[00:00:01] Speaker 02:
The last argued case this morning was the United Therapeutics Corporation versus the Quidia Technologies, 2022, 2217, and 231021.

[00:00:13] Speaker 02:
Mr. Sukhduan, is it?

[00:00:19] Speaker 00:
Yes, Your Honor, Sukhduan.

[00:00:20] Speaker 00:
Thank you.

[00:00:23] Speaker 00:
Good morning, Your Honors.

[00:00:24] Speaker 00:
Sonja Sutong on behalf of the Appellant for Quidia.

[00:00:27] Speaker 00:
We did brief a claim construction issue concerning the 793 patent with respect to the phrase treating pulmonary hypertension.

[00:00:34] Speaker 00:
And believe if this court actually construes that phrase to include safety and efficacy in treating pulmonary hypertension, we would prevail on the issues of lack of enablement and lack of written description.

[00:00:47] Speaker 02:
Well, the word safety isn't in the claim.

[00:00:49] Speaker 00:
You're right.

[00:00:50] Speaker 00:
And the word efficacy is also not in the claim either.

[00:00:52] Speaker 00:
But yet the court, in the opinion, determined that the claim only required efficacy, not safety.

[00:00:59] Speaker 00:
I did want to turn to the 793 enablement issue, unless you'd like to talk about the claim construction issue.

[00:01:05] Speaker 02:
Please proceed.

[00:01:06] Speaker 00:
Well, with respect to enablement, under the district court's current construction that excluded safety, the claims of the 793 patent are still non-enabled.

[00:01:14] Speaker 00:
The basis for the district court's determination on enablement rests on a study called the FIRST study.

[00:01:22] Speaker 00:
And that was the administration of a prostacycline called eprosynol to patients with isolated group two pulmonary hypertension.

[00:01:30] Speaker 00:
And that was, by all accounts, a failed study, terminated prematurely because it caused death.

[00:01:35] Speaker 00:
The drug caused death.

[00:01:37] Speaker 02:
Well, enablement has to be in the specification.

[00:01:42] Speaker 02:
And this pattern does address enablement quite a bit.

[00:01:47] Speaker 02:
Look at column 7.

[00:01:50] Speaker 02:
D-prosynil can be administered by inhalation.

[00:01:53] Speaker 02:
There are almost two columns of enablement.

[00:01:57] Speaker 00:
Those descriptions, Your Honor, discuss how you administer the drug.

[00:02:01] Speaker 00:
And we don't dispute that the patent itself clearly tells you that you inhale the triposanol.

[00:02:07] Speaker 02:
Well, the claim is to a method of treating pulmonary hypertension, and the patent tells you how to do it.

[00:02:12] Speaker 00:
The claim is directed to a treating pulmonary hypertension, but the scope of pulmonary hypertension

[00:02:16] Speaker 00:
pulmonary hypertension includes all five groups.

[00:02:20] Speaker 00:
So that's what the district court found.

[00:02:22] Speaker 00:
That includes isolated group two.

[00:02:24] Speaker 00:
And you have to enable the full scope of the claim in order for the claim to be enabled.

[00:02:29] Speaker 00:
Isolated group two comprises, and however you want to look at it, comprises 50% of the population.

[00:02:35] Speaker 02:
Isn't that an FDA issue?

[00:02:36] Speaker 00:
No, it's not.

[00:02:37] Speaker 00:
It's a patent issue.

[00:02:40] Speaker 00:
When you look at if a patentee is going to claim,

[00:02:43] Speaker 00:
pulmonary hypertension by administering a drug in a certain way, they have to enable that full scope of treatment.

[00:02:51] Speaker 00:
Here our position is, and I believe the experts are in line with this issue,

[00:02:58] Speaker 00:
Within pulmonary hypertension, there are five groups.

[00:03:01] Speaker 00:
One of those groups, isolated group two, is a post capillary disease.

[00:03:06] Speaker 00:
It's a left heart disease.

[00:03:08] Speaker 00:
That comprises 50% of all patients with pulmonary hypertension.

[00:03:13] Speaker 00:
If you look at it.

[00:03:13] Speaker 03:
Did the court below say 50%?

[00:03:16] Speaker 03:
Did the court below agree with that?

