[00:00:13] Speaker 03:
Mr. Hodgstedtler, please proceed.

[00:00:22] Speaker 03:
Wait a sec, let him.

[00:00:37] Speaker 04:
Please proceed.

[00:00:40] Speaker 04:
It was obvious to lower the dose of the testosterone drug than in overdosed patients in three published clinical studies.

[00:00:49] Speaker 04:
That, in essence, is our argument.

[00:00:51] Speaker 04:
There was no dispute that the drug used in the clinical studies was the composition recited in the asserted claims.

[00:00:58] Speaker 04:
The district court clearly erred in failing to find from the stipulated fact that the articles that describe the clinical studies also inherently described the recited composition.

[00:01:09] Speaker 03:
But inherent disclosure requires that something necessarily be true.

[00:01:16] Speaker 03:
And the testimony in this case was that any of a large number of co-solvents could have been used, and that the ratios could have been different.

[00:01:26] Speaker 03:
It turns out that what they actually used in those studies did correspond to the claims.

[00:01:31] Speaker 03:
But that's not what the references disclose.

[00:01:33] Speaker 03:
And quite frankly, nor do they inherently disclose that under our law of inherency.

[00:01:39] Speaker 04:
Your Honor, I don't agree.

[00:01:41] Speaker 04:
The fact that there is no dispute that the composition was in fact used.

[00:01:50] Speaker 03:
That doesn't mean it's inherently disclosed.

[00:01:54] Speaker 03:
I don't understand how you want to mess up the law of anticipation and inherency.

[00:01:58] Speaker 03:
It's a straightforward, it's never been articulated any differently than the document necessarily includes that.

[00:02:06] Speaker 03:
And in this case, you can't say this

[00:02:09] Speaker 03:
document necessarily includes it.

[00:02:11] Speaker 03:
It turns out that study did in fact include it, but the testimony of record was that any number, I believe it's five different co-solvents would have worked and different ratios would have worked, and all the experts agreed on that.

[00:02:21] Speaker 03:
So I don't understand how we would mess up the law of inherency, which is what you're asking us to do, by concluding that even though the document doesn't necessarily result in someone understanding that this is what was used,

[00:02:36] Speaker 03:
It should nonetheless be deemed to be inherently disclosed.

[00:02:39] Speaker 04:
Your Honor, I don't believe anywhere in the records does it say that another combination would have obtained exactly the same combination of pharmacogenetic profile and the results.

[00:02:53] Speaker 04:
The testimony was that there were other solvents that could be used.

[00:02:58] Speaker 04:
But in this case, though, the

[00:03:05] Speaker 04:
The only people of skill today recognize that what was used in those studies was, in fact, was necessarily the reciting composition.

[00:03:18] Speaker 03:
It is what was used.

[00:03:19] Speaker 03:
But at A404, they point out that Custofarm's expert conceded a post that would not know that the prior art necessarily used a formula of 40% castor oil and 60%

[00:03:33] Speaker 03:
Benzoyl Benzoate, and that is pointing to the expert testimony at A404.

[00:03:38] Speaker 03:
So in addition to the fact that there were at least five co-solvents that could have been used, of which only one was Benzoyl Benzoate, they've got evidence they point to that would support the fact-finding the district court made in this case.

[00:03:52] Speaker 04:
Your Honor, that goes to the recognition requirement.

[00:03:55] Speaker 04:
And there is no requirement that persons of ordinary skill recognize at the time what the composition was.

[00:04:01] Speaker 04:
And that testimony, I believe,

[00:04:02] Speaker 04:
was directed to that.

[00:04:04] Speaker 02:
OK, so let me see if I can understand.

[00:04:07] Speaker 02:
There might be two strains of inherency that we're discussing right now.

[00:04:14] Speaker 02:
One is the one that I understand that Judge Moore is questioning you about, which is when someone's reading those articles, a person of ordinary skill in the art, even though the articles don't expressly say benzoyl-benzoate and a ratio of 40 to 60 between castor oil and benzoyl-benzoate,

[00:04:31] Speaker 02:
Nevertheless, a person of skill would necessarily understand while reading that reference in context, aha, there's definitely benzyl benzoate in here, and it's at a 40 to 60 ratio.

