[00:00:00] Speaker 01:
Our case this afternoon is 151335, AstraZeneca versus Breath Limited, Mr. Sipes.

[00:00:13] Speaker 06:
Thank you, Your Honor.

[00:00:14] Speaker 06:
This is Christopher Sipes on behalf of AstraZeneca, plaintiff in the matter below.

[00:00:19] Speaker 06:
Your Honor, we believe this is a somewhat unusual case.

[00:00:23] Speaker 06:
This is a case in which the desirability of the claimed product was well-known and well-established.

[00:00:30] Speaker 06:
And the challenge in the claim to invention was achieving it, was being able to make it.

[00:00:34] Speaker 06:
And what we have here is extraordinary evidence, objective indicia, that the product could not be achieved in the prior art.

[00:00:44] Speaker 06:
We have, for example, a long record of failure by AstraZeneca and by others.

[00:00:50] Speaker 06:
We have an acknowledgment by defendants' own expert about why it was

[00:00:56] Speaker 06:
that there was so much failure.

[00:00:58] Speaker 06:
She said.

[00:00:58] Speaker 01:
OK, well, let me just stop you there, because what one might say is extraordinary about this case, and I assume you've been on the other side of this, where a district court does 165 pages of fact-finding, goes through the testimony of perhaps not all of the 29 witnesses, but a large number of those witnesses.

[00:01:18] Speaker 01:
So tell us where.

[00:01:20] Speaker 01:
I mean, tell us what was wrong with what she did, because most of it is a deferential standard of review.

[00:01:26] Speaker 01:
And she did enormously detailed stat findings on most of the areas you're touching on, right?

[00:01:31] Speaker 06:
Yes, Your Honor.

[00:01:31] Speaker 06:
No, this Court has held, and it's correct, that the way in which objective considerations are evaluated can be reviewed, you know, as a matter of law.

[00:01:40] Speaker 06:
For example, the Allergan v. Apotex case.

[00:01:43] Speaker 06:
There were two issues here that were sort of controlling legal issues.

[00:01:47] Speaker 06:
And we believe with all due respect to the district court, and with some inducement from defendants, she got them both wrong.

[00:01:53] Speaker 06:
The first had to do with whether or not the objective indicia, the record, for example, of commercial success, of long felt need, and candidly of failure, was negated because it was being driven by FDA and regulatory requirements to enter the market at all, rather than the explicit consumer demand.

[00:02:15] Speaker 01:
Maybe so, that's one way of looking at it perhaps, but it's not, one could argue, but it's not so much that she negated it, it's just she said that if, that's not the be all and end all, that can't possibly be, you know, the FDA requirement can't govern it or everything, every commercial success.

[00:02:35] Speaker 01:
that derives from an FDA approval would automatically give you enough to upset an obvious NIMS chronic patient determination.

[00:02:44] Speaker 01:
So what did she actually do about the FDA?

[00:02:47] Speaker 06:
So for example, here are some of her statements to make it clear how she handled it at A139 in discussing Longfellow's needs.

[00:02:55] Speaker 06:
It is true, as Asia has claimed, that a sterile product may have been preferred based on health risks.

[00:03:01] Speaker 06:
Yet the evidence conclusively demonstrates that,

[00:03:04] Speaker 06:
Had the FDA determined that Pulmicor rescues could be sold in the US without being sterile, the unmet need would have been met.

[00:03:11] Speaker 06:
So she therefore discounted the long felt need and the fact that Pulmicor was the first product to meet that need.

[00:03:19] Speaker 06:
That was a legal error.

[00:03:21] Speaker 00:
The fact that the long felt need being the felt need for sterility, the felt need for the product which, per the FDA, had to be sterile.

[00:03:32] Speaker 06:
What was needed, the long felt need, was for an FDA approved nebulized corticosteroid to be FDA approved, to be available on the market.

[00:03:41] Speaker 06:
It had to be sterile.

[00:03:42] Speaker 06:
And there was agreement by both plaintiff and defendant's experts that FDA's push for sterility dated back to the 1980s.

[00:03:49] Speaker 06:
And you'll notice, for example, on page A31, in her opinion, she cites to a Lachman reference from 1986 as describing the benefits of sterility.

[00:03:58] Speaker 06:
So the need for nebulized corticosteroids in order to come on the market is an FDA-approved product.

[00:04:05] Speaker 00:
You say nebulized, but nebulized is not one of the claim limitations.

[00:04:12] Speaker 00:
That is correct.

[00:04:13] Speaker 00:
So in terms of the claim limitations,

[00:04:16] Speaker 00:
Where is the long felt need for a sterile product, which I take it really is the only thing that was different about this product?

[00:04:27] Speaker 06:
A nebulized corticosteroid is an inhaled suspension.

[00:04:31] Speaker 00:
I understand.

[00:04:31] Speaker 00:
But that wasn't what the claims required.

[00:04:35] Speaker 06:
To be a nebulized corticosteroid would require it to be pharmaceutically acceptable, highly pure, and sterile.

[00:04:43] Speaker 06:
That is what the claim is drawn to.

[00:04:45] Speaker 00:
Right, if the claim was drawn to nebulized steroids, but it's not.

[00:04:52] Speaker 00:
So where's the long felt need per the claim?

[00:04:57] Speaker 06:
The long felt need would have been in the pharmaceutical industry.

[00:05:00] Speaker 06:
In order to meet the desire for a inhaled corticosteroid suspension, a nebulized corticosteroid, one would have to develop a pharmaceutically acceptable, highly pure sterile micronized corticosteroid

[00:05:14] Speaker 06:
suspension.

[00:05:15] Speaker 06:
That is what a nebulized corticosteroid suspension is.

[00:05:19] Speaker 06:
It is highly pure, pharmaceutical acceptable, and sterile.

[00:05:24] Speaker 06:
The issues and their own experiment is the issue with achieving that was the rate limit was sterility.

[00:05:30] Speaker 06:
So the claim limits are drawn specifically to the challenge in the art.

[00:05:36] Speaker 06:
And what is claimed is precisely what was needed.

[00:05:42] Speaker 06:
In order to provide nebulized therapy to young children, one would need a micronized corticosteroid suspension.

[00:05:49] Speaker 01:
Well, but you're not saying that that's what actually drove demand.

[00:05:53] Speaker 01:
You're saying that because you couldn't have gotten the product in the market here in the US without it, it inferentially drove demand?

[00:06:01] Speaker 01:
Is that your theory?

