[00:00:02] Speaker 01:
R pharmaceutical versus TWI pharmaceuticals.

[00:00:09] Speaker 01:
Case number 151880.

[00:00:14] Speaker 01:
This is a case on appeal from the District Court for the District of Maryland.

[00:00:23] Speaker 01:
Judge Wallach and I, this is deja vu all over again, because we're back up here after remand.

[00:00:29] Speaker 03:
That means I can rest during this one.

[00:00:36] Speaker 00:
Mr. Brown, you want three minutes for rebuttal?

[00:01:02] Speaker 00:
Okay, you may begin.

[00:01:03] Speaker 05:
Good morning, Your Honors.

[00:01:04] Speaker 05:
Since we've been here before, I'm going to jump right into the central issue that was here before that we believe was the central issue the judge committed again on the second time around was the misapplication of the Inherency Doctrine.

[00:01:19] Speaker 05:
And we think it's very clear from particularly the discussion on A10 of the District Court's decision that she's conflated Gina Species Law

[00:01:31] Speaker 05:
with the inherency doctrine and disregarded this court's clear instruction and this court's analysis in the first decision.

[00:01:39] Speaker 05:
Let me do a little housekeeping here.

[00:01:41] Speaker 04:
Sure.

[00:01:43] Speaker 04:
In the blue brief at 17, you quote the district court as stating that Dr. Beach, quote, spoke in generalities.

[00:01:51] Speaker 04:
In fact, the district court said that Dr. Beach sometimes spoke in generalities.

[00:01:59] Speaker 04:
At 26, you say, the district court recognized that Dr. Beach's testimony had serious shortcomings that prevented it from serving as clear and convincing evidence of inherency.

[00:02:10] Speaker 04:
In fact, the district court said his testimony might not independently satisfy TWI's inherency burden, but that his, quote, his testimony nonetheless strengthens TWI's case.

[00:02:29] Speaker 04:
Let me ask you two questions.

[00:02:31] Speaker 04:
One, why do you leave out the words sometimes if that doesn't substantially change the meaning of the court statement?

[00:02:41] Speaker 05:
I apologize for that, Your Honor.

[00:02:43] Speaker 05:
In my estimation, the entirety of the testimony relating to this issue was in generalities, and I think the entirety that the district court quoted with respect to both the enablement and the inherency issues were

[00:02:59] Speaker 04:
You don't think there's a difference, though, between sometimes the court's determination that Dr. Beach sometimes spoke in generalities and the court saying he spoke in generalities?

[00:03:14] Speaker 05:
There is certainly a difference.

[00:03:16] Speaker 05:
There is certainly a difference between those two, Your Honor, and I apologize if that's... What statement of the district court supports the assertion that Dr. Beach's testimony had serious shortcomings?

[00:03:29] Speaker 05:
I believe that is our characterization of the impact of that, which is when she said that his testimony might not serve to independently serve as clear and convincing evidence of inherency, we believe that echoes the finding this court already made the first time the court considered the exact same testimony and found that it did not.

[00:03:48] Speaker 05:
When the court says his testimony nonetheless strengthens TWI's case?

[00:03:54] Speaker 05:
It's evidence she relied on to

[00:03:59] Speaker 05:
It's evidence she relied on in support of the finding of inherency, but in our position of it, she relied.

[00:04:06] Speaker 05:
This court already considered that testimony the first time around, found it was insufficient.

[00:04:10] Speaker 01:
We said it wasn't enough standing alone.

[00:04:12] Speaker 01:
Correct.

[00:04:13] Speaker 01:
And she's agreeing that it's not enough standing alone.

[00:04:15] Speaker 05:
Correct.

[00:04:15] Speaker 01:
But then she goes on to say it's not standing alone.

[00:04:18] Speaker 05:
Correct.

[00:04:19] Speaker 01:
Okay, so there was a different record now.

[00:04:21] Speaker 01:
It's that testimony taken in the context of the other things on which she based her factual findings.

[00:04:27] Speaker 05:
That is correct.

[00:04:28] Speaker 05:
And so we believe there are two fundamental errors in what happened in that analysis by the district court.

