[00:00:37] Speaker 04:
Next case is Amgen versus Apotex, 2017, 10-10.

[00:00:43] Speaker 04:
Mr. Groombridge.

[00:00:47] Speaker 02:
Thank you, Your Honor, and may it please the Court.

[00:00:50] Speaker 02:
I would like to begin by talking about the one gram per liter limitation.

[00:00:56] Speaker 02:
And specifically, in Amgen's view, the principle enunciated in this Court's decision in the Sinovian case

[00:01:06] Speaker 02:
leads to or should lead to a finding of infringement as a matter of law.

[00:01:13] Speaker 02:
What Sinovian says that if the FDA application document, in that case an ENDA but here of course an ABLA, speaks to the relevant parameter, recited in the claims, and if from

[00:01:33] Speaker 02:
the FDA application documented is clear that the applicant is seeking approval to do something that is covered by the claim.

[00:01:43] Speaker 02:
Even if it may also embrace subject matter not covered by the claim, then that is nonetheless an infringement as a matter of law.

[00:01:50] Speaker 02:
And that is what we think is clearly established by the ABLA documents here.

[00:01:55] Speaker 00:
Well, you argue that in the ABLA documents they show that the

[00:02:01] Speaker 00:
that there could be some variation, but there's nothing that indicates that the variation could be of any particular measure.

[00:02:10] Speaker 00:
Are you saying just because there's some possibility out there that they could read on the claims that we're supposed to assume as a matter of law that they do?

[00:02:18] Speaker 02:
No, Your Honor, that's not what we're saying.

[00:02:19] Speaker 02:
And I think that that issue was addressed in this Court's decision in one of the fearing cases.

[00:02:24] Speaker 02:
That's precisely not what we're saying.

[00:02:26] Speaker 02:
And I think I would respectfully disagree with the way, Your Honor, characterized our view of the ABLA.

[00:02:33] Speaker 02:
That what we think is the ABLA specifies an amount of inclusion bodies, 0.9 to 1.4 grams per liter.

[00:02:42] Speaker 02:
We know that that is not a wet weight, because when the ABLA wants to talk about a wet weight, it does.

[00:02:48] Speaker 02:
For example, in the appendix 5588, where it specifically refers to the weight of the inclusion bodies after the washing step, and when they've been centrifuged, characterizes that as a wet weight.

[00:03:06] Speaker 02:
When it talks about forming the refolding mixture, it does not characterize that amount as a wet weight.

[00:03:12] Speaker 02:
And indeed it gives only one specification, which we find in the appendix of 5595.

[00:03:17] Speaker 02:
And it says the only requirement that is specified is a purity of greater than or equal to 75%.

[00:03:25] Speaker 02:
And I think that the district court found that what that purity means is that of the protein present, at least 75% of it has to be filgrastone.

[00:03:36] Speaker 02:
So Your Honor, in our view, what Apotex is seeking FDA approval for here

[00:03:41] Speaker 02:
is a process in which it is allowed to refold inclusion bodies at a concentration of 0.9 to 1.4 grams per liter and the only thing, the only requirement that is imposed on those inclusion bodies is that they consist of at least 75% for Grastem, the protein in them and if we do the arithmetic there that means they are seeking approval

[00:04:04] Speaker 02:
to conduct a refolding process at a concentration that includes, and in fact it exceeds, one gram per litre.

[00:04:12] Speaker 02:
They're also seeking approval for a range that goes below that, but under the holding of this court in Sanovian that doesn't matter.

[00:04:21] Speaker 02:
And in our view you're unaware where the analysis went wrong in the district court in part is that it focuses on a different requirement

[00:04:32] Speaker 02:
on the requirement that is characterized as a key process parameter.

[00:04:36] Speaker 04:
You're putting an awful lot of emphasis on your synovian argument.

[00:04:40] Speaker 02:
At the beginning, Your Honor, yes, there's another point I would like to get to that is unrelated to synovian.

[00:04:48] Speaker 02:
But the key process parameter, which specifies a certain amount of protein,

[00:04:58] Speaker 02:
is by its very terms something that is able to be departed from.

[00:05:05] Speaker 02:
In fact, that is why when we look at the specifications in the ABLA, there is no acceptance criterion.

[00:05:12] Speaker 02:
There is a dash in the column acceptance criterion for that parameter because Apotex is allowed to depart from that.

[00:05:20] Speaker 02:
And indeed, this is addressed explicitly in the ABLA and the citation in the appendix is 67, 24 to 25.

[00:05:28] Speaker 02:
that explains the significance of those terms and says, if it's a key process parameter, that is non-critical.

[00:05:34] Speaker 02:
That means that you can depart from it.

[00:05:37] Speaker 02:
And it may affect things like yield, but it doesn't affect product quality.

[00:05:41] Speaker 02:
And therefore, you're not constrained by that.

[00:05:43] Speaker 02:
And so what we have here very clearly, in our view, Your Honor, just looking at the ABLA, is there is a situation in which they are seeking approval to do something that falls within the scope of the claims.

[00:05:55] Speaker 00:
But don't the ABLAs themselves

[00:05:57] Speaker 00:
indicate that the key process parameters have to be carefully maintained within a very strict range?

