marketing and approval are not intended to be at the same time.

[00:20:04] Speaker 00:
That's clearly the intention of this and that informs what's going on in L8A.

[00:20:09] Speaker 00:
If we look at LHB, the purpose of LHB, the notice is to allow an orderly time, six months, in which a second phase of litigation can be conducted to benefit both parties and the courts.

[00:20:27] Speaker 00:
that if we look at the effect of the District Court's interpretation and the interpretation by Sandoz on L8B, the idea that you can give notice immediately has the effect that you can then eliminate, reduce the period, 180-day period for preliminary injunctions to zero, because the body of patents that are the subject of L8B

[00:20:57] Speaker 00:
are a body of patents that take more than 180 days to identify.

[00:21:02] Speaker 00:
And so if I can just give you notice, as Sandoz did here, I can just say, good news, I've filed a post in our application and it is my intention to mark it as soon as I can.

[00:21:11] Speaker 00:
What I've effectively done is reduce the time period that the statute contemplates under L8B to zero.

[00:21:17] Speaker 00:
And that can't be the right interpretation.

[00:21:20] Speaker 00:
One final point on that.

[00:21:21] Speaker 00:
I would also have the effect under L9A of reducing the standstill on declaratory judgements to zero.

[00:21:30] Speaker 00:
Because that standstill ends when the notice is given.

[00:21:33] Speaker 00:
So we'll look at this and say there is no way that you can read this admittedly complicated statutory regime.

[00:21:39] Speaker 00:
to make sense if you accept the premise that the district court adopted and that Sanders advocates, that notice can be given on day one.

[00:21:47] Speaker 00:
And when you think about it, why would an applicant submit a K application unless at some point it intended to market this?

[00:21:55] Speaker 00:
Well, what is the purpose of ATA?

[00:21:57] Speaker 00:
What was the print of the policy?

[00:21:59] Speaker 00:
It can't merely be that the applicant has decided to go to the trouble of filing a K application.

[00:22:05] Speaker 00:
It must be something more than that.

[00:22:07] Speaker 00:
And the only way it makes sense is if something more is an additional period of six months in which to have an orderly litigation of whatever patents didn't get scrapped up in the first wave of litigation.

[00:22:19] Speaker 02:
And let's hear from the other side.

[00:22:20] Speaker 02:
We'll send you some regardless questions to Greenbridge.

[00:22:25] Speaker 04:
May it please the court?

[00:22:28] Speaker 04:
Deanne Maynard for Sandoz.

[00:22:30] Speaker 04:
The district court correctly concluded that Sandoz did nothing unlawful under the BPCIA.

[00:22:36] Speaker 04:
That alone defeats Amgen's appeal.

[00:22:40] Speaker 04:
The BPCI procedures on which ANGIN relies create multiple ways to the same substantive end.

[00:22:48] Speaker 03:
They're awfully detailed.

[00:22:50] Speaker 03:
They're awfully detailed concerning the exchange of information.

[00:22:54] Speaker 03:
Why would that have been for not, if you could just skip it?

[00:22:59] Speaker 04:
They're awfully detailed, but it's not just the L2 to L6, which they like to focus on.

[00:23:13] Speaker 04:
They create very detailed scheme, and you have to look at both the artificial acts of infringement and all of L. As you pointed out Judge Laurie, L9 is also part of L, and it expressly contemplates a series of if-then.

[00:23:26] Speaker 04:
If this happens, then this can happen.

[00:23:28] Speaker 04:
If this happens, then this can happen.

[00:23:30] Speaker 04:
It's Sandoz that's operating completely within the confines of the BPCIA.

[00:23:37] Speaker 04:
It's Amgen that's trying to look outside the BPCIA and ask the court to impose state remedies found nowhere in the BPCIA.

[00:23:47] Speaker 04:
And in fact, when Congress wanted to allow for injunctions, it provided for them.

[00:23:52] Speaker 02:
What is your explanation of why the statute says shall instead of may?

[00:23:58] Speaker 04:
It says shall instead of may for two reasons, Judge Newman.

[00:24:04] Speaker 04:
It says shall in the sense of in the L2 clause and the patent exchange provisions from L2 to L6 in the sense of if you want to go through this process, this is the information you must provide.

[00:24:17] Speaker 02:
If you want my data, if you want to be a K applicant, which I gather Sanders has done,

[00:24:25] Speaker 02:
has used the data, hasn't gone through their own clinical trials or all the rest of it, then this is what you shall do.