[00:06:03] Speaker 06:
Well, more than that, Your Honor.

[00:06:06] Speaker 06:
Both the success of the product and the long felt need resulted from meeting FDA requirements.

[00:06:12] Speaker 06:
That has been the limiting step of entering the market in the U.S.

[00:06:16] Speaker 06:
to provide

[00:06:18] Speaker 01:
So you want us to say, as a matter of law, if one of the steps of the claim are what was necessary to assure or to secure FDA approval, then by definition, it's satisfying unmet needs and commercial success?

[00:06:35] Speaker 06:
No, Your Honor, this is slightly different than that.

[00:06:36] Speaker 06:
This is a case in which the FDA requirement, sterility is an element of the claim, is the element of the claim,

[00:06:44] Speaker 06:
that their own expert admitted is the rate limiting step to achieving success.

[00:06:50] Speaker 06:
This is not, for example, if one has a formulation patent and one comes in the market and achieves success, well, FDA doesn't require specific formulations, specific excipients.

[00:07:00] Speaker 06:
There's no nexus necessarily in that way.

[00:07:03] Speaker 06:
This is different.

[00:07:05] Speaker 06:
This is a case in which the barrier and the express requirement is exactly what was in the claims.

[00:07:12] Speaker 06:
It had to be sterile.

[00:07:13] Speaker 06:
highly pure, and pharmaceutically acceptable.

[00:07:15] Speaker 06:
Those three things at the same time.

[00:07:17] Speaker 06:
That's what's claimed.

[00:07:19] Speaker 06:
That was the rate-limiting step.

[00:07:21] Speaker 06:
That's what was needed in order to obtain an FDA-approved product.

[00:07:24] Speaker 06:
So there was a long-held need for that highly pure, pharmaceutically acceptable sterile suspension.

[00:07:31] Speaker 00:
Well, now, the FDA actually didn't impose the requirement of sterility, I take it, with specific reference to this product until

[00:07:42] Speaker 00:
pretty shortly before you came up with the sterile product, right?

[00:07:46] Speaker 06:
And we think that further illustrates our point.

[00:07:48] Speaker 06:
So FDA was pushing for sterility from well before, but the problem was it did not appear achievable with suspensions.

[00:07:55] Speaker 06:
There are many technical difficulties.

[00:07:57] Speaker 06:
The FDA recognized those difficulties in making the suspension.

[00:08:01] Speaker 04:
It was not achievable.

[00:08:06] Speaker 04:
Don't you really mean it was not easily achievable on a commercial scale, a large scale?

[00:08:15] Speaker 04:
Because certainly it was achievable on a smaller scale, a laboratory scale.

[00:08:20] Speaker 06:
I don't believe that's correct and I don't believe the record shows any laboratory trials which succeeded either.

[00:08:25] Speaker 06:
To the contrary, AstraZeneca's own efforts, which would have included the research efforts by some of the scientists here, failed with everything.

[00:08:33] Speaker 06:
O'Neill, in the O'Neill patent, there's an effort to make it do sterile filtration.

[00:08:38] Speaker 06:
That failed for O'Neill.

[00:08:40] Speaker 06:
There is no record of success with any of the methods in the past, regardless of scale.

[00:08:48] Speaker 00:
What do you say is missing from the Bratzan patent?

[00:08:51] Speaker 00:
Is that just the question of purity as opposed to serility?

[00:08:56] Speaker 00:
Because that was a pharmaceutical composition of a suspension, if I recall correctly, which was sterile.

[00:09:06] Speaker 06:
The Bratzan patent was the 76th, one of the early composition patents

[00:09:13] Speaker 06:
And what was described there was a research effort that shows a suspension for injection.

[00:09:18] Speaker 06:
There's no indication that it was sterile, although injections on a commercial scale would be sterile.

[00:09:24] Speaker 06:
We don't know what was it.

[00:09:25] Speaker 06:
It doesn't expressly say sterile.

[00:09:27] Speaker 06:
It's a research effort.

[00:09:28] Speaker 06:
There's no indication that that example was on the market as a sterile product.

[00:09:34] Speaker 06:
We don't know what the purity was.

[00:09:36] Speaker 06:
We don't even know if it was pharmaceutically acceptable.

[00:09:39] Speaker 06:
If you look at that patent,

[00:09:40] Speaker 06:
The entire disclosure is simply a reference to a steroid suspension for injection.

[00:09:45] Speaker 06:
We don't know how, if it was sterilized, how it was sterile, what the purity was.

[00:09:50] Speaker 06:
And remember, one of the issues here is take moist heat.

[00:09:54] Speaker 06:
The evidence is very clear that moist heat degrades budessinide.

[00:09:58] Speaker 06:
In fact, defendants themselves.

[00:10:00] Speaker 06:
Breath in its patent referenced using standard moist heat, and there was too much degradation that would move it outside the claimed limits of our patents.

[00:10:10] Speaker 06:
For all we know, there was moist teeth, because degradation, there isn't even a reference to purity.

[00:10:16] Speaker 06:
We don't know what was done in that patent.

[00:10:19] Speaker 06:
But we do know that it doesn't disclose any purity level, whether it was pharmaceutically acceptable.

[00:10:24] Speaker 06:
It doesn't even reference sterility.

[00:10:26] Speaker 06:
But if it was sterilized, for example, with moist teeth, that might be fine for research perspectives.

[00:10:30] Speaker 06:
But it doesn't overcome the challenge here, which is to be highly pure, sterile, and pharmaceutically acceptable.

[00:10:36] Speaker 06:
And moist teeth is a very standard sterilization technique, but the O'Neill

[00:10:41] Speaker 06:
of moist teeth.

[00:10:42] Speaker 06:
The standard autoclaving doesn't work.

[00:10:45] Speaker 06:
And that's not just me saying that.

[00:10:46] Speaker 06:
That's what Brett Watson said in their patent.

[00:10:50] Speaker 06:
They tried it.

[00:10:51] Speaker 06:
They experimented with moist teeth.

[00:10:53] Speaker 06:
And they concluded moist teeth created too much degradation.

[00:10:57] Speaker 06:
So what we have here is a situation where we actually have evidence of what happened with each of these prior art methods.

[00:11:04] Speaker 06:
And each one failed.

[00:11:06] Speaker 06:
And in fact, we as Seneca came into FDA

[00:11:10] Speaker 06:
and reviewed that with FDA, not just looking forward to what we would do, but what we had done.

