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

[00:01:00] Speaker 01:
Okay, the next argued case is number 16-15-18, Los Angeles Biomedical against Eli Lilly and Company.

[00:01:08] Speaker 01:
So we have an appeal and cross-appeal of Ms.

[00:01:11] Speaker 01:
Davison.

[00:01:22] Speaker 02:
May it please the court?

[00:01:23] Speaker 02:
The board's determination that the claims of the 903 patent are obvious should be reversed.

[00:01:29] Speaker 02:
The 903 patent claims the first pharmaceutical treatment for the disease of penile fibrosis using a novel method of administering a family of drugs known as PDE5 inhibitors.

[00:01:41] Speaker 02:
It is undisputed that at the time of the invention, a person of skill in the art would have expected PDE5 inhibitors to promote, to worsen fibrosis.

[00:01:53] Speaker 02:
based on the then understanding of the underlying physiology.

[00:01:59] Speaker 02:
Given that expectation, a person of skill in the art interested in curing penile fibrosis would not have turned to PDE5 inhibitors as a candidate therapy prior to the invention claimed in the 903 patent.

[00:02:14] Speaker 02:
There simply was no reasonable expectation of success in using PDE5 inhibitors to arrest or regress penile fibrosis

[00:02:23] Speaker 02:
as the 903 patent claims require.

[00:02:26] Speaker 02:
And consequently, it was also entirely unexpected when the inventors of the 903 patent successfully did so.

[00:02:34] Speaker 03:
Can I ask you to please turn to one of your arguments, and that is the claim language, an individual with at least one of a penile tunic fibrosis and corporal tissue fibrosis.

[00:02:48] Speaker 03:
The board found that, despite that claim,

[00:02:53] Speaker 03:
language, it was possible to construe this as someone with just ED symptoms and not actually one who has either of those fibrosis.

[00:03:05] Speaker 03:
And you make an argument that the plain language of that limitation demands that somebody have one of these fibrosis.

[00:03:11] Speaker 03:
The main argument I understand being made against you is that you waived this argument because you didn't make it in response to the IPR.

[00:03:20] Speaker 03:
Can you address whether it's waived or not?

[00:03:22] Speaker 02:
Your Honor, it is not waived.

[00:03:24] Speaker 02:
We have always maintained that this claim an individual with at least one of the penaltunical fibrosis or corporal tissue fibrosis must be construed as an individual actually having penile fibrosis.

[00:03:39] Speaker 02:
Now, when the board actually determined that that should be construed as requiring merely an individual that has symptoms that may be associated with penile fibrosis, such as ED,

[00:03:50] Speaker 02:
our criticism of that construction is that it goes against a meaning of the claims that is very clear from the language of those claims.

[00:04:01] Speaker 02:
That is not something that we have waived.

[00:04:03] Speaker 02:
We've maintained that construction all along, Your Honor.

[00:04:11] Speaker 02:
That the board found the 903 claims to be obvious is largely the result of unreasonable claim constructions

[00:04:20] Speaker 02:
that altered what the claimed invention is.

[00:04:24] Speaker 02:
The board effectively struck three key limitations.

[00:04:28] Speaker 02:
It eliminated the requirement of therapeutic efficacy of arresting or regressing penile fibrosis.

[00:04:34] Speaker 02:
It changed the target disease from penile fibrosis to erectile dysfunction.

[00:04:41] Speaker 02:
And it eliminated the continuous long-term regimen that's essential to PDE5 inhibitor efficacy against penile fibrosis.

[00:04:50] Speaker 02:
And since those errors permeate the rest of the board's obviousness analysis, I'll turn to each of those claim constructions first.

[00:04:59] Speaker 02:
So regarding arrest or regression of at least one of the penile tunic fibrosis and corporal tissue fibrosis, the board construed that as merely the intended result of giving a PDE5 inhibitor up to 1.5 milligrams per kilogram per day for at least 45 days.

[00:05:17] Speaker 02:
And even under the broadest reasonable interpretation standard that applies during RPR proceeding, that was unreasonable.

[00:05:26] Speaker 02:
In refusing to give patentable weight to the arresting or regressing element, the board ignored a distinct step, which requires therapeutic efficacy.

[00:05:37] Speaker 02:
So arresting or regressing, it's not a preamble.