[00:04:38] Speaker 05:
First of all, we think it is clear from the discussion on A10 of her decision that she is applying the inherency doctrine in combining it and conflating it with Gina Species' law.

[00:04:53] Speaker 05:
And she makes the statement, in the context of obviousness, examples are enough.

[00:04:57] Speaker 05:
And this court's previous analysis of the Inherency Doctrine made clear that the same analysis applies in the anticipation context as in the obviousness context.

[00:05:09] Speaker 05:
And the reason we are getting to Inherency in the first instance, the only reason Inherency is relevant in an obviousness analysis is because the prior art on its own did not suggest or motivate arriving at the limitation.

[00:05:22] Speaker 05:
There's no dispute, it's based on the finding, the previous finding, the food effect was unknown,

[00:05:27] Speaker 05:
We discovered that.

[00:05:28] Speaker 05:
We also discovered a particular solution to that food effect, and we included the food effect limitations.

[00:05:34] Speaker 05:
There's no motivation to get there, and there is no description of that limitation.

[00:05:38] Speaker 01:
That was all decided in the prior case.

[00:05:39] Speaker 05:
That was all decided in the prior case.

[00:05:41] Speaker 05:
But the only reason we're getting to inherency is because of that.

[00:05:44] Speaker 05:
So the clear import, we believe, of the court's previous decision is, unless the skilled artisans sitting with all of the art, which relied on for obviousness, with the motivations found by the district court

[00:05:55] Speaker 05:
will necessarily and inevitably solve the food effect, while not pursuing it, pursuing other motivations, but will inevitably necessarily solve the food effect that's required for inherency.

[00:06:08] Speaker 05:
We think it's clear from her analysis on page A10, and she cites this Inrei Kozo case, which is a genus species case, juxtaposed to the sentence, in the context of obviousness, examples are enough.

[00:06:20] Speaker 05:
She's applying that when you combine that art, if some of the things you get

[00:06:25] Speaker 05:
necessarily have the property, that's enough for inherency.

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And we would submit that's no different than saying probabilities are possibilities.

[00:06:35] Speaker 05:
If you sometimes always get the result, then it's inherent.

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And then that flows into my second principle argument on inherency, which is the record.

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The only testimony at trial that this case was not an inherency case at trial, Dr. Beach

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did not get on the stand and say, if you do X, Y, and Z, you will always get something else.

[00:06:54] Speaker 05:
He was testifying principally that the food effect was known and that that was his principal argument.

[00:06:59] Speaker 01:
The trial court came up with the concept of inherency on her own.

[00:07:02] Speaker 05:
It was argued post trial in the briefs, but it was not presented at trial.

[00:07:05] Speaker 05:
And so he doesn't have the testimony you would normally see in an inherency case.

[00:07:10] Speaker 05:
So this court considered the strongest testimony the last time around, found it wasn't enough on its own.

[00:07:16] Speaker 05:
She went back now and went into our examples in our patent that are not in the prior art.

[00:07:20] Speaker 05:
They were the result of substantial work knowing about the food effect that we discovered.

[00:07:24] Speaker 05:
There's column after column after column in the patent describing how they tested a bunch of variations and they finally got to example nine, the preferred embodiment.

[00:07:32] Speaker 05:
It's very particular.

[00:07:33] Speaker 05:
We lay out the formulation of that in our reply brief.

[00:07:35] Speaker 05:
It's got a whole bunch of examples, a whole bunch of particular ingredients.

[00:07:40] Speaker 05:
That solved the food effect.

[00:07:41] Speaker 05:
That's not evidence that what somebody of ordinary skill in the art would have

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necessarily done without the benefit of our specification would inevitably get.

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And then she took our commercial embodiment, which was derived directly from that, and then TWI's commercial embodiment, which was derived directly from ours.

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And so those three data points are not, we would submit, they're not evidence of a necessary result.

[00:08:10] Speaker 05:
They don't provide the necessary relevance.

[00:08:13] Speaker 05:
And we weren't

[00:08:14] Speaker 05:
Nobody addressed these, and we think this falls squarely within the cases we've cited, that this cannot be done on attorney argument.