[00:11:15] Speaker 00:
What about Preferred, if that's the right pronunciation?

[00:11:20] Speaker 06:
I believe it's Preferred, but it's a Scandinavian product, and I don't want to... So Preferred was in the early 80s, and it was made... It's very clear that it was made through... There was an ethylene oxide process applied to that, and that was actually in the prosecution history

[00:11:39] Speaker 06:
And there was evidence of... So it was sterile.

[00:11:42] Speaker 06:
Well, it's not clear.

[00:11:44] Speaker 06:
It was labeled sterile.

[00:11:46] Speaker 00:
At that time, and this is set forth... It's your product, and your company is calling it sterile.

[00:11:51] Speaker 00:
That's a pretty good indication.

[00:11:53] Speaker 00:
At least you believe it's sterile then.

[00:11:55] Speaker 00:
Well, yes.

[00:11:55] Speaker 06:
And then what happened is two concerns were raised.

[00:11:59] Speaker 06:
One was the residues, and the other was, can the ethylene oxide penetrate to kill microorganisms

[00:12:06] Speaker 06:
inside the powder.

[00:12:08] Speaker 00:
Now that's a very factual question, and Judge Bum found with respect to both of those that these were soluble problems under the prior law, right?

[00:12:16] Speaker 06:
Well, with all due respect to Judge Bum, I believe what she found is there was a reasonable expectation of success.

[00:12:23] Speaker 06:
That's not the same as saying actual success.

[00:12:27] Speaker 06:
We think that there are two requirements to be shown, and this is standard law.

[00:12:33] Speaker 06:
You need to show both a motivation to combine

[00:12:36] Speaker 06:
to achieve the claimed invention and a reasonable expectation of success.

[00:12:40] Speaker 06:
We think the court and the defendants urging erroneously overlooked the first element and looked only at reasonable expectation without actually asking the first question, which is, does it achieve success?

[00:12:56] Speaker 06:
And there is no evidence.

[00:12:57] Speaker 01:
Tell me again, you're saying that the motivation to combine requires a showing that you actually could achieve success with absolute certainty?

[00:13:08] Speaker 06:
What it requires is showing that the combination achieves the claimed invention.

[00:13:13] Speaker 06:
The test is that a post-up would have been motivated to combine the teachings of the prior references

[00:13:20] Speaker 06:
to achieve the claimed invention, it is defendant's burden to show that the combination, for example, O'Neill moist heat and budessinide, achieves the claimed invention.

[00:13:30] Speaker 00:
But we know that moist heat is a workable solution to the problem, because that's why we're here.

[00:13:39] Speaker 00:
Moist heat are sterile filtration, right?

[00:13:42] Speaker 06:
Your Honor, I actually know that the testing on the prior moist heat

[00:13:47] Speaker 06:
showed that there was degradation and you didn't meet the 98.5.

[00:13:52] Speaker 00:
No, but a moist heat methodology did achieve the invention.

[00:13:57] Speaker 00:
That's why we have an infringement, actually.

[00:14:00] Speaker 06:
That's right, but that moist heat process is not the prior art moist heat.

[00:14:04] Speaker 00:
For example, Apotex... Well, if it had been the prior art moist heat, of course we'd have anticipation.

[00:14:09] Speaker 00:
But the question is, does the combination of the prior art directions towards using moist heat plus the skill of a person of ordinary skill in the art yield a successful process?

[00:14:24] Speaker 00:
And we do know that there was a successful process.

[00:14:27] Speaker 00:
Therefore, that part of your argument, it seems to me, at least with respect to moist heat and sterile filtration, goes away.

[00:14:33] Speaker 06:
Your Honor, if the moist heat

[00:14:35] Speaker 06:
that the defendant was using was the priority.

[00:14:37] Speaker 06:
That would be obvious because the priority does not teach applying moist teeth to budesonide.

[00:14:42] Speaker 06:
But in that case, they acknowledge, or I think they've admitted in their evidence that it's not.

[00:14:48] Speaker 06:
For example, aptotechs specifically refer to

[00:14:52] Speaker 06:
They are moist heat processes innovative.

[00:14:54] Speaker 06:
That's A8694.

[00:14:56] Speaker 06:
And if you look at it, it's lower temperature.

[00:14:59] Speaker 06:
It's shorter period of time.

[00:15:00] Speaker 06:
It's much less water.

[00:15:02] Speaker 06:
Actually, we think, generally, it looks more like the low dry heat that we discovered.

[00:15:06] Speaker 06:
But it doesn't matter.

[00:15:08] Speaker 06:
None of them has put on evidence to say the moist heat process they're doing is the priority.

[00:15:12] Speaker 06:
It's not O'Neill, which is the combination they urged.

[00:15:16] Speaker 06:
O'Neill, we know.

[00:15:18] Speaker 06:
This is what the district court said at A84.

[00:15:21] Speaker 06:
She acknowledged, for example, that Brecht's own MacArthur patent suggests that moist heat sterilization causes unacceptable degradation.

[00:15:31] Speaker 06:
But she said she rejected this evidence because it has no persuasive value as the question is what was known prior to 1997.

[00:15:38] Speaker 06:
That's at A84.

[00:15:40] Speaker 06:
And again, A85.

[00:15:42] Speaker 06:
There is no evidence prior to 97 warning a post that that's not willing to lead to grave.

[00:15:47] Speaker 06:
So we think that the key point, Your Honor, is the discounting of the failures of the long-felt need and the commercial success, because that requirement of sterility, which is in the claim, the ability to achieve sterile, highly pure pharmaceuticals, which is in the claim, came about through pressure from FDA and was a barrier to getting on the market.

[00:16:09] Speaker 06:
And we think that was a legal error to discount the objective considerations on the basis that they were coming from the regulatory agency.

[00:16:17] Speaker 01:
Okay.

[00:16:19] Speaker 01:
You're a minute over.

[00:16:20] Speaker 01:
We'll restore two minutes of your rebuttal time and we'll try to even it out.

[00:16:25] Speaker 01:
So you're all set on dividing time?

[00:16:28] Speaker 01:
Yes, Judge.

[00:16:30] Speaker 03:
William Rocosi on behalf of Watson and Brett.

[00:16:33] Speaker 03:
The court should affirm the judgment of the district court after got the broad construction it wanted and now it doesn't want to live with the prior consequences that are set forth, as your honor mentioned, in very detailed fact findings.

[00:16:44] Speaker 03:
that are based on admissions of Astra, credibility determination.