[00:05:40] Speaker 02:
It's not a whereby clause.

[00:05:42] Speaker 02:
It doesn't duplicate the other claim elements.

[00:05:45] Speaker 02:
nor is it necessarily the result of practicing the other claim elements.

[00:05:51] Speaker 02:
Because the claims method otherwise specifies only a maximum dosage and a minimum treatment duration, efficacy is not certain.

[00:06:00] Speaker 02:
So without that arresting or regressing limitation, the 903 patent claims would not require therapeutic efficacy.

[00:06:11] Speaker 02:
As for how this element should be construed, the specification contains ample evidence that the inventors use arrest to mean stop and regress to mean reverse penile fibrosis.

[00:06:30] Speaker 02:
Turning back to that limitation that an individual has at least one of the penile tunic fibrosis and corporal tissue fibrosis, the board construed that element.

[00:06:41] Speaker 02:
to require merely that an individual have symptoms that may be associated with penile fibrosis, such as ED.

[00:06:47] Speaker 02:
Again, because of the clear language of the claims, the claims require that an individual must actually have penile fibrosis.

[00:06:58] Speaker 02:
And moreover, it's undisputed in this case that erectile dysfunction has many different causes.

[00:07:04] Speaker 02:
So a man may have erectile dysfunction because he's depressed, as a side effect from other medications,

[00:07:10] Speaker 02:
for neurological or hormonal reasons.

[00:07:12] Speaker 03:
Is your argument, just so I understand it, that Montorsi and Whitaker at most disclose whatever diagnostic daily or non-daily routine they have, they disclose treating ED in elderly patients or treating ED.

[00:07:30] Speaker 03:
But treating ED is not necessarily the same thing as treating someone with one of these fibrosis.

[00:07:36] Speaker 02:
That's correct, Your Honor.

[00:07:37] Speaker 02:
So an individual with ED

[00:07:39] Speaker 02:
Having ED does not mean that you have penile fibrosis.

[00:07:43] Speaker 02:
Having penile fibrosis does not mean that you have ED.

[00:07:46] Speaker 02:
And if you cure ED, that doesn't mean you cure penile fibrosis.

[00:07:50] Speaker 02:
And conversely, if you cure penile fibrosis, that doesn't mean that you cure erectile dysfunction.

[00:07:57] Speaker 02:
So by focusing on that symptom of erectile dysfunction, the board's construction impermissibly encompasses individuals who have no penile fibrosis whatsoever.

[00:08:07] Speaker 02:
And on the flip side,

[00:08:09] Speaker 02:
The board's construction also leaves out individuals who have penile fibrosis, but no ED, but who would have benefited from that therapy.

[00:08:19] Speaker 02:
Now, properly construed, the limitation requires that an individual have tunicle or corporal fibrosis and that the fibrosis be clinically significant.

[00:08:30] Speaker 02:
Lily argued below that any degree of fibrosis can... Do you mean by clinically?

[00:08:34] Speaker 00:
Well, perhaps you're going there.

[00:08:36] Speaker 02:
Yes, so Lilly had argued below that even an extra molecule of collagen would be sufficient.

[00:08:42] Speaker 02:
But the claims clearly require treatment of a medical condition, which ultimately requires that a person of skill in the art could either recognize that someone has penile fibrosis or already has one.

[00:08:54] Speaker 00:
As in a medical condition, as in something that has manifested itself with symptoms.

[00:09:00] Speaker 00:
Correct, Your Honor.

[00:09:01] Speaker 00:
Right.

[00:09:01] Speaker 00:
But isn't that where the ED

[00:09:05] Speaker 00:
construction comes in.

[00:09:07] Speaker 00:
That's a typical, at least for this patient group, that's a typical indication of penile fibrosis, right?

[00:09:15] Speaker 02:
So, Your Honor, some men with penile fibrosis do have erectile dysfunction, but the problem is that by focusing on simply that symptom of ED, because ED has many other causes other than penile fibrosis, just because a man has ED does not mean that he has penile fibrosis also.

[00:09:34] Speaker 02:
And that's the heart of the issue with this construction.

[00:09:38] Speaker 03:
Well, just because someone has ED doesn't mean they have a fibrosis.

[00:09:41] Speaker 03:
But if someone has a fibrosis, does that mean they have ED?