[00:06:03] Speaker 02:
I would say not, Your Honour.

[00:06:04] Speaker 02:
I would say the only thing that is cited by Apotex and was not referenced by the District Court, it's in the table, it's the note, if you will, in the table that appears in the District Court's finding of Fact 19.

[00:06:19] Speaker 02:
I don't believe it's mentioned anywhere.

[00:06:21] Speaker 02:
There is a note that says something to the effect of this is the qualified range based on the experiments that are conducted.

[00:06:29] Speaker 02:
That doesn't say that you can't go outside that range.

[00:06:32] Speaker 02:
Millie says these are the experiments that we've conducted to date.

[00:06:36] Speaker 02:
And when we look at the definitions of key process parameter, key process parameter is one of two things that are designated as non-critical.

[00:06:47] Speaker 02:
I think this appears at 6725.

[00:06:50] Speaker 00:
Part of the problem here is what burden you have.

[00:06:57] Speaker 00:
It's your burden to prove infringement.

[00:06:59] Speaker 00:
It's not their burden to disprove it.

[00:07:02] Speaker 00:
So you're saying that just because there's some possibility that they could infringe

[00:07:09] Speaker 00:
that we're supposed to assume they do infringe.

[00:07:11] Speaker 00:
And yet everything, the ABLAs themselves have a calculation that's .708.

[00:07:16] Speaker 00:
I recognize that not all the batch records were produced, but those few that were produced did show a range even much lower than that with respect to the protein calculation.

[00:07:28] Speaker 00:
So why haven't you failed to prove infringement?

[00:07:33] Speaker 02:
Your Honor, we've come back to look at this under the

[00:07:36] Speaker 02:
the controlling law, what we look at is what are they seeking approval to do?

[00:07:40] Speaker 02:
What are they asking FDA to allow them to do?

[00:07:43] Speaker 02:
What they're asking FDA to allow them to do is to refold protein at concentrations that certainly exceed one gram per liter.

[00:07:51] Speaker 02:
And the calculations based on that key process parameter are non-limiting.

[00:07:56] Speaker 02:
And if they were given approval, I think the measure is this, that they could operate with inside that 0.9 to 1.4 range.

[00:08:06] Speaker 02:
which is specified, it's not a situation where the ABLA is silent, and be above one gram per liter in the refolding mixture.

[00:08:13] Speaker 02:
That's what they're asking the FDA to allow them to do.

[00:08:19] Speaker 03:
I think you're probably going to have to go over ground that you've just gone over to answer this, but tell me what's wrong with the following.

[00:08:28] Speaker 03:
Either the ABLA addresses this matter

[00:08:36] Speaker 03:
in which case there's enough evidence to conclude that what you can infer from the ABLA is, was it 0.708 grams per liter?

[00:08:46] Speaker 03:
Or it just leaves it open and doesn't constrain it or authorize it, in which case the two batch evidence seems to indicate a number even lower, around 0.56 or something.

[00:09:02] Speaker 03:
Either way, you have not proved

[00:09:05] Speaker 03:
satisfaction of the greater than one gram per liter.

[00:09:08] Speaker 03:
So what's wrong with, and the two either-or's are maybe one can summarize them as synovian and Glaxo.

[00:09:18] Speaker 02:
Our view is that this is a synovian case, not a Glaxo case, Your Honor, and that the ABLA does address this.

[00:09:25] Speaker 02:
And indeed, first of all, that the ABLA makes clear that when it's talking about a wet weight, it says a wet weight,

[00:09:33] Speaker 02:
And thus the weight that we're talking about in the range 0.9 to 1.4 is not a wet weight, it's not so specified.

[00:09:43] Speaker 02:
And indeed when it says that the amount of inclusion body should be equivalent to 0.9 to 1.4, what it's saying is that's not a wet weight.

[00:09:52] Speaker 02:
And if we look at the immediately preceding part of that where it does spell out a wet weight, it gives a different range of numbers, 2.8 to 4.

[00:10:00] Speaker 02:
And so in our view, Your Honor, what we've got is a situation where the ABLA absolutely addresses this issue.

[00:10:06] Speaker 02:
It allows Apotex, if it be approved, to operate within a range.

[00:10:09] Speaker 03:
The term allow is a bit of an uncertain term.

[00:10:15] Speaker 03:
It can mean

[00:10:17] Speaker 03:
an absence of constraint or it can mean an affirmative authorization?

[00:10:21] Speaker 02:
I use it to mean an affirmative authorization, Your Honor.

[00:10:23] Speaker 02:
In other words, I don't use it to mean a situation where the ABLA is silent and therefore it's not prohibited.

[00:10:30] Speaker 02:
I use it to mean a situation in which the Food and Drug Administration has said, you can operate within this range and that is explicitly approved by us.

[00:10:39] Speaker 02:
And that range, on any fair reading of the ABLA, includes one gram per liter in the refolding

[00:10:46] Speaker 02:
That's what we think the ABLA discloses.