[00:16:48] Speaker 01:
What about the main argument that your friend seems to make about the commercial success and long-term need with regard to her discounting or not, I don't know how much emphasis they would rely on, the FDA approval?

[00:17:05] Speaker 01:
If they couldn't put it on the market here without the sterility component, so isn't that it?

[00:17:12] Speaker 01:
So they get a re-achieved sterility and it's on the market, case closed.

[00:17:16] Speaker 01:
There's your nexus, right?

[00:17:17] Speaker 03:
We would disagree, Your Honor, two points to that.

[00:17:20] Speaker 03:
Number one, she did not discount FDA approval.

[00:17:23] Speaker 03:
She just refused to stop there.

[00:17:25] Speaker 03:
She took the extra step and actually delved into what is satisfying that need, what is the need, what's satisfying it, what's driving the success.

[00:17:34] Speaker 01:
Nobody disputes.

[00:17:35] Speaker 01:
They could not have gotten on the market without needing the sterility component, right?

[00:17:40] Speaker 03:
Well, as of right now in the record, the FDA said we expect it to be sterile because everything else is sterile.

[00:17:46] Speaker 03:
So there's no skepticism there either.

[00:17:48] Speaker 03:
But back to Your Honor's commercial success and need point, the district court didn't refuse to consider it.

[00:17:53] Speaker 03:
She just refused to apply a legal rule that FDA approval requirements automatically satisfy nexus and commercial success.

[00:18:01] Speaker 00:
And the problem- Let me follow up on the Chief Judge's question.

[00:18:05] Speaker 00:
I suppose that the FDA had imposed this requirement 10 years early.

[00:18:09] Speaker 00:
Everything else is the same.

[00:18:10] Speaker 00:
And it took 10 years.

[00:18:12] Speaker 00:
for somebody to come up with a sterilization protocol that would satisfy the FDA.

[00:18:18] Speaker 00:
Would that then, would you agree that that constitutes Longfell's unmet need?

[00:18:23] Speaker 00:
Everybody wants in the market.

[00:18:25] Speaker 00:
It's a highly, let's stipulate, it's a highly valuable asset to have.

[00:18:33] Speaker 00:
Everybody wants him and only AstraZeneca comes up with it.

[00:18:37] Speaker 00:
Longfell's need?

[00:18:39] Speaker 03:
Well, but if it's commensurate in scope with the claims, as Your Honor mentioned during the earlier argument, so here's just a broad powder and suspension claim.

[00:18:48] Speaker 03:
If, for example, no one was able to make a sterile steroid suspension for a decade, then that could weigh in favor of the analysis.

[00:18:56] Speaker 03:
But that was the point I wanted to mention, Your Honor.

[00:18:58] Speaker 03:
There had been sterile steroids.

[00:18:59] Speaker 03:
for 50 years prior to this invention, dozens of them had been sterilized and in fact using the ETO method that you just heard disparage yet again, ophthalmic steroids, things that you put in your eye had been successfully sterilized.

[00:19:15] Speaker 00:
I'm sorry.

[00:19:17] Speaker 00:
I'm dropping down into the acronym.

[00:19:18] Speaker 00:
Ethylene oxide.

[00:19:19] Speaker 00:
Yes, sir.

[00:19:20] Speaker 00:
Ethylene oxide.

[00:19:21] Speaker 00:
It's called EO in the brief.

[00:19:22] Speaker 03:
Yes, I apologize.

[00:19:23] Speaker 03:
EO had been used for five decades before this invention.

[00:19:27] Speaker 03:
And in fact, even in the 1990s and today, it's continually being used to make sterile steroid suspensions, number one.

[00:19:34] Speaker 03:
Number two, Preferred wasn't that successfully sterilized.

[00:19:37] Speaker 00:
I guess none of you use that system, right?

[00:19:40] Speaker 03:
We did not, but the defendants used other prior art methods.

[00:19:44] Speaker 00:
That's not one of them that has been used commercially.

[00:19:48] Speaker 03:
not on bidesonide, except in 1980 it was used commercially with bidesonide.

[00:19:53] Speaker 03:
In 1994, the mid-90s, ethylene oxide was used commercially with other sterile steroids.

[00:19:59] Speaker 03:
So to follow up on your honor's hypothetical, we don't have that here.

[00:20:03] Speaker 03:
We have in the arts dozens and dozens of successes of sterile steroids using all kinds of methods, EO, irradiation for Preferred and other sterile steroids,

[00:20:15] Speaker 03:
The defendants all succeeded.

[00:20:17] Speaker 03:
That is undisputed in this record.

[00:20:19] Speaker 03:
I think it's very telling that no one that actually tried to make a sterile bidesonide and get FDA approval ever failed.

[00:20:27] Speaker 03:
Each defendant succeeded, and they did it with prior art methods.

[00:20:30] Speaker 03:
For example, like sterile filtration, the oldest of all of them.

[00:20:34] Speaker 03:
Their own expert, Dr. Williams, admitted that Watson's supplier uses a method that is identical to that found in the prior art, all the standard methods found in that 1994 FDA guide.

[00:20:45] Speaker 03:
He described it as a very old method and one that's been long known in the art.

[00:20:49] Speaker 03:
other parties succeeded with prior art methods.

[00:20:53] Speaker 03:
So we don't have those failures of others in the art.

[00:20:56] Speaker 03:
We don't have skepticism on FDA's part because they expected it to be sterile.

[00:21:00] Speaker 03:
They said, it better be.

[00:21:02] Speaker 03:
It would be unprecedented not to have one.

[00:21:04] Speaker 00:
And that's perfectly consistent with the way... Although they added that if you can't do it, we'll give you a pass.

[00:21:09] Speaker 03:
They did.

[00:21:10] Speaker 00:
They said if you... And that seems to be... It indicates at least that the FDA was agnostic as to the prospects of sterilization.

[00:21:17] Speaker 03:
I think the record shows they weren't agnostic because even their own witness, Mr. Mathers, testified that FDA wasn't skeptical and that they thought, in fact, it was possible.

[00:21:26] Speaker 00:
And if you look at the way the art had advanced by that... I would classify it according to the record, Your Honor, that they acknowledged the difficulties of a suspension.

[00:21:42] Speaker 03:
But we have to look at that in context and not in a vacuum when FDA is looking and seeing that no one has ever failed to make a steroid suspension.

[00:21:51] Speaker 03:
everyone had succeeded up until that point.

