[00:00:00] Speaker 04:
Pleasure of moving the admission of my four law clerks.

[00:00:05] Speaker 04:
I wish to become members of the bar of this court.

[00:00:08] Speaker 04:
So, could you please stand?

[00:00:12] Speaker 04:
And Judge Moore will preside for purposes of these motions.

[00:00:19] Speaker 04:
First, I move the admission of David Bender, who is a member of the bar and has good standing of the highest court of New York.

[00:00:27] Speaker 04:
I have knowledge of his credentials.

[00:00:28] Speaker 04:
I'm satisfied that he possesses the necessary qualifications.

[00:00:33] Speaker 04:
And next, I move the admission of Stanley Chin, who's a member of the bar and is in good standing with the highest court of California.

[00:00:41] Speaker 04:
I have knowledge of his credentials and am satisfied that he possesses the necessary qualifications.

[00:00:49] Speaker 04:
Next, I move the admission of Andrew W. Robb, who's a member of the bar and is in good standing with the highest court of California.

[00:00:56] Speaker 04:
I have knowledge of his credentials and am satisfied that he possesses the necessary qualifications.

[00:01:02] Speaker 04:
And then finally,

[00:01:03] Speaker 04:
I move the admission of Alissa Ventubigan, who is a member of the bar and is in good standing with the highest court of Illinois.

[00:01:10] Speaker 04:
I have knowledge of her credentials and am satisfied that she possesses the necessary qualifications.

[00:01:16] Speaker 04:
I'd like to say with respect to all four of you that not only do you have the necessary qualifications, which is sort of a minimum standard, that you have been exceptional law clerks, each and every one of you.

[00:01:28] Speaker 04:
and it has been an immense pleasure to have you and I'm proud to have you as members of the bar here and I look forward to your appearing before us and I'm sure you will do as excellent a job when you appear before us as you have as a law clerk.

[00:01:43] Speaker 04:
So thank you.

[00:01:45] Speaker 01:
Any objection Evan?

[00:01:47] Speaker 02:
I have no doubt based on Judge Dyck's recommendation that they're eminently qualified.

[00:01:55] Speaker 01:
This is one, I'd say apart from marrying each of you someday, this is the most fun day of your life.

[00:02:02] Speaker 01:
But some of them are married already.

[00:02:04] Speaker 01:
You better not be married.

[00:02:07] Speaker 01:
This is one of the nicest and most joyous things that we judges get to do for our clerks.

[00:02:15] Speaker 01:
So I welcome each of you to our bar and please turn and face the Admiral who will administer the oath.

[00:02:21] Speaker 02:
the region.

[00:02:33] Speaker 04:
Congratulations.

[00:02:39] Speaker 04:
I will turn to our 2 cases this morning.

[00:02:43] Speaker 04:
First of the number 1412 74.

[00:02:46] Speaker 04:
moment of pharmaceuticals in courses to have a pharmaceuticals.

[00:02:52] Speaker 04:
Miss Maynard.

[00:02:56] Speaker 01:
Thank you, Your Honor.

[00:02:57] Speaker 01:
Just as a preliminary matter, the court granted the motion to consolidate the arguments of the two cases.

[00:03:01] Speaker 01:
And so we will be arguing, I'll be arguing both the first two cases, my opening position, and then I believe my colleagues in the office are going to take their turn.

[00:03:10] Speaker 01:
That's fine.

[00:03:10] Speaker 01:
Thank you, Your Honor.

[00:03:13] Speaker 01:
May it please the court, Deanne Maynard for appellant

[00:03:16] Speaker 01:
and momentum.

[00:03:19] Speaker 04:
Could I understand what your position is at this point?

[00:03:24] Speaker 04:
I've read the briefs carefully.

[00:03:26] Speaker 04:
Do I understand correctly that you're saying that the running of the process itself is protected by the safe harbor but that the use of it for commercial sale is not protected and that there's an infringement

[00:03:42] Speaker 04:
under 271 G as a result.

[00:03:44] Speaker 04:
Is that a fair statement of the position?

[00:03:47] Speaker 01:
No, Your Honor.

[00:03:49] Speaker 01:
That's partly correct.

[00:03:50] Speaker 01:
Our position is that the plain text of both section 271 E and 271 G make both the use, the use is not protected under 271 E and the sales are infringing on your 271 G. So your position is that the running of the test itself

[00:04:10] Speaker 04:
is not protected by the State Farmer.

[00:04:12] Speaker 01:
That's correct, Your Honor.

[00:04:13] Speaker 01:
The Amphistar and Teva's manufacturer are using Memento's patented method to make each commercial batch of inoxaparins for sale.

[00:04:24] Speaker 01:
That commercial exploitation of the patented invention is not covered by the plain text of Section 271E.

[00:04:30] Speaker 04:
If I understand you're briefed correctly, what you're saying is that the running of the test has a dual purpose, that it's run

[00:04:39] Speaker 04:
to ensure FDA compliance and that it also, quite apart from that, has a commercial purpose.

[00:04:46] Speaker 04:
Is that my understanding that correctly?

[00:04:49] Speaker 01:
Yes and no, Your Honor, if I may.

[00:04:51] Speaker 01:
So just a step back.

[00:04:52] Speaker 01:
When the Safe Harbor covers activities that one do to develop information for submission to the FDA for regulatory approval, that could be pre-marketing approval or post-marketing approval, but it would still have to be for developing information that one's going to provide to the FDA for some type of regulatory approval.

[00:05:09] Speaker 01:
That's how the Supreme Court has consistently interpreted the 271E, and that's consistent with its purpose.

[00:05:15] Speaker 01:
But once one moves past... Why?

[00:05:18] Speaker 01:
What in 271E says anything about approval?

[00:05:22] Speaker 01:
It says development and submission of information under a federal law.

[00:05:28] Speaker 01:
Why are you infusing the word approval?

[00:05:31] Speaker 01:
No doubt Merck and Lilly talked about approval because they were approval cases.

[00:05:35] Speaker 01:
But I don't see where approval gets morphed into E1.

[00:05:41] Speaker 01:
because it has to be the development and submission of information under a federal law.

[00:05:46] Speaker 01:
Here the federal law is the FDCA.

[00:05:48] Speaker 01:
That refers the court to the FDCA.

[00:05:50] Speaker 01:
When the FDCA talks about submissions, it repeatedly talks about submissions in the context of presenting something to the FDA for some sort of approval to do something.

[00:06:01] Speaker 01:
do a new drug, file an IND, file an ANDA.

[00:06:05] Speaker 04:
We dealt with that in the original opinion.

[00:06:07] Speaker 04:
Let's assume for the moment that we're not going to change that aspect of the original opinion, that the keeping of the information which is available to the FDA falls within the safe harbor.

[00:06:21] Speaker 04:
Let's just assume that for a moment.

[00:06:23] Speaker 04:
My understanding is that you are arguing that even if that is so, that the testing here has a commercial purpose that is unrelated to the FDA compliance.

[00:06:37] Speaker 04:
Is that correct?

[00:06:37] Speaker 01:
That's correct, Your Honor.

[00:06:38] Speaker 01:
So I would like to fight hard the premise that your first opinion should be binding.

[00:06:43] Speaker 01:
I think under Supreme Court law it isn't.

[00:06:45] Speaker 01:
All you decided was likelihood of success.

[00:06:48] Speaker 01:
Taking that premise, you are correct that they are not using the test solely to develop and submit information under the FDCA.

[00:06:59] Speaker 01:
They are using the test in their commercial manufacturing to decide which batches

[00:07:05] Speaker 01:
go into the final product and which batches do not.

[00:07:09] Speaker 04:
Okay, now that's where I'm a little confused because I've read the briefs and I've looked at the references and what is it, what is the evidence that we have at this point that it has that commercial purpose unrelated to FDA compliance?

[00:07:32] Speaker 01:
So in the Amphistar record,

[00:07:35] Speaker 01:
there's a declaration from Mr. Crawford.

[00:07:38] Speaker 01:
That's it.

[00:07:39] Speaker 02:
Who's Mr. Crawford?

[00:07:40] Speaker 01:
He is a former pharmaceutical executive with lots of experience in the pharmaceutical industry.

[00:07:46] Speaker 01:
Okay.

[00:07:47] Speaker 01:
And he describes the purpose.

[00:07:48] Speaker 01:
It's at, in the Amphistar JA, Your Honor, it is at JA 12-432.

[00:07:52] Speaker 04:
Is that in the first one?

[00:07:57] Speaker 01:
Yes, it is, Your Honor.

[00:07:58] Speaker 01:
It is very back.

[00:08:02] Speaker 01:
Is your argument that the word solely means that if you're doing it in order to comply with an FDA requirement, but also doing it for commercial purposes and wouldn't qualify under the State Harbor?

[00:08:19] Speaker 01:
Because isn't everything you do in part for commercial purposes at some point?

[00:08:24] Speaker 01:
Well, I think first, Your Honor, and this would be fighting the premise of Judge Dagg's question, but there is

[00:08:32] Speaker 01:
nothing about required by the FDA in the text of the safe harbor either.

[00:08:37] Speaker 01:
The fact that the FDA requires manufacturers to retain these records applies to every drug for both branded and generic that's manufactured in the United States.

[00:08:48] Speaker 01:
If that is enough to fall within the safe harbor, then... Well, wait.

[00:08:52] Speaker 01:
Okay.

[00:08:52] Speaker 01:
So now you're arguing maintenance versus submission.

[00:08:55] Speaker 01:
I guess I... So there's two... I mean, you would say there are three statutory interpretation arguments here.

[00:09:02] Speaker 01:
I wouldn't agree with you on one of them, but the other two, where I'm open-minded, is the word solely and the word submission.

[00:09:08] Speaker 01:
I'm an all-out-on-the-table kind of gal, because there's a lot of issues in this case, so I want to help you focus on what you might actually prevail on.

[00:09:15] Speaker 01:
So solely and submission.