[00:10:51] Speaker 03:
On the assumption that the ABLA affirmatively authorizes, what specifically do you say overcomes their evidence that when you do the minimum 75% protein and whatever the inclusion body process parameter of 4 to 11, you end up with

[00:11:14] Speaker 03:
the .708.

[00:11:16] Speaker 02:
They're not constrained by those numbers.

[00:11:19] Speaker 02:
In other words, if I'm working from memory, but the numbers that are approximately 4.2 to 11.8 are not limiting.

[00:11:26] Speaker 02:
In other words, those are not a specification.

[00:11:28] Speaker 02:
And when we look at that part of the ABLA, it has a column headed acceptance criterion, which means this is something that you have to meet.

[00:11:37] Speaker 02:
And if it's a requirement, there's a value in there.

[00:11:42] Speaker 02:
So for example, the media line above

[00:11:43] Speaker 02:
impurity it says greater than equal to seventy five percent.

[00:11:47] Speaker 02:
You can't release them.

[00:11:48] Speaker 03:
You happen to have the page saved.

[00:11:52] Speaker 02:
It's fifty five ninety five in the appendix.

[00:11:55] Speaker 02:
Thanks.

[00:12:02] Speaker 00:
Can I turn to your other argument with respect to the buffer strength should be unlimited?

[00:12:07] Speaker 00:
Yes your honor.

[00:12:09] Speaker 00:
If we conclude that the patent doesn't limit

[00:12:13] Speaker 00:
buffer strength and there is just an absolutely no outside limit and it is unlimited, why doesn't that render the patent indefinite?

[00:12:22] Speaker 02:
Because I think there are numerous examples of patents in which they specify there's a lower limit but no upper limit.

[00:12:28] Speaker 02:
And what the patent teaches us, if we look at the bottom of column eight and the text that carries over to the top of column nine, it says here's a technical reason why if the redox buffer strength is too low,

[00:12:43] Speaker 02:
things will go badly, the reaction will be uncontrolled.

[00:12:46] Speaker 02:
Conspicuous by its absence from the patent is any comparable text that says if we go too high, here are bad things that will happen.

[00:12:54] Speaker 00:
Well, there is a lot of text that talks about capping it at 100, correct?

[00:13:00] Speaker 02:
The same text is about effectively bounded at 100 is repeated five or six times, I think.

[00:13:06] Speaker 04:
At least five times.

[00:13:09] Speaker 02:
Yes, Your Honor, at least five times.

[00:13:11] Speaker 02:
But in our view, there's no indefiniteness here because this is a situation, and I don't think indefiniteness was argued on this, this is a situation in which a skilled person can clearly understand this.

[00:13:25] Speaker 02:
And indeed, the upper limit, as the district court found, is that that effectively bounded language reflects solubility concerns.

[00:13:35] Speaker 02:
So, a skilled person would know how much he could give a citizen.

[00:13:37] Speaker 04:
Whatever the reason, that was the interpretation of the district court.

[00:13:41] Speaker 02:
That's correct, Your Honor, but as a factual matter.

[00:13:45] Speaker 02:
And I don't think there was any disagreement.

[00:13:50] Speaker 02:
In other words, I think the testimony at trial was unanimous that the reason for that limit had something to do with solubility.

[00:14:00] Speaker 04:
Apotex is well clear of that.

[00:14:02] Speaker 02:
Apotex is well clear of the 100.

[00:14:06] Speaker 02:
In our view here, when we read this pattern, this is a classic example of, there's a broad introductory statement at the bottom of column two in the summary of the invention.

[00:14:13] Speaker 02:
It says, when it introduces this idea, it says two millimolar or greater, and then it goes on to talk about various embodiments, and that's where the language effectively bounded at 100 appears.

[00:14:24] Speaker 02:
And it's hard for

[00:14:25] Speaker 02:
I would submit to imagine how someone could write a claim, what language they would use to try to express that there is no, the claim does not impose an upper limit apart from saying something like two millimolar or greater.

[00:14:41] Speaker 02:
That it has a plain meaning and all we ask is that it be given that plain meaning.

[00:14:46] Speaker 02:
If I may, with my remaining time, I did want to touch on, to go back to the

[00:14:52] Speaker 02:
one gram per liter and just touch on the BPCIA issue in which as the court I'm sure is aware what happened in this case the ABLA was disclosed the BPCIA exchanges did take place Apotex did provide a detailed factual and legal statement regarding the reasons why it did you ever ask for a request for admission to pin them down to that?

[00:15:20] Speaker 02:
We did not ask a request for admission.

[00:15:22] Speaker 02:
We certainly did ask their expert, for example, in discovery, Your Honor, and in discovery she said she confirmed the statement that was made.

[00:15:31] Speaker 02:
in the 3B submission.

[00:15:33] Speaker 02:
And it was, in fact, not until trial that she then repudiated that testimony and said that she had misspoken.

[00:15:41] Speaker 00:
What is your position with respect to the weight?

[00:15:44] Speaker 00:
I mean, you originally said these should be binding, these patent dance disclosures, and then you backed off in your reply brief and said, well, they should at least have some probative weight.

[00:15:53] Speaker 02:
Your Honor, we have never said they should be binding, and our position

[00:15:55] Speaker 02:
is this, that the Supreme Court and every court that has ever looked at this has made clear that these exchanges are part of a very carefully calibrated scheme to prepare to litigate.