[00:03:18] Speaker 00:
The the court I don't I'm not sure found a fact finding with respect to the total population of 50% but it was unrefuted testimony from liquidius expert dr. Winkler And that is the position that was presented to the court, but you're correct.

[00:03:37] Speaker 00:
There is no express finding

[00:03:40] Speaker 00:
if you step away from the 50%.

[00:03:42] Speaker 03:
I mean, I don't even know if it matters, to be honest with you.

[00:03:44] Speaker 03:
But I mean, I looked at the evidence underlying that.

[00:03:47] Speaker 03:
And I was like, oh, here's a study with 5,000 people.

[00:03:49] Speaker 03:
And 50% of them, this is how they presented.

[00:03:53] Speaker 03:
And then there was something else that was a study just for group two.

[00:03:56] Speaker 03:
And 52% of those people had isolated group two.

[00:04:00] Speaker 03:
So it just, I don't know.

[00:04:02] Speaker 03:
I wasn't sure about that evidence.

[00:04:03] Speaker 03:
But even if it were 20%, would you still be standing here making the same argument?

[00:04:07] Speaker 00:
Yes, we would.

[00:04:08] Speaker 00:
Because when you look at the scope of the claim, whether you look at it 50% of the population, 20% of the population, even if you look at it as one out of five, five groups, group two is one of those groups.

[00:04:21] Speaker 00:
Under the trustees of the University of Boston case, one out of six was sufficient to establish non-enablement.

[00:04:28] Speaker 02:
But counsel, every claim to a method of treatment of an ailment has refinements.

[00:04:35] Speaker 02:
In 1880 or whenever it was, if there had been a claim, probably was, to a method of treating pain with aspirin.

[00:04:43] Speaker 02:
There are lots of patients who shouldn't take aspirin.

[00:04:48] Speaker 02:
Are we going to bifurcate or multifurcate every claim to a method of treatment?

[00:05:00] Speaker 02:
And to all of the people?

[00:05:03] Speaker 02:
Does a patent specification have to resemble a package circular that the FDA approves?

[00:05:11] Speaker 00:
No.

[00:05:12] Speaker 00:
The patent specification does not need to meet FDA standards.

[00:05:17] Speaker 00:
Why not?

[00:05:18] Speaker 00:
No.

[00:05:19] Speaker 00:
What here, the study that the district court relied on, and it's really the sole basis for the finding of enablement, is a failed study.

[00:05:27] Speaker 00:
It did not treat the pulmonary hypertension of this patient population.

[00:05:32] Speaker 00:
the issue with respect to parsing out, we would argue that when the claim expressly requires a certain number of groups to be treated, and it is known in the specification and in the prior art, the first study, that it does not treat that population, that study cannot be used to enable it.

[00:05:55] Speaker 02:
This isn't a claim to treatment of one, two, three, four, and five types.

[00:05:59] Speaker 00:
It is, Your Honor.

[00:05:59] Speaker 00:
It is, Your Honor, expressly.

[00:06:01] Speaker 00:
The district court expressly found that when you look at Appendix 58, finding a fact number three.

[00:06:09] Speaker 00:
Treating pulmonary hypertension includes all five groups.

[00:06:12] Speaker 00:
That is an express finding by the court.

[00:06:14] Speaker 00:
So it is treating all five groups.

[00:06:16] Speaker 03:
Is that a claim interpretation?

[00:06:18] Speaker 00:
That is both a finding a fact and a claim interpretation.

[00:06:23] Speaker 03:
How is the finding a fact?

[00:06:25] Speaker 00:
Well, first, the specification defines in column one

[00:06:30] Speaker 00:
Pulmonary hypertension is groups one through five.

[00:06:34] Speaker 00:
The experts in this case agreed when they talked about whether you would treat one through five what pulmonary hypertension encompasses.

[00:06:43] Speaker 00:
There's no dispute that the scope of the claim and claim construction, when you look at it, could be a legal issue.

[00:06:49] Speaker 00:
But it has to be based on facts, what a person with a lower skill in the art would understand.

[00:06:53] Speaker 00:
There's no dispute on that.

[00:06:56] Speaker 00:
What Appellee has argued in their brief

[00:06:59] Speaker 00:
is that you could actually construe the claim differently.

[00:07:01] Speaker 00:
You construe the claim post-capillary, which would be isolated group two, or pre-capillary, which is the scope that they say is enabled.