[00:09:44] Speaker 02:
No, not necessarily.

[00:09:46] Speaker 02:
So only some men with chinical or corporal fibrosis end up having ED.

[00:09:51] Speaker 02:
It's not a 100% correlation.

[00:09:59] Speaker 00:
To come back to clinically significant, you mean manifesting itself in symptoms that a patient would go to a doctor to have addressed?

[00:10:17] Speaker 00:
Yes, Your Honor.

[00:10:17] Speaker 00:
And what symptoms other than ED would that patient, I mean, Peyronie's disease, is that

[00:10:22] Speaker 02:
Yes, so Peyronie's disease, for example, is often accompanied by penile curvature.

[00:10:27] Speaker 02:
It may be accompanied by an actually palpable fibrotic plaque.

[00:10:31] Speaker 02:
It's often accompanied by pain.

[00:10:33] Speaker 02:
So these are all additional symptoms that a person with penile fibrosis might experience, for example.

[00:10:39] Speaker 00:
Right, but also it's accompanied frequently, I gather, by ED.

[00:10:44] Speaker 02:
Some number of patients with penile fibrosis also have erectile dysfunction.

[00:10:48] Speaker 00:
Well, I mean, Peyronie's disease.

[00:10:49] Speaker 02:
Yes.

[00:10:50] Speaker 02:
Some men with Peyronie's also have it, but not all of them.

[00:10:54] Speaker 01:
But this really fits with what Judge Bryson was asking.

[00:10:57] Speaker 01:
It seems to me that it ought to have been feasible to draft claims which avoided capturing what's already being experienced in the art.

[00:11:10] Speaker 01:
But I can't see that these claims exclude

[00:11:14] Speaker 01:
And perhaps this is what was troubling the board as well, exclude what's already known.

[00:11:22] Speaker 02:
So, Your Honor, I believe they do exclude what's known once the claim terms are properly construed.

[00:11:28] Speaker 02:
So this is not, these claims are not to a treatment or they're not to a method of relieving the symptoms of erectile dysfunction, which is what had been in the prior art previously.

[00:11:43] Speaker 02:
What these claims are intended to cover is an actual curative therapy for penile fibrosis, which is distinct from erectile dysfunction.

[00:11:55] Speaker 01:
OK.

[00:11:55] Speaker 01:
Let's hear from the other side, and we'll come back to this on rebuttal.

[00:11:59] Speaker 00:
Could I just ask one quick question?

[00:12:01] Speaker 00:
You had a third issue that you alluded to at the beginning, and I missed it.

[00:12:08] Speaker 00:
What was your third issue besides the omitted

[00:12:13] Speaker 00:
regressing and arresting and the changed target disease.

[00:12:19] Speaker 02:
Also, the board had also eliminated the requirement for a continuous long-term regimen.

[00:12:25] Speaker 00:
Right, okay, thanks.

[00:12:26] Speaker 01:
Do you want to pursue that?

[00:12:28] Speaker 00:
No, that's fine.

[00:12:28] Speaker 00:
I just wanted to make sure I understood that.

[00:12:30] Speaker 01:
Okay, thank you.

[00:12:32] Speaker 01:
Mr. Feldman.

[00:12:34] Speaker 04:
Your Honor, thank you.

[00:12:36] Speaker 04:
So on behalf of Lula, Your Honors, I'd like to pick up and

[00:12:44] Speaker 04:
We see three key problems with LA Biomeds' appeal.

[00:12:48] Speaker 04:
Basically, they've appealed all the claim constructions.

[00:12:51] Speaker 04:
And the way we read the court's findings, the board's findings, nothing changes even under their claim constructions.

[00:13:01] Speaker 04:
Likewise, their arguments argue alternative information from record, but don't show error in the board's

[00:13:09] Speaker 04:
findings don't show that they're unsupported.

[00:13:11] Speaker 03:
Well, why don't you start with the one that I was asking her about and explain why, even under their construction, Montorsi or Whitaker disclosed using this regimen to treat someone with one of these fibrosis.

[00:13:27] Speaker 04:
Absolutely, Your Honor.

[00:13:29] Speaker 04:
So what the board found on appendix 22 is that treatment of ED

[00:13:37] Speaker 04:
in elderly patients or patients with atherosclerosis, as suggested by both Montorsi and Whitaker, would result in the treatment of patients with the fibrosis.