[00:16:08] Speaker 02:
And our position is that, as we said in the reply brief, that they should be treated as something analogous to, for example, contentions in the local patent rules of courts that have those things.

[00:16:18] Speaker 02:
If you make an honest mistake or something happens that couldn't have been predicted,

[00:16:23] Speaker 02:
and you want to change it.

[00:16:24] Speaker 02:
Of course no one would say, too bad, you made a mistake, you're stuck.

[00:16:27] Speaker 02:
That's not justice.

[00:16:29] Speaker 02:
But in our view, there should be some mechanism like seeking a good cause requirement to say, look, we want to depart from this and there's a good reason to do it.

[00:16:38] Speaker 00:
So in the absence of that kind of request, then you would argue that it should be binding.

[00:16:43] Speaker 02:
What I would say, Your Honor, is I am reluctant to make a statement categorically across all fact situations that it should be binding.

[00:16:50] Speaker 02:
What I would say is that it cannot simply be discarded.

[00:16:53] Speaker 02:
as inconvenience when a litigant wishes to now take a contrary position.

[00:16:57] Speaker 00:
Well, if it was weighed and given probative value, like an admission by a party opponent, couldn't that still be outweighed by the fact that the record discloses that it was just not correct?

[00:17:13] Speaker 02:
Conceivably, yes, Your Honor, although we would submit not under the circumstances of this case, where there were ample opportunities to correct it, and it was not until trial.

[00:17:21] Speaker 02:
and without explanation that we were told that it was all wrong.

[00:17:26] Speaker 04:
Mr. Groombridge, why don't we hear from the other side and we'll give you your three minutes.

[00:17:30] Speaker 04:
Thank you, Your Honor.

[00:17:34] Speaker 04:
Mr. Gollum.

[00:17:43] Speaker 01:
Thank you, Your Honors, and may it please the Court

[00:17:46] Speaker 01:
With respect to the one gram per liter and the synovian.

[00:17:49] Speaker 00:
Wait, can I start at the back end first?

[00:17:52] Speaker 00:
Sure.

[00:17:52] Speaker 00:
So you never did move to amend your letters, did you?

[00:17:57] Speaker 01:
We never did move to amend our letters.

[00:17:59] Speaker 01:
But in answer to your question, they did ask requests for admissions.

[00:18:03] Speaker 01:
We denied it.

[00:18:04] Speaker 01:
They asked interrogatories.

[00:18:06] Speaker 01:
We denied it.

[00:18:07] Speaker 01:
We also filed summary judgment on the issue.

[00:18:10] Speaker 01:
They knew exactly where it was.

[00:18:13] Speaker 00:
Is it your position that these

[00:18:14] Speaker 00:
patent dance letters that everybody says are very important to this entire process should get zero weight?

[00:18:22] Speaker 01:
Well, I don't think the court gave them zero weight.

[00:18:24] Speaker 01:
The court clearly considered them in his findings.

[00:18:29] Speaker 01:
He said he considered them, but they were not as probative as the other evidence.

[00:18:33] Speaker 00:
Well, didn't he actually say they get no probative weight?

[00:18:36] Speaker 00:
That's a little bit different.

[00:18:39] Speaker 01:
Well, it's unclear.

[00:18:40] Speaker 01:
He had to have considered them.

[00:18:42] Speaker 01:
Because to say they didn't get weight, he had to have considered them.

[00:18:48] Speaker 01:
He clearly considered them, and he said that the other stuff was much more important.

[00:18:54] Speaker 01:
There was extensive evidence to the contrary.

[00:18:57] Speaker 00:
But it was really trial by ambush.

[00:18:59] Speaker 00:
I mean, even when your expert purported to testify on this topic, the judge sustained an objection to that testimony on the grounds that this whole issue of the

[00:19:11] Speaker 00:
water content was not an issue.

[00:19:15] Speaker 01:
It wasn't a trial by ambush.

[00:19:16] Speaker 01:
They took Dr. Dowd's deposition, the fact witness.

[00:19:19] Speaker 01:
He told them what was in the inclusion bodies.

[00:19:22] Speaker 01:
He told them about the water.

[00:19:24] Speaker 01:
Like I said, they asked interrogatories.

[00:19:26] Speaker 01:
They asked requests for admissions.

[00:19:28] Speaker 01:
The patent itself talks about, in two places, washed inclusion bodies that are frozen.

[00:19:34] Speaker 01:
That means they have water in them.

[00:19:37] Speaker 01:
All we did was have an exact calculation at trial.

[00:19:41] Speaker 01:
as to how much water.

[00:19:42] Speaker 01:
But when you look at the trial testimony of Dr. Wilson, he admitted that he knew that there was water in there and that he just didn't take it into account.

[00:19:55] Speaker 01:
That was one of the four very important factors why the court found that they didn't meet their burden.

[00:20:01] Speaker 01:
This is not a situation where it's our burden to prove anything.

[00:20:05] Speaker 01:
it's their burden to prove infringement.