[00:07:10] Speaker 00:
In that instance, you would be construing the claim to preservability because there's nothing in the specification of the patent or testimony from the experts in this case to cause that demarcation with respect to pulmonary hypertension.

[00:07:23] Speaker 03:
What about the fact that all of the examples are pre-capillaries?

[00:07:26] Speaker 00:
All of the examples are pre-capillary.

[00:07:29] Speaker 00:
There's no dispute on that.

[00:07:31] Speaker 00:
But what's important is that the examples use the term pre-capillary.

[00:07:35] Speaker 00:
The specification also uses the term pulmonary hypertension.

[00:07:39] Speaker 00:
And the claim uses the term pulmonary hypertension.

[00:07:41] Speaker 03:
What about the fact that there's evidence on both sides that a person with an area of scale of the heart seeing the active drug in this claim would have understood that it wouldn't be ideal to apply that drug

[00:07:54] Speaker 03:
to a post-capillary patient.

[00:07:57] Speaker 00:
And that goes to the factual error in relying on the first study.

[00:08:01] Speaker 00:
because the experts agree on that.

[00:08:03] Speaker 00:
So when you look at that evidence, what Opposa is entitled to do is to look at the patent.

[00:08:11] Speaker 00:
And the patent claims, and the inhalation of trapezoidal is the novel aspect of this claim.

[00:08:18] Speaker 00:
It had never been inhaled.

[00:08:20] Speaker 00:
It had never been claimed as inhaled in this manner before.

[00:08:23] Speaker 00:
So when Opposa, looking at the patent, says, oh,

[00:08:26] Speaker 00:
So when looking at that patent claim, the doctors in this case,

[00:08:41] Speaker 00:
have a right to say, well, if I inhale tripostinal, maybe that route of administration as opposed to the prior routes of administration, which were IV, or subcutaneous, or oral tablets, that might impact group two differently than other groups.

[00:08:58] Speaker 00:
So when you look at the claim, that's what they would believe.

[00:09:01] Speaker 00:
The fact that later on, through the first study, establishes that it will not work, it does not treat, that supports the enablement.

[00:09:08] Speaker 00:
Their claim construction argument saying you should construe the claim to cover pre-capillary, again, reinforces the lack of enablement.

[00:09:15] Speaker 00:
And the point you raised, Judge Stoll, that the experts agree

[00:09:19] Speaker 00:
that trapezoid or trapezoid cyclin wouldn't be used in an isolated group two, only further confirms that the district court circumvented those facts, undisputed facts, relied on a reference that was undisputedly a failure, and nonetheless said that the full scope of the claims were enabled.

[00:09:39] Speaker 03:
One of the things the district relied on was the claim language, therapeutically effective single event dose.

[00:09:44] Speaker 03:
Correct.

[00:09:47] Speaker 03:
I think that means that we're talking about administering at one time.

[00:09:53] Speaker 03:
Is that right?

[00:09:53] Speaker 00:
Do I understand that correctly?

[00:09:55] Speaker 00:
That was an issue with respect to infringement, which is not on appeal.

[00:10:01] Speaker 00:
How the district court construed therapeutically effective amount was a hemodynamic change.

[00:10:08] Speaker 00:
And what the district court said is that because the first study shows a hemodynamic change in those group two patients,

[00:10:16] Speaker 00:
that establishes enablement.

[00:10:18] Speaker 00:
But the facts are what the experts testified to.

[00:10:22] Speaker 00:
Dr. Waxman, who was UT's expert, and Dr. Winkler, which was Liquidia's expert, they all testified that for an isolated group two patient,

[00:10:32] Speaker 00:
Their hemodynamics, their PVR, are normal.

[00:10:35] Speaker 00:
And you would not administer a drug like traposanol, which is going to vasodilate the precapillary to patients who have normal hemodynamics.

[00:10:46] Speaker 00:
It has no treatment effect.

[00:10:48] Speaker 01:
So to come back to Judge Lurie's hypothetical about the aspirin,

[00:10:52] Speaker 01:
And it would seem to be correct that the mere fact that there are some patients who aren't going to benefit from the treatment doesn't result in a lack of enablement or invalidation of the patent.

[00:11:05] Speaker 01:
How do you draw the line between that example and the situation that we have here?