[00:13:48] Speaker 04:
And there you have similar findings on appendix 28 that the daily treatment would result in treatment of ED in which there is underlying corporal fibrosis.

[00:13:58] Speaker 03:
And so the argument from LA Biomed... So treatment of elderly patients with ED

[00:14:07] Speaker 03:
would treat fibrosis, but that's not the same thing as a disclosure of it, right?

[00:14:12] Speaker 03:
This is an obviousness rejection.

[00:14:14] Speaker 03:
We have to look at the references for what they teach.

[00:14:17] Speaker 04:
Sure.

[00:14:17] Speaker 03:
So how does it teach it?

[00:14:19] Speaker 04:
What Montourcy teaches is that, and this is on appendix 5597, ED from aging.

[00:14:29] Speaker 04:
So we're not talking about all ED.

[00:14:30] Speaker 04:
We're talking about Montourcy.

[00:14:31] Speaker 04:
But ED from aging is the result of atherosclerosis-induced cavernousal

[00:14:37] Speaker 04:
ischemia leading to CVOD.

[00:14:40] Speaker 04:
CVOD is one of the claimed fibrosis.

[00:14:42] Speaker 04:
It's in claim three.

[00:14:44] Speaker 04:
And so the class of ED that Montorsi is specifically teaching to treat is ED that results from fibrosis.

[00:14:52] Speaker 04:
And so it matters not if some ED is not for fibrosis.

[00:14:56] Speaker 04:
Montorsi's population is ED due to fibrosis.

[00:15:00] Speaker 04:
And therefore, when you treat a Montorsi patient, ED due to fibrosis,

[00:15:05] Speaker 04:
you're treating a patient with fibrosis.

[00:15:07] Speaker 01:
But it looks as if they've made discoveries about fibrosis which are much broader and which they're trying to capture in their claim as well.

[00:15:17] Speaker 04:
Whether they've made discoveries broader, I would dispute that, but it's irrelevant because if anything within the scope of the claim is obvious, the claim is invalid.

[00:15:25] Speaker 04:
And so clearly one of the types of fibrosis they're trying to cover is CVOD.

[00:15:31] Speaker 04:
The Montorci elderly patients have CVOD, the fibrotic condition.

[00:15:37] Speaker 04:
And Montorci at least renders that condition obvious.

[00:15:41] Speaker 04:
And if that condition is obvious, the whole claim is obvious.

[00:15:45] Speaker 04:
And likewise, Whitaker's patients are not merely ED patients.

[00:15:50] Speaker 04:
They're patients whose ED results from circulatory dysfunction arising from conditions such as diabetes and atherosclerosis.

[00:15:58] Speaker 04:
And again, Montorci explains.

[00:16:01] Speaker 04:
that ED due to conditions such as atherosclerosis is a fibrotic condition.

[00:16:07] Speaker 04:
And so the references specifically teach treating patients who have ED, excuse me, patients who have ED due to fibrosis.

[00:16:17] Speaker 04:
And therefore, the claim construction argument about whether or not the claim covers people who only have a molecule of extra fibrosis or whether it claims patients who have no fibrosis at all is

[00:16:31] Speaker 03:
irrelevant to the findings, the findings were that the patients who are taught and suggested to be treated are fibrotic ED patients.

[00:16:49] Speaker 03:
as clearly as you just stated, which if you're correct about the science would make this issue moot for me, they don't say that arthrosclerosis, or I don't know how to pronounce these words, but they don't say that that is necessarily a fibrosis.

[00:17:04] Speaker 03:
They say that focal fibrosis are associated with ED in this patient.

[00:17:08] Speaker 03:
That's kind of like saying a cough is associated with people who have the flu or something like that.

[00:17:14] Speaker 03:
That's the way I read it.

[00:17:16] Speaker 03:
I'm pausing.

[00:17:17] Speaker 03:
You're making very clear statements of science that I don't understand necessarily.

[00:17:22] Speaker 03:
And it might just be because I don't understand the science.

[00:17:25] Speaker 03:
But the board twice says Montessori teaches is associated with the development of corporal fibrosis.

[00:17:31] Speaker 03:
And that seems like very precise language in a scientific area.