[00:24:33] Speaker 02:
You don't have to use the mGen data.

[00:24:36] Speaker 02:
You can create your own.

[00:24:38] Speaker 02:
Then you're home free.

[00:24:40] Speaker 04:
No, Your Honor.

[00:24:40] Speaker 04:
That's not the question here.

[00:24:43] Speaker 04:
So yes, there is a choice between going under A and going under K. But why isn't it the question?

[00:24:48] Speaker 02:
If you have a statute, this is an integrated statute.

[00:24:51] Speaker 02:
There were

[00:24:52] Speaker 02:
From the record, it looks as if there were extensive hearings, trade-offs, a debate, a connection of the pros and cons of Hatch-Waxman for biosimilars.

[00:25:05] Speaker 02:
And here we have a complicated statute.

[00:25:08] Speaker 02:
And you say only some of it counts?

[00:25:10] Speaker 04:
No, Your Honor.

[00:25:11] Speaker 04:
In fact, it's Sando that's giving meaning to all of it.

[00:25:14] Speaker 04:
And it's Amgen that's trying to look outside it for remedy.

[00:25:17] Speaker 04:
The way that the Shal provision works is it starts with L2.

[00:25:21] Speaker 04:
If the K applicant wants to engage in the patent exchange process in the back and forth of the L2 to L6 provisions, then it shall provide certain information.

[00:25:33] Speaker 04:
It also may provide additional information, but it doesn't have to want to continue.

[00:25:37] Speaker 04:
But then in L9C, the statute provides, if the applicant doesn't provide the application, then the sponsor may immediately bring the patent to unlimited by the patent.

[00:25:51] Speaker 02:
But even that subsection does not excuse the giving of notice.

[00:25:56] Speaker 02:
It relates only to providing information.

[00:25:59] Speaker 04:
Isn't that right?

[00:26:02] Speaker 04:
Well, are you asking about L8, Your Honor, or are you asking about the notice in L8?

[00:26:07] Speaker 04:
The L9 also provides for the failure to comply with L8, although Sandoz complied here, so that question is not before the court.

[00:26:14] Speaker 04:
But L9B provides that expressly, that if

[00:26:20] Speaker 04:
the applicant failed to comply with the notice provision in LAA that the recourse for the sponsor is to bring an immediate patent suit for declaratory infringement.

[00:26:32] Speaker 02:
And you can't really look at the LAA- How is the sponsor supposed to know that anything is going on without notice?

[00:26:38] Speaker 02:
How can you file suit if no one tells you I'm getting ready to infringe your patent?

[00:26:44] Speaker 04:
If someone were to completely go under the radar and launch without anyone knowing, without there ever being any public notice, then the sponsor's remedy would be to bring a patent infringement.

[00:26:57] Speaker 04:
But that problem, Your Honor, that problem that pains under either party's view of the notice provision, the only debate.

[00:27:02] Speaker 02:
It's hard to make sense of the extensive legislative debate.

[00:27:07] Speaker 02:
about those provisions based on the way you're interpreting it.

[00:27:10] Speaker 02:
So help us.

[00:27:11] Speaker 04:
Yes, Your Honor.

[00:27:12] Speaker 04:
So on the legislative debate, all of the legislative discussion is about previous Congresses.

[00:27:17] Speaker 04:
There's very little actual history about this Act that was passed.

[00:27:21] Speaker 04:
So on its terms, though,

[00:27:23] Speaker 01:
if i think it's very important to focus on the act of infringement in two seventy-one e but before you get there you seem to be reading l two l six it's an option and then if the applicant doesn't choose that option then there's the l nine option and i don't see either through the language or the structure of l where there's a hint that it's

[00:27:51] Speaker 01:
that it's a choose-your-own-adventure situation for the K applicant.

[00:27:55] Speaker 01:
It seems much more like the L2 through L6 keep saying over and over and over again, shall do this, shall do that.

[00:28:03] Speaker 01:
Then L9 finally gets to, well, if the K applicant fails to provide the application in a timely way, then the patent owner can bring a DJ action at that point.

[00:28:15] Speaker 01:
Well, so in that sense, it does feel like it's mandatory.

[00:28:20] Speaker 01:
And then if you fail to meet your requirements that are your obligations under the statute, then you deal with the consequences in L9C.