[00:11:10] Speaker 01:
Is it because the patent identifies a separate group that doesn't benefit from it?

[00:11:14] Speaker 01:
What's the difference?

[00:11:16] Speaker 00:
The difference is, and the way the cases read, is that there have to be a significant number of inoperable embodiments to trigger over to the non-enablement side.

[00:11:27] Speaker 00:
Here, we take the position that there is a significant number.

[00:11:31] Speaker 00:
You can have inoperable embodiments and still be enabled.

[00:11:35] Speaker 00:
But if the number of inoperable embodiments becomes significant, then the enablement becomes a question.

[00:11:40] Speaker 00:
Here, how we look at it, and what the district court found is that

[00:11:46] Speaker 00:
Group two is one of five groups.

[00:11:48] Speaker 00:
That is a significant number of groups.

[00:11:50] Speaker 03:
If you look at pre-post... Is it only one of six, anyway, or something like that?

[00:11:54] Speaker 00:
It's one of five.

[00:11:55] Speaker 00:
There are five groups.

[00:11:56] Speaker 03:
Well, and the reason why, let me explain.

[00:11:57] Speaker 03:
The reason why is because there's...

[00:11:59] Speaker 03:
post-capillary patients who have combined with pre-capillary and post-capillary.

[00:12:06] Speaker 03:
Correct.

[00:12:06] Speaker 03:
So that's kind of six groups, right?

[00:12:08] Speaker 00:
No, because those combined fall into group two.

[00:12:13] Speaker 00:
The understanding of the clinicians, the persons of skill and the art, are that there are five groups, not six.

[00:12:20] Speaker 03:
And the pre-post... I know why I'm asking this, because I thought, I could be wrong, but I thought there was evidence in this case that

[00:12:26] Speaker 03:
the claimed invention could be effective to treat somebody who's combined.

[00:12:32] Speaker 00:
There was testimony that it might work for someone who's combined because the combined patient, group two, has a pre-capillary component.

[00:12:41] Speaker 00:
It would work on the- I don't think the district court had a fact finding on that issue.

[00:12:47] Speaker 00:
The district court focused in on the post-capillary versus the pre-capillary aspect.

[00:12:53] Speaker 00:
Coming back to your question, and I apologize.

[00:12:56] Speaker 00:
The line is a significant amount of inoperative embodiments that goes to Judge Laurie's question about the aspirin.

[00:13:03] Speaker 00:
Here, pre and post, if you look at it in that context, it's one out of two.

[00:13:08] Speaker 00:
That's a significant number.

[00:13:10] Speaker 00:
We believe one out of five is a significant number.

[00:13:13] Speaker 00:
We believe when you look at the total patient population of pulmonary hypertension, 50%.

[00:13:19] Speaker 01:
What's the 50% number based on?

[00:13:22] Speaker 00:
So there is a study that a liquidity expert, Dr. Hill, testified to that when they looked at five something thousand pulmonary hypertension patients, half of those patients fell into this isolated group too.

[00:13:38] Speaker 02:
It's in the record and I can provide the record site when I come back up.

[00:13:48] Speaker 00:
I will save the rest unless you have any further questions.

[00:13:52] Speaker 02:
We'll give you two minutes of the bottle.

[00:13:53] Speaker 02:
Thank you, Your Honor.

[00:14:02] Speaker 02:
Mr. Dre.

[00:14:02] Speaker 02:
Mr. Dre, has this patent been invalidated by the PTAB?

[00:14:07] Speaker 04:
There is a final written decision holding these claims unpatentable.

[00:14:11] Speaker 04:
That's correct, Your Honor.

[00:14:12] Speaker 04:
Of course, that's on appeal to this court, and we'll get here in due course.

[00:14:18] Speaker 04:
for the reasons that we've set out in our brief, it has not been invalidated because it has not been, that proceeding is not yet final.

[00:14:28] Speaker 01:
So turning to the enablement point, do you agree that if there were a significant number of patients covered by these claims who wouldn't benefit from this therapy, that it wouldn't be enabled?

[00:14:40] Speaker 04:
I don't agree with that.

[00:14:41] Speaker 04:
I mean, I don't think that those are the facts here.

[00:14:43] Speaker 04:
But I think that the question whether to apply the invention to a particular group of patients, whether because there's a better therapy or because it's contraindicated for some reason, that, I think, does not speak to whether it's enabled.