[00:21:53] Speaker 03:
And FDA didn't even know about Preferred where Astra had succeeded back in 1980.

[00:21:58] Speaker 03:
And again, the fact findings have not been challenged.

[00:22:01] Speaker 03:
And I think that's very important here that you don't even see the words clear air in their papers except in footnotes.

[00:22:07] Speaker 03:
And this court's made clear over and over that that's a waiver of the right to even challenge those facts.

[00:22:13] Speaker 03:
Now, to get to the Chief Judge Pro's point again, my second point on commercial success

[00:22:18] Speaker 03:
analysis is this court's case law says you want to look at objective indicia to avoid the hindsight trap.

[00:22:25] Speaker 03:
And that's very important for the court to look at it.

[00:22:28] Speaker 03:
But here, if we look at this record, there is no possibility of hindsight.

[00:22:32] Speaker 03:
When there are admissions by all of their experts in the record that everyone wanted to sterilize B. destini, number one.

[00:22:39] Speaker 03:
Number two, admissions that you would have a strong motivation to use the conventional sterilization methods, again, admitted,

[00:22:45] Speaker 03:
And then for two of the methods, sterile filtration and moist heat, their own experts, Dr. Williams and Dr. Akers, admitted the skilled person would have a reasonable expectation of success in creating and achieving the sterile product using those methods.

[00:22:59] Speaker 03:
So we don't have that same issue of we need these secondary considerations to avoid hindsight.

[00:23:05] Speaker 03:
There is no hindsight.

[00:23:07] Speaker 03:
Motivation to combine to achieve all of the art combinations, all admitted here.

[00:23:12] Speaker 03:
And there is no actual success standard.

[00:23:15] Speaker 03:
They want to manufacture a legal air saying that somehow the judge failed to require actual success in the art.

[00:23:21] Speaker 03:
Well, we believe there was actual success in the art with Preffrid and Braxton and the dozens of sterile steroids.

[00:23:28] Speaker 03:
The fact of the matter, the standard is reasonable expectation of success to achieve that claimed sterile product.

[00:23:36] Speaker 03:
And again, we have fact finding after fact finding on not just one method, but four methods.

[00:23:41] Speaker 03:
And this is a product claim.

[00:23:42] Speaker 03:
So we only have to show any way to make it

[00:23:45] Speaker 03:
The district court found there are at least four ways to make it successfully to the skilled person's eyes or any combination thereof.

[00:23:53] Speaker 03:
So we believe there was well more than enough here and not even an attempt to show clearly erroneous.

[00:23:59] Speaker 03:
And again, my last comment, Your Honor, we have to be careful with this commercial success and FDA approval requirement issue.

[00:24:06] Speaker 03:
And I would point, I believe it's the Gao case or Cao case that Judge Lin, where

[00:24:12] Speaker 03:
You were dealing, or the court was dealing with secondary considerations, commercial success, and need in dealing with evidence that was coming in on an approved FDA product, Opana ER, that embodied the claims.

[00:24:24] Speaker 03:
Now, the court looked at that and didn't stop with FDA approval, Opana ER, and sales.

[00:24:29] Speaker 03:
The court went a step further and said, we really need to see though what's actually driving that success.

[00:24:34] Speaker 03:
We're not going to stop there.

[00:24:37] Speaker 03:
And in that case, what would have had to go differently if FDA approval was the end all be all.

[00:24:41] Speaker 03:
Now, we acknowledge FDA approval.

[00:24:43] Speaker 03:
The court looked at it.

[00:24:44] Speaker 03:
But you can't stop there.

[00:24:45] Speaker 03:
You have to drop down and see what was the claimed feature that's not in the prior art driving success.

[00:24:52] Speaker 03:
And there's no contest here.

[00:24:54] Speaker 03:
Sterility was not driving success.

[00:24:56] Speaker 03:
Physicians don't prescribe this drug because of sterility.

[00:25:00] Speaker 03:
And the need identified by their own expert, Dr. Varelli, wasn't for a sterile product.

[00:25:04] Speaker 03:
It was just for a nebulized product.

[00:25:06] Speaker 03:
And beyond a shadow of a doubt, we have a perfect test case that we know Sterile is not responsible for success or satisfying need, because non-sterile bidesonide was fabulously successful overseas.

[00:25:18] Speaker 03:
It was prescribed by their own expert to her own patient.

[00:25:21] Speaker 03:
It was used in the US clinical trials.

[00:25:23] Speaker 03:
So Sterile had nothing to do with what was going on here and driving or satisfying need.

[00:25:29] Speaker 03:
And with that, Your Honor, I believe I don't want to cut into all my

[00:25:32] Speaker 03:
College time.

[00:25:33] Speaker 01:
Actually, you've still got two minutes on your clock.

[00:25:35] Speaker 01:
We've been running them individually.

[00:25:37] Speaker 01:
One minute.

[00:25:38] Speaker 01:
Oh, I apologize, Your Honor.

[00:25:42] Speaker 03:
Feel free to sit down.

[00:25:42] Speaker 03:
I can take it, Your Honor.

[00:25:44] Speaker 03:
Once there's any other questions, I will yield my time to my colleagues.

[00:25:47] Speaker 03:
Thank you.

[00:25:57] Speaker 02:
May it please the court?

[00:25:58] Speaker 02:
Taras Gracie of Stepton Johnson on behalf of Sandoz.

[00:26:01] Speaker 02:
I wanted to talk specifically about the moist teat sterilization process and with specific regard to O'Neill.

[00:26:09] Speaker 02:
That's a patent that issued in 1976 and what O'Neill teaches is O'Neill teaches a method of using the commercial moist teat sterilization process but it saturates it with a sodium chloride solution and what O'Neill then states is

[00:26:24] Speaker 02:
After step A, which is the first step where the moist heat sterilization is used, or they call it autoclaving or steam sterilization.

[00:26:30] Speaker 02:
It's all the same.

[00:26:33] Speaker 02:
It said that analytical studies, including infrared analysis, indicated intact dexamethasone acetate with no decomposition, even after autoclaving the steroid sodium chloride mixture in step A for one hour at 121C.

[00:26:46] Speaker 02:
Now, that's very important because what we heard from AstraZeneca's council is, well, there's other art that says that O'Neill doesn't work.

[00:26:54] Speaker 02:
Well, that's not correct or that it results in impurities.

[00:26:57] Speaker 02:
O'Neill itself says that there are no degradation, that there's no decomposition.

[00:27:02] Speaker 02:
But how does AstraZeneca back up its statement?