[00:04:42] Speaker 02:
And that strain of inherency, you agree, is not what you're advancing.

[00:04:48] Speaker 02:
Is that fair to say?

[00:04:50] Speaker 02:
It's a different strain, which is that the actual formulation that was being used by those authors and those articles

[00:05:00] Speaker 02:
was necessarily the very formulation that's being recited in these claims.

[00:05:05] Speaker 02:
And so even though it could not be appreciated by a person of ordinary skill in the art, reading those articles at the time, they were somehow inherently a necessary characteristic of the formulation that was being reported on in those articles.

[00:05:23] Speaker 02:
Is that your theme of your inherency argument?

[00:05:27] Speaker 04:
As I understand it, Your Honor, those two

[00:05:28] Speaker 04:
Inherency themes, as you put it, actually come together.

[00:05:32] Speaker 02:
In Continental Can, the... But before you tell me what Continental Can is, I want you to tell me what your particular theory of Inherency is.

[00:05:44] Speaker 02:
Did I get it right or did I get it wrong?

[00:05:46] Speaker 04:
You got it slightly wrong, Your Honor.

[00:05:49] Speaker 04:
Okay.

[00:05:50] Speaker 04:
Inherency does require a person of ordinary skill to recognize that the disclosure necessarily

[00:05:58] Speaker 04:
encompass the invention.

[00:06:00] Speaker 04:
However, in the Shearing case, it established that that recognition does not have to occur during the prior art period.

[00:06:06] Speaker 04:
Today, a person of ordinary skill reading the articles knows that the composition is the recited composition.

[00:06:12] Speaker 04:
So those two issues, as we see it, come together.

[00:06:16] Speaker 04:
And the key is that the recognition of the necessary result does not have to occur during the prior art period.

[00:06:22] Speaker 02:
But I guess the concern I have about your argument is that

[00:06:27] Speaker 02:
What was disclosed in those articles was an incomplete disclosure of what that formulation was.

[00:06:36] Speaker 02:
It gave you some of the ingredients, but it didn't give you all the ingredients.

[00:06:40] Speaker 02:
It's almost like the article had said, we have this interesting new formulation for administering testosterone, and we've come up with this really special vehicle for administering it.

[00:06:56] Speaker 02:
But I'm not going to tell you what my secret vehicle is.

[00:07:01] Speaker 02:
And now I'm just going to report out the favorable results that I have from my secret vehicle.

[00:07:10] Speaker 02:
Do you think that would put the invented vehicle in the possession of the public once an article like that was published?

[00:07:22] Speaker 04:
It would put it into the possession of the public

[00:07:26] Speaker 04:
once the public recognized the inherent disclosure.

[00:07:30] Speaker 04:
This court, I believe, has rejected on several occasions the idea that the recognition had to occur during the prior hearing.

[00:07:39] Speaker 02:
I guess I'm worried that if there is some kind of formulation with five ingredients, but let's say the author only chooses to identify one of the five ingredients and says, I'm not going to tell you the other four, and no one

[00:07:53] Speaker 02:
reading the article would be able to figure out what those other four are.

[00:07:57] Speaker 02:
I don't know if we can say that that five ingredient formulation was actually disclosed and taught in that prior art reference.

[00:08:07] Speaker 03:
And let me follow up on Judge Chen's hypothetical, because I think it's very useful.

[00:08:15] Speaker 03:
Your argument is effectively when, 20 years later, the formula for Coke does get known.

[00:08:22] Speaker 03:
It's obvious based on this article, even though it wasn't disclosed.

[00:08:26] Speaker 03:
And it's obvious as of that date earlier, even though people didn't know it.

[00:08:31] Speaker 03:
That's your problem.

[00:08:32] Speaker 03:
Your problem isn't that you want to use the information once it became known, as of the date it became known.

[00:08:39] Speaker 03:
You want to use the information and give it the date of the articles for prior purposes, for obviousness.