[00:28:33] Speaker 01:
Now, you might end up in the same situation in that when it says shall L2 to L6, there isn't some kind of

[00:28:44] Speaker 01:
absolute requirement that you have to do that.

[00:28:48] Speaker 01:
But it's a question of if you fail to meet your requirement, then L9C applies.

[00:28:54] Speaker 04:
I think when you look at the whole stats, the whole BBCIA in context, including the CJ, the amendments to the Declaratory Judgment Act, as well as the artificial infringement provisions, as well as all of L, that's not the conclusion one comes to.

[00:29:07] Speaker 04:
And the district court correctly concluded that.

[00:29:09] Speaker 04:
And to your fail point, Judge Chen, so the statute expressly in L, and this is on page 360 of the Blue Breeze detachment, in L,

[00:29:20] Speaker 04:
There's a subheading called failure to reach agreement.

[00:29:25] Speaker 04:
The statute uses the word fail when it's not talking about a mandatory obligation that one has not done.

[00:29:32] Speaker 04:
It's just something that happens when one doesn't do one thing, then something else happens.

[00:29:37] Speaker 04:
When there's a failure to reach agreement in four, that pushes you to L5.

[00:29:41] Speaker 04:
On the shall provisions, when one looks at L2, if one wants to

[00:29:46] Speaker 04:
proceed to the next step and sometimes it's the sponsor and sometimes it's the advocate.

[00:29:50] Speaker 04:
You shall do this.

[00:29:51] Speaker 01:
It would be a very... But L2 doesn't say the word if.

[00:29:54] Speaker 04:
But L9 does.

[00:29:56] Speaker 04:
And you have to look at the whole thing in context.

[00:29:58] Speaker 04:
Because L9, when you look at it in context, you'll see that the entire section of L is a series of if-then kind of shells.

[00:30:04] Speaker 04:
If you want to do this, then you shall do that.

[00:30:06] Speaker 04:
If you don't do this, then this is the consequence.

[00:30:10] Speaker 04:
I mean, it's important to keep in mind here, their only substantive rights at issue in this whole scheme are patents.

[00:30:15] Speaker 04:
That's the title of L, patents.

[00:30:17] Speaker 04:
And it's just a procedure in many different processes.

[00:30:20] Speaker 04:
And all kinds of situations are covered.

[00:30:22] Speaker 04:
to put the parties into the artificial infringement suit in 271E2.

[00:30:27] Speaker 04:
That's the whole point of this.

[00:30:29] Speaker 04:
It's just process.

[00:30:30] Speaker 04:
There's no substantive rights created in this section at all for anyone.

[00:30:34] Speaker 01:
What if L9 didn't exist?

[00:30:36] Speaker 01:
What if it would have been stopped at L8?

[00:30:38] Speaker 04:
Well, if there was no L9, it would be a very different question and a harder issue for us.

[00:30:44] Speaker 04:
But L9 does exist and they're reading it as if it's not there.

[00:30:47] Speaker 04:
And L9, if you think of L9 as all the ifs, thens, and L9b captures a lot of ifs, thens.

[00:30:54] Speaker 04:
It captures a lot of ifs, thens from various provisions up in the L. So you could also have written the statute where you moved all the ifs, thens up to where they go, and it would have been more repetitive and perhaps more complicated.

[00:31:07] Speaker 04:
But it would have led to the same outcome, which is if ANGIN has any patent rights,

[00:31:11] Speaker 04:
They should litigate them.

[00:31:13] Speaker 03:
That's what Congressmen have to do.

[00:31:14] Speaker 03:
Let me ask you about the notice provision.

[00:31:16] Speaker 03:
Yes, please.

[00:31:18] Speaker 03:
How can one reasonably interpret that as meaning give notice 180 days before a date which was then undetermined?

[00:31:31] Speaker 03:
Doesn't that really mean after approval date because then you know what the date is?

[00:31:38] Speaker 04:
No, Your Honor, there's nothing in the language of it that talks about after anything.

[00:31:42] Speaker 04:
And when Congress wanted to say after licensing, it did so.

[00:31:46] Speaker 04:
So there are provisions in the statute that expressly talk about things happening after the first licensure of bonds, for example.

[00:31:53] Speaker 02:
The language says after.

[00:31:54] Speaker 02:
You need to tell us why that doesn't count.