[00:09:17] Speaker 01:
Tell me how I should construe solely, which is the heart of Judge Dyke's question, and that was also what I was getting at with you, but you then morphed your answer into submission versus maintenance.

[00:09:28] Speaker 01:
So I would like you, if you could, to keep those as separate and discrete.

[00:09:33] Speaker 01:
Does that help?

[00:09:35] Speaker 01:
Yes, thank you.

[00:09:35] Speaker 01:
I'll focus on solely, but I would like to address the mission, because I would like to convict your honor about this.

[00:09:42] Speaker 04:
Why don't we do that later?

[00:09:43] Speaker 04:
Let's stick with one thing at a time, OK?

[00:09:45] Speaker 04:
Thank you.

[00:09:46] Speaker 04:
So you have this declaration.

[00:09:48] Speaker 04:
What does this declaration say about the commercial purpose of the testing that's non-FDA related?

[00:09:55] Speaker 01:
The declaration, both the Crawford Declaration and the AmpliSAR record and the Loon Supplemental Declaration in the Pebble record establish that they're doing it for quality control purposes in order to sort which batches are the drug they're trying to make and which batches are not the drug they're trying to make.

[00:10:13] Speaker 04:
Okay, so where do I find that in this declaration?

[00:10:15] Speaker 04:
Where does he say this?

[00:10:16] Speaker 01:
So if you look at JA12432.

[00:10:21] Speaker 04:
Okay.

[00:10:24] Speaker 01:
So that's the beginning, I'm sorry.

[00:10:26] Speaker 01:
So paragraph 24 on 12-4-3-9.

[00:10:32] Speaker 01:
And that paragraph, not all of which I think I can read out loud, but essentially it establishes

[00:10:39] Speaker 01:
that they use the process on intermediate drug substance to decide which batches of intermediate drug substance conform to what they're trying to make and which do not.

[00:10:49] Speaker 01:
This is a 15 to 25 percent.

[00:10:50] Speaker 01:
Is that what I'm not supposed to say out loud?

[00:10:52] Speaker 01:
No, I'm allowed to say that.

[00:10:53] Speaker 01:
That's in the end.

[00:10:55] Speaker 01:
I think that's fine, Your Honor.

[00:10:57] Speaker 01:
So what they're trying to do, then they test their batches.

[00:11:02] Speaker 01:
So it's going along the assembly line.

[00:11:04] Speaker 01:
As a manufacturing company, for quality control purposes, they want to make sure that what they sell is what they're intending to sell.

[00:11:10] Speaker 01:
They're checking it with our test, and that is a crucial step in their manufacturing process, to decide what goes on and becomes in the syringe that they sell and what doesn't.

[00:11:19] Speaker 01:
Then if it passes the test,

[00:11:21] Speaker 01:
It gets joined together with other batches of conforming substance and ultimately continues along into the final product that is the syringe.

[00:11:28] Speaker 01:
They're doing the test for quality control purposes.

[00:11:31] Speaker 04:
Yeah, but the question is, are they doing the test for FDA purposes or independently for commercial quality control purposes?

[00:11:40] Speaker 02:
Is the FDA requiring them to do that quality control?

[00:11:44] Speaker 01:
The FDA requires drug manufacturers, yes, to do everything that they've promised to do in their ANDA or their NDA.

[00:11:52] Speaker 01:
But once you move into routine commercial exploitation of a patented invention, which is what this is, they're just using our process as part of making their inox apparent.

[00:12:02] Speaker 01:
And they don't have to use our process.

[00:12:04] Speaker 04:
That's a crucial factual difference between the record now... Well, what you're saying that they would be doing this anyway, even if there weren't an FDA requirement?

[00:12:12] Speaker 01:
As a drug manufacturer, a responsible drug manufacturer, they would definitely be doing something to make sure that what they're going to sell in their syringe is actually what they're purporting it to be, and that they're selling it for.

[00:12:22] Speaker 01:
Yes, Your Honor.

[00:12:23] Speaker 01:
Otherwise, there's all kinds of consequences to drug manufacturers if they don't do that.

[00:12:26] Speaker 04:
Well, is this a disputed issue as to whether this is done for non-FDA purposes?

[00:12:33] Speaker 01:
Well, we've asserted in these declarations, with the Lew Declaration and the Crawford Declaration, that these are done for quality control purposes.

[00:12:39] Speaker 01:
I do think that this is not done solely... No, no, I understand what you think.

[00:12:46] Speaker 04:
What I'm asking you is, is this a matter that's disputed between the parties, that there is this non-FDA purpose?

[00:12:54] Speaker 01:
I believe it is disputed.

[00:12:55] Speaker 01:
I expect they will tell you they're doing it solely to comply with the FDA's requirements.

[00:12:59] Speaker 01:
But I think they would be doing something to ensure

[00:13:01] Speaker 01:
that their product is... Would that then make it a question of fact that's inappropriate for resolution and summary judgment?

[00:13:07] Speaker 01:
That, at a minimum, that would require reversal.

[00:13:09] Speaker 01:
Summary judgment was granted in their favor on this record.

[00:13:13] Speaker 01:
But I would like to switch, if I may, to the submission version.

[00:13:16] Speaker 02:
Before you do, let me switch you a little bit on focus on this question.

[00:13:22] Speaker 02:
You argue that even if Safe Harbor exempts commercial use of the method,

[00:13:30] Speaker 02:
Teva's sales activity isn't exempted.

[00:13:34] Speaker 02:
Has the patent on inoxaparin active ingredient expired?

[00:13:41] Speaker 01:
Yes, that's my understanding.

[00:13:42] Speaker 01:
Or it was held invalid.

[00:13:43] Speaker 01:
It's not in play anymore.

[00:13:45] Speaker 02:
Are there any patents on the actual chemical synthesis of the drug?

[00:13:53] Speaker 01:
I do not know whether anyone claims a patent on the manufacturing method.

[00:13:57] Speaker 02:
Okay.

[00:13:59] Speaker 02:
What precedent or ledge history supports the view that a patent covering neither the active ingredient nor the actual chemical synthesis should prevent sales of an oxaparin as opposed to preventing use of the method?

[00:14:17] Speaker 01:
Because the whole purpose of the legislation was to prevent people from using patented processes by others in order to make products that they were going to sell.

[00:14:28] Speaker 01:
And so what CAVA has done, they've effectively done exactly what the principal purpose of the legislation was to stop, which is moved abroad or using our patented process abroad as an essential step to making the final product that they're selling, which is the drug in the syringe.

[00:14:48] Speaker 04:
to try to avoid liability, and when they bring that... Are you saying that a quality control process is a process by which the product is made?

[00:14:56] Speaker 04:
Is that the idea?

[00:14:57] Speaker 01:
The test for whether the product is made by something is whether it's an essential step to the end product.

[00:15:03] Speaker 04:
So your content and the answer is yes.

[00:15:06] Speaker 01:
In this situation, I don't think you have to hold as broadly as every quality control test, Ed Stein?

[00:15:10] Speaker 01:
For example, let me give you an example, Ms.

[00:15:12] Speaker 01:
Mayer.

[00:15:12] Speaker 01:
Suppose that there's a quality control test at the very end because I only want to sell the best of my batches.

[00:15:19] Speaker 01:
really be known for just the purest form of something and the very best and so at the end I've got 20 things that could arguably be sold but I want to sell only the top three and I do a quality control to see which one is the best, the purest or whatever and then I sell it.

[00:15:34] Speaker 01:
You would agree that that doesn't feel like made by language, right?

[00:15:38] Speaker 01:
That would definitely be a harder case but that's not what we have here.

[00:15:41] Speaker 01:
What we have here is the raw material is on one end of the process.

[00:15:44] Speaker 01:
It moves along the manufacturing to the syringe that's sold.

[00:15:47] Speaker 01:
That would be more like testing the syringe.

[00:15:48] Speaker 01:
That would be more like the Philip Adams case.

[00:15:50] Speaker 01:
This isn't that.

[00:15:51] Speaker 01:
This is in the middle of the process, where as the place that I'm pointing to in the Crawford affidavit, Your Honor, and then in the Lou supplemental decoration for Teva is JA 5162-69.

[00:16:01] Speaker 01:
This is testing of intermediate drug substance to decide what goes on and what doesn't.

[00:16:06] Speaker 01:
Almost like a machine.

[00:16:07] Speaker 01:
Let me make it simple so I can understand.

[00:16:09] Speaker 01:
I'm baking a cake.

[00:16:11] Speaker 01:
I got two bowls of white powder in front of me.

[00:16:13] Speaker 01:
One is sugar, one's salt.

[00:16:15] Speaker 01:
I don't know which one's which.

[00:16:16] Speaker 01:
Recipe calls for a cup of sugar and a piece in the salt.

[00:16:21] Speaker 01:
That's the salt.

[00:16:22] Speaker 01:
Boom.

[00:16:23] Speaker 01:
It's that part of the process, my finger sticking in the salt to figure out which one is salt so I make the recipe properly, part of making the cake.

[00:16:32] Speaker 01:
I would argue it could be, Your Honor, this is a much more complicated situation here.

[00:16:36] Speaker 01:
The whole premise of their 271E argument is that this is a necessary step to determining whether what they're allowing to become in their final product is the inoxaparine sodium that they are allowed to sell.

[00:16:49] Speaker 04:
But what happens when they're testing the intermediate?

[00:16:52] Speaker 04:
Suppose the intermediate flunks the test.

[00:16:54] Speaker 04:
Is it discarded?

[00:16:55] Speaker 01:
Yes, Your Honor.

[00:16:57] Speaker 01:
It's discarded and that's what the batch records show and the records in here show that.

[00:17:06] Speaker 01:
If one looks at the batch records in both of the JAs, one can see, and I can walk you through it if you want to take the time to do that, that the lots are, multiple batches are tested.

[00:17:18] Speaker 01:
If they pass the test, they are then joined together in one lot and then go along the process and are later formulated into the product that is the syringe.

[00:17:26] Speaker 01:
And under 271G, it is the product that is the syringe in the infringing sale.