[00:20:08] Speaker 00:
I've got a problem with the fact that the trial court relied on testimony that he sustained an objection to.

[00:20:14] Speaker 00:
That's improper, right?

[00:20:17] Speaker 01:
Well what happened is on cross-examination the door was opened by Mr. Groombridge and his team and so we were allowed on redirect to put that evidence in.

[00:20:28] Speaker 00:
What about the fact that the

[00:20:29] Speaker 00:
89 batch records were not disclosed.

[00:20:33] Speaker 00:
Again, how can a trial court rely on documents that were never provided during discovery?

[00:20:40] Speaker 01:
I believe he relied on the two batch records that were in the ABLA to come up with confirmation that the number was less than the .708 and I think he just relied on the others that there were a lot of them done.

[00:20:52] Speaker 00:
But we should assume that we can't rely on those because they were never part of the record, right?

[00:20:58] Speaker 01:
Well I think that the testimony was part of the record and the judge took the testimony of the witness and said there's not clear error for him considering the credibility and the testimony of the witness.

[00:21:11] Speaker 01:
All of this evidence, a lot of this evidence that Mr. Groombridge is discussing was actually elicited by his team.

[00:21:20] Speaker 01:
The water issue on cross-examination with Dr. Wilson came from their own expert who said, I knew about the water and I was a bit worried about it.

[00:21:31] Speaker 01:
They knew about the water.

[00:21:33] Speaker 00:
Again, what they're doing, the only... But wouldn't have known what the water content was and Dr. Dowd's testimony, he admitted he had no first-hand knowledge.

[00:21:46] Speaker 01:
They knew what the water was because they could have figured it out just like he figured it out in the math that he did on APPX 4790.

[00:21:57] Speaker 01:
He walked through the entire process with them.

[00:22:01] Speaker 00:
What does your ABLA mean when it says key process parameters have to be

[00:22:08] Speaker 00:
have to be narrowly controlled but you can see that they can be varied.

[00:22:14] Speaker 00:
So is there any limitation on how far they can be varied?

[00:22:18] Speaker 01:
Well, the question was asked of Dr. Dowd at trial what the KPP means and his answer was, quote, effectively that's a specification upon which we need to maintain the process within for the batch to be acceptable.

[00:22:33] Speaker 01:
And he further said that they would throw it out if it was beyond there.

[00:22:36] Speaker 03:
So what do you make of page 5595?

[00:22:38] Speaker 03:
This is the dash under the acceptance criterion column.

[00:22:46] Speaker 01:
Well, I think that I make the same thing Your Honor said earlier.

[00:22:49] Speaker 01:
If there is no upper limit, then there's also no lower limit, and there's no specification at all.

[00:22:58] Speaker 01:
So then we would be outside of Synovian,

[00:23:01] Speaker 01:
and into Glaxo.

[00:23:03] Speaker 01:
And under Glaxo the court found without any clear error that the batch records reflected that the protein concentration was nowhere near one gram per liter.

[00:23:14] Speaker 01:
But Mr. Groombridge just said in his earlier argument that it wasn't a specification.

[00:23:20] Speaker 01:
So therefore if it isn't a specification according to them, then we are in Glaxo world

[00:23:25] Speaker 01:
where the court specifically found that the protein concentration doesn't meet the one gram per liter.

[00:23:32] Speaker 03:
So maybe I'll ask the question this way, and I might be mischaracterizing Mr. Groombridge, but one version of my understanding of what he says is when it says under the acceptance criterion dash, that is a form of saying anything along these lines is just hunky-dory with us.

[00:23:56] Speaker 03:
So that's a synovian case.

[00:23:58] Speaker 03:
We affirmatively authorize you to do anything you want in this for this row, this item.

[00:24:09] Speaker 03:
And anything you feel like doing is certainly going to include more than one gram per liter.

[00:24:17] Speaker 01:
No, that's not the only testimony that was elicited on the issue was they couldn't exceed it or they would have to throw it out.

[00:24:26] Speaker 01:
The dash itself is speculation from Mr. Groombridge.

[00:24:32] Speaker 01:
There's no testimony on what the dash means.

[00:24:33] Speaker 01:
About what the dash means in this document.

[00:24:35] Speaker 01:
And again, if it means that you can go past it, it means you can go anywhere, either way, so then it's not a spec.

[00:24:43] Speaker 01:
But the court found that you couldn't do that, and that it was a spec, and that we did not infringe.

[00:24:51] Speaker 00:
Again, it's there but... And you agree then that it means that you're not authorized to engage in any conduct that could infringe?

[00:25:01] Speaker 01:
Correct.

[00:25:01] Speaker 01:
The only evidence out there was if it did exceed that, we would have to throw it out because it would be beyond the spec.

[00:25:10] Speaker 01:
That's the only evidence that's in the record.

[00:25:13] Speaker 01:
But if you are allowed to exceed it, then it is not a spec and you go to Glaxo.

[00:25:20] Speaker 01:
and the court found that we don't infringe under black soap.

[00:25:23] Speaker 01:
Again, this is a burden issue, and the court put out in paragraph 32 four different reasons why Amgen did not meet its burden.