[00:31:56] Speaker 02:
no your honor the language doesn't say that when it approved.

[00:32:01] Speaker 04:
If we can look at it together it's on page three sixty two at the top right hand corner numbering of the public health and welfare statute in the back of the blue brief.

[00:32:12] Speaker 04:
You're actually on I'm sorry on two and three sixty one on the right hand column at the top is L. eight

[00:32:19] Speaker 04:
It's called notice of commercial marketing.

[00:32:22] Speaker 04:
Importantly, it's called notice of commercial marketing.

[00:32:25] Speaker 04:
It doesn't have anything about any kind of stay, any kind of 180 day stay and preliminary injunction.

[00:32:31] Speaker 04:
A notice of commercial marketing.

[00:32:33] Speaker 04:
The subsection K applicant shall provide notice to the reference product sponsor

[00:32:39] Speaker 04:
not later than a hundred eighty before the date of commercial marketing.

[00:32:43] Speaker 04:
It's the before modified the first commercial marketing and then of what?

[00:32:47] Speaker 04:
Of the product of the biological product license.

[00:32:50] Speaker 03:
Then your notice was effective in March when the approval

[00:32:57] Speaker 03:
occurred and then you couldn't shouldn't be able to market for 180 days which is in September.

[00:33:04] Speaker 04:
Well that's fair reading your honor.

[00:33:06] Speaker 04:
Under our reading our July 2014 notice was fully effective and it wasn't

[00:33:11] Speaker 04:
In any sense, too early on the fact of this case, Sandoz correctly predicted that they were going to attempt to... At that point in time, it's entirely speculative.

[00:33:20] Speaker 01:
You had just filed the application.

[00:33:22] Speaker 01:
We have no idea, anybody has any idea, when or if that application is going to get approved.

[00:33:29] Speaker 01:
So it sounds a little nonsensical to say that that is an appropriate form of notice of commercial marketing when we don't have any clue on whether your application will ever get approved.

[00:33:42] Speaker 04:
Well, two points about that, Your Honor.

[00:33:43] Speaker 04:
The application was filed.

[00:33:45] Speaker 04:
And the application is what... So when all of... At that point, it's aspirational.

[00:33:52] Speaker 04:
When all of the other litigation, I mean, all of L, even under their view, the way that L2 to L6 works, the litigation on those patents all occurs based only on the filing of the application, which is also how Hatch-Wackman works, right?

[00:34:04] Speaker 04:
All you have at that time is the application.

[00:34:06] Speaker 04:
That's plenty of information, especially once you get into discovery and you get the other information to know.

[00:34:11] Speaker 04:
Sandoz gave notice of what it believed, which is that it was going to get approval.

[00:34:15] Speaker 01:
It in the first or second quarter of 2015 and then in fact it did and noticed I disagree We're right at the very beginning of the FDA reviewing and approving or denying these types of applications I don't think anybody in July last year had a good sense of when the FDA was actually going to act and then approve your application

[00:34:38] Speaker 04:
I believe there are actually estimates of when the FDA is expected to approve products in the timeline.

[00:34:45] Speaker 04:
They put out the timeline.

[00:34:46] Speaker 04:
I can't remember if that's in the record or not.

[00:34:48] Speaker 03:
But when they accept your application, there's no implication there that at some point it will be approved.

[00:34:54] Speaker 03:
Is there?

[00:34:56] Speaker 03:
And certainly not when?

[00:34:57] Speaker 04:
Well, Sanders expected that it was going to get approval and then it did indeed get approval.

[00:35:04] Speaker 04:
I mean, Sanders had a lot of experience with this product.

[00:35:06] Speaker 03:
They were going back and forth with the FDA.

[00:35:10] Speaker 03:
Did that occur at the time of acceptance such that FDA says, yeah, well, you just need to add a few more items and we'll approve it maybe next spring?

[00:35:19] Speaker 04:
I don't know, Your Honor, what's in the record on that issue.

[00:35:23] Speaker 04:
But the important point is that the statutory language is what this Court is interpreting.

[00:35:28] Speaker 04:
And it only says 180 days before commercial marketing.

[00:35:33] Speaker 04:
And Sandoz gave notice in July of 2014.

[00:35:35] Speaker 04:
It has not marketed since then.

[00:35:38] Speaker 04:
It's been six months.