[00:08:46] Speaker 04:
Well, what we want to say is that a publication is a dedication

[00:08:51] Speaker 04:
to the public of all that's contained therein.

[00:08:53] Speaker 04:
And if the public learns later something new about that disclosure, that information is not taken away.

[00:09:00] Speaker 03:
But it wasn't contained therein.

[00:09:01] Speaker 03:
That's your problem.

[00:09:02] Speaker 03:
The information wasn't contained therein.

[00:09:06] Speaker 03:
The public didn't become

[00:09:08] Speaker 03:
in possession of that information until later in time.

[00:09:12] Speaker 03:
And it doesn't necessarily get contained therein.

[00:09:15] Speaker 03:
So the kinds of cases you're talking about where it's, even if the public doesn't know about it, is where there is a natural physiological response that will always happen to a particular drug.

[00:09:26] Speaker 03:
It may be people didn't know about it at the time, but it always happens.

[00:09:30] Speaker 03:
So once we learn that it always happens, that disclosure necessarily included it because nothing else could have resulted in that.

[00:09:36] Speaker 03:
But here, any number of different co-solvents could have resulted in what the article reported.

[00:09:44] Speaker 03:
We just found out later what they actually used.

[00:09:47] Speaker 03:
But any number of them could have.

[00:09:48] Speaker 03:
It's not necessarily the case that it had to be these.

[00:09:52] Speaker 04:
Now, as we pointed out in our blue brief, in the Atlas powder case, that necessarily resulted.

[00:09:57] Speaker 04:
The practice of the prior reference didn't necessarily result in the claim to venture it, depending on how you

[00:10:06] Speaker 04:
how you practiced it, and there was no recognition of that.

[00:10:10] Speaker 04:
And so the logic of those cases, Your Honor, we submit actually counsels in favor of saying that when it's here, there's no question that, in fact, what is disclosed in the articles was the recited composition.

[00:10:27] Speaker 04:
Then the public is in possession of that information, and if they learn more about it later,

[00:10:33] Speaker 04:
then the public's entitled.

[00:10:36] Speaker 02:
But I guess you would agree that at the time those articles were published, there was not enough information in those articles for someone else, a person of skill in the art, to go out and make and use that formulation.

[00:10:51] Speaker 02:
Is that fair to say?

[00:10:52] Speaker 04:
No, I wouldn't agree not to make and use the formulation.

[00:10:56] Speaker 04:
They would not, however, have known.

[00:10:57] Speaker 02:
I'm sorry, did you agree or disagree with me?

[00:11:01] Speaker 02:
At the time of those articles' publication, a person of skill in the art would not be able to make and use the claim formulation in the sense that they would know, aha, I'm going to use benzyl benzoate.

[00:11:16] Speaker 02:
I'm going to use a ratio of castor oil to benzyl benzoate of 40 to 60.

[00:11:22] Speaker 04:
The testimony was that a person of ordinary skill would not have known immediately what the combination was

[00:11:28] Speaker 04:
It would have been a matter of routine experimentation to get to the 40-60 combination because it was a commercial product.

[00:11:34] Speaker 04:
I see them in my rebuttal time.

[00:11:37] Speaker 03:
Let's save your rebuttal time.

[00:11:38] Speaker 03:
Mr. Gwertz.

[00:11:51] Speaker 00:
May it please the court, Nevin Gwertz on behalf of Bayer and Indo Pharmaceuticals.

[00:11:56] Speaker 00:
Patents at issue claim a novel dose, regimen, and formulation of testosterone undecanoate that work in combination to provide long-acting serum testosterone levels in a broad population of hypogonadal men.

[00:12:11] Speaker 00:
The prior art does not contain the claimed 750-milligram dose, the claimed four-week followed by subsequent 10-week injection interval regimen, or the 40% castor oil, 60% benzyl benzoate formulation

[00:12:26] Speaker 00:
let alone any of the three in combination with one another.

[00:12:30] Speaker 01:
Tell us what your views are on the inherency question that we were discussing with your opposing counsel.

[00:12:37] Speaker 00:
Absolutely.