[00:25:35] Speaker 01:
Most importantly, its own witness, Dr. Wilson, who said he didn't account for the water.

[00:25:41] Speaker 01:
And again, inclusion bodies is not the right place to look for protein.

[00:25:46] Speaker 01:
The reason why Amgen went there is because when you look at the actual spec for protein, the maximum is .708.

[00:25:55] Speaker 01:
That doesn't help them.

[00:25:57] Speaker 01:
Even with this claim construction, which we assert is not correct, but doesn't matter if you go with our non-infringement position, because it should be two grams per liter and not one, but that's the only thing they argued.

[00:26:10] Speaker 01:
Inclusion bodies equal protein.

[00:26:12] Speaker 01:
And the court looked at that and said,

[00:26:15] Speaker 01:
They did not meet their burden on there because they didn't account for the water.

[00:26:19] Speaker 01:
All of the evidence from Dr. Dowd and Dr. Robinson, they cross-examined them.

[00:26:25] Speaker 01:
They elicited the information themselves.

[00:26:28] Speaker 01:
Mr. Groombridge asked Dr. Dowd something like, so you're saying it's two-thirds water.

[00:26:35] Speaker 01:
That went unrebutted.

[00:26:36] Speaker 01:
All of the evidence with respect to the water went unrebutted.

[00:26:40] Speaker 01:
They never put Dr. Wilson back up to say, no, that's not an accurate calculation.

[00:26:44] Speaker 01:
No, this isn't true.

[00:26:46] Speaker 01:
All of the evidence went unrebutted, and the judge found based on that evidence, they didn't meet their burden.

[00:26:53] Speaker 01:
And there's no clear error here on that issue.

[00:26:57] Speaker 00:
Why does the amount of water matter?

[00:26:59] Speaker 00:
It's really just the question of how much protein there is, right?

[00:27:02] Speaker 01:
Yes, but because they were using inclusion bodies as their basis to show protein, we had to show that it wasn't all protein because that was their argument.

[00:27:12] Speaker 01:
That inclusion bodies were effectively pure protein and therefore it met that claim limitation.

[00:27:18] Speaker 04:
Are they two-thirds water?

[00:27:20] Speaker 01:
They are two-thirds water.

[00:27:23] Speaker 03:
Can I switch topics and just ask you about the other issue?

[00:27:28] Speaker 01:
The two-millimolar?

[00:27:30] Speaker 03:
Yes, the 100 millimolar piece of the construction.

[00:27:36] Speaker 03:
Where does that come from?

[00:27:38] Speaker 01:
Well, it comes from the fact that, as the Court pointed out, there are five places that discuss the issue of the two millimolar.

[00:27:46] Speaker 01:
In every single place, they say it's effectively bounded at 100.

[00:27:52] Speaker 01:
In addition, all of the examples

[00:27:54] Speaker 01:
show nothing more than 20.

[00:27:56] Speaker 01:
There is no disclosure of anything more than 100.

[00:28:01] Speaker 00:
But each of those places refer to a preferred embodiment.

[00:28:07] Speaker 01:
It's the only thing disclosed.

[00:28:09] Speaker 01:
It's not the preferred embodiment.

[00:28:10] Speaker 00:
Well, there have been many cases where there was an alternative not disclosed and we haven't limited the claims in that way.

[00:28:17] Speaker 01:
Right, but in this case, because every time they talk about it,

[00:28:21] Speaker 01:
it is effectively limited by that 100.

[00:28:25] Speaker 01:
Therefore, the court found that was an express definition.

[00:28:29] Speaker 01:
And that's consistent with SIMED, where it's the only thing disclosed, and it is particularized to that one claim term when you're looking at the spec.

[00:28:38] Speaker 01:
It is not the preferred embodiment.

[00:28:40] Speaker 01:
They had 20, they had 14, they had different examples with different numbers.

[00:28:45] Speaker 01:
But every time they talked about it within the spec,

[00:28:49] Speaker 01:
They basically defined it as being bound.

[00:28:51] Speaker 00:
But the claim doesn't have the 100 cap, does it?

[00:28:56] Speaker 01:
No, it doesn't.

[00:28:57] Speaker 00:
All it says is 2 or greater, right?

[00:29:00] Speaker 01:
It says 2 or greater.

[00:29:01] Speaker 01:
So under Phillips, you look to the specification, and you see if there's anything that limits the claim terms.

[00:29:08] Speaker 01:
And the court said it's defined because it's effectively limited at 100 every time it's talked about.

[00:29:14] Speaker 01:
It's not a preferred embodiment.

[00:29:16] Speaker 01:
It is a definition.

[00:29:17] Speaker 03:
Do I understand the relationship among these basically two issues in this case that if you prevail on the one gram per liter, the other issue does not matter?

[00:29:31] Speaker 01:
Correct, Your Honor.

[00:29:32] Speaker 01:
Absolutely.

[00:29:34] Speaker 01:
We only need to not infringe one limitation.

[00:29:37] Speaker 01:
So that is absolutely correct.

[00:29:41] Speaker 01:
I'll address, I think we've addressed the letters.

[00:29:48] Speaker 01:
Again, I think that the real issue here, can we talk about waiver for a moment?