[00:35:39] Speaker 04:
Even if this Court thought that that was not sufficient, Sandoz regave notice on the day of approval

[00:35:47] Speaker 04:
And as Judge Glory mentioned, six months from that would be September 2nd.

[00:35:50] Speaker 04:
That would be the outside date that any injunction against marketing could apply under their theory, even if the court... Isn't it true that when an application is filed, the application can be amended?

[00:36:01] Speaker 01:
It can migrate?

[00:36:02] Speaker 01:
The actual elements of the biologic can change or the mechanisms that you're submitting?

[00:36:09] Speaker 01:
can change.

[00:36:11] Speaker 01:
It's not like you have a fixed product right there that is static and for the rest of the pendency of the application, it's going to always remain the exact same thing.

[00:36:24] Speaker 04:
All of the BPCIA procedures envision, even under Amgen theory, the L2 through L6 provisions, envision

[00:36:31] Speaker 04:
early litigation based on the filing of the application, which in this court is quite familiar with in Hatch-Waxman.

[00:36:37] Speaker 04:
That's the basis on which those claims are tried.

[00:36:41] Speaker 04:
If you just imagine a situation where, and the statute actually takes account of a lot of different situations, if you imagine a situation where what if Sandoz had provided its application

[00:36:52] Speaker 04:
and started down the patent exchange process and then obtained approval in the middle of the patent exchange process.

[00:36:59] Speaker 04:
There is nothing about that process that would have entitled Amgen to an injunction against marketing at that point in time.

[00:37:06] Speaker 04:
They would have had to go to court and show that there was some chance that they could prove patent infringement.

[00:37:13] Speaker 04:
They don't want to litigate their patents here.

[00:37:16] Speaker 04:
They told the world they have no material patent left on this product and that they expect competition in the United States.

[00:37:21] Speaker 03:
What about the method of use patent 427?

[00:37:24] Speaker 04:
Well, they've alleged that.

[00:37:26] Speaker 04:
That's count three.

[00:37:28] Speaker 04:
That's still below in the district court.

[00:37:30] Speaker 04:
But that actually proves that this system works this way.

[00:37:33] Speaker 04:
That's what Congress said.

[00:37:34] Speaker 04:
If the application isn't provided to you, you may sue immediately.

[00:37:38] Speaker 04:
They sued immediately.

[00:37:39] Speaker 04:
They've gotten the information that they claim they need in discovery.

[00:37:43] Speaker 04:
And if they have patents, they should litigate them.

[00:37:45] Speaker 04:
Those are the only substantive rights at issue in this whole statute.

[00:37:49] Speaker 04:
And as Judge Chen pointed out, nothing, nothing in K links approval to these provisions in L. It's very different, as counsel conceded from the Hatch-Waxman in that regard.

[00:38:00] Speaker 04:
Approval is not tied to the outcome of litigation.

[00:38:03] Speaker 04:
And there's nothing about the exchange provisions themselves alone

[00:38:07] Speaker 04:
So even if they were to force us to jump through these unnecessary hoops here, when they could just get this information in the ongoing litigation, that wouldn't entitle them, in conjunction to force us to jump through these procedural hoops for nothing.

[00:38:21] Speaker 04:
Even if they were to get that, that wouldn't get them a bar to commercial marketing.

[00:38:25] Speaker 01:
Because there's some things- Can I ask you another question?

[00:38:29] Speaker 01:
Yes, please.

[00:38:31] Speaker 01:
Let's assume that you didn't comply with L2, and so

[00:38:35] Speaker 01:
But what that means is that L9C gets triggered, and so the patent owner has the right, also under E2C2, to file a patent infringement action, and it did that.

[00:38:48] Speaker 01:
And so all the provisions of L2 through L6 fall away, and necessarily L7.

[00:38:56] Speaker 01:
Would L8 also fall away with that?

[00:38:59] Speaker 01:
Because L8 arguably is part of the overall subsection L regime and L8 references all of these other L2, L3, L5 and L7 refers to L8, L9 refers to L8.

[00:39:17] Speaker 01:
Maybe it's all integrated together and so the whole question of

[00:39:22] Speaker 01:
whether there has to be a 180 days notice or something like that just falls away once we're in the territory of L9C.

[00:39:30] Speaker 04:
That would be one reading.

[00:39:32] Speaker 04:
Another reading, though, I think is that... It's not a reading that you were promoting, though.