[00:12:37] Speaker 00:
And I think actually, Your Honor, Judge Chen's hypothetical that he posed to my friend is fitting and was one that was similarly used at the trial court level.

[00:12:46] Speaker 00:
And I'd like to elaborate and give an example.

[00:12:49] Speaker 00:
If the prior art included a letter for hypothetically from Dean Kamen that said,

[00:12:54] Speaker 00:
I'm about to come out with an invention that has a handlebar, two wheels, and goes really fast, and then subsequently claimed in a subsequent patent the segue, that prior art would not inherently anticipate the segue because it allows for both a bicycle to be described and a segue.

[00:13:13] Speaker 00:
And the same issue is here, where the prior art describes the formulation as, and I would just quote, 250 milligrams testosterone undecanoate.

[00:13:23] Speaker 00:
dissolved in 1 milliliter castor oil.

[00:13:25] Speaker 00:
And that's at Appendix 1125.

[00:13:27] Speaker 00:
That description, that teaching in the prior art, allows for any number of formulations that contain benzyl benzoate or other co-solvents at various different ratios.

[00:13:39] Speaker 00:
So too the segue example where the prior art describes a situation that allows for many different possibilities.

[00:13:46] Speaker 00:
This court's cases specifically state, and I would quote from Henry Ricard,

[00:13:51] Speaker 00:
that what may be present is not necessarily known, and obviousness cannot be predicated on what may not necessarily be known.

[00:14:02] Speaker 02:
But it is true that the formulation that was being discussed by the authors of those articles, it was, in fact, it did have benzyl-benzoate in the 40-60 ratio.

[00:14:15] Speaker 02:
Is that fair to say?

[00:14:16] Speaker 00:
Yes, Your Honor.

[00:14:17] Speaker 02:
And so in that sense, we could say that

[00:14:20] Speaker 02:
an inherent characteristic of the composition being discussed in those articles were those particular features.

[00:14:28] Speaker 02:
And so what I'm wondering is there are cases of our court, like in Ray Krish, where there's, in the prior art, a disclosed gene.

[00:14:39] Speaker 02:
And then later on, someone else goes through all the effort and work of discovering an inherent characteristic of that gene, the promoter region.

[00:14:50] Speaker 02:
And then we said, well, nobody knew about the details of that promoter region.

[00:14:58] Speaker 02:
Nevertheless, it was an inherent characteristic of that prior art structure.

[00:15:03] Speaker 02:
So then, therefore, it's just there's no patentability here.

[00:15:09] Speaker 02:
And so that's the struggle here in trying to understand how this fits within that kind of case law.

[00:15:18] Speaker 00:
Absolutely, Your Honor.

[00:15:19] Speaker 00:
And if you'll allow me, I think both the in-rate crish and the atlas powder clases are sort of crushing on this point.

[00:15:26] Speaker 00:
As you noted in crish, it was the promoter region of the human involocrine gene.

[00:15:30] Speaker 00:
And in atlas powder, the inherent characteristic, as you put it, was the presence of interstitial air in the ammonium nitrate.

[00:15:39] Speaker 00:
And in atlas powder, we had a formulation in the prior art containing ammonium nitrate and fuel oil

[00:15:45] Speaker 00:
And what was that issue there is the inherency of air within ammonium nitrate itself.

[00:15:51] Speaker 00:
Such as here, if the claim in the patent was to castor oil that contained, let's say, 1% water content, and the evidence at trial was that castor oil necessarily 100% of the time had 1% water content, that would be inherent.

[00:16:07] Speaker 00:
But that's not what the claims in these patents state.

[00:16:11] Speaker 00:
We're talking about benzoyl benzoate, a second ingredient

[00:16:14] Speaker 00:
in the formulation.

[00:16:15] Speaker 00:
And the testimony at trial was that the person of skill would have a choice among cursor.

[00:16:20] Speaker 02:
Are you going to get to the facts of Krish pretty soon?

[00:16:22] Speaker 00:
Sure.

[00:16:23] Speaker 00:
Krish dealing with the promoter region and the human involucrum gene, that promoter region is present.