[00:08:21] Speaker 05:
Nobody testified about these three examples at trial that they were representative of the prior art or anything.

[00:08:27] Speaker 05:
If they did, we get to cross examine them.

[00:08:28] Speaker 05:
We get to put on an expert that says, that's not true.

[00:08:31] Speaker 05:
We have all kinds of rights that flow from this.

[00:08:33] Speaker 05:
And this court has said in numerous cases we cite, you've got to have expert testimony to say this.

[00:08:38] Speaker 05:
And that's where we think, in effect, we've cited this also as a burden shift.

[00:08:44] Speaker 05:
case, I normally don't raise a burden shift because it's not something that normally succeeds here.

[00:08:50] Speaker 01:
You waited the last time.

[00:08:52] Speaker 05:
We did, because we feel like the unfairness of it in this instance, if we're going to be hit with an inherency case, we deserve to know it at trial.

[00:08:59] Speaker 05:
The expert's got to get on the stand and say it, and she's effectively saying, I mean, we've got a dog study in the patent that gets results outside the claim.

[00:09:09] Speaker 05:
Somebody, if TWI wanted to show inherency, they should have talked about that and explained it.

[00:09:14] Speaker 05:
They didn't.

[00:09:14] Speaker 05:
We didn't put in an expert to respond about it.

[00:09:17] Speaker 05:
And so there's no record on it.

[00:09:19] Speaker 01:
Did you ask her to reopen Discovery for purposes of this follow-on procedure?

[00:09:24] Speaker 05:
No.

[00:09:24] Speaker 05:
Neither party asked the case to be reopened.

[00:09:29] Speaker 05:
It was re-argued on the same record that was based on the reading.

[00:09:33] Speaker 01:
Well, then it's kind of hard for you to argue surprise to us or unfairness when you didn't ask

[00:09:39] Speaker 01:
the court or explain to the court why you might need any additional material or an additional opportunity to present an expert?

[00:09:46] Speaker 05:
Well, it was TWIs at the first trial.

[00:09:49] Speaker 05:
It was their burden of proof to carry their case.

[00:09:52] Speaker 05:
They did not put on an inheritance case.

[00:09:54] Speaker 05:
No one got on and said, when I do certain things, I necessarily get a certain result.

[00:09:58] Speaker 05:
So we weren't responding to that.

[00:10:00] Speaker 05:
And on remand, they were stuck with a record, we believed.

[00:10:02] Speaker 05:
If they wanted to reopen it and put on more evidence, we believe they should have been stuck with a record that they tried.

[00:10:08] Speaker 05:
We didn't even realize opening the record was something that was an option.

[00:10:13] Speaker 05:
We thought this was a remand on the same record.

[00:10:15] Speaker 01:
And it probably was, I'm just asking.

[00:10:19] Speaker 05:
Yes.

[00:10:19] Speaker 01:
All right.

[00:10:19] Speaker 01:
Let's talk about enablement.

[00:10:21] Speaker 05:
Yes.

[00:10:22] Speaker 01:
OK.

[00:10:24] Speaker 01:
So what are your complaints about the trial court's determination as it relates to enablement?

[00:10:29] Speaker 05:
Certainly.

[00:10:30] Speaker 05:
So her enablement discussion, the principal complaint we have, it runs from A12 to A13.

[00:10:36] Speaker 05:
And she has two statements that basically no amount of experimentation would allow the claims to be practiced outside of this particular 100 to 700 nanometer range that she selects.

[00:10:50] Speaker 05:
And that it would make it practically impossible.

[00:10:54] Speaker 05:
And TWI on page 51 of their brief makes the same statement, and they cite the record.

[00:10:59] Speaker 05:
There are precisely two pages of the record that are cited in the district court and in TWI's brief on the enablement.

[00:11:09] Speaker 05:
It's A3113 and A3119.

[00:11:12] Speaker 05:
And on those pages, Dr. Beach doesn't say anything that we think can fairly support

[00:11:23] Speaker 05:
this practically impossible.