[00:39:36] Speaker 04:
...is that L8 is freestanding.

[00:39:37] Speaker 04:
Well, Sandoz gave notice here.

[00:39:38] Speaker 04:
Sandoz gave notice here under our theory, and Sandoz gave notice under their theory.

[00:39:41] Speaker 04:
So there's absolutely no question here about whether it is or isn't.

[00:39:45] Speaker 04:
But I think that if one L8A is a freestanding notice provision,

[00:39:50] Speaker 04:
But in L8B, and I would like to explain how I think L8B works, the patents that are in L8B, what's covered by those provisions shifts over time, depending on where parties are in the process.

[00:40:03] Speaker 04:
So here, of course, we didn't provide the application.

[00:40:07] Speaker 04:
So on day 21, they could have brought the suit.

[00:40:09] Speaker 04:
They could have gotten all the information.

[00:40:10] Speaker 04:
But in a situation where the parties are going through a suit, it doesn't always have to be this two-phase that they're envisioning.

[00:40:17] Speaker 04:
That's what I'm saying.

[00:40:18] Speaker 04:
There are many different ways.

[00:40:19] Speaker 04:
And Congress's statute, if you go through it and imagine different hypotheticals in your head and you figure out how it goes, it's amazing how much of it is already taken care of.

[00:40:28] Speaker 03:
Is the preliminary injunction issue moving?

[00:40:31] Speaker 04:
This court, I think it is moot, Your Honor.

[00:40:33] Speaker 04:
They sought a preliminary injunction pending the merits decision, and the merit has been reached.

[00:40:38] Speaker 04:
To the extent the court doesn't think it's moot, the district court made factual findings here after consideration of substantial evidence.

[00:40:45] Speaker 04:
that Amgen would have no irreparable harm, had not proven any irreparable harm from Sandoz's launching, that in fact would preclude any injunctive relief under any theory, state law or anything else, because it's always, even under the UCL of California, one has to prove the traditional eBay factors.

[00:41:02] Speaker 03:
Now this is initially an unfair competition, California unfair competition case, premised on this federal statute.

[00:41:11] Speaker 04:
That's right, your honor.

[00:41:12] Speaker 04:
So any injunction first could only be limited to California.

[00:41:17] Speaker 04:
That's this court's holding in Athena.

[00:41:21] Speaker 04:
no injunctions warranted even under the UCL because, as we've been discussing, no unlawful action occurred.

[00:41:29] Speaker 04:
Congress knew how to call the L sections a violation when it wanted to, and I'd like to point the Court's attention to L1H, where it talks about the breaches of the confidentiality provisions.

[00:41:42] Speaker 04:
And significantly, and unlike all the other provisions in L, Congress provided

[00:41:48] Speaker 04:
called a violation of the confidentiality provisions.

[00:41:53] Speaker 04:
Let me point you to it.

[00:41:56] Speaker 04:
It's on page 359, Judge Lurie, in the blue, back of the blue, the bottom right.

[00:42:02] Speaker 04:
It's called a set of a violation.

[00:42:04] Speaker 04:
So Congress called a breach of the confidentiality provisions a violation of the VPCIA, unlike any of the other L provisions.

[00:42:11] Speaker 04:
And it expressly provided that that would be deemed irreparable harm and one could seek an injunction for that, unlike these other provisions where Congress provided no remedies to compel any steps.

[00:42:23] Speaker 04:
Instead, it said, if they aren't followed, you go immediately to the patent infringement suit.

[00:42:28] Speaker 04:
And Judge Tanna, I think 271E, 2C, 1, and 2 only create an act of infringement when either one of those are fully met.

[00:42:42] Speaker 04:
E to C double I. It's only an act of infringement once one fails to turn over the application.

[00:42:51] Speaker 04:
So on day 21, they were able, they should have, they could have, if they had wished, brought suit July 28th.

[00:42:58] Speaker 01:
Practical matter, how would a patent owner even know about that act of infringement if there's no notice provided at all that the K applicant filed the K application?

[00:43:09] Speaker 04:
Well here, I'm just trying to understand how the statute works.

[00:43:15] Speaker 04:
Right.

[00:43:16] Speaker 04:
And I think that the statute, that would be a problem under either party's interpretation.

[00:43:24] Speaker 02:
That's a very important question.

[00:43:26] Speaker 02:
How would they know?