[00:16:29] Speaker 00:
The DNA sequence to that region is present 100% of the time.

[00:16:33] Speaker 00:
In the prior art, the gene itself was in the prior art.

[00:16:36] Speaker 00:
The record demonstrated the size of the promoter region and the plasmid of origin.

[00:16:40] Speaker 00:
And this court in that case said,

[00:16:42] Speaker 00:
even understanding that other practitioners, other skilled artisans, had tried to sequence it and come up with a different event, we know that the promoter region in Critch, 100% of the time, has that particular DNA sequence.

[00:16:56] Speaker 00:
Here, it is not true that practicing the prior art, 100% of the time, yields a 40% castor oil, 60% benzobenzoyate ratio.

[00:17:06] Speaker 00:
In fact, the only evidence that Custofarm has put forward in the trial court level

[00:17:11] Speaker 00:
of that inherency was a stipulation that as of 2007, four years after the critical date, that in fact the ratio had that particular formulation.

[00:17:25] Speaker 00:
I think another way to consider this problem is the idea of whether or not the use of this particular formulation in the prior art was invalidating is tantamount to a public use argument.

[00:17:37] Speaker 00:
That argument was not made at the trial court level and in any event

[00:17:41] Speaker 00:
would not be relevant here because the particular clinical study is at issue.

[00:17:45] Speaker 02:
Do we have a different legal standard for understanding public use and on sale bar compared to what needs to be disclosed in a prior art reference for purposes of 102?

[00:17:58] Speaker 02:
And let me explain what I'm getting at.

[00:18:00] Speaker 00:
Sure.

[00:18:00] Speaker 02:
It seems like our law on public use and on sale bar, as long as the product is

[00:18:09] Speaker 02:
in use or on sale, you don't have to disclose all the little details of that product and it'll still be an invalidating act.

[00:18:21] Speaker 02:
Whereas for prior art references, we don't seem to have that kind of a flexible standard.

[00:18:30] Speaker 02:
We require every itty bitty

[00:18:33] Speaker 02:
claim element to actually be disclosed or necessarily be inherently disclosed in some way?

[00:18:40] Speaker 02:
Do you understand the question I'm getting at?

[00:18:43] Speaker 00:
I'll try, if you will.

[00:18:45] Speaker 00:
But as I understand it, there are differences between the 102 doctrines of this court and 103.

[00:18:54] Speaker 00:
The obviousness analysis here relying on the teaching of the prior art and what a person of skill would understand.

[00:18:59] Speaker 02:
I'm talking about prior art publications versus public use acts.

[00:19:05] Speaker 02:
They're both part of section 102 and yet for prior art references, I take it you're advancing the idea that even if the product is being discussed and disclosed,

[00:19:18] Speaker 02:
you still need to actually describe all the claim elements for it to be an invalidating reference, unlike the public use.

[00:19:26] Speaker 00:
Or that those claim elements would be necessarily present 100% of the time.

[00:19:30] Speaker 00:
I think if you look at the inherency cases of this court, there is this idea of if practicing the prior art would necessarily mean practicing the subsequent claimed invention.

[00:19:41] Speaker 00:
And that's where I think you get some of the merit between the doctrines that you see.

[00:19:44] Speaker 00:
But in this case,

[00:19:46] Speaker 00:
The actual testimony, the record evidence upon which the district court made its factual findings is that there were possibilities to practice that 250 milligrams TU in castor oil.

[00:20:00] Speaker 00:
That could be practiced a number of different ways with a number of different co-solvents at a number of different ratios.

[00:20:06] Speaker 00:
And it is that nature of the practice of the priority, including many different formulations other than those claimed

[00:20:14] Speaker 00:
That is why the Inherency Doctrine has no place in this case.

[00:20:19] Speaker 03:
Apart from the Inherency Doctrine, I don't understand the fact finding that it would not have been obvious or there wouldn't have been a motivation to lower the testosterone from 1,000 milligrams to 750 milligrams in light of the evidence of record that studies done with 1,000 milligrams showed that subjects were above what the ACEE

[00:20:43] Speaker 03:
rated as healthy and normal in light of the dosage.