[00:11:26] Speaker 05:
It's the same testimony we talked about last time.

[00:11:29] Speaker 05:
It is very general.

[00:11:32] Speaker 05:
And it says, if I can pick out a couple, as we go up in particle size from that to micron particle size and larger, we get very large particles and decreased bioavailability.

[00:11:49] Speaker 05:
He doesn't say that with work and formulation and the teachings of the patent and all the examples that this can't be overcome.

[00:11:56] Speaker 05:
He says, we get decreased bioavailability as we go down in particle size below a certain cutoff.

[00:12:02] Speaker 05:
Let's call it, for sake of this, 100 microns.

[00:12:05] Speaker 05:
The particles tend to reaggrade and begin to act as large particles.

[00:12:08] Speaker 05:
Again, no statement that it's impossible, no statement that it can't be done, no statement of what type of work needs to be done.

[00:12:16] Speaker 05:
We think this case falls squarely within the Cephalon v. Watson case.

[00:12:19] Speaker 05:
where, again, it's more or less the statement that, and we think the critical part of it appears on A3-119.

[00:12:31] Speaker 05:
He's giving the printable part of his testimony.

[00:12:34] Speaker 05:
If it's less than 100 nanometers or greater than 750 nanometers, this is line 16 through 20, then it's really not enabled because there is nothing in the patent that shows me particle sizes of the product in that range that meet the claims of the patent.

[00:12:48] Speaker 05:
So he's effectively saying, the patent doesn't show me examples in this range.

[00:12:52] Speaker 05:
Therefore, it's not enabled.

[00:12:54] Speaker 05:
He doesn't do any analysis of any of the WANS factors other than sort of this general statement.

[00:13:01] Speaker 05:
In fact, the district court found he considered the WANS factors.

[00:13:04] Speaker 05:
She cites page A3119, page lines 12 to 16.

[00:13:08] Speaker 05:
And I'll read the entirety.

[00:13:11] Speaker 05:
Doctor, was it explained to you that there are several factors to consider in determining whether there is undue experimentation?

[00:13:16] Speaker 05:
Answer, yeah.

[00:13:17] Speaker 05:
I was educated as to what enablement consists of by counsel.

[00:13:20] Speaker 01:
But what, I mean, let's worry about whether, you know, we can talk about whether he's properly invoked the language of the Wands Factors.

[00:13:30] Speaker 01:
Let's look at the specification.

[00:13:31] Speaker 01:
Show me where in the specification there is anything that would teach these hugely broad ranges.

[00:13:38] Speaker 05:
So there are a couple of, a couple of significant points within the specification that

[00:13:46] Speaker 05:
One of the significant ones that our expert testified about at trial was a discussion of multimodal particle size distributions.

[00:14:01] Speaker 05:
And since the claims define it as by weight, our expert pointed out that you could, I don't have the specific citation, I can find it in a second, but since the claims are by weight,

[00:14:16] Speaker 05:
you could have a large population of very small particles and a few larger particles and someone would be able to circumvent a narrower claim.

[00:14:23] Speaker 05:
And so with that, you can still have the effective average be higher up near 2,000 and get what's within the claim.

[00:14:30] Speaker 05:
Another thing I think is important, we cite this in our reply brief.

[00:14:36] Speaker 05:
If you look at, there's a chart on page 10 of our reply brief that our expert introduced

[00:14:46] Speaker 05:
during trial.

[00:14:48] Speaker 05:
And in that chart, the patentees obtained food effects ranging from 55 percent, the upper end of the narrowest claim, down to 8 percent, and that's actually effectively negative 8 percent, but fasted CMAC was higher, got this full range, and that was by varying, that was one variable was changed, which was dose concentration.

[00:15:11] Speaker 05:
They were loading more drug,

[00:15:13] Speaker 05:
concentrating more drug and less vehicle.

[00:15:16] Speaker 05:
And that one factor was able to cause a very significant impact on the food effect.

[00:15:25] Speaker 05:
The dog study, they got a significant change by changing the identity and the amount of the surfactant.

[00:15:29] Speaker 05:
They went from around 70% to 85% food effect.