[00:17:32] Speaker 01:
That's the sale.

[00:17:33] Speaker 01:
So this is testing.

[00:17:35] Speaker 01:
It's an essential step in the words of Bayer v. Hauser and biotechnology.

[00:17:39] Speaker 01:
It's an essential step along the process.

[00:17:40] Speaker 01:
And we have to decide this question regardless of what we conclude on 271E.

[00:17:44] Speaker 01:
Isn't that correct?

[00:17:45] Speaker 01:
That's true for two reasons, Your Honor.

[00:17:46] Speaker 01:
Both in Teva, that's the basis of the liability.

[00:17:49] Speaker 01:
And in the Ampostar case, it's the basis of the liability for Actavis and Watson, who are selling only.

[00:17:55] Speaker 01:
But to your point, Judge Wallach, the biotechnology case is closer to what we have here.

[00:18:01] Speaker 01:
It is a case about a plasmid.

[00:18:03] Speaker 01:
The patented method there makes the plasmid.

[00:18:07] Speaker 01:
The plasmid then makes another thing that makes the thing that is ultimately sold.

[00:18:12] Speaker 01:
So this is just like that.

[00:18:14] Speaker 01:
It's an essential step in the process from going with the starting heparin material to the syringe.

[00:18:19] Speaker 01:
And if you don't do it, you won't end up with the right thing in the syringe.

[00:18:22] Speaker 01:
So, first, before you actually tell me your arguments on the merits, I'd like you to tell me why it isn't either law of the case or some sort of binding precedent

[00:18:40] Speaker 01:
when some overly eager judge decides to write an opinion that addresses those issues of statutory interpretation, even though they weren't raised free for argument by anybody at any point below or on appeal.

[00:18:50] Speaker 01:
So tell me why our court and or this case isn't governed by that prior decision of that overly excited judge.

[00:18:58] Speaker 01:
What the court was deciding before was whether or not Mumento was likely to succeed.

[00:19:04] Speaker 01:
That was the limit of your holding the court's

[00:19:07] Speaker 01:
stated it multiple times in its opinion.

[00:19:08] Speaker 01:
And wasn't it true that only pre-approval and post-approval was argued to us, but not solely or the submission-maintenance question?

[00:19:14] Speaker 01:
That's correct, Your Honor, which is precisely why... One argued below and one argued to us last time.

[00:19:19] Speaker 01:
That's exactly right, Your Honor, which is precisely why the Supreme Court has said preliminary injunction opinions are only about what they've decided, which is who's likely to succeed.

[00:19:27] Speaker 01:
But there are two key aspects, but one of the ones you have focused on, Your Honor, is exactly right, which is neither submission nor maintenance are the distinction that the FDCA draws between those two terms

[00:19:37] Speaker 01:
was briefed before this court and it's very significant to the ultimate outcome on the merits here.

[00:19:43] Speaker 01:
It's now in this record.

[00:19:44] Speaker 01:
The FDCA treats those two terms differently.

[00:19:47] Speaker 04:
Wouldn't it be fair to say that the first time around this issue of 271G infringement and the question of whether this testing has a non-FDA purpose was not argued, right?

[00:20:01] Speaker 01:
That's true, too, Your Honor.

[00:20:03] Speaker 01:
And also, in addition, the tests that we sought to leave to amend in the district court, which the district court swept in under 271E, were not before the court before.

[00:20:11] Speaker 01:
And we think the district court has done an overly generous view of 271E to keep us from amending those, and that that was an error of law.

[00:20:18] Speaker 01:
And we should be allowed to add those tests as well.

[00:20:21] Speaker 01:
But to Judge Moore's point, the submission point

[00:20:25] Speaker 01:
It's clear from the text of the statute that submitting and maintaining are two distinct activities.

[00:20:31] Speaker 01:
Well it's clear from the text of the FDCA statute.

[00:20:34] Speaker 01:
It's not clear from the text of the Hatch-Waxman Act.

[00:20:35] Speaker 01:
I can't find the word maintaining anywhere else in the relevant statute that we're actually enforcing here.

[00:20:41] Speaker 01:
I mean, do you agree?

[00:20:42] Speaker 01:
Yes, but that's helpful to us, Your Honor, because it's only the development and submission of information that falls within the safe harbor.

[00:20:49] Speaker 01:
The maintenance of information doesn't fall within the safe harbor.

[00:20:51] Speaker 01:
But also, to your point, it's the development and submission of information under a federal law.

[00:20:55] Speaker 01:
And as you know, the FDCA is one of those federal laws.

[00:20:58] Speaker 01:
So it makes sense to look to that law to see what's a submission.

[00:21:01] Speaker 01:
And that law makes clear it repeatedly uses submission.

[00:21:05] Speaker 01:
Sometimes it's close to marketing approval.

[00:21:07] Speaker 01:
But it's submission, submitting a change to use the drug for a new use.

[00:21:11] Speaker 01:
submitting a change to your label.

[00:21:13] Speaker 01:
But just the ordinary routine maintenance of commercial records is not called a submission.

[00:21:19] Speaker 01:
Because you have to maintain everything.

[00:21:20] Speaker 01:
Labeling, shipping documents, basically any piece of paper that is produced in the course of manufacturing, shipping, selling, or anything the jug is required to be maintained.

[00:21:30] Speaker 01:
Exactly.

[00:21:30] Speaker 01:
Under the same backdrop.

[00:21:33] Speaker 04:
Before we get to Sully, one more question on that.

[00:21:36] Speaker 04:
It seems to me there's a difference here between the maintenance of all the manufacturing records to show that

[00:21:42] Speaker 04:
you're complying with your own manufacturing procedures and maintaining records that are designed to show that you are complying with FDA requirements.

[00:21:52] Speaker 04:
This falls into the latter category, doesn't it?

[00:21:56] Speaker 01:
all records though your honor there's so many fda requirements you're you're required by the fda to do everything that's in your nda and in your anda and then you're required by these batch regulations that the court relied on in moment to one to keep records of all of it so basically what you would be able to do under the logic of mint one is here proposed

[00:22:15] Speaker 01:
Sanofi's method of manufacturing in your hand.

[00:22:17] Speaker 04:
I think you're not addressing my question, which is whether there's a difference between keeping records which show that you're complying with an FDA requirement, and everybody agrees there's an FDA requirement here.

[00:22:30] Speaker 04:
and keeping records which are designed to show your manufacturing process so if there is an issue later on as to your manufacturing process that can be looked at for that purpose.

[00:22:43] Speaker 04:
In other words, not all of the records that you're talking about are designed to document

[00:22:48] Speaker 04:
compliance with FDA requirements.

[00:22:50] Speaker 04:
No, or am I mistaken?

[00:22:51] Speaker 01:
Yeah, I'm not sure, you know, I'd like to address that when I get back up.

[00:22:54] Speaker 01:
I'm not sure there's a distinction that you're trying to draw, Your Honor.

[00:22:57] Speaker 01:
All the records are required by the FDA.

[00:22:59] Speaker 01:
You're required to keep all these records, everything that you do.

[00:23:03] Speaker 02:
It's a Venn diagram, in effect.

[00:23:05] Speaker 02:
The FDA requires you to keep all the records you say you're going to keep.

[00:23:10] Speaker 02:
as well as everything else we tell you to keep.

[00:23:13] Speaker 01:
Is that fair to say?

[00:23:14] Speaker 01:
I can give a more precise answer when I stand up, Your Honor, but Judge, I just don't think there's a distinction.

[00:23:19] Speaker 01:
And it wouldn't matter here.

[00:23:21] Speaker 01:
It would still make the safe harbor a safe ocean.

[00:23:23] Speaker 01:
you would still be able to tell the FDA that you're going to use someone else's patented method to make your product.

[00:23:29] Speaker 01:
And as long as your ANDA was approved, then the FDA doesn't look to see whether or not, it's not approving ANDAs and NDAs based on any patent-based test.

[00:23:37] Speaker 01:
It doesn't look to see whether you're violating somebody's patent.

[00:23:40] Speaker 01:
Nothing in the safe harbor suggests that the FDA was given compulsory licensing authority by requiring, or the USP for that matter.

[00:23:48] Speaker 04:
But this one is to show bioequivalency to the NDA product, right?

[00:23:52] Speaker 01:
No, Your Honor.

[00:23:52] Speaker 01:
No, Your Honor.

[00:23:53] Speaker 01:
So just to clarify, bioequivalency is something you show during the regulatory approval process in order to be allowed to make a generic drug.

[00:24:02] Speaker 01:
Bioequivalency is that your drug will have the same effect on the human body as the brand of drug.

[00:24:06] Speaker 01:
Once you get marketing approval, then you simply have to comply with the manufacturing processes that you told the FDA you were going to do.

[00:24:15] Speaker 01:
That's what every drug manufacturer does.

[00:24:17] Speaker 01:
That's what these batch regulations are for.

[00:24:20] Speaker 01:
They could have, we have not charged with infringement any activity that occurred for the purposes of showing vial equivalency to get approved.

[00:24:28] Speaker 04:
No, no, I understand that.

[00:24:29] Speaker 04:
But I thought the purpose of these tests was to show that the continued manufacture of the product was the same as what was proposed in the first place.

[00:24:39] Speaker 01:
No, Your Honor.

[00:24:40] Speaker 01:
The purpose of these batch regulations, and this is in our reply brief, like on pages, the very introduction of the gray brief to the AMPSTAR case,

[00:24:48] Speaker 01:
is to show that you're complying with the manufacturing procedures that you told the FDA you would comply with.

[00:24:55] Speaker 01:
There's not this continuing approval that AmpStar argued in the first case.

[00:25:00] Speaker 01:
You're approved.

[00:25:01] Speaker 01:
Then you must keep doing it.

[00:25:02] Speaker 01:
Every drug manufacturer must keep doing what they told the FDA they were going to do, branded and generic.

[00:25:08] Speaker 01:
and so the upshot of the rationale would be if you told the FDA, so in that sense, everything's required.