[00:20:47] Speaker 03:
Did I get all those facts right, by the way?

[00:20:50] Speaker 00:
I'll slightly alter some of those facts, which is first that the three prior studies show mean serum testosterone level.

[00:20:58] Speaker 00:
The mean serum testosterone level in each of the three studies

[00:21:02] Speaker 00:
after the initial dose at 1,000 milligrams is within both the AACE guidelines as well as all other normal guidelines.

[00:21:09] Speaker 03:
Well, the mean, but that's the mean.

[00:21:11] Speaker 03:
I mean, there were some subjects in the study that were above the healthy dose guidelines.

[00:21:18] Speaker 00:
In the prior art itself, there is only a record of a single anomaly subject at 40.8 serum testosterone level after the first dose.

[00:21:27] Speaker 00:
The other evidence is not in the prior art.

[00:21:29] Speaker 00:
And if you look at footnote 20, the district court's opinion, the court notes that that evidence is not in the prior art and would not be considered.

[00:21:37] Speaker 00:
There was also testimony at the trial court level that such a level slightly above the normal range would not cause a concern for a clinician because the prior testosterone treatments that were in the prior art, these are other testosterone esters, it was common for testosterone

[00:21:56] Speaker 00:
serum testosterone levels to fluctuate several fold greater than the normal range.

[00:22:02] Speaker 00:
This is at Appendix 1161 and the district court finding at Appendix 32 regards that this would not cause a concern to a clinician.

[00:22:11] Speaker 00:
Moreover, we look at the conclusions of the prior articles themselves, which do not address any sort of safety concern and do not suggest any overdose.

[00:22:20] Speaker 00:
In fact, they suggest the contrary and state at

[00:22:25] Speaker 00:
Appendix 1129 that the serum testosterone levels does not result in supranormal serum testosterone levels above the normal range.

[00:22:35] Speaker 00:
And inherent in the overdose theory that is being put forward is, as the district court notes, the idea of the AACE guidelines.

[00:22:46] Speaker 00:
The evidence at trial is that the AACE guidelines were one of many different normal ranges that were present at the time.

[00:22:53] Speaker 00:
Custofarm's own expert

[00:22:55] Speaker 00:
admitted in a book that was edited and published contemporaneous, the critical date here, that of all the guideline ranges and the normal ranges at the time, the 10 to 35 nanomole per liter range was the most common use by clinicians.

[00:23:11] Speaker 00:
And it is within that range that we understand.

[00:23:14] Speaker 03:
You said that there was only, I want to make sure I understand the facts right, only one

[00:23:17] Speaker 03:
subject who was above, is it the ACEE 10 to 30 range?

[00:23:23] Speaker 03:
Is there only one subject above that range?

[00:23:26] Speaker 00:
Both normal ranges.

[00:23:28] Speaker 00:
AAC.

[00:23:29] Speaker 00:
AAC or double AAC, I'm not sure which one it is.

[00:23:32] Speaker 00:
But in the very article which starts at appendix 1125, there is the mention of a single outlier patient.

[00:23:42] Speaker 03:
Yes, go ahead.

[00:23:43] Speaker 00:
And it is above both the AACE guidelines, as well as what would have been the other normal ranges, including those adopted.

[00:23:50] Speaker 03:
Are there other patients who are reported to be above the AACE guidelines in those articles?

[00:23:58] Speaker 00:
Not in the prior art, unless you extrapolate from standard deviations, meaning that if you take two standard deviations away from the mean, you could extrapolate that there might be.

[00:24:11] Speaker 00:
But there is no evidence in the prior art

[00:24:13] Speaker 00:
itself other than for that one patient of other individuals who were actually outside of the priority range.

[00:24:24] Speaker 02:
What about Prolaton?

[00:24:27] Speaker 02:
That was a known vehicle of administering a drug.

[00:24:33] Speaker 02:
So why not use testosterone with any known vehicle, and Prolaton is one of them.