[00:15:33] Speaker 05:
And so there are significant things that can be changed.

[00:15:36] Speaker 05:
They identify surface stabilizer.

[00:15:38] Speaker 05:
They identify the surfactant.

[00:15:39] Speaker 05:
They identify the amount of the vehicle.

[00:15:43] Speaker 01:
But the trial court, as to the dog study trial court, made a specific finding that it was not particularly informative because there was testimony that said there are large differences between food effects in humans and in dogs.

[00:16:00] Speaker 05:
Almost, Your Honor.

[00:16:02] Speaker 05:
I want to point that out.

[00:16:03] Speaker 05:
There was no testimony about the dog study at trial.

[00:16:06] Speaker 05:
It was because there wasn't an inherency case put on.

[00:16:11] Speaker 05:
argued based on one internal email that some scientists that I don't know what his qualifications are to talk about dog studies said the results might not be the same.

[00:16:21] Speaker 05:
And she made a fact finding on that.

[00:16:23] Speaker 05:
But there was no testimony about the dog study.

[00:16:24] Speaker 01:
But she also made a specific fact finding that above and below certain ranges, there was no sufficient bioavailability to result in a Feud effect.

[00:16:37] Speaker 01:
And we'd have to find that to be clear error

[00:16:39] Speaker 01:
in order for us to overturn her enablement determination, wouldn't we?

[00:16:46] Speaker 05:
It would either be clear error or under the standard, the description in the cyclobenzeprine case that just failure of proof.

[00:16:54] Speaker 05:
And we would submit that in the Cephalon v. Watson case on enablement, we think that the case is right on point where this court has continually rejected

[00:17:06] Speaker 05:
conclusory enablement cases.

[00:17:08] Speaker 05:
You get up and say, it's not enabled, and you don't go through the factors.

[00:17:12] Speaker 05:
How much experimentation is required?

[00:17:14] Speaker 05:
What are the examples?

[00:17:15] Speaker 05:
There's a lot of examples in this patent.

[00:17:17] Speaker 05:
What are they?

[00:17:17] Speaker 05:
What do they teach a person of ordinary skill in the art?

[00:17:20] Speaker 05:
What would you do?

[00:17:20] Speaker 05:
Why is that insufficient?

[00:17:21] Speaker 05:
How much work would it take?

[00:17:23] Speaker 05:
There's no discussion of any of this.

[00:17:24] Speaker 05:
This is just, it's simply Dr. Beach saying, it's really not enabled because the patent doesn't give me examples in these higher ranges.

[00:17:35] Speaker 05:
And that's really the sum total.

[00:17:37] Speaker 05:
There's two pages, A3113 and A3119.

[00:17:41] Speaker 01:
You've eaten up all your rebuttal time.

[00:17:42] Speaker 01:
We'll give you two minutes.

[00:17:54] Speaker 06:
Good morning, Your Honor.

[00:17:55] Speaker 06:
Don Mazurka on behalf of TWI.

[00:17:57] Speaker 01:
How do you respond to the argument that regardless of what kind of case you might have been able to make, because your record

[00:18:05] Speaker 01:
from below was so weak.

[00:18:08] Speaker 01:
You never argued in herency below.

[00:18:10] Speaker 01:
You didn't have an expert.

[00:18:11] Speaker 01:
You testified to in herency.

[00:18:13] Speaker 01:
The district court came up with the concept of in herency after trial.

[00:18:17] Speaker 01:
So how do we say that you had a sufficient record on in herency below to allow us to say that you really locked it down the second time around, or that the trial court locked it down the second time around?

[00:18:31] Speaker 06:
Well, yes, sir.

[00:18:32] Speaker 06:
Just on that point,

[00:18:34] Speaker 06:
The notion that we didn't argue an inherency case from the beginning is just false.

[00:18:40] Speaker 06:
We were arguing from the very beginning of the case in our pretrial briefs everywhere around that we were relying on the Parr versus the Parr v. Santaris case, where the court said that measuring the blood levels of an obvious formulation does not make it non-obvious, including those in the claims.

[00:19:00] Speaker 06:
And so we put in proof.