[00:27:05] Speaker 02:
They look at two post-ART patents.

[00:27:07] Speaker 02:
We have to keep in mind the critical date is in 1997, and O'Neill was in 1976, so 21 years before the critical date.

[00:27:15] Speaker 02:
They look to Bernini, the Bernini patent, and they look to McCaffer, both of which use steroids is true.

[00:27:22] Speaker 02:
But both just said they simply used the standard moist heat sterilization process known in the art.

[00:27:29] Speaker 02:
That's not O'Neill.

[00:27:30] Speaker 02:
O'Neill autoclaves at 121C for 20 to 30 minutes.

[00:27:35] Speaker 02:
But it's autoclaving a steroid solution that's been saturated with sodium chloride.

[00:27:40] Speaker 02:
And that's critical.

[00:27:41] Speaker 02:
That's what the district court stated when it evaluated defendant's expert Ms.

[00:27:47] Speaker 02:
Moldenhauer and found her testimony to be convincing.

[00:27:50] Speaker 02:
Dr. Williams himself admitted to me that if he was a post in 1997 looking at the prior art and he read O'Neill, he would swap in Budestanide and you'd have a reasonable expectation of success.

[00:28:02] Speaker 02:
That's the plaintiff's own expert who said that.

[00:28:04] Speaker 02:
And with regard to, again, Bernini and McCaffer, all they say is they use the wet steam process under conditions similar.

[00:28:14] Speaker 02:
And I think what they're trying to do is create some kind of

[00:28:17] Speaker 02:
operability argument, or perhaps say the prior art is not enabling.

[00:28:19] Speaker 02:
That's a heavy burden for them to meet.

[00:28:21] Speaker 02:
Prior art is presumed to be enabled.

[00:28:23] Speaker 02:
And yet, did the district court analyze this?

[00:28:27] Speaker 02:
Yes, they did.

[00:28:28] Speaker 02:
And what Judge Baum said throughout her 166-page opinion was that A, she didn't find the AstraZeneca's witness credible, other than Dr. Williams on this point, but B, this is just a vague statement about similar conditions, not the precise conditions, and neither McCaffer

[00:28:45] Speaker 02:
Norm Bernini actually go through what is in step A of O'Neill, and then come to the conclusion that, well, if we moist eat sterilized, we end up with some degradation.

[00:28:55] Speaker 00:
Are you going to talk about sterile filtration, or is your colleague going to talk about that?

[00:29:01] Speaker 02:
Well, I could yield back some time to Mr. O'Cozy, because that was more his issue.

[00:29:05] Speaker 00:
OK, well, that's all right.

[00:29:07] Speaker 00:
And if you want to give it a shot,

[00:29:11] Speaker 00:
Well, you can tell me what you want to say about it, and if you don't want to say anything about it, that's fine.

[00:29:17] Speaker 02:
Sure, I'm happy to say, well, here's what I'll say about it.

[00:29:19] Speaker 02:
First of all, you know, sterile filtration was known and set forth.

[00:29:22] Speaker 02:
It's been a long-used process.

[00:29:24] Speaker 02:
It was set forth in the 1994 guidelines.

[00:29:27] Speaker 02:
Then we can look to Harris.

[00:29:28] Speaker 02:
Now, Judge Bum decided, looked at the issue.

[00:29:31] Speaker 00:
She thought Harris was not prior.

[00:29:32] Speaker 02:
She did, and that's exactly what I was going to say.

[00:29:34] Speaker 02:
Now, we disputed that, but we don't even need to dispute it, because there's no doubt that it's contemporaneous art.

[00:29:38] Speaker 02:
And contemporaneous art, as this court has held, can be used to show the level or skill in the art.

[00:29:43] Speaker 02:
So you look to Harris, and that's great.

[00:29:45] Speaker 02:
But you don't even have to get there.

[00:29:46] Speaker 02:
You can look at the 1994 inspection guide.

[00:29:48] Speaker 02:
And this is clearly, oh, I can't tell.

[00:29:51] Speaker 02:
It's my time.

[00:29:52] Speaker 01:
You're over, but that's OK.

[00:29:55] Speaker 02:
I want to get in Mr. Baseman.

[00:29:57] Speaker 02:
So I'll just finish with this, that Judge Bum looked at Dr. Aker's testimony, which is from AstraZeneca, and Mr. Zacayo, and found

[00:30:07] Speaker 02:
that there is no doubt that one could have a reasonable expectation of success using filter sterilization.

[00:30:13] Speaker 02:
Thank you, Your Honor.

[00:30:14] Speaker 00:
Thank you.

[00:30:23] Speaker 05:
May it please the Court?

[00:30:23] Speaker 05:
Richard Basin for Apotex.

[00:30:25] Speaker 05:
I just want to reemphasize a point that was made by Mr. Acose that the defense have produced an overwhelming amount of evidence to establish that there was a reasonable expectation of success in creating the claimed product.

[00:30:38] Speaker 05:
It's undisputed and the court recognized that there were five well-known sterilization methods.

[00:30:43] Speaker 05:
These were analogous to the tools in a workman's toolbox.

[00:30:47] Speaker 05:
If one of ordinary skill in the art had a job to do and they had tools in their toolbox, obviously a person with skill in the art with five tools in their toolbox would believe they had a greater likelihood of success than the worker with just one tool in that toolbox.

[00:31:04] Speaker 05:
The question here on obviousness was, a worker having all five of those sterilization methods in their toolbox, would they have had a reasonable expectation of success?

[00:31:12] Speaker 05:
Now what the defendant showed at trial was that four of those tools, all on their own, they're the only two in the toolbox.

[00:31:19] Speaker 05:
created a reasonable expectation of success in creating the product.

[00:31:22] Speaker 00:
What would you say is to Mr. Sipes' point, and now focusing just on the two methods that are not employed, as I understand it, by any of the defendants at least?

[00:31:34] Speaker 00:
What do you say to his point that it has not been shown that either the EOR irradiation actually work to achieve the invention?

[00:31:44] Speaker 00:
They may have been a reasonable expectation, but that expectation is presumably defeated by the fact that you don't have any example of somebody that's actually using those methods.

[00:31:54] Speaker 05:
Well, first of all, the ethylene oxide is absolutely shown to work in their preferred

[00:31:59] Speaker 00:
But let's assume right now that we really got anticipation.

[00:32:05] Speaker 05:
Well, no, we don't, because it was a foreign use, Your Honor.