[00:25:15] Speaker 01:
Everything that you tell the FDA you're going to do is required.

[00:25:18] Speaker 04:
Okay, I understand.

[00:25:19] Speaker 04:
What was the other question about submission?

[00:25:21] Speaker 01:
Solely.

[00:25:22] Speaker 01:
I really wanted you to address solely because

[00:25:25] Speaker 01:
Justice Scalia, quite frankly, just dropped it out of murk.

[00:25:28] Speaker 01:
I mean, he quoted the, I'm trying to figure out what solely means.

[00:25:34] Speaker 01:
And he just dropped it out of the quote as though it weren't actually part of the statute, which is really not the way I generally view him on statutory interpretation.

[00:25:43] Speaker 01:
And so I don't know that it was meaningful.

[00:25:44] Speaker 01:
It wasn't argued in that case or anything.

[00:25:45] Speaker 01:
And I'm trying to figure out what solely modifies.

[00:25:49] Speaker 01:
Does it mean

[00:25:50] Speaker 01:
that when you are doing it, you really have to be doing it for FDA approval or for an FDA submission of some sort, but you can then, clearly you can then later use the information that resulted from those tests for publicity, for raising capital, whatever.

[00:26:07] Speaker 01:
But what does Soli model?

[00:26:09] Speaker 01:
Soli for uses reasonably related to development and submission information.

[00:26:14] Speaker 01:
What do I do with solely?

[00:26:15] Speaker 01:
Well, two things.

[00:26:17] Speaker 01:
One, I think you're right that solely has to be given some meaning because it's there.

[00:26:21] Speaker 01:
I think it modifies for uses.

[00:26:24] Speaker 01:
It has to be solely for uses

[00:26:26] Speaker 01:
really related to the development and submission of information.

[00:26:30] Speaker 01:
Here, the use they're putting, to which they are putting our patented method, is commercial manufacturing.

[00:26:38] Speaker 01:
It's a commercial manufacturing method in the patent.

[00:26:40] Speaker 01:
That's their use of it.

[00:26:40] Speaker 04:
Well, but that's true in the very beginning of the approval process, when you're developing

[00:26:45] Speaker 04:
an alternative drug, you're doing it obviously with an eye to our ultimate commercial exploitation.

[00:26:51] Speaker 04:
This is not an abstract approval by the FDA.

[00:26:54] Speaker 04:
It's an approval so that you can commercialize it, correct?

[00:26:57] Speaker 01:
But that's very different context, Judge Dyke.

[00:27:00] Speaker 01:
So when you're doing it to get approval, you're doing it to prove to the FDA that I am able to make the drug I am trying to get approval to make.

[00:27:08] Speaker 04:
So solely in that context doesn't mean solely for FDA purposes.

[00:27:12] Speaker 01:
Well, there you are doing it

[00:27:15] Speaker 01:
You're doing it solely to develop information to give to the FDA to try to get approval.

[00:27:21] Speaker 04:
You're doing it also to develop a commercial product, right?

[00:27:24] Speaker 01:
Well, if that were true, then there would be nothing within the safe harbor, right?

[00:27:28] Speaker 01:
Because solely, you're doing it then to get approval.

[00:27:33] Speaker 01:
There's no dispute that they're doing it now.

[00:27:36] Speaker 01:
to make sure their product that continues along the manufacturing line and goes into the, into the syringe.

[00:27:41] Speaker 04:
I don't understand the distinction.

[00:27:42] Speaker 04:
I mean, in the first place when you're developing the product, your idea is, I'm doing this to develop a commercial product.

[00:27:51] Speaker 04:
And you are also developing information in the course of that for the FDA.

[00:27:56] Speaker 04:
So it isn't, the information is not solely for the FDA, it's also even at that stage for commercial purposes, no?

[00:28:04] Speaker 01:
It is ultimately down the road, incidentally, going to set you up to commercially market.

[00:28:10] Speaker 01:
That's the purpose of the safe harbor.

[00:28:11] Speaker 01:
I mean, the whole legislative history shows that it's to allow the generics to get ready to market so that there won't be an undue extension on the branded patent because it takes a while to get regulatory approval.

[00:28:22] Speaker 01:
But I think if you go back to the reason the legislation was passed and the Roche v. Buller case that it was meant to overturn, there

[00:28:31] Speaker 01:
They, this court held, you know, the opinion of this court said that even though they were using the patent intervention solely to try to apply to the FDA to get approval, there was infringement.

[00:28:40] Speaker 01:
And that was the impetus, part of the impetus for the legislation.

[00:28:43] Speaker 01:
In that light, Judge Dyke, I think you can say that when you're doing it to develop information, which developing information is more than just record, regular, ordinary commercial activity.

[00:28:54] Speaker 01:
It has a different connotation to develop information, to submit for potential regulatory approval, which is exactly what Merck and Eli Lilly talk about the purpose, then it is solely for that purpose.

[00:29:03] Speaker 01:
But here, it's not solely for that purpose.

[00:29:05] Speaker 01:
Even if it's also incidentally to maintain records to show that they're complying with their FDCA, they're doing it to manufacture each commercial batch for sale.

[00:29:15] Speaker 01:
And that's just totally different than the batches when they were making them to try to show the FDCA they could get regulatory approval.

[00:29:21] Speaker 01:
That's the kind of development and submission that the FDCA where it talks about submission.

[00:29:25] Speaker 01:
So I think you have to look at the word solely for uses, reasonably related to development mission altogether as a package in context.

[00:29:34] Speaker 01:
Can I make one more point to check about commercial?

[00:29:36] Speaker 04:
Just hold on to it.

[00:29:38] Speaker 04:
Yeah.

[00:29:40] Speaker 01:
Just briefly.

[00:29:40] Speaker 01:
Quickly.

[00:29:40] Speaker 01:
Quickly.

[00:29:41] Speaker 01:
In context, too, if you look at the broader Hatch-Waxman scheme, like in the E provision, E2, when you bring a suit, the E4 remedies talk about stopping commercial sales, which is distinct from the uses under E1 for approval.

[00:29:55] Speaker 04:
Thank you, Your Honor.

[00:29:56] Speaker 04:
OK.

[00:29:56] Speaker 04:
We'll give you four minutes for the bottle.

[00:29:58] Speaker 04:
Thank you very much.

[00:29:59] Speaker 04:
And the other parties will get some additional time also.

[00:30:04] Speaker 03:
Let me please the court.

[00:30:06] Speaker 03:
Henry Dinger, I'm arguing for Teva Pharmaceuticals.

[00:30:09] Speaker 03:
And in the case against Teva, you don't have to deal with the interpretation of E1, even though I'm prepared to argue that you already did so in the earlier Memento v. Ampisar case.

[00:30:24] Speaker 02:
Mr. Dinger, is there a business or a legal reason Teva has to use Memento's patented process if it wants to sell an oxaparin?

[00:30:35] Speaker 03:
The answer is I don't know.

[00:30:36] Speaker 03:
I don't think there's anything in the record that addresses that, because this court in Memento 1 said that it didn't matter.

[00:30:45] Speaker 03:
Even if there were alternatives, the statute doesn't require it.

[00:30:48] Speaker 02:
Well, you indicate in your brief, in the red brief, that the FDA requires manufacturers to comply with a USP monograph for an oxyparin.

[00:31:01] Speaker 03:
Which requires release tests.

[00:31:03] Speaker 03:
The FDA requires that the inoxaparin that is sold, the generic inoxaparin that is sold, have certain chemical characteristics.

[00:31:12] Speaker 03:
And the test that Teva uses, and Teva has only received FDA approval to sell inoxaparin that has those chemical characteristics.

[00:31:22] Speaker 03:
The test in question is intended to establish that the batch that is sampled has those characteristics.

[00:31:31] Speaker 03:
That is why it is

[00:31:33] Speaker 03:
reasonably related to the submission and the development and submission of information under federal pharmaceutical law.

[00:31:40] Speaker 02:
Does the USP monograph still recite the release test that was performed when an oxaparin was first approved in 1993?

[00:31:50] Speaker 03:
I don't know the answer to that.

[00:31:53] Speaker 03:
And I'm not sure that's in the record, Your Honor.

[00:31:55] Speaker 03:
I mean, that wasn't the basis on which the case, the summary judgment was argued or the district court decided it.

[00:32:01] Speaker 04:
Does the testing here have a purpose other than FDA?

[00:32:05] Speaker 03:
I mean, if the question is, would it be done had not the FDA required it?

[00:32:14] Speaker 03:
The answer is, we don't know.

[00:32:16] Speaker 03:
The fact is, it is done in order to demonstrate that the anoxaparin that's being produced conforms to the drug that was approved when the FDA approved Arana.

[00:32:27] Speaker 04:
I understand there seems to be

[00:32:31] Speaker 04:
a lack of facts in the record about some of these issues, which may have to be developed later.

[00:32:37] Speaker 04:
But let's assume that there was proof and it were established that the testing would have been done for commercial purposes anyway, quite apart from any FDA requirements.

[00:32:51] Speaker 04:
Would we then be within the safe harbor or not?

[00:32:54] Speaker 03:
I would say no, Your Honor, because the cases of this court have made it clear that whatever solely means

[00:33:00] Speaker 03:
You've explained what it doesn't mean.

[00:33:02] Speaker 03:
And what it doesn't mean is that you can't use information if you use a patented process that is otherwise within the safe harbor.

[00:33:10] Speaker 03:
And the use of that patent generates information.

[00:33:13] Speaker 03:
This court has made clear that you can use the information generated.

[00:33:18] Speaker 04:
That seems to be a bit different from my hypothetical in the sense that the FDA information is generated and the FDA information is used for other purposes.

[00:33:29] Speaker 04:
Whereas in my hypothetical, the initial processing or testing has a dual purpose, one for the FDA and also for commercial purposes, and that it would have been done for commercial purposes even if there hadn't been an FDA requirement.

[00:33:44] Speaker 03:
I don't believe that issue was developed at all below, but I suggest that it is.