[00:19:01] Speaker 06:
We argued that from the beginning.

[00:19:03] Speaker 06:
That was the law at the time.

[00:19:04] Speaker 06:
We didn't have the benefit of this court's TWA or Parr versus TWA case.

[00:19:11] Speaker 06:
And we structured our proof along that to make the point and to show throughout the trial that all the patentee did here was substitute the prior art nanoparticles

[00:19:23] Speaker 01:
Magestral nanoparticles which were explicitly disclosed in the the fact of a food effect but they but you Did not argue below and so my question is did you have evidence to support the conclusion that that you fell within?

[00:19:38] Speaker 01:
The description of what you'd have to show that that was in our original opinion.

[00:19:43] Speaker 06:
Yes We did your honor we had we had judged our dr. Beach and even their own expert dr. Liversidge all testified that the food effect reduction is a physical property and

[00:19:53] Speaker 06:
of the particle size.

[00:19:56] Speaker 06:
It's the particle size is the only factor that has any bearing on the food effect.

[00:20:03] Speaker 06:
It's because of the noise of Whitney equation about the smaller the particle size, you increase the surface area of the compound.

[00:20:15] Speaker 06:
And that advances, increases the dissolution, the solubility.

[00:20:20] Speaker 06:
And then Dr. Beach and everybody testified about the improved solubility, improves bioavailability.

[00:20:25] Speaker 06:
The improved bioavailability naturally reduces the food effect because now the drug is so soluble, it's equally soluble as it is when it's ingested with food.

[00:20:35] Speaker 01:
But again, that still just talks about a generalized food effect.

[00:20:39] Speaker 01:
What evidence supported the conclusion that the food effect

[00:20:44] Speaker 01:
of the claimed ranges was necessarily inherent.

[00:20:49] Speaker 06:
Right.

[00:20:49] Speaker 06:
Well, because of that, we were able to show that the particle size of the prior art was 100 to 400.

[00:21:00] Speaker 06:
And Judge Blake made a factual finding that the prior art disclosed use of magestral particles of 100 to 400.

[00:21:09] Speaker 06:
And we had the proof that the particles of this size produce

[00:21:14] Speaker 06:
the food effect that is claimed.

[00:21:17] Speaker 06:
She went to less than 60% because that was the smallest claim construction.

[00:21:21] Speaker 06:
She took all the data that was before her on that point and was able to look at that.

[00:21:25] Speaker 06:
Yes, these particles of this size and the prior are produced necessarily the food effect.

[00:21:30] Speaker 06:
It is a physical property of the particles.

[00:21:31] Speaker 06:
These particles are there.

[00:21:32] Speaker 06:
And just like Your Honor did in the Alcon case, said that if it's the same particle, it's not unreasonable to say it gets the same effect.

[00:21:40] Speaker 06:
And that's what we proved.

[00:21:43] Speaker 06:
We proved it was the exact same thing and the measurements of the particle size.

[00:21:48] Speaker 06:
These were the measurements were up to 330 were the D90s and the data sets that were part of the record at trial that were all admitted to be producing food effect of well less than 60%.

[00:22:03] Speaker 01:
Should we be concerned about the trial court citation to COSO when

[00:22:08] Speaker 01:
that was a range case where the question of examples is a totally different animal than here.

[00:22:16] Speaker 01:
I mean, we specifically said that you've got to find inherency as to all of the claimed limitations.

[00:22:21] Speaker 06:
Yes, Your Honor.

[00:22:22] Speaker 06:
And the plaintiffs, the defendants misrepresent what the judge did there.

[00:22:27] Speaker 06:
When the judge was citing, when she said that examples are enough, she was responding to their argument

[00:22:33] Speaker 06:
that we had to show that the food effect was necessarily present at all particle sizes they claimed, all the way up to 2,000 nanometers.

[00:22:42] Speaker 06:
And she said, that's not right.

[00:22:43] Speaker 06:
They show that this range, this example here between, she called an example, but she meant that the range of 100 to 400 is within that 2,000.