[00:32:08] Speaker 05:
I think under the present law, we might have.

[00:32:10] Speaker 05:
But the problem was we didn't.

[00:32:11] Speaker 00:
You're right.

[00:32:12] Speaker 00:
It is a foreign use.

[00:32:13] Speaker 00:
But in any event, let's assume preferred away from the moment.

[00:32:17] Speaker 00:
What I'm trying to get at is, is it the case that reasonable expectation is not enough if, in fact, there isn't a demonstration of, in fact, achievement of the invention?

[00:32:30] Speaker 05:
No, I think the law is pretty clear.

[00:32:32] Speaker 05:
We're making obvious misarguments.

[00:32:34] Speaker 05:
We don't have to show absolute predictability.

[00:32:37] Speaker 00:
There's no predictability, but do you have to show achievement?

[00:32:40] Speaker 00:
In other words, normally that's not a problem because there's no issue that something was achieved because you have an infringement action.

[00:32:48] Speaker 00:
The person who is accused of infringement.

[00:32:52] Speaker 00:
But that's not necessarily true when you have four different methods, only two of which are being actually used and two of which are not.

[00:33:00] Speaker 00:
So my question is, don't you have to show that in fact, irradiation actually works?

[00:33:08] Speaker 00:
And there's evidence that it actually works, as opposed to there merely being a reasonable expectation that it will work.

[00:33:17] Speaker 05:
First of all, I have a hard time if the test is reasonable expectation.

[00:33:22] Speaker 05:
That presumes you don't have to, but you're asking me to say reasonable expectation equals knowing it will work.

[00:33:27] Speaker 00:
There are many instances in which there is a reasonable expectation that something will work, which is defeated by reality.

[00:33:33] Speaker 00:
It turns out it doesn't work.

[00:33:36] Speaker 00:
You're not arguing, I take it, that all you need is a reasonable expectation that will work, even if in fact it is shown

[00:33:44] Speaker 00:
conclusively that it doesn't work.

[00:33:47] Speaker 05:
If there's conclusive evidence, it won't work.

[00:33:49] Speaker 05:
That's correct.

[00:33:49] Speaker 05:
But I think during trial, we heard a whole litany of experts came up to talk about these five known sterilization methods.

[00:33:55] Speaker 05:
They're in the USP.

[00:33:57] Speaker 05:
They govern all the pharmaceutical industry.

[00:33:59] Speaker 05:
And those of skill in the art know they can use them and have used them successfully in other products.

[00:34:05] Speaker 05:
For example, ethylene oxide, one of the things AstraZeneca keeps arguing, when you push them on the nebulization, that's not part of the claim.

[00:34:12] Speaker 05:
Your argument starts to morph that the FDA was skeptical about being able to make a steroglucocorticoid steroid suspension.

[00:34:19] Speaker 05:
And that's in their brief.

[00:34:20] Speaker 05:
They actually say it.

[00:34:21] Speaker 05:
They don't say nebulize.

[00:34:22] Speaker 05:
They just say a steroglucocorticoid steroid suspension, and that no one had ever done it before.

[00:34:28] Speaker 05:
And that's just patent.

[00:34:29] Speaker 05:
That's demonstrably false.

[00:34:31] Speaker 05:
Their own expert, Dr. Danel, had listed seven different corticosteroids in commercial ophthalmic products, 16 different products,

[00:34:39] Speaker 05:
sterile, pharmaceutically acceptable on the market, beginning in the 1950s all the way to the 1990s, 50 years, people have been sterilizing and making product.

[00:34:48] Speaker 05:
So to say these sterilization methods wouldn't work on these products, it's just not true, because there's actual products on the market that are being sterilized.

[00:34:57] Speaker 05:
Sterile corticosteroid suspensions.

[00:34:59] Speaker 00:
But not Budesonite.

[00:35:01] Speaker 05:
Well, Budesonite had been sterile.

[00:35:03] Speaker 05:
You struck upon it.

[00:35:04] Speaker 05:
Bratson, it showed it was sterile.

[00:35:05] Speaker 05:
There's no evidence in the record.

[00:35:07] Speaker 00:
But Bratson doesn't fully anticipate it.

[00:35:10] Speaker 05:
Well, because there's no purity of Brassica.

[00:35:12] Speaker 05:
The testimony is sterile.

[00:35:14] Speaker 05:
Well, that's why this was born, Your Honor.

[00:35:17] Speaker 05:
I think if everything was 102, I think when we were back here back in 2012, I was worried about Radhakrishnan pattern with the liposomes.

[00:35:24] Speaker 05:
And I had everything but one element, and you sent us back.

[00:35:26] Speaker 05:
So we're trying to get it right this time.

[00:35:29] Speaker 05:
And I think we did, because all those elements are there in the prior art.

[00:35:33] Speaker 05:
Bratzin is a sterile corticosteroids for injection.

[00:35:37] Speaker 05:
All the people agreed.

[00:35:38] Speaker 05:
All the experts agreed.

[00:35:39] Speaker 05:
They would have known it was sterile.

[00:35:40] Speaker 00:
When you say Bratzin is sterile, you're inferring sterility from the fact that it's injection?

[00:35:47] Speaker 05:
Yes, because all our experts recognize you would never inject it.

[00:35:50] Speaker 05:
These were used in tests on humans.

[00:35:51] Speaker 05:
You would never inject a human with something that wasn't sterile.

[00:35:55] Speaker 05:
So the presumption of those with skill in the art reading that would presume that it was sterile.

[00:36:02] Speaker 05:
Thank you.

[00:36:03] Speaker 01:
Thank you.

[00:36:04] Speaker 01:
All right, we'll give you four minutes for rebuttal, just to keep things even.

[00:36:07] Speaker 01:
Thank you.

[00:36:09] Speaker 06:
Let me start with what Mr. Roccozzi mentions, that we have a test case here.

[00:36:13] Speaker 06:
We do have a test case here.

[00:36:14] Speaker 06:
He points to Europe as a test case.

[00:36:16] Speaker 06:
Europe is a great test case.

[00:36:18] Speaker 06:
In Europe, there are several different kinds of nebulized corticosteroids in the market.

[00:36:23] Speaker 06:
All of them are highly pure, pharmaceutically acceptable corticosteroid suspensions.

[00:36:28] Speaker 06:
Only one of them has come into the US.

[00:36:30] Speaker 06:
And that's homochore spiels.

[00:36:32] Speaker 06:
And the reason for that, we know too.