[00:33:49] Speaker 03:
Both under this court's interpretation of 270E1,

[00:33:55] Speaker 03:
and under 271G it is not relevant, at least in the Teva case, because to the extent we use this process, and that's disputed, but you can assume that we do for purposes of this appeal, our product is not made by

[00:34:10] Speaker 03:
this process.

[00:34:11] Speaker 01:
Before you move on to that though, can I ask you, when you file your submission to the FDA and you get approved to manufacture a drug, aren't you approved to manufacture it only precisely as you submitted and were approved?

[00:34:32] Speaker 03:
It must conform to the specifications set forth in the abbreviated new drug application.

[00:34:38] Speaker 03:
Yes, you're required to do that.

[00:34:39] Speaker 01:
The natural extension of your argument, it seems to me, would be that every step in the manufacturing process, every single step is required by the FDA because you are required to submit to the FDA exactly what steps you will undertake.

[00:34:57] Speaker 01:
then you're not allowed to deviate from it.

[00:35:00] Speaker 01:
The problem I have, the problem is, if simply FDA requirement is necessary, then there's nothing left under your argument, because you have to submit to the FDA precisely what you will do, and then you have to follow it.

[00:35:14] Speaker 01:
And if you deviate from it, you're not following FDA requirements.

[00:35:18] Speaker 03:
Yes, to the extent that the manufacturing process is identified in the end, you have to follow it.

[00:35:25] Speaker 01:
You would be violating FDA requirements if you failed to do so, correct?

[00:35:31] Speaker 03:
Yes.

[00:35:33] Speaker 03:
You would, although this information goes to the very definition of the drug that's approved.

[00:35:39] Speaker 03:
The noxaparin goes to establish the FDA has defined the characteristics that establish bioequivalency.

[00:35:45] Speaker 04:
Well, it seems to me, to follow up on Judge Moore's question, you've got a hard row to hoe if the contention is that you've selected a manufacturing process and told the FDA about it, and therefore it comes within the safe harbor in EEK.

[00:36:02] Speaker 04:
And that seems to me a hard argument.

[00:36:05] Speaker 04:
You have to be, I would think, saying that the testing here is designed to show

[00:36:14] Speaker 04:
F.D.A.

[00:36:15] Speaker 04:
compliance for an independent F.D.A.

[00:36:18] Speaker 04:
requirement rather than a requirement of your own manufacturing process that you've chosen for your own reasons.

[00:36:24] Speaker 04:
Is that clear enough?

[00:36:26] Speaker 03:
I understand the question, Your Honor, but I think this Court has already said it doesn't matter whether there are non-infringing alternatives.

[00:36:36] Speaker 03:
I think the Court squarely held that.

[00:36:38] Speaker 04:
That's fine, but the fact that there are non-infringing alternatives is probably true

[00:36:44] Speaker 04:
initially developing information for initial FDA approval.

[00:36:48] Speaker 04:
There may be different ways of doing it, and yet it doesn't make any difference that you've chosen a patented method.

[00:36:54] Speaker 04:
You still get the benefit of the safe harbor.

[00:36:56] Speaker 04:
This question, it seems to me, is a little bit different.

[00:36:59] Speaker 04:
It looks like bootstrapping.

[00:37:03] Speaker 04:
If you say, oh, well, we chose the manufacturing method, we told the FDA how we were going to manufacture the drug.

[00:37:09] Speaker 04:
and therefore the process is a process that's required by the FDA.

[00:37:16] Speaker 04:
That doesn't feel right.

[00:37:19] Speaker 03:
I think it is the same issue, Your Honor, but I really would like to get to the made by argument because the answer to your question doesn't matter in the Teva case because the only basis for liability directed at Teva is 271G, which requires that the product that we sell in the United States be

[00:37:38] Speaker 03:
made by the patented process overseas.

[00:37:42] Speaker 04:
No, that's not true.

[00:37:45] Speaker 04:
Neither side has bothered to look at the Senate report at the time this legislation was passed, which says specifically that it applies both to products made in the United States and made abroad.

[00:37:58] Speaker 04:
And the reason for that is that before 271G was enacted under Supreme Court and Circuit authority and our predecessor courts authority,

[00:38:07] Speaker 04:
271A was not infringed by the making of a product according to a patent process.

[00:38:15] Speaker 04:
So the Senate report, if you look at the Senate report, you will see an explicit statement that this is covering both the products made abroad and those made in the United States.

[00:38:28] Speaker 03:
But the fact remains, in order for 271G to apply the product

[00:38:36] Speaker 03:
that is imported or sold must be made by the patented process.

[00:38:40] Speaker 03:
The only patent here is a patent process.

[00:38:42] Speaker 03:
There are no product patents at issue in this case.

[00:38:47] Speaker 03:
And so it must be shown that these inoxaparent products that Teva sells in the United States were made by a process.

[00:38:57] Speaker 03:
And it wasn't because of the nature of the patent in suit.

[00:39:00] Speaker 03:
This is a patent that is solely designed to generate information.

[00:39:05] Speaker 03:
Data about a product.

[00:39:07] Speaker 01:
I don't know, data about a product so you can decide which pieces, which batches to move forward with for further manufacturing.

[00:39:15] Speaker 02:
Is it made by, if you are not permitted to sell it, other ones?

[00:39:21] Speaker 03:
No, I don't think so, Your Honor.

[00:39:23] Speaker 03:
And your opinion in the Philip M. Adams case supports that.

[00:39:29] Speaker 03:
In that case, the plaintiff alleged that the patent allegedly

[00:39:34] Speaker 03:
infringed by the certification process that was challenged was integrated into the manufacturing process.

[00:39:41] Speaker 03:
And this court said, no.

[00:39:43] Speaker 03:
All it does is develop information about the product that it conforms to a particular standard, just as the patent is alleged to be used in this case.

[00:39:54] Speaker 03:
And this court repeatedly said, that's not good enough.

[00:39:56] Speaker 03:
It is not a step in manufacture.

[00:39:59] Speaker 03:
It is not a step in synthesis.

[00:40:02] Speaker 03:
That is how this court in the Bayer case distinguished biotechnology group.

[00:40:08] Speaker 03:
In that case, the patented process was used to synthesize something, to create a material object.

[00:40:17] Speaker 03:
Here, the only purpose of the patent is to develop information.

[00:40:22] Speaker 03:
And even if the information is used in a manufacturing process, that does not change the analysis.

[00:40:31] Speaker 03:
It is not a patent to make anything that is sold.

[00:40:40] Speaker 03:
My time is up.

[00:40:40] Speaker 03:
I'm happy to have additional questions.

[00:40:43] Speaker 03:
OK, thank you.

[00:40:54] Speaker 04:
Mr. Hayes?

[00:40:58] Speaker 04:
Oh, I'm sorry.

[00:41:01] Speaker 00:
Mr. Shah.

[00:41:02] Speaker 00:
Thank you, Your Honor.

[00:41:03] Speaker 00:
May it please the Court, Fatih Shah for the Amphistar appellate.

[00:41:06] Speaker 00:
Let me start with the solely limitation, since that's gotten some attention today.

[00:41:11] Speaker 00:
It is true that this patent, the 886 patent, to the extent that it's infringed at all, is used for the purpose of complying with the FDA requirements.

[00:41:21] Speaker 00:
That is what the safe harbor requires.

[00:41:23] Speaker 00:
There is no dispute that Amphistar is using this patent to comply with the FDA requirements.

[00:41:29] Speaker 00:
Now, with the other side saying, well, they're also using this.

[00:41:32] Speaker 00:
as part of their manufacturing process.

[00:41:34] Speaker 00:
I would submit that is not true.

[00:41:35] Speaker 00:
There's nothing in the record that would suggest that Amplistar would use this method, this allegedly patented method, to use this without the FDA requirement.

[00:41:45] Speaker 00:
But putting that aside, even assuming there was some other commercial purpose at use here, of which there is no evidence, I think this court's decision, and it's twice foreclosed, one by this opinion in Momento 1, this court's opinion in Momento 1, but before that, by this court,

[00:42:01] Speaker 00:
opinion in the ABTOX case.

[00:42:03] Speaker 00:
Here is what ABTOX case specifically says about the solely limitation, and I'm quoting from page 1030 of the ABTOX decision.

[00:42:10] Speaker 00:
The statute therefore does not look to the underlying purposes or attendant consequences of the activity.

[00:42:18] Speaker 00:
as long as the use is reasonably related to FDA approval.

[00:42:22] Speaker 00:
In other words, the statutory language allows the company to use its data from the test for more than FDA approval.

[00:42:29] Speaker 00:
And here's the sentence, a few sentences down in that same paragraph, quote, as long as the activity is reasonably related to obtaining FDA approval, Jacob's intent, the company's intent, or alternative uses are irrelevant to its qualification to invoke

[00:42:45] Speaker 00:
the 271E1 shield.

[00:42:48] Speaker 04:
That is precisely the situation.

[00:42:50] Speaker 04:
And the other cases on which you rely are cases in which the information would have been developed for the FDA only.

[00:42:59] Speaker 04:
The purpose of the original development of the information was only for FDA purposes.

[00:43:04] Speaker 04:
And then once the information was available, it was then used for these other purposes.

[00:43:08] Speaker 00:
Your Honor, that's not, if I may respectfully respond, that's not true in Abtox.

[00:43:13] Speaker 00:
The whole premise of Abtox litigation is, the other side argued, they're not doing this for FDA approval.

[00:43:19] Speaker 00:
They're just doing this so that they can promote their product.

[00:43:21] Speaker 00:
They're developing this information to promote the product.

[00:43:24] Speaker 00:
They never had any intent to submit it to the FDA.

[00:43:27] Speaker 00:
That is the fact situation in Abtox.

[00:43:30] Speaker 00:
Here, we're on stronger ground than Abtox.

[00:43:33] Speaker 00:
because everyone agrees they're at least doing this to comply with the FDA requirement.