[00:29:54] Speaker 01:
The claim construction issues, the judicial estoppel, and the waiver.

[00:30:00] Speaker 01:
I couldn't tell from Mr. Groombridge's argument.

[00:30:03] Speaker 01:
I'm hearing that he believes the letters are binding.

[00:30:07] Speaker 01:
I think we cited to 104E rule of evidence, which says that a factual finding must be able to be looked at in terms of weight,

[00:30:17] Speaker 01:
and credibility in view of other stuff and therefore could not be binding.

[00:30:22] Speaker 00:
Well, he thinks they're binding in the absence of a motion to amend and a showing of good cause, which you didn't do.

[00:30:28] Speaker 00:
And you had plenty of opportunities to do that, didn't you?

[00:30:31] Speaker 00:
I mean, to show up at trial with a whole new theory that is inconsistent with your patent dance letter seems kind of completely inconsistent with the purpose of the act.

[00:30:42] Speaker 01:
We didn't show up with a whole new theory.

[00:30:44] Speaker 01:
We told them all along that we didn't infringe because

[00:30:47] Speaker 01:
We didn't meet this limitation, and that inclusion bodies contained other stuff besides protein.

[00:30:53] Speaker 01:
That was our answer to every discovery issue, and they took his deposition.

[00:30:58] Speaker 01:
Dr. Dowd specifically said that they contained water in his deposition.

[00:31:04] Speaker 01:
They were on notice of that.

[00:31:05] Speaker 01:
It wasn't a surprise to them.

[00:31:07] Speaker 01:
The court found that it wasn't a surprise to them.

[00:31:10] Speaker 01:
He said they should have known about it.

[00:31:13] Speaker 01:
There's a finding of fact where he says,

[00:31:17] Speaker 01:
that they should have known about the water.

[00:31:20] Speaker 01:
I believe it's 38 or something like that.

[00:31:24] Speaker 01:
They weren't surprised at all.

[00:31:27] Speaker 01:
And in fact, when we get to the issue of the waiver, at the closing argument, Mr. Groombridge said, quote, I would like to be clear.

[00:31:38] Speaker 01:
We are not suggesting that the letters are in some way binding.

[00:31:42] Speaker 00:
That's a waiver.

[00:31:44] Speaker 00:
basically say those letters can be treated as meaningless.

[00:31:48] Speaker 00:
Aren't we acting in a way that's completely inconsistent with the congressional purposes behind the act?

[00:31:57] Speaker 01:
It's no different than the notice letters in Hatch-Waxman.

[00:32:01] Speaker 01:
And I don't think that the court said that they were meaningless.

[00:32:03] Speaker 01:
He viewed them in view of the other evidence and weighed it and said the other evidence was more probative than that.

[00:32:12] Speaker 01:
Again, in the Hatch-Waxman context,

[00:32:14] Speaker 01:
the letters are mandatory and you're allowed to change your positions.

[00:32:18] Speaker 01:
So how can these letters, which are not mandatory, this dance is optional as the Supreme Court said in the Amgen v Sando case, so if these letters are optional, how can you be stuck with this way early on before discovery, before anything happens, when they knew very well what we were arguing and in fact the letter

[00:32:41] Speaker 01:
is incorrect and doesn't even say what they say it says.

[00:32:46] Speaker 01:
It says that there's a concentration of filgrastum, that's the protein of interest.

[00:32:50] Speaker 01:
They're saying it's inclusion bodies, so they're not even making the same argument.

[00:32:55] Speaker 01:
If this court was to say that those letters are binding admissions, it would chill the entire process.

[00:33:01] Speaker 01:
Everybody would look at this and say, there's no way I'm gonna do this optional situation and be bound by this before I take discovery, before I have claim construction,

[00:33:11] Speaker 01:
before anything like that happens.

[00:33:13] Speaker 01:
Under Takeda, as I said, there are mandatory letters, and you're allowed to change your position.

[00:33:19] Speaker 01:
The situation should be no different here.

[00:33:21] Speaker 00:
But even under Takeda, you have to ask to change your position, correct?

[00:33:24] Speaker 01:
No, you don't.

[00:33:25] Speaker 01:
It depends on what court you're in.

[00:33:27] Speaker 01:
If you're in Texas, where they have mandatory disclosures, or in New Jersey, that's true.

[00:33:32] Speaker 01:
In this court, you don't have mandatory disclosures.

[00:33:36] Speaker 01:
We answered their interrogatories.

[00:33:38] Speaker 01:
We answered their request to admit.

[00:33:40] Speaker 01:
They asked us,

[00:33:41] Speaker 01:
if the inclusion bodies met the protein limitation.

[00:33:45] Speaker 01:
And we denied that.

[00:33:46] Speaker 01:
We filed summary judgment that we don't meet it from the inclusion bodies.

[00:33:51] Speaker 01:
They knew exactly what we were doing.

[00:33:53] Speaker 04:
Mr. Gollib, your red light is on.

[00:33:55] Speaker 04:
You haven't taken note of that.

[00:33:57] Speaker 04:
But I'll give you a couple more minutes since we've given Mr. Broombridge more time.