[00:43:27] Speaker 02:
How could they do what's provided for in terms of filing a suit for infringement if they have no notice?

[00:43:35] Speaker 02:
Not even a 20-day notice.

[00:43:36] Speaker 04:
My point is, even under their interpretation... I'm just asking, what is the answer to that?

[00:43:43] Speaker 04:
If it really went under their area, they might not know, but holding the statute means what they say won't fix that problem, because if someone's really going to withhold their... You think it doesn't matter?

[00:43:51] Speaker 02:
Are you saying that it doesn't matter whether you know or not?

[00:43:55] Speaker 02:
I'm saying it's not... Does it matter whether you can comply or subject to that aspect of the statute?

[00:44:01] Speaker 04:
I'm saying if one really truly doesn't know,

[00:44:04] Speaker 02:
That is a problem under either party's interpretation of the L prediction.

[00:44:12] Speaker 04:
except if you don't do it, then the statute contemplates someone might not turn it over.

[00:44:19] Speaker 04:
So either way, whether the provisions are mandatory in all circumstances or only a mandatory condition precedent won't solve that problem.

[00:44:26] Speaker 04:
But there are many reasons why applicants have every incentive, as we did here, even when we didn't want to engage in the process, give notice.

[00:44:33] Speaker 04:
Because as you know from the bond briefing, it's very expensive to market these products.

[00:44:38] Speaker 04:
and it would cost a lot to go on the market and then be immediately enjoying.

[00:44:43] Speaker 04:
I think a district court would be very sympathetic, Judge Newman, to any patentee's claim if someone did become a stealth applicant and launch.

[00:44:52] Speaker 02:
Do you have any more questions?

[00:44:56] Speaker 01:
How come you didn't argue preemption?

[00:44:58] Speaker 04:
Well, because the UCL is self-granting, Judge Chen, so the UCL expressly provides that unless expressly provided elsewhere, and here the remedies are exclusive.

[00:45:08] Speaker 04:
The E2C remedies expressly provide that these are the only remedies, these patent law remedies are the only remedies any court can award for the artificial acts of infringement in E2C 1 and 2.

[00:45:22] Speaker 04:
So these are just procedures, and Congress was just trying to allow parties to do their substantive rights.

[00:45:29] Speaker 04:
If I could, we would request that the court, if it's inclined to rule for us, list the injunction immediately and require a posting of the bond for the period of time that the injunction was in place so that things can recover.

[00:45:42] Speaker 04:
Thank you.

[00:45:44] Speaker 02:
OK.

[00:45:45] Speaker 02:
Mr. Greengrass, you have some extra time.

[00:45:49] Speaker 00:
So I think the fundamental problem here is this.

[00:45:54] Speaker 00:
What this regime is designed to give a patent holder like Amgen is two things, information and time to analyze that information and enforce its patent rights in an orderly fashion.

[00:46:06] Speaker 00:
And the argument that if all... Failing which?

[00:46:10] Speaker 00:
Failing which, no information and no time.

[00:46:14] Speaker 00:
What we see then is exactly the kind of problem that has manifested itself in this case.

[00:46:19] Speaker 00:
load on the judicial system with emergency applications, people coming in and saying they're about to launch, I only just found out about this, I need to protect my margin.

[00:46:29] Speaker 03:
Failing which we didn't finish the sentence, L9, right?

[00:46:32] Speaker 00:
Your Honor, L9, the way I would look at it is neither a remedy nor an exclusive remedy.

[00:46:40] Speaker 03:
But it says that certain things don't happen then, therefore.

[00:46:45] Speaker 00:
I don't believe it ever says therefore.

[00:46:46] Speaker 00:
What it says is if

[00:46:48] Speaker 00:
are that the ban on declaratory judgment actions is lifted in certain circumstances.

[00:46:55] Speaker 00:
That is not a remedy for the non-provision of the information.

[00:47:00] Speaker 01:
Just as... L9C, it says if the subsection K applicant fails to provide the application and information required under paragraph 2A, L2.

[00:47:11] Speaker 01:
Correct.

[00:47:12] Speaker 01:
The reference product sponsor may bring an action under section 221 of Title 28.

[00:47:17] Speaker 00:
It does, although notably only for a small subset of the patents that would otherwise be in play.

[00:47:23] Speaker 00:
I can't bring an action for a method of manufacturing patent under that section.