[00:43:38] Speaker 00:
They couldn't sell this drug without using it to comply with the FDA process.

[00:43:42] Speaker 00:
Now, Memento is arguing, well, they're also using it for this commercial objective.

[00:43:46] Speaker 01:
And if one thing is clear in Abtox... Can you maybe... You're kind of yelling at us.

[00:43:52] Speaker 00:
Oh, I'm sorry.

[00:43:52] Speaker 01:
So try to tone the decibels down a little bit.

[00:43:56] Speaker 01:
Sure.

[00:43:56] Speaker 01:
slow down a little bit too because you're going really fast.

[00:43:59] Speaker 01:
When it comes to solely though, I understand your argument about what ABTOX stands for.

[00:44:05] Speaker 01:
It's not a bad argument.

[00:44:07] Speaker 01:
Judge Dyke pointed out that there may be some differences.

[00:44:11] Speaker 01:
Importantly, how does it give meaning to the word solely?

[00:44:16] Speaker 01:
What you tell me

[00:44:17] Speaker 01:
how, I mean, because I can't read the word out of the statute, and if I read out perhaps the way you're suggesting I should read that prior page of ours, I may be down by it, and if I am, I'll live with that, but how does the word solely still have any meaning at all in the statute under your interpretation?

[00:44:34] Speaker 00:
Sure, Your Honor, so I think solely does still have content under our reading of the statute, and I think the SG's brief, the Solicitor General's brief in the Klassen case,

[00:44:43] Speaker 00:
which was also addressing the scope.

[00:44:47] Speaker 00:
They, I think, proffer the work that Soli is doing in the statute.

[00:44:52] Speaker 00:
And here's what they say.

[00:44:53] Speaker 00:
A particular use may be, and it's on page 17 of the SG's brief, that the particular use may be reasonably related to the development and submission of information, and therefore may fall within the safe harbor even if it serves other purposes as well and also advances other commercial objectives.

[00:45:09] Speaker 00:
It cites ABTOC.

[00:45:10] Speaker 00:
Then it says,

[00:45:11] Speaker 00:
By contrast, and here's where it gives work to Soli to answer your question.

[00:45:16] Speaker 00:
By contrast, if a defendant makes multiple uses of a patented invention, e.g.

[00:45:21] Speaker 00:
by selling a patented drug commercially while simultaneously administering it to research subjects during a controlled study, one use may provide a basis of infringement liability even though the other use falls within the safe harbor.

[00:45:35] Speaker 00:
So what solely the work is doing, let's say a company is using the patent invention in two wholly distinct subset of its activities.

[00:45:43] Speaker 00:
One is using it as part of a clinical research study.

[00:45:46] Speaker 00:
The other, it's selling the drug.

[00:45:48] Speaker 00:
What the SG's brief does, it gives content to solely.

[00:45:50] Speaker 00:
It says, well, yes, the clinical study, that's certainly protected.

[00:45:54] Speaker 00:
But just simply selling a drug for commercial purposes, that's not.

[00:45:58] Speaker 00:
And so that's what solely does.

[00:45:59] Speaker 00:
It doesn't give a blanket use to the company to use the patented product for whatever

[00:46:03] Speaker 00:
purposes, for whatever uses it wants to, if it's using it for multiple different things, it has to be one of those and not the other.

[00:46:11] Speaker 01:
You stopped short of the page 18 paragraph, which further elaborates on what they mean, and I'm not sure that the government is really arguing what you said, which is that they say in

[00:46:28] Speaker 01:
In post-approval context, that inquiry may be substantially more difficult because the drug makers simultaneously engage in ordinary commercial manufacture and sale of the product in question.

[00:46:38] Speaker 01:
In such circumstances, the more nuanced analysis is required.

[00:46:42] Speaker 01:
A drug maker's use of a patented invention in routine commercial activity is not immunized

[00:46:47] Speaker 01:
from infringement liability merely because, for example, the company may periodically report adverse reactions to the FDA.

[00:46:54] Speaker 01:
Why doesn't that feel a lot like this case?

[00:46:57] Speaker 01:
You are maintaining these documents just in case the FDA wants to come and inspect them, which they, by the way, don't do very often, but they do do randomly and occasionally.

[00:47:06] Speaker 01:
So, and then, even then, they come by and inspect them.

[00:47:10] Speaker 01:
I'm not sure if that means submitted.

[00:47:12] Speaker 01:
They can, if they so choose, ask you to copy them and they'll take them away with them.

[00:47:16] Speaker 01:
Maybe that means the submitted language, maybe.

[00:47:19] Speaker 01:
But you see, I kind of feel as though the maintenance of records in this scenario feels a lot like keeping records to report adverse reactions.

[00:47:28] Speaker 00:
Yes.

[00:47:29] Speaker 00:
Well, no, Your Honor.

[00:47:30] Speaker 00:
So if we're going to move to the submit versus maintenance argument,

[00:47:33] Speaker 01:
What if this is also in solely?

[00:47:35] Speaker 01:
You're telling me the SGE supported your view of solely, and I actually think it doesn't.

[00:47:40] Speaker 01:
I think the subsequent sentences indicate that they think that when you're doing something for mass production and commercial manufacturing, it doesn't fall.

[00:47:49] Speaker 00:
No, I would disagree with you.

[00:47:50] Speaker 00:
I think the SGE brief does support our example.

[00:47:52] Speaker 00:
If you read a couple sentences after the sentences you read, it then repeats the example that I gave of when a use wouldn't be solely.

[00:47:59] Speaker 00:
Likewise, if it directs it to a clinical trial,

[00:48:01] Speaker 00:
as opposed to routine commercial sales, that would be protected under the plain terms of the statute.

[00:48:07] Speaker 00:
But here's the point I would make.

[00:48:10] Speaker 00:
There's slippery slope argument that this will open it up to everything in Ananda.

[00:48:16] Speaker 00:
This will license the wholesale infringement of manufacturing processes, or to the extent the SG briefs, purely commercial manufacturing processes.

[00:48:26] Speaker 00:
That is not what this case is.

[00:48:28] Speaker 04:
Stop there.

[00:48:29] Speaker 04:
That seems to be a critical point.

[00:48:31] Speaker 04:
What I referred to as bootstrapping where you use a process in the course of the manufacturing.

[00:48:37] Speaker 04:
You have to keep the records to show that you use the process that you told the FDA that you were going to use.

[00:48:44] Speaker 04:
It can't be that by choosing a process and then telling the FDA about it and keeping records to show that you did it brings about the safe harbor.

[00:48:56] Speaker 04:
It has to be something more than that, no?

[00:48:58] Speaker 00:
Yes, it does have to be something more than that.

[00:49:00] Speaker 00:
Let me tell you the two things that's more than that.

[00:49:02] Speaker 00:
One is this is an FDA prescribed test to meet the USP standard.

[00:49:05] Speaker 00:
The USP standard has to be 15 to 25 percent.

[00:49:08] Speaker 00:
The USP also has a companion test, which it makes the official test.

[00:49:12] Speaker 00:
That's the language it uses.

[00:49:14] Speaker 00:
I'm not saying it's the only test.

[00:49:15] Speaker 00:
And this Court has had, even if there are alternatives,

[00:49:18] Speaker 01:
That's not dispositive because... But you keep talking about all that as though it matters.

[00:49:22] Speaker 01:
First off, it doesn't matter to his client at all, right?

[00:49:25] Speaker 01:
Because at best, it's law of the case, and his client's not sucked into law of your case.

[00:49:31] Speaker 01:
And at worst, under the Supreme Court jurisprudence, it's not binding because it was a tentative finding made at the preliminary stage of the analysis.

[00:49:40] Speaker 01:
which wasn't made briefed or argued before anybody, so it kind of feels an awful lot like it fits right in that Supreme Court sweet spot on why it isn't given law of the case status.

[00:49:50] Speaker 00:
Well, Your Honor, even if you want to depart from your prior opinion, which I submit was completely correct on the non-infringing... I appreciate the validation.

[00:49:58] Speaker 00:
But if I can explain why it's correct, it's because the non-infringing alternative solely, as this court pointed out, does not modify the patented invention.

[00:50:07] Speaker 00:
It modifies its use as reasonably related to.

[00:50:09] Speaker 00:
There's nothing in the safe harbor that suggests it has to be the solely available use in order to qualify it.

[00:50:15] Speaker 00:
But here is why, Judge Dyke, any of your question, why it doesn't encompass everything in there.

[00:50:19] Speaker 00:
I think there's a sharp distinction to be drawn

[00:50:22] Speaker 00:
between the type of testing method here to comply with the USP standard to show it's within the 15 to 25 percent range that it's the same product and any number of wholesale manufacturing processes that would be used to do it.

[00:50:35] Speaker 00:
The limitation comes from the text of the safe harbor itself.

[00:50:38] Speaker 01:
But the FDA doesn't require you to use their patented process.

[00:50:44] Speaker 01:
This record is clear.

[00:50:46] Speaker 01:
This was not the record before the course previously at the preliminary injunction stage.

[00:50:52] Speaker 01:
where everybody accepted that let's assume for purposes of PI this is the only way of doing it.

[00:50:57] Speaker 01:
But the record now is clear that this is not the only way of doing it.

[00:51:01] Speaker 01:
There are non-infringing processes you can use to determine whether your batch falls in the 15 to 25 percent range.

[00:51:08] Speaker 01:
So how can you say their patented process is required for you to use

[00:51:14] Speaker 01:
to comply with FDA requirements.

[00:51:15] Speaker 00:
Well, Your Honor, again, I would disagree with you.

[00:51:18] Speaker 00:
It wasn't presented in the first case.

[00:51:20] Speaker 00:
Momentum made that argument.

[00:51:21] Speaker 01:
I want to know how you can respond to the argument on the merits, why you are required by the FDA to use their patented process when there are non-infringing methods you could use to obtain the identical information.

[00:51:32] Speaker 00:
Your Honor, because the word solely does not modify the patent invention.

[00:51:36] Speaker 00:
There's nothing in the safe harbor that says you must use.