[00:14:57] Speaker 01:
This invention is enabled for the reasons that... So the fact that it would be inoperative for a significant number of the class covered

[00:15:06] Speaker 01:
by the patent is irrelevant to the enablement?

[00:15:08] Speaker 04:
Well, respectfully, Your Honor, I took your question to ask whether it would be beneficial, which is not, I think, quite the same thing as your second question.

[00:15:20] Speaker 01:
Let's just assume, hypothetically, we can come to the second part of this later.

[00:15:25] Speaker 01:
But let's assume that it is not beneficial, it doesn't result in the treatment of a significant number of patients covered by the claims.

[00:15:40] Speaker 01:
Does that mean a lack of enablement because it's significantly inoperative?

[00:15:45] Speaker 04:
Well, because these claims claim a therapeutically effective amount of treprosanil to treat pulmonary hypertension, the patent does have to enable the use of a therapeutically effective amount to treat pulmonary hypertension.

[00:16:04] Speaker 04:
But the construction of the claims is, I think, the questioning.

[00:16:07] Speaker 01:
You're sort of wandering all over the place.

[00:16:09] Speaker 01:
I don't think you're answering my question.

[00:16:11] Speaker 01:
If you have a claim,

[00:16:13] Speaker 01:
that covers five classes, and let's assume that this one does, and that one class, group two here, let's assume it's 50% of the patient population, and if it simply doesn't work, hypothetically, for that group two, doesn't that show a lack of enablement?

[00:16:36] Speaker 04:
So you'll allow me to come back to why we didn't read the preface, of course.

[00:16:41] Speaker 04:
But to answer your question, it could, it would depend on what the background knowledge of the skilled artisan would be.

[00:16:48] Speaker 04:
So in other words, if it's compatible with the knowledge of the skilled artisan to treat or withhold treatment based on accepted practice in the art, for example, it could still be enabled.

[00:17:00] Speaker 01:
So you could write a claim that's substantially inoperative,

[00:17:04] Speaker 01:
people would know that it was an operative it's still valid.

[00:17:07] Speaker 04:
Well I think this points to exactly the line drawing problem that you asked my friend about.

[00:17:13] Speaker 01:
But answer my question is that I mean that seems kind of odd.

[00:17:17] Speaker 01:
You're saying that you could write a claim that's substantially an operative as to a majority of the patient population.

[00:17:23] Speaker 01:
But the fact that people would know that it was inoperative is sufficient to solve the enablement problem.

[00:17:29] Speaker 04:
Is that what you're saying?

[00:17:32] Speaker 04:
So there are a lot of things built into your question that are not the facts of this case.

[00:17:35] Speaker 04:
I understand.

[00:17:36] Speaker 04:
Right.

[00:17:36] Speaker 04:
Let me answer it directly.

[00:17:39] Speaker 04:
So I think that that could be an enablement problem, but it would turn on the knowledge of the skilled artisan.

[00:17:44] Speaker 01:
So what do you mean it would turn on?

[00:17:46] Speaker 01:
What knowledge?

[00:17:47] Speaker 04:
On web so if it depends on how the claim is worded right here We have because we are talking about a claim that actually claims therapeutic efficacy right and so if you were talking about Differently worded claims that that didn't claim that Then the enablement inquiry would look different.

[00:18:06] Speaker 04:
It might well.

[00:18:07] Speaker 01:
Okay.

[00:18:07] Speaker 01:
Well, let's assume that the hypothetical that the claim claims therapeutic efficacy

[00:18:13] Speaker 04:
Right, so then it does have to tell the skilled artisan how to practice the claim in a way that is therapeutically effective.

[00:18:21] Speaker 04:
So in your hypothetical, it's not therapeutically effective to a large number of people.

[00:18:25] Speaker 04:
Yes, that could be an enablement problem.

[00:18:28] Speaker 04:
But first, there are several reasons why those are not the facts of this case.

[00:18:33] Speaker 04:
One is the finding that for all patients, under the construction that the other side has not appealed and that my friend got to at the latter part of his argument,

[00:18:43] Speaker 04:
Therapeutic efficacy, in this case, means improving the patient's hemodynamics.

[00:18:47] Speaker 04:
That's all.