[00:22:57] Speaker 06:
And so by showing that it's obvious, it's necessarily there between 100 and 400,

[00:23:02] Speaker 06:
they've proven the claim is obvious because a specific example will invalidate a genus.

[00:23:09] Speaker 01:
Okay, let's go to enablement, unless you have something else on in here.

[00:23:12] Speaker 06:
No, Your Honor, those are the two points I want to respond to.

[00:23:15] Speaker 06:
On enablement, again, I think they make two points.

[00:23:20] Speaker 06:
One was in this multimodal argument.

[00:23:23] Speaker 06:
I mean, the district court's findings were, you know, it's pretty simple.

[00:23:27] Speaker 06:
She said,

[00:23:28] Speaker 06:
She said, we know that the food effect is a result of the reduced particle size.

[00:23:34] Speaker 06:
And so there's no way, based upon all the evidence and all the scientific, and there's only one example, there's only one particle size that is in the specification.

[00:23:43] Speaker 06:
That's 130, if you use the patent's nomenclature.

[00:23:46] Speaker 06:
So they have a range, they've claimed a range from 0 to 2000, which is really 2200, and they have one example in terms of the particle sizes within that range.

[00:23:56] Speaker 06:
130 nanometers is the average particle size.

[00:23:59] Speaker 06:
And there's all the evidence in there that, for example, Dr. Beach talked about Danizal.

[00:24:05] Speaker 06:
He talked about all the other examples.

[00:24:07] Speaker 06:
We had the prior art, Dr. Liversidge explaining this technology, explaining how it works, explaining that it's exponential when you go, when you, there was evidence that

[00:24:20] Speaker 06:
3055, for example, where Dr. Beach testified, and there was an example about when you reduce danizol particles from 4 microns to 0.45 microns, the increase in bioavailability was tenfold.

[00:24:36] Speaker 06:
So we know that it's exponential, the difference, as you approach the smaller particle size and the improvements in bioavailability and the attendant food effects.

[00:24:46] Speaker 06:
So the district court's conclusion

[00:24:48] Speaker 06:
that it was impossible.

[00:24:49] Speaker 06:
There's nothing in the patent, and actually the patent itself says that the smaller the particle size, the more likely you're going to get the claimed benefits.

[00:24:59] Speaker 06:
I mean, there is actually a statement in the patent that basically supports the district court's finding that it's not operable because they claimed 2000 to zero, and actually she was able to say that when you get down to a lower range of that,

[00:25:11] Speaker 06:
that 130, yes, you can get it, but then above that you can't, because as you make the particles bigger, they become less soluble, you can't get the bioavailability, and there's no trick.

[00:25:21] Speaker 06:
There was no trick when Dr. Liversidge invented the prior art of nanocrystal technology to improve the solubility of the prior art, and so there's no other method that anybody talks about to overcome the intended problems of the solubility of these molecules.

[00:25:37] Speaker 02:
It may be hyper-technical,

[00:25:40] Speaker 02:
I'm struggling with why we call that enablement.

[00:25:46] Speaker 02:
It's really failure-proof, isn't it?

[00:25:48] Speaker 06:
Well, no.

[00:25:49] Speaker 06:
It's enablement because the patentee has an obligation to enable a person of skill and the art to use the full scope of the claims invention.

[00:25:57] Speaker 06:
And when you have a... Less than 2,000, whatever that means.

[00:26:00] Speaker 06:
As of the year, right.

[00:26:02] Speaker 06:
The less than 2,000.

[00:26:03] Speaker 06:
And so the cases like the Magistl case and the

[00:26:09] Speaker 06:
Alcon case, I believe, are the ones that are most instructive here.

[00:26:13] Speaker 06:
If you claim a range, you have to enable the full scope of the range.

[00:26:17] Speaker 06:
And if someone later comes along and discovers how to get this food effect that's claimed with 2000 nanometers in size, they're going to be blocked because the patentees here claimed it already, even though they didn't teach you how to do it.

[00:26:37] Speaker 06:
And so that's the problem here.

[00:26:38] Speaker 06:
It's like, well, you don't have to prove everything within the range, but you have to enable a full scope of the range, enough of the range.