[00:36:35] Speaker 06:
And that is because of sterility.

[00:36:37] Speaker 06:
So we know from the European test case that sterility is the challenge.

[00:36:42] Speaker 06:
That achieving sterility while maintaining high purity and maintaining pharmaceutical acceptability in a micronized corticosteroid suspension is extremely difficult.

[00:36:53] Speaker 06:
That's telling facts.

[00:36:54] Speaker 06:
We have remarkable.

[00:36:55] Speaker 04:
That was the challenge that you needed to meet to get FDA approval.

[00:36:59] Speaker 04:
to come into the United States and sell in the United States.

[00:37:12] Speaker 04:
That's absolutely correct.

[00:37:17] Speaker 06:
Well, we do know that the law says there's a presumption of nexus if it's an embodiment of the claims, which we have here.

[00:37:23] Speaker 06:
And the burden shifts to defendants to show by clear and convincing evidence that the subject matter of mention did not contribute to the success of the product.

[00:37:31] Speaker 06:
That's the Echo Lochem case at 227, F3, 1378, Cycle of Benzoprene at 1078 and Note 5, certainly achieving

[00:37:42] Speaker 06:
FDA approval is an important component of commercial success.

[00:37:45] Speaker 06:
It's hard to believe it didn't.

[00:37:47] Speaker 06:
But there's another element, too.

[00:37:48] Speaker 06:
Wherever you are in the world, you rely on the regulatory agency as the consumer to assure safety.

[00:37:55] Speaker 06:
And so in some sense, FDA is the gatekeeper here.

[00:37:58] Speaker 06:
It is without achieving FDA success, one has no success.

[00:38:03] Speaker 06:
And after all, as a matter of logic, the fact that sterility was viewed as so important in the US

[00:38:11] Speaker 06:
shouldn't negate the importance of the injective condition, and certainly the artisans in the field are working with an eye to what FDA wants.

[00:38:21] Speaker 00:
Talk about sterile filtration.

[00:38:23] Speaker 00:
Why is it not the case, particularly in light of the admissions by one of the doctor's acres, and I guess it's Dr. Lee, why is it not the case that that was a known reliable means of sterilization, but it just was burdensome, expensive, cumbersome, and was not commercially possible?

[00:38:46] Speaker 06:
We believe that here is where hindsight is most dangerous.

[00:38:51] Speaker 06:
There is no denying that all of these methods, including filter sterilization, were known, filter sterilization followed by septic processing.

[00:38:58] Speaker 06:
But this we know too.

[00:39:00] Speaker 06:
First of all, we know that AstraZeneca tried it and failed at the time.

[00:39:07] Speaker 06:
More strikingly, they refer to the 94 FDA guidance.

[00:39:10] Speaker 06:
That never mentions corticosteroids.

[00:39:12] Speaker 06:
There is not a single piece of prior art

[00:39:15] Speaker 06:
that reports successful sterile filtration and aseptic processing of any corticosteroid.

[00:39:21] Speaker 06:
In fact, O'Neill, on which they rely, reports failure.

[00:39:27] Speaker 00:
What do you do with the admissions, though, by Dr. Akers and Dr. Lee, where they basically said, yeah, that system, we would expect that would work?

[00:39:36] Speaker 06:
I believe what Dr. Achor said and what the testimony shows is that sterile filtration and aseptic processing, if it could be done perfectly, would achieve a sterile product.

[00:39:47] Speaker 00:
They had doubts.

[00:39:48] Speaker 00:
They said this is really difficult.

[00:39:50] Speaker 00:
But difficult doesn't get you where you need to go.

[00:39:52] Speaker 06:
What Dr. Achor said is that it's unclear that it could have been done because there were several steps that would have to be overcome.

[00:40:00] Speaker 06:
Aseptic crystallization is hard.

[00:40:01] Speaker 06:
That's where O'Neill failed.

[00:40:03] Speaker 06:
That's at column 3, 33 to 40 of O'Neill.

[00:40:06] Speaker 06:
After that, you have a problem with micronization.

[00:40:08] Speaker 06:
Steckel, on which they rely, Steckel actually was developing, that's 97, was developing a new micronization technique, because as he said, trying to micronize.

[00:40:18] Speaker 06:
And this is not aseptic.

[00:40:20] Speaker 06:
So this is when you can actually get in and manipulate the system.

[00:40:23] Speaker 06:
They said, mechanization of cortical steroids is beset with problems, because it's soft and waxy.

[00:40:29] Speaker 06:
And that's not aseptic.

[00:40:31] Speaker 06:
What we don't have anywhere in the prior art is

[00:40:35] Speaker 06:
any evidence of success with any corticosteroid with stereofiltration and aseptic processing.

[00:40:41] Speaker 06:
And more than that, we don't have evidence when later when one of the events came to do it 10 years later, they used a whole new system that didn't exist then, very sophisticated computer control equipment that was not available then, in all of these four methods.

[00:40:56] Speaker 06:
And this is why we think objective indicium here is so important, is

[00:41:00] Speaker 06:
We have no demonstration.

[00:41:01] Speaker 06:
We have all this evidence for all the methods of failure, AstraZeneca's failure, the report of failure with moist heat from defendants.

[00:41:09] Speaker 06:
In fact, Mr. Cote said there is no evidence that anyone failed.

[00:41:14] Speaker 06:
Their own chief scientist, McCaffer, testified that three different companies, this is an A4955 to 56, came to him and said they had failed to make a sterile budesonite suspension.

[00:41:27] Speaker 06:
So they believed it to be impossible.

[00:41:29] Speaker 06:
That's McCaffer's own testimony at 4955 to 56.

[00:41:34] Speaker 06:
We have real-world evidence with budesonide.

[00:41:38] Speaker 06:
Not, you know, O'Neill might have succeeded with dexamethasone, but with budesonide, as the McCaffer patent reports, they failed because of degradation.

[00:41:48] Speaker 06:
Irradiation failed.

[00:41:49] Speaker 06:
Budesonide is hard.

[00:41:51] Speaker 06:
We have real-world evidence of failure.

[00:41:53] Speaker 06:
No, they did no testing.

[00:41:55] Speaker 06:
They never carried out O'Neill to show success.

[00:41:59] Speaker 06:
This is a case where we felt proper evaluation of the objective indicia make it clear that this was an achievement and a non-obvious achievement, and the court disregarded all of that real-world evidence.

[00:42:16] Speaker 00:
Thank you.