[00:51:39] Speaker 01:
You stood here and argued in response to Judge Dyke's question that you are required to perform this process by the FDA.

[00:51:48] Speaker 01:
No, you are not.

[00:51:49] Speaker 01:
I want a clear yes or no.

[00:51:50] Speaker 01:
Are you required to perform the patent process by the FDA or are you simply required?

[00:51:54] Speaker 01:
I guess you can't ask this yes or no, so I'm giving you alternatives.

[00:51:56] Speaker 01:
Are you required to perform the patent process by the FDA or are you required to determine whether or not it's 15 to 25% compliant?

[00:52:04] Speaker 00:
It is the latter and the way that Amphistar satisfies the latter is by doing the official USP test.

[00:52:11] Speaker 04:
And in terms of initial approval, there's no requirement in the statute that the test be the only way of doing it as long as you run the test

[00:52:22] Speaker 04:
to submit to the FDA.

[00:52:24] Speaker 04:
Nobody's ever contended that that wouldn't be covered by the safe harbor simply because there was an alternative test in that context.

[00:52:30] Speaker 00:
That's right.

[00:52:31] Speaker 00:
Yes, Your Honor, and it's the same text that applies pre-approval and post-approval.

[00:52:35] Speaker 00:
So I don't know where you read in that limitation in the post-approval category that suddenly says the non-infringing alternatives, which are OK in the pre-approval test, are no longer OK in the post-approval test.

[00:52:48] Speaker 01:
But let me go back to my question one more time.

[00:52:50] Speaker 01:
Are you required to perform the patented process by the FDA?

[00:52:55] Speaker 00:
No, Your Honor.

[00:52:56] Speaker 00:
We perform that to satisfy the FDA requirement that it satisfies the 15 to 25% requirement.

[00:53:03] Speaker 01:
To be clear, you choose.

[00:53:05] Speaker 01:
to use the patented process to satisfy an FDA requirement, but you are not required to use that process.

[00:53:12] Speaker 00:
Well, Your Honor, when you say choose, I'm not sure how to answer that with a yes or no, because the FDA, when it has the USP 15 to 25% standard, that comes with an official companion test.

[00:53:23] Speaker 00:
And if you use that official companion test

[00:53:26] Speaker 00:
which Amphistar uses, then you know you've met all the efficacy reliability requirements.

[00:53:32] Speaker 00:
You can certainly go out and innovate on your own and come up with another test that may be more effective or more reliable.

[00:53:38] Speaker 01:
The record reflects the fact that there are already known non-infringing processes that could absolutely give you the same compliance information.

[00:53:47] Speaker 00:
Your Honor, they contest they use another test

[00:53:50] Speaker 00:
that is non-infringing, but they made that same contention in Memento 1.

[00:53:54] Speaker 00:
This court said Memento 1 makes this argument that the fact that there are non-infringing alternatives does not affect the analysis for the reasons that I stated.

[00:54:02] Speaker 00:
I don't want to repeat myself, but that's what that is.

[00:54:04] Speaker 00:
Now, if I can address just briefly the policy argument or the scenario that you are drawing that, well, does this sweep into all the manufacturing methods that might be in Enanda?

[00:54:15] Speaker 04:
And I think the time- The idea is you choose a manufacturing method

[00:54:19] Speaker 04:
You're required to inform the FDA about that.

[00:54:24] Speaker 04:
And you're required to maintain records to show that you kept within the parameters of your own manufacturing process.

[00:54:31] Speaker 04:
That's correct, right?

[00:54:32] Speaker 04:
But you do have to keep those records.

[00:54:34] Speaker 00:
Yes, Your Honor.

[00:54:35] Speaker 00:
But here's the distinction in this case.

[00:54:36] Speaker 00:
This has nothing to do with the chosen manufacturing method.

[00:54:39] Speaker 00:
There's no patents over the manufacturing method.

[00:54:42] Speaker 00:
There's nothing about Amplistar's chosen manufacturing methods that are issued here.

[00:54:45] Speaker 00:
The question is the same as requirement.

[00:54:47] Speaker 00:
Is this the same product?

[00:54:49] Speaker 00:
they produce at the end of their process that they said they would produce in their ANDA.

[00:54:54] Speaker 00:
And the patent here is a testing patent.

[00:54:57] Speaker 00:
It is specifically designed to develop information.

[00:55:01] Speaker 00:
And that is what the Safe Harbor requires, development of information reasonably related to development.

[00:55:06] Speaker 00:
It is not like a manufacturing patent.

[00:55:09] Speaker 00:
And when you use a manufacturing patent or process, you're using it to make the product.

[00:55:14] Speaker 00:
Now, that may incidentally generate records that you have to keep.

[00:55:18] Speaker 00:
under the maintenance record requirements, but that is not the main purpose, that is not the main use.

[00:55:23] Speaker 00:
It is much more directly related and therefore much more reasonably related to the development of information to use a testing patent like Momentos than it would be a wholesale manufacturing process which incidentally generates the record.

[00:55:38] Speaker 04:
But that argument it seems to me gets into the question of what the purpose of the test is.

[00:55:43] Speaker 04:
You know, you distinguish the hypothetical, the bootstrapping hypothetical I gave to you on the ground that in that situation the primary purpose of the test is commercial rather than for the FDA.

[00:56:00] Speaker 04:
So why don't, if purpose matters, don't we have to get into purpose here?

[00:56:05] Speaker 04:
Is the purpose of this test to generate records to show FDA compliance?

[00:56:13] Speaker 04:
or is the purpose of the test to ensure compliance with commercial processes?

[00:56:23] Speaker 04:
It seems to me that the purpose of the test, as you're explaining it, is

[00:56:28] Speaker 00:
Your Honor, I don't think you have to get into purpose because there can't be any dispute on this record from an objective standpoint that at least Amphistar is doing this that's reasonably related to complying with the FDA requirement that they show that it's within the 15-25% standard.

[00:56:43] Speaker 00:
The fact that it may also be serving some other commercial end does not disqualify it from the safe harbor that we're at.

[00:56:51] Speaker 00:
So that's how I think I would deal with the purpose inquiry.

[00:56:54] Speaker 00:
And if I could just point you to the JA-102, which is the actual text of the patent claims, their 886 patent claims, it makes clear this is not some broad-scale manufacturing patent or manufacturing process.

[00:57:07] Speaker 00:
The terms of the claims itself, Claim 1 and Claim 6, it claims, quote, a method for analyzing an inoxaparin sample.

[00:57:16] Speaker 00:
for the presence of a sugar quote that results from a method of making an oxaparin, and the last line of that claim, of both claims, is to thereby analyze the an oxaparin sample.

[00:57:27] Speaker 00:
This isn't about making, manufacturing an oxaparin, some wholesale sweeping decision in Momenta 1.

[00:57:34] Speaker 00:
This is about testing the product to develop information, to generate the data, to show the FDA that they're making the same thing that they said they would make.

[00:57:44] Speaker 00:
And to take Judge Moriarty,

[00:57:45] Speaker 00:
baking cake hypothetical, I think it's a good one.

[00:57:48] Speaker 00:
I think our case is even stronger because at least in your baking cake hypothetical, you're using the salt in the actual cake.

[00:57:56] Speaker 00:
Here, you're simply taking a sample out of a batch, running the test, and throwing out the sample.

[00:58:01] Speaker 00:
There is nothing from the patented process.

[00:58:03] Speaker 01:
Then you're using the other samples.

[00:58:05] Speaker 01:
That's like you threw out the sugar but kept the salt.

[00:58:09] Speaker 01:
You're using the ones that are compliant and throwing out the

[00:58:11] Speaker 00:
I respectfully disagree, Your Honor.

[00:58:12] Speaker 00:
The default method is, it uses all of its batches.

[00:58:17] Speaker 00:
The only thing that's going on here is if it runs a test, which it has to run to comply with the FDA requirement, it could not sell this stuff.

[00:58:25] Speaker 00:
without running the test.

[00:58:27] Speaker 00:
If that test comes out and says, this does not comply with the FDA requirement, then they discard that batch.

[00:58:32] Speaker 00:
There is nothing in the 886 patent that covers anything related to the processing, the manufacturing, the making of that.

[00:58:40] Speaker 00:
It's like if you have a food processing plant and a health inspector comes in, takes a test of the product and says,

[00:58:47] Speaker 00:
this doesn't meet the standards, throw out that batch.

[00:58:50] Speaker 00:
You would not say that that was part of the making of that food product.

[00:58:54] Speaker 00:
That's exactly what's going on here.

[00:58:56] Speaker 00:
They are doing the test per FDA requirements, and they throw out the sample.

[00:59:01] Speaker 00:
That's what's happening.

[00:59:02] Speaker 00:
It's a testing by the terms of their own patent.

[00:59:05] Speaker 00:
It is a testing patent to analyze the sample.

[00:59:08] Speaker 00:
It does nothing more.

[00:59:09] Speaker 00:
This is not a case about broad manufacturing methods.

[00:59:12] Speaker 00:
And you haven't seen a single case in the two and a half years since Momentum One has been in the books.

[00:59:17] Speaker 00:
that has come up on the slippery slope that they suggest, you do not have a single amicus before this court from any patent holder, manufacturing methods holder, saying that this pose a problem.

[00:59:27] Speaker 00:
And we think that's because the limitations of the safe harbor as this court construed it in Momenta 1 provide more than adequate protection from the slippery slope arguments that they make.

[00:59:38] Speaker 02:
Mr. Shah, I want to ask you about the dog that barked in the night.

[00:59:43] Speaker 02:
You'll recall that Watson says, well, Holmes, the dog didn't bark, and Holmes says, precisely.

[00:59:50] Speaker 02:
So in possum, the SJ's brief doesn't say some stuff.

[00:59:56] Speaker 02:
It says, the moment of court additionally held the proposes of 271E1,

[01:00:05] Speaker 02:
Information may begin submitted to the FDA if it is preserved in records that FDA regulations require a manufacturer to make approval for inspection on FDA requests.