[00:18:49] Speaker 04:
Whereas the study that my friend referred to as a failed study, that's a chronic intravenous administration over a very long term of this medication.

[00:19:00] Speaker 02:
So it's not... Mr. Jay, would you distinguish this enablement case where we're talking about enabling treatment of a disease

[00:19:10] Speaker 02:
Distinguish that from the case of the Supreme Court, for example, where we're talking about a genus of compounds where we found it not enabled because there just wasn't enough indication of enablement with respect to the full scope of the claim.

[00:19:30] Speaker 02:
Isn't that different trying to parcel out

[00:19:39] Speaker 02:
bisect, dissect treatment of disease.

[00:19:46] Speaker 02:
Isn't that quite different from

[00:19:48] Speaker 02:
the case of a bunch of compounds in a genus claim?

[00:19:51] Speaker 04:
I do agree with that, Your Honor, because in the treatment claim, you have to say that the enablement inquiry would then pick up FDA-type questions about which patients this shouldn't be used with.

[00:20:03] Speaker 04:
That invites exactly the line-drawing problem that both you and Judge Zike were asking my friend about.

[00:20:08] Speaker 02:
That's why we see this as different.

[00:20:09] Speaker 02:
And doesn't that open Pandora's box with respect to method of treatment claims?

[00:20:13] Speaker 02:
Because there's a wide variety

[00:20:17] Speaker 04:
What's necessary to enable a claim is to teach the skilled artisan how to make or use the claimed invention.

[00:20:29] Speaker 04:
Here the claimed invention is the method of treatment and the patent teaches, you know, what condition it treats, what drug to use, what dose to use, how to administer it.

[00:20:39] Speaker 04:
That's exactly right.

[00:20:40] Speaker 04:
That is not what's important.

[00:20:42] Speaker 04:
Whether to administer the drug compared to other therapies, for example, is not part of the enablement inquiry.

[00:20:49] Speaker 04:
And then the other reason, just to get back to Judge Dike's one-on-one inquiry, the other reason why this is not like the hypothetical that you posited is that there are findings in this case that, as construed, this will improve the hemodynamics of a patient to whom you administer the claimed dose.

[00:21:04] Speaker 01:
OK, but there are no findings as to what percent of the patient population

[00:21:10] Speaker 01:
the claim is an operator.

[00:21:13] Speaker 04:
Well, I disagree, Your Honor, because the finding is that as to patients in all the groups, if you administer the claimed dose, it will be effective to reduce the, to improve the patient's hemodynamics.

[00:21:25] Speaker 04:
That's all that's necessary.

[00:21:28] Speaker 04:
So there's no evidence at all, Your Honor, that a single administration, which is what is claimed here, would do that.

[00:21:35] Speaker 04:
The safety concern that's raised in the first study, that's a long-term study, chronic

[00:21:43] Speaker 04:
administration intravenously of this medication.

[00:21:46] Speaker 04:
There is no testimony that administering a single dose would pose the kind of safety issues that would be non-enabling.

[00:21:54] Speaker 04:
What there is testimony to is that the other side's expert says he would act with caution.

[00:22:01] Speaker 04:
And I think that's as far as they got on the administration of a single dose.

[00:22:04] Speaker 04:
He said at page, I think, 13200 that his testimony was based on the other side's claim construction

[00:22:13] Speaker 04:
of therapeutically effective, which the district court did not accept and which has not been appealed to this court.

[00:22:18] Speaker 04:
But that's quite relevant for the court's consideration of the enablement point.

[00:22:23] Speaker 04:
I do want to answer the 50% point, Judge Stoll.

[00:22:25] Speaker 04:
I think it's not relevant because of the answer that I just gave.

[00:22:30] Speaker 04:
In other words, the finding is that if you give this dose to someone in isolated group two, it will still improve the patient's hemodynamics.

[00:22:37] Speaker 04:
But there is no finding on the 50%

[00:22:41] Speaker 04:
Figure and our expert testified that in his experience admittedly this is not Something that the district were resolved, but at 13183 you'll see the doctor in dr. Raxman's experience treating a couple thousand patients He thought though the proportion was lower we again the district were did not need to resolve that question precisely because of its finding that

[00:23:04] Speaker 04:
it would be therapeutically effective, even as to isolated group two patients.