[00:17:34] Speaker 03:
Associated with is not the same thing as when it teaches this earth-verse sclerosis thing, that that is teaching a fibrosis, and therefore it discloses it.

[00:17:46] Speaker 04:
The board does say multiple times, I think you're reading from appendix page 22, they also say on appendix page 28, where the heading claimed to, thus the ordinary artisan would have understood that doses up to 1.5 milligram per kilogram per day, where they find obvious from the references, would be well tolerated and that the obvious daily treatment would result in treatment of ED in which there is an underlying fibrosis.

[00:18:13] Speaker 04:
So they're clearly recognizing

[00:18:15] Speaker 04:
that there is underlying fibrosis.

[00:18:17] Speaker 04:
In some EDs.

[00:18:19] Speaker 00:
That's the problem, isn't it?

[00:18:23] Speaker 00:
The way the board construed an individual with at least one of the two forms of penile fibrosis is as someone who has ED.

[00:18:36] Speaker 00:
But that's not really an accurate

[00:18:40] Speaker 00:
definition of someone with penofibrosis, is it?

[00:18:43] Speaker 00:
It may be an accurate definition with respect to some people who have ED, but not all.

[00:18:48] Speaker 00:
You would agree with that.

[00:18:49] Speaker 00:
It's correct with respect to... Well, let's start with... You would agree with that proposition, right?

[00:18:53] Speaker 00:
That not all ED patients have fibrosis.

[00:18:55] Speaker 00:
Right.

[00:18:56] Speaker 00:
And therefore, if you define Fibrotic patients by saying their people, by saying they are

[00:19:04] Speaker 00:
the entire universe of people that have ED are fibrotic patients, and that would be error, would it not?

[00:19:09] Speaker 00:
I don't think anyone made that... But isn't that exactly what the board is saying on page 8 when they say that an individual with at least one of the two forms of penofibrosis requires the individual have symptoms that may be associated with penofibrosis such as ED, i.e.

[00:19:26] Speaker 00:
if you have ED, you've got penofibrosis.

[00:19:29] Speaker 04:
It depends how you read what associated means.

[00:19:32] Speaker 04:
If you say that there's

[00:19:34] Speaker 04:
a possible correlation or a necessary correlation.

[00:19:36] Speaker 04:
If you read it as a possible correlation, that may be mistaken.

[00:19:40] Speaker 04:
If you read it as a necessary correlation, which is consistent with their findings that the patients from Montorosie and Whitaker do have ED due to fibrosis, then it all fits together.

[00:19:53] Speaker 04:
And regardless of how you read the claim construction, the finding of fact is that even under LA Biomed's construction, you have to have clinically significant ED

[00:20:02] Speaker 04:
Montorsi's patients have ED, which is clinically significant due to fibrosis.

[00:20:08] Speaker 04:
And Montorsi expressly teaches that.

[00:20:09] Speaker 04:
That's not the interpretation of the board.

[00:20:11] Speaker 00:
But all patients who have pneumonia have a cough, let's hypothesize.

[00:20:18] Speaker 00:
That doesn't mean everybody who has a cough has pneumonia.

[00:20:20] Speaker 00:
And if you define people with pneumonia as people with a cough, then that would be wrong.

[00:20:26] Speaker 00:
And I think that's a very simple-minded way to say it.

[00:20:30] Speaker 00:
But it seems to me that's what the board is saying.

[00:20:32] Speaker 00:
on page 8.

[00:20:34] Speaker 00:
Now, you may be able to explain why that's not so, but that's the way that two-sentence segment of the board's opinion looks to me.

[00:20:42] Speaker 04:
If you read that out of context of the rest of the opinion, I can see how you read it that way, Your Honor.

[00:20:50] Speaker 04:
But if you read it in context of the opinion, the actual finding, the actual finding is that Montorsi's patients have ED.

[00:20:57] Speaker 04:
They're not saying, I mean,

[00:20:59] Speaker 04:
excuse me, Montorcy's patients actually have ED due to fibrosis.

[00:21:03] Speaker 04:
Whether the claim construction should be a little bit narrower or whether it's appropriate breadth, depending on how you interpret it, is irrelevant because the patients have ED due to fibrosis.

[00:21:14] Speaker 04:
They have a clinically significant symptom, ED.