[00:26:44] Speaker 06:
And here the court found that over 2 thirds of the claimed range particle sizes were non-enabled.

[00:26:51] Speaker 06:
So that should be this positive of the enablement case.

[00:26:54] Speaker 06:
There was one example.

[00:26:55] Speaker 06:
And Dr. Beach testified about every one of the Wands factors.

[00:26:58] Speaker 06:
We cited it in our brief.

[00:27:00] Speaker 06:
The district court was able to ascertain

[00:27:03] Speaker 06:
of that testimony about each of the, we're not required to say these are the Wands Factors.

[00:27:07] Speaker 06:
Let's talk about Wands Factor 1.

[00:27:09] Speaker 06:
No, he addressed every one of the Wands Factors in the course of his testimony and then when the people argued the record, we were able to point to all the Wands Factors were considered, but the main one here is that it really isn't possible to practice this invention based upon what we know today and what we know back then outside of the sweet spot here, which is 130.

[00:27:27] Speaker 01:
Okay, anything else?

[00:27:31] Speaker 01:
Thank you, Your Honor.

[00:27:36] Speaker 03:
Help me understand, Mr. Brown, if you would, what's wrong with that enablement argument that your colleague made?

[00:27:47] Speaker 05:
Certainly.

[00:27:48] Speaker 05:
So there's a couple of things I'd like to address that are wrong with.

[00:27:53] Speaker 03:
You do agree you have to enable the full range?

[00:27:56] Speaker 05:
Well, I think there's a couple of points here.

[00:28:00] Speaker 05:
First of all, there's no dispute that we enable

[00:28:02] Speaker 05:
independently the full scope of each range, that you can make from 2000 down to zero, and you can make the entirety of the food effect.

[00:28:10] Speaker 05:
So we're outside of Magso.

[00:28:11] Speaker 05:
We solve the food effect all the way down to zero.

[00:28:13] Speaker 05:
The argument they're making, which the district court characterized as the union argument, is we have to be able to do them both simultaneously.

[00:28:20] Speaker 05:
And so we don't think there's actual legal support for that.

[00:28:22] Speaker 05:
That doesn't fall with any of the cases.

[00:28:24] Speaker 05:
We don't claim, you don't fall within our claim unless you eliminate the food effect to the requisite amount.

[00:28:29] Speaker 05:
And it's different than the Alcon

[00:28:32] Speaker 05:
And so we think, I haven't seen a case that directly addresses it either way, but we think that's outside of the scope of the court's existing jurisprudence.

[00:28:40] Speaker 05:
We enable the full scope of every range, unlike MagSill, where you couldn't do above 12% and you claimed 10 to infinity.

[00:28:47] Speaker 05:
So it's a very different situation.

[00:28:49] Speaker 05:
But second, there is a failure of proof here.

[00:28:52] Speaker 05:
They didn't put on, Dr. Beach didn't go through any sort of analysis like you would see in the Cephalon v. Watson case and address what would actually have to be done

[00:29:02] Speaker 05:
I did want to address the page that counsel cited, page A3055.

[00:29:08] Speaker 05:
And at line 21 on that, the witness, I believe it's Dr. Beach, said, yes, for this specific compound, HO221.

[00:29:18] Speaker 05:
So he limited his testimony to Danizal.

[00:29:21] Speaker 05:
And incidentally, in the original district court decision, she rejected TWI's proposition that Danizal served as an appropriate model

[00:29:30] Speaker 05:
for magestral acetate.

[00:29:31] Speaker 05:
They argued that because of what was known about Danizal, you would know about the food effect and you would know all these other properties.

[00:29:37] Speaker 05:
She rejected that.

[00:29:38] Speaker 05:
She made a fact finding adverse to that.

[00:29:40] Speaker 05:
And so the record for enablement is what appears on the two pages that I cited earlier, and it just doesn't meet this court's case law that has rejected conclusory enablement cases.

[00:29:54] Speaker 00:
Okay.

[00:29:54] Speaker 00:
Thank you.

[00:29:56] Speaker 00:
Cases will all be submitted.