[00:23:08] Speaker 04:
We think that's the simplest basis on which to affirm the district court, but that finding is not clearly erroneous, especially because it's tied to the claim construction.

[00:23:16] Speaker 04:
If I could, I'd like to turn to the cross appeal, unless the court has further questions about the 793 patent.

[00:23:24] Speaker 03:
Oh, and on the cross-appeal... Can I just ask you real quickly about the written description?

[00:23:30] Speaker 03:
The written description asks us whether a person of ordinary scale in the art would think that the inventor was in possession of the invention.

[00:23:37] Speaker 03:
So I just want your take on, you know, here in this case, in order to get a certain claim destruction, I think your expert said something like, I would never apply that treatment, or I wouldn't apply this kind of treatment.

[00:23:48] Speaker 03:
I would know from looking at the claim that I would not apply this to a group two patient.

[00:23:53] Speaker 03:
How does that play into whether a person born in a new family or being

[00:23:58] Speaker 03:
the specification and reading the claim would think that the inheritance and possession did.

[00:24:05] Speaker 04:
So just basics first.

[00:24:07] Speaker 04:
The means of administration and the dose and all of that, that's set out.

[00:24:12] Speaker 04:
And the studies, which all involve the administration of a single dose, that's all set out.

[00:24:17] Speaker 04:
And so the testimony that you're referring to, our expert said that he would administer diuretics instead, for example.

[00:24:26] Speaker 04:
So I think that it is not necessary for written description to establish that it would be a good idea or certainly not the best therapy to administer the claimed method.

[00:24:41] Speaker 04:
What's claimed is the therapeutically effective dose, and there are studies demonstrating the possession of that therapeutically effective dose as administered to pulmonary hypertension patients.

[00:24:51] Speaker 04:
It's not necessary for a description that you have a study as to every possible subcategory of patients to which you might administer the claim method.

[00:24:58] Speaker 04:
There are actual studies involving administering the claimed dose and the claimed means of administration.

[00:25:03] Speaker 01:
But wouldn't you have to have a written description of support for the idea that it's effective with respect to that part of the patient population?

[00:25:13] Speaker 01:
And in this respect, it looks somewhat similar to NOVO, right?

[00:25:16] Speaker 04:
I don't know it's a nouveau I don't think so your honor because nouveau is not about a part of a patient population at all nouveau and of course nouveau in this case are both clear error cases nouveau is affirming a finding of no written description in this case you have a finding of adequate written description but let's even setting that aside

[00:25:33] Speaker 04:
Nuvo is about whether for any administration the claimed dose would be effective to increase gastric pH and there was no basis in the specification or in the knowledge of the skill artisan to think that it would work for that.

[00:25:48] Speaker 04:
Here we have actual studies of administering this dose, this therapy to pulmonary hypertension patients.

[00:25:53] Speaker 04:
I think that that's a major difference.

[00:25:55] Speaker 04:
So if I can turn just briefly to the cross appeal.

[00:26:00] Speaker 04:
Let me just start with the invalidity argument on the 066 patent, the anticipation of the product by process claims.

[00:26:07] Speaker 04:
So we think that where the district court went wrong in this case is that it didn't look at the structural features that are imparted by using the different process.

[00:26:18] Speaker 04:
In other words, this is not the same old

[00:26:22] Speaker 04:
medication, this is a new substance, and that is a new pharmaceutical composition.

[00:26:27] Speaker 04:
That's because, if you look at the claim language, you will see that the composition has to include a lower level of impurities.

[00:26:37] Speaker 04:
Now, the impurities could be reduced to zero.

[00:26:40] Speaker 02:
So one could avoid anticipation by claiming the compound with impurities?

[00:26:47] Speaker 02:
I mean, that sounds absurd.

[00:26:49] Speaker 02:
The compound is old.

[00:26:51] Speaker 02:
described in Moriarty.

[00:26:53] Speaker 02:
And there are even some impurities in Moriarty.

[00:26:57] Speaker 02:
98.7% pure.

[00:27:01] Speaker 02:
And so putting impurities into the claim distinguishes it.

[00:27:05] Speaker 04:
So these are specific impurities that have particular therapeutic significance, and you will find that in the testimony of Dr. Taust in the record, especially at page 13069.