[00:47:26] Speaker 00:
It has to be a patent that claims the product.

[00:47:29] Speaker 03:
But how about 271?

[00:47:32] Speaker 00:
There would be a technical act of infringement.

[00:47:36] Speaker 00:
The problem, Your Honor, is we wouldn't know.

[00:47:37] Speaker 00:
The whole purpose of this regime is to arm us.

[00:47:40] Speaker 03:
But wouldn't you find out if you brought a 271 action and did discovery?

[00:47:46] Speaker 00:
Ultimately, yes, but the whole purpose of the regime is to not have us running into court.

[00:47:52] Speaker 00:
And if you think, Your Honor, about what is contended here, the record establishes we have a portfolio of about 400 patents, many manufacturing patents, that could be relevant.

[00:48:00] Speaker 00:
The argument is made on the other side, oh, no problem if we don't go through the exchange process.

[00:48:06] Speaker 03:
If the purpose of the statute is to avoid litigation, it's already failed.

[00:48:11] Speaker 00:
Certainly true, Your Honor, but I would suggest that... It doesn't show promise of success.

[00:48:17] Speaker 00:
If shall means shall, I'm confident, Your Honor, that the litigation burden on the court system will be reduced.

[00:48:23] Speaker 00:
And that is part of why we are here.

[00:48:26] Speaker 00:
And one final point that I wanted to make, and I think it's important to not get lost here, is the statutory regime contemplates that the first phase of litigation could be many years before the second phase.

[00:48:41] Speaker 00:
You can file the K application four years in, but you can't get approval until 12 years in.

[00:48:48] Speaker 00:
So all of these procedures that are saying, oh, don't worry about, with respect to the notice provisions.

[00:48:54] Speaker 00:
What they're really being said is, we're going to file it four years, and say we intend to mark it at year 12, and what you should do is go to a district court and ask for a preliminary injunction.

[00:49:05] Speaker 03:
No, probably an atypical case, because you're right at the beginning.

[00:49:09] Speaker 03:
Other innovators are probably going to be within the 12 years and of course we have to interpret the statute not just for these bodies but in terms of what it really means.

[00:49:25] Speaker 00:
I think part of why we're here is that we see this not just for the present dispute about a product that has been on the market for many years, but as something that is integral to how this regime is going to work going forward.

[00:49:39] Speaker 00:
And ultimately, as a patent holder, what this is intended to get us, I would repeat, is information.

[00:49:45] Speaker 00:
and time in which to analyze that information, exchange contention and come to court in an orderly fashion and not have to have a fire drill.

[00:49:55] Speaker 00:
And the argument that is being made on the other side with utmost respect is

[00:49:59] Speaker 00:
Oh, what's the harm?

[00:50:01] Speaker 00:
Let's just go and jump to a lawsuit.

[00:50:02] Speaker 00:
And that guts the statutory regime.

[00:50:05] Speaker 00:
The one final point, Your Honor, with respect to whether this is moot, again, with greatest respect to my adversaries, I would say I think there's a miscitation of the record.

[00:50:15] Speaker 00:
And the citation that's given for that is A469.

[00:50:19] Speaker 00:
There's two requests that were made.

[00:50:21] Speaker 00:
It ignores the second request, which, if anyone is interested, appears in lines 25 through 27.

[00:50:26] Speaker 01:
What's the status of the patent infringement action?

[00:50:28] Speaker 01:
It's staged.

[00:50:30] Speaker 00:
And both parties agreed that it made sense to try and get the views of this court and then be able to go back to the district court and say, how do we move forward?

[00:50:40] Speaker 03:
And what's the patent involved?

[00:50:41] Speaker 03:
427?

[00:50:41] Speaker 03:
427.

[00:50:43] Speaker 03:
New process patents.

[00:50:45] Speaker 00:
Exactly.

[00:50:45] Speaker 00:
There's a method of use patent, which is 427.

[00:50:48] Speaker 00:
Very shortly before the stay, we identified two method of manufacturing patents that we believe are implicated here.

[00:50:54] Speaker 00:
There could be others, but the stay came down at that point.

[00:50:58] Speaker 02:
OK.

[00:50:59] Speaker 02:
Any more questions from the Supervisor?

[00:51:00] Speaker 02:
Thank you, thank you both, the kids have taken over the submission.

[00:51:03] Speaker 00:
Thank you very much.