[01:00:15] Speaker 02:
We express no view on the correctness of that conclusion or the court's ultimate conclusion.

[01:00:24] Speaker 00:
Yes.

[01:00:25] Speaker 02:
So what does that silence mean?

[01:00:28] Speaker 00:
Well, I think we take the SG at its word.

[01:00:30] Speaker 00:
It didn't take a position of its view on this court's interpretation of submission.

[01:00:34] Speaker 01:
But on submission, I would submit, even if you use the- Do you think we should ask the government for a suit?

[01:00:41] Speaker 01:
teams like they have some?

[01:00:43] Speaker 00:
Well, they said they don't take a position.

[01:00:45] Speaker 00:
So I don't think they have views.

[01:00:46] Speaker 00:
But I don't think it's necessary, because I think this court- They don't take views on whether we were correct or not.

[01:00:51] Speaker 00:
Right.

[01:00:52] Speaker 01:
And in fact, they went to great pains to say, we don't take views on whether you're correct on your statutory interpretation or whether you've got the outcome of the case correct.

[01:00:58] Speaker 00:
Well, here, Your Honor, is why I don't think you need to revisit submission.

[01:01:02] Speaker 00:
And if you do revisit, you should come to the same outcome that you came to.

[01:01:05] Speaker 00:
And that's because even if you apply the plain meaning of submission that Momenta offers on page 40 of its brief,

[01:01:12] Speaker 00:
That is to present something to somebody for approval or study.

[01:01:16] Speaker 00:
That's quoting their brief, page 40.

[01:01:18] Speaker 01:
That's their plain-meaning definition.

[01:01:20] Speaker 01:
You argue to me that the SG's brief clearly supports your view solely.

[01:01:25] Speaker 01:
I mean, you're giving me a great idea here.

[01:01:27] Speaker 01:
Why don't we ask him and find out?

[01:01:29] Speaker 00:
Well, Your Honor, you obviously can do whatever you think is fit.

[01:01:33] Speaker 00:
I think this court's decision in Momentum 1, the arguments here provide ample ground to affirm

[01:01:38] Speaker 00:
and come to the same conclusion that it came onto its interpretation of the safe harbor and then reached the 271G argument, what I would say about submission again is we meet the plain meaning of submission that they present, present something to somebody for approval or study.

[01:01:53] Speaker 00:
The fact that they do that on-site, Deputy Inspectors, rather than mailing in the records should not be a distinction on which it turns.

[01:02:01] Speaker 00:
And again, even if there was some ambiguity as to whether this activity falls within the scope of submission, the language of the statute is not that they must do it for submission.

[01:02:13] Speaker 00:
It must be reasonably related to a submission.

[01:02:16] Speaker 00:
And I would think we're OK on submission alone, but certainly if you add the gloss of whether keeping records so that the FDA can come, inspect it, photocopy it, and take it with them is at least reasonably related to making those records available for approval or study.

[01:02:31] Speaker 04:
Okay, thank you, Mr. Shaw.

[01:02:33] Speaker 04:
Thank you, Your Honors.

[01:02:34] Speaker 04:
Ms.

[01:02:34] Speaker 04:
Maynard, you've got four minutes here.

[01:02:37] Speaker 01:
Thank you, Your Honors.

[01:02:38] Speaker 01:
I'd like to start with the patent.

[01:02:40] Speaker 01:
So this is a manufacturing patent, and if I can draw your attention to A84, which is the patent in the back of the blue brief in the Amphistar case.

[01:02:52] Speaker 01:
In particular, at line, in the detailed description, column 28, line 31,

[01:03:00] Speaker 01:
This information can be used to standardize the production of low molecular weight heparin composition.

[01:03:07] Speaker 01:
I'm on page 884.

[01:03:11] Speaker 01:
I'm in column 28.

[01:03:13] Speaker 01:
This is only one of several places in the patent.

[01:03:17] Speaker 01:
I beg your pardon.

[01:03:19] Speaker 01:
I'm in column 28.

[01:03:20] Speaker 01:
I'm in line 31.

[01:03:22] Speaker 01:
It starts with the word further.

[01:03:24] Speaker 01:
Further, this information can be used to standardize the production of LMWH composition.

[01:03:29] Speaker 01:
Thus resulting in LMWH with less batch-to-batch variability and improved ratios of desirable and undesirable activities.

[01:03:38] Speaker 01:
We pull out in the Crawford affidavit, which is in the Amphistar JA at page 12, 436, paragraph 19, multiple places in the patent that talk about manufacturing and reducing batch-to-batch variability.

[01:03:51] Speaker 01:
And then significantly, the last step of claim 53 is selecting a batch for further processing.

[01:04:00] Speaker 01:
on page A105, column 70 starting around line 24, selecting a batch of anoxaparin based upon a comparison of the determination of the test of the presence of the structural signature associated with the non-naturally occurring sugar.

[01:04:22] Speaker 01:
associated with peak nine, figure one, to the reference standard for a NOxA parent.

[01:04:26] Speaker 04:
But all that shows is you could use it for those purposes.

[01:04:30] Speaker 04:
It doesn't show that the capitalese here are using it for that purpose.

[01:04:35] Speaker 04:
That's the question that we were asking.

[01:04:38] Speaker 01:
Well, that's precisely what we've accused them of in the complaint, Judge Dyke, that that is what... I'm not sure about that.

[01:04:44] Speaker 04:
I mean, the complaint seems to focus more on their doing this for FDA purposes.

[01:04:49] Speaker 04:
but understand your they they have an objective of this contention being within the scope of the case, but the fact is it seems to me we don't we can't help from this record whether this is only for FDA purposes or whether it has a commercial purpose.

[01:05:07] Speaker 01:
Well, you want to address the complaint point.

[01:05:10] Speaker 01:
The complaint references the requirements of the USP to establish our reasonable belief that they were probably infringing our patent.

[01:05:17] Speaker 01:
But what they're alleged with doing in the complaint, and then on this record, the uncontested affidavits of Lew in both the Teva record and the Amplestar record detail at great length how they are infringing each step of the claims, including the step of Claim 53.

[01:05:33] Speaker 01:
To your point about the solely Judge Dyke,

[01:05:36] Speaker 04:
What they are using... So we don't know whether you're right or whether they're right.

[01:05:40] Speaker 01:
Well, this was resolved on the safe harbor grounds, Your Honor, on a summary judgment against us.

[01:05:46] Speaker 04:
Obviously, there's more... So you're saying there's a fact issue.

[01:05:49] Speaker 04:
If this is a determinative, if the commercial purpose of this is determinative, we have a fact issue, right?

[01:05:59] Speaker 01:
No one disputes that they are... Yes, no.

[01:06:02] Speaker 01:
Yes, if there's a fact dispute, there would have to be a reversal.

[01:06:05] Speaker 01:
But I think it's important to step back and look at the statute as a whole.

[01:06:11] Speaker 01:
It says solely for uses reasonably related to the development and submission of information under the FDCA.

[01:06:17] Speaker 01:
And when you look at the situations in which information is submitted, they all involve approval, FDA approval.

[01:06:24] Speaker 01:
What they are doing here and what we've accused them of doing here is

[01:06:27] Speaker 01:
simply using it in the ordinary commercial exploitation routine commercial manufacturer.

[01:06:32] Speaker 01:
It's just like the SG's brief.

[01:06:34] Speaker 01:
I think the SG's brief supports our position, not their position with respect to solely the SG's.

[01:06:37] Speaker 01:
I guess we'll figure that out at some point, is my guess.

[01:06:40] Speaker 01:
But apart from that question, I don't understand how either of the two passages you read to me support your notion that this is a manufacturing process.

[01:06:48] Speaker 01:
When you look at claim 52 right after the section you read, it says selecting a batch.

[01:06:53] Speaker 01:
The very next line is to thereby analyze the sample.

[01:06:56] Speaker 01:
So I don't see how that says you're not selecting a batch for further manufacturing, like you alluded to.

[01:07:02] Speaker 01:
It's to analyze.

[01:07:03] Speaker 01:
It's to analyze.

[01:07:06] Speaker 01:
Two points, Your Honor.

[01:07:06] Speaker 01:
One, it's my understanding that in claimees speak, this is the way you write a claim like this, where you start out the preamble and you close it with to analyze.

[01:07:15] Speaker 01:
Importantly, in the claim construction... I beg your pardon.

[01:07:34] Speaker 01:
it starts and ends with analyze.

[01:07:36] Speaker 01:
If I may draw your attention to the claim construction order in the court below, it's in the Teva JA at A2345.

[01:07:43] Speaker 01:
It interpreted this selecting a batch of Anaxa Perrin

[01:07:47] Speaker 01:
to mean selecting a quantity of an oxaparin that was produced in a single process for further testing or processing.

[01:07:56] Speaker 01:
And I think if you look at the passages in the Crawford affidavit that detail more parts of the patent, Your Honor, I think you'll see that this patent is about using the analysis to reduce batch-to-batch variability in manufacturing.

[01:08:07] Speaker 01:
That's exactly the use to which they're putting it here.

[01:08:12] Speaker 01:
Figuring out using information you gain from manufacturing always helps you improve or stays the course for manufacturing.

[01:08:22] Speaker 01:
It doesn't morph that information or the test that you performed to get it into a manufacturing test.

[01:08:27] Speaker 01:
Here they're using it though, Your Honor, to decide what, they're using it just like you would a mechanical sorter, a long conveyor belt, to decide which part...

[01:08:38] Speaker 01:
No, even more than that, Judge Wallach.

[01:08:40] Speaker 01:
They're using it to decide whether interim drug substance goes in or out along the manufacturing line.

[01:08:48] Speaker 01:
And if it fails the test, it's like it's rejected by the mechanical sorter.

[01:08:55] Speaker 04:
passed the test it goes on and it's going to get there with other matches that path and pulled in the syringe okay thank you miss manor we're out of time thank all of you know uh... the two cases are submitted with our section for the death