[00:27:17] Speaker 04:
And it's the reduction of that impurities that's the improvement in the prior art.

[00:27:22] Speaker 02:
So triprostinal is in the prior art, but this formulation within- This isn't a method of eliminating impurities in triprostinal by

[00:27:35] Speaker 02:
Hydrolyzing, precipitating, or recrystallizing, this is a pharmaceutical composition.

[00:27:41] Speaker 04:
It is a pharmaceutical composition, but because the claim language says that the composition includes the lower level of impurities, that is what separates this from the prior art.

[00:27:52] Speaker 04:
That fundamentally goes to what is claimed rather than the application of the doctrine.

[00:27:59] Speaker 04:
Let's see.

[00:28:01] Speaker 04:
I'm about to run into my rebuttal time.

[00:28:03] Speaker 04:
I haven't mentioned Sanovia, so unless the court has any questions on that issue.

[00:28:09] Speaker 02:
We'll save you rebuttal time if there is something to rebut.

[00:28:13] Speaker 04:
I understand.

[00:28:13] Speaker 04:
Thank you very much.

[00:28:16] Speaker 02:
Mr. Suptuong?

[00:28:19] Speaker 00:
Thank you.

[00:28:20] Speaker 00:
With respect to the 50%, it's appendix site 369930699.

[00:28:26] Speaker 00:
And particularly in that study, which Dr. Hill and I misspoke.

[00:28:30] Speaker 00:
I said our expert was Dr. Winkler on this issue.

[00:28:32] Speaker 00:
It's Dr. Hill.

[00:28:33] Speaker 00:
52% have had isolated group two.

[00:28:37] Speaker 00:
His testimony corresponding to that goes to appendix site 13168.

[00:28:43] Speaker 00:
With respect to the parsing out, I'm coming back to the aspirin question again.

[00:28:47] Speaker 00:
If someone had come along later on and found that aspirin worked for a specific type of pain,

[00:28:54] Speaker 00:
They found that that administration worked.

[00:28:58] Speaker 00:
It wasn't disclosed in the prior art.

[00:29:00] Speaker 00:
And they can establish that it was unexpected that it worked for a particular type of painting.

[00:29:05] Speaker 00:
You'd get a patent claim on that.

[00:29:06] Speaker 00:
That is what UT and the 793 patent is trying to preclude now.

[00:29:11] Speaker 00:
If someone in the future were to determine that if you administer trapezoidal in some other manner to treat this population

[00:29:22] Speaker 00:
then they would be able to argue that it would be unexpected, non-obvious, and try to get a patent claim on that.

[00:29:29] Speaker 00:
So it's not a parsing out in terms of, well, I disclose a compound.

[00:29:34] Speaker 00:
and be able to use it for every disease or all of pH that's enabled.

[00:29:39] Speaker 00:
Here, the significant number of patients that fall into this category, however you parse it out, is enough to tilt it over to the non-enablement side of things.

[00:29:49] Speaker 01:
OK, but their argument in that respect is that it does help those patients.

[00:29:54] Speaker 01:
It is a therapy for those patients because it causes vascular violation.

[00:29:59] Speaker 00:
actually the evidence is that it does not help those patients.

[00:30:04] Speaker 00:
Dr. Waxman, UT's expert, and Dr. Hill both said that a vasodilator like traposinal would have no treatment, no impact on a group two patient.

[00:30:16] Speaker 00:
Because the cause of the disease is on the left side of the heart post capillary vasodilators work on the pre capillary side and in fact, dr. Hill testified that the administration of a

[00:30:33] Speaker 00:
vasodilator like trapezoidal would likely cause the problems you see in that first study because now you're opening up the the precapillary more blood is rushing through to the left side of the heart that's going to cause the pulmonary edema and in fact the the study the first study was terminated prematurely because of death and

[00:30:58] Speaker 00:
This is an instance where the evidence establishing enablement, the district court's factual finding to establish enablement of the claims, rests solely on a study that was terminated prematurely because the drug, not some other cause, but because of the drug, increased the mortality rate in this particular patient population.

[00:31:19] Speaker 02:
Also, as you can see, your time has expired.

[00:31:23] Speaker 00:
I appreciate it.

[00:31:25] Speaker 02:
Thank you, Your Honor.

[00:31:27] Speaker 02:
So we'll take the case on the submission.