[00:24:43] Speaker 00:
And Your Honor, we don't dispute that Proluton may have been one of the sort of things on the tool shed of the inventor.

[00:24:51] Speaker 00:
But the point here is that whether or not the district court's finding that there would be no motivation to use the formulation of Proluton, given that it was a short-acting injectable, was not a formulation with a testosterone, ester or testosterone of any type, that the person of skill would not be motivated to combine

[00:25:12] Speaker 00:
Proluton, which is in the Pushpalatha reference, with the other prior art articles, when in fact there were other prior art articles that included both testosterone esters in castor oil, and those articles showed that the amount of castor oil was greater than 60% in order to achieve the potential long-acting objective that was put forward in these patents.

[00:25:35] Speaker 00:
And those can be found at appendix 1154,

[00:25:38] Speaker 00:
1622 and 1637.

[00:25:40] Speaker 00:
That's the Humpel, the 791 patent reference, and European patent reference 794.

[00:25:47] Speaker 00:
Those are the examples of formulations with castor oil and other testosterone esters with a different formulation than that claimed.

[00:25:56] Speaker 02:
Did Judge Robinson point to those?

[00:25:59] Speaker 00:
They are indirectly referenced because she references the testimony about those

[00:26:07] Speaker 00:
in the record.

[00:26:11] Speaker 03:
Do you have anything further?

[00:26:13] Speaker 00:
No, Your Honor.

[00:26:14] Speaker 03:
Thank you very much.

[00:26:15] Speaker 03:
Okay.

[00:26:17] Speaker 03:
We have some rebuttal time.

[00:26:24] Speaker 04:
Thank you, Your Honor.

[00:26:26] Speaker 04:
Judge Jen, Henry Krish is the case that we contend supports our herency a position.

[00:26:34] Speaker 04:
Henry Krish

[00:26:36] Speaker 04:
The prior art did not know what the promoter sequence was.

[00:26:39] Speaker 04:
And in a prior art attempt to sequence it failed.

[00:26:45] Speaker 04:
So it did not necessarily result, the sequence didn't necessarily result from the practice of the prior art.

[00:26:52] Speaker 04:
And yet this court still found inherency.

[00:26:56] Speaker 04:
But the AACE was one of two standards.

[00:27:03] Speaker 04:
It was the expert standard.

[00:27:05] Speaker 04:
It was the less common standard.

[00:27:07] Speaker 04:
There weren't multiple.

[00:27:08] Speaker 04:
There were two.

[00:27:09] Speaker 04:
And in both Berra and in Nieschlag, there were patients who were overdosed by the AACE standards.

[00:27:20] Speaker 04:
With respect to Prolutin Depot, the motivation, as we explained in our briefs, to use that was separate and apart from whether or not you were looking for a long-acting

[00:27:35] Speaker 04:
injectable.

[00:27:38] Speaker 04:
It was also desirable to have a concentrated steroid injectable drug and Prolutene Depot was the only 250 milligram per milliliter injectable drug on the market.

[00:27:51] Speaker 04:
It was desirable to use a commercial product because you had no FDA issues and that would have been a separate motivation to try the Prolutene Depot and we know it would have worked because the

[00:28:04] Speaker 04:
claimed invention, the composition, is simply testosterone and decanoate substituted for the exact same vehicle.

[00:28:17] Speaker 04:
Opposing counsel used an example that I didn't quite follow, but he said if castor oil inherently contained 1% water, then that would be an example of inheritance.

[00:28:29] Speaker 04:
But an antlers powder, if we follow that,

[00:28:33] Speaker 04:
It would have been that, inherently, castor oil could have anywhere from 1% to 10% water.

[00:28:39] Speaker 04:
And that was part of the fact that one of those ranges, in fact, would produce the claimed invention was found to make it inherent.

[00:28:51] Speaker 04:
Those are the only points I have in rebuttal unless the court has any other questions.

[00:28:55] Speaker 03:
OK, great.

[00:28:56] Speaker 03:
Thank both counsel for their arguments.

[00:28:58] Speaker 03:
The case is taken under submission.