[00:34:02] Speaker 04:
Take two minutes if you need it.

[00:34:05] Speaker 01:
Your Honor, I don't need it.

[00:34:06] Speaker 01:
I think I just need to say that the court

[00:34:09] Speaker 01:
made specific findings that the Amgen did not prove infringement for specific factors and the weight of the evidence should not be overturned.

[00:34:21] Speaker 01:
There is no clear error here.

[00:34:23] Speaker 01:
Thanks very much.

[00:34:25] Speaker 04:
Thank you, Mr. Gallup.

[00:34:26] Speaker 04:
Mr. Groombridge has three minutes for rebuttal.

[00:34:32] Speaker 02:
Thank you, Your Honor.

[00:34:34] Speaker 02:
With respect to

[00:34:38] Speaker 02:
my friend's assertions that they did disclose this theory.

[00:34:44] Speaker 02:
We disagree, but I would point the court to this by way of example, which is page 9605 in the appendix.

[00:34:51] Speaker 02:
It's the deposition of their expert, Dr. Robinson, about one year after

[00:34:56] Speaker 02:
the 3B letter in about three months before the trial.

[00:34:59] Speaker 03:
I'm sorry, but regardless of any of that, you do not have an argument here that this was improperly admitted, that is the new theory, because it wasn't disclosed in an expert report.

[00:35:12] Speaker 03:
I didn't see anything like that.

[00:35:15] Speaker 03:
That's correct.

[00:35:16] Speaker 03:
So your only argument is they said something in the patent dance letters turns out to be false, they say,

[00:35:26] Speaker 03:
We have evidence that it's false.

[00:35:29] Speaker 03:
The district judge said it's false.

[00:35:31] Speaker 03:
I'm going to go with the truth.

[00:35:33] Speaker 03:
What's the problem unless you're making an argument, which I think you're not quite making, that what they said in the patent dance letters is actually legally binding and they're stuck with it even though it's false?

[00:35:44] Speaker 02:
We're certainly not saying it's legally binding and they're stuck with it though it's false.

[00:35:47] Speaker 02:
What we are saying, Your Honor, is that

[00:35:49] Speaker 02:
they should not, under the circumstances of this case, have been allowed simply to repudiate it.

[00:35:54] Speaker 02:
And the district court should not have given it no weight, which is how we read the decision, particularly when it goes to this key contested issue.

[00:36:05] Speaker 02:
And it represents their reading of their own VLA document, which is front and center.

[00:36:11] Speaker 00:
But what's your response to your friend on the other side saying that they actually responded to your interrogatory request

[00:36:19] Speaker 00:
and denied that your reading of their ABLAs is accurate.

[00:36:25] Speaker 02:
We disagree, and I'm not sure what my friend is talking about.

[00:36:28] Speaker 02:
I would say that to my knowledge, and certainly what's in the record before this court, there is no such assertion.

[00:36:36] Speaker 02:
The summary judgment papers, the summary judgment motion to which he alluded, was based on a theory, a different theory of non-infringement, that the minimum protein concentration had to be just the protein of interest.

[00:36:48] Speaker 02:
He therefore grasped

[00:36:49] Speaker 02:
not all protein and that certainly was framed it was the subject of summary judgment motion which we prevailed right it's not the theory that they then unveiled a trial and on which the district court decided it and I would just read here's a question and answer from this deposition question what's in those inclusion bodies that's not a protein of some form answer there can be membranes cell membranes lipids no mention of water there was not one point

[00:37:17] Speaker 02:
to our knowledge, and certainly in the record here, where somebody said, oh, these things are two-thirds water.

[00:37:24] Speaker 02:
And that was the fundamental problem.

[00:37:26] Speaker 02:
And, Judge Toronto, just one final point.

[00:37:30] Speaker 02:
To talk about the Glaxo versus Cenovian issue, in our view, the proper reading of the BLA is 0.9 to 1.4.

[00:37:38] Speaker 03:
Let me just ask you very specifically.

[00:37:39] Speaker 03:
Did you have evidence about the meaning of the dash?

[00:37:43] Speaker 03:
in that column on fifty five ninety five.

[00:37:45] Speaker 03:
I believe there is no evidence, there's no testimony that says what that dash means.

[00:37:49] Speaker 03:
Isn't that, I mean I guess it feels to me like that's what your case on that rests on and yet you don't have evidence.

[00:37:55] Speaker 03:
You're asking us to say this dash means we the FDA recognize that there is this process parameter we hereby affirmatively authorize you to do anything you want on that process parameter but I'm hearing it just from you not from evidence.

[00:38:12] Speaker 02:
Well, Your Honor, I would direct the Court to page 6725, where it's talking about a key process parameter.

[00:38:22] Speaker 02:
It says, if the acceptable range is exceeded, it may affect the process, e.g.

[00:38:28] Speaker 02:
yield duration, but not product quality.

[00:38:32] Speaker 02:
That says you can exceed it.

[00:38:36] Speaker 04:
Thank you, Mr. Groombridge.

[00:38:38] Speaker 04:
We will take the case under revisement.

[00:38:39] Speaker 04:
Thank you, Your Honor.