[00:21:17] Speaker 04:
They have it due to fibrosis.

[00:21:18] Speaker 04:
It's a clear teaching of Montorcy.

[00:21:20] Speaker 04:
It's not speculation.

[00:21:22] Speaker 04:
It's been 5597 that ED from aging

[00:21:27] Speaker 04:
as the population he wants to treat, is a result of atherosclerosis-induced cavernosal ischemia, leading to cavernosal fibrosis and veno-occlusive dysfunction.

[00:21:39] Speaker 04:
So it's clear that the population, regardless of whether the claim construction is perfect or not, the fact findings are that the patients actually have symptomatic fibrosis causing ED.

[00:21:51] Speaker 03:
Which fact-finding, I assume it's on 22, which is the fact-finding where the board expressly holds, as clearly as you keep stating it, that Montorsi discloses treating patients with fibrosis?

[00:22:09] Speaker 04:
So I was reading, Your Honor, just now from Montorsi itself.

[00:22:15] Speaker 03:
No, no, the board fact-finding is what I'm interested in.

[00:22:17] Speaker 04:
I understand.

[00:22:18] Speaker 03:
Because what Montorzi says, like at 5596, is animal studies have identified an association between amino occlusive dysfunction of the corporal cavernosa and corporal fibrosis.

[00:22:29] Speaker 03:
Animal studies.

[00:22:30] Speaker 03:
I mean, that's why you're making these very strong assertions of scientific fact.

[00:22:34] Speaker 03:
And I'm not.

[00:22:35] Speaker 00:
So the segment of the board's opinion that you're focusing on, I take it as lines 10 through 15 or so from page 22, right?

[00:22:45] Speaker 04:
That's the conclusion they get to.

[00:22:48] Speaker 04:
There's support earlier in the opinion as well.

[00:22:51] Speaker 04:
This is the ultimate finding.

[00:22:52] Speaker 04:
Yes, sir.

[00:22:53] Speaker 04:
And so Judge Moore, starting on page 14.

[00:22:58] Speaker 03:
I understand.

[00:22:58] Speaker 03:
That's fine.

[00:22:59] Speaker 03:
Oh, if you want to go to a different page, I'm sorry.

[00:23:01] Speaker 04:
Yeah, on page 14, in the middle of the page under the quote, the board is recognizing under the quote, Montorci teaches, therefore, as ED from aging appears to be a slowly progressive disorder,

[00:23:13] Speaker 04:
It would appear wise for the patient to seek medical intervention early so as to minimize the development of veno-occlusive dysfunction.

[00:23:20] Speaker 04:
That veno-occlusive dysfunction is the CVOD claim 3 fibrosis.

[00:23:25] Speaker 04:
And so there's that teaching there.

[00:23:26] Speaker 03:
But you want to minimize the development of a fibrosis.

[00:23:29] Speaker 03:
That doesn't mean that these people are necessarily having one.

[00:23:33] Speaker 03:
You want to minimize the development of one, not you want to treat one that already exists.

[00:23:38] Speaker 04:
No, I appreciate that, Your Honor.

[00:23:40] Speaker 04:
And then on page 20,

[00:23:45] Speaker 04:
The board is recognizing that the argument on line three, Petitioner notes that Montorci teaches that atherosclerosis affects the venal occlusive mechanism of the corporal cavernoso, teaching the daily use of PD5 inhibitor.

[00:24:01] Speaker 03:
And so... I don't think that's at all relevant to this question, but that's OK.

[00:24:05] Speaker 03:
Can I catch you a good joke?

[00:24:07] Speaker 03:
I don't think it's relevant to this question, but I think it gives you a good jumping off point.

[00:24:11] Speaker 03:
You only have three minutes left.

[00:24:12] Speaker 03:
And I'd really like you to turn to the daily dosing issue, which is the thing that she really mentioned at the outset, didn't get much of a chance to talk about.

[00:24:21] Speaker 03:
But I'd like to ask you to show me where in either Montorsi or Whitaker it discloses the daily dosing requirement.

[00:24:32] Speaker 03:
Or do you dispute that there is a daily dosing requirement?

[00:24:35] Speaker 04:
No, they teach daily dosing.

[00:24:37] Speaker 03:
But you don't dispute that the claims require daily dosing?

[00:24:42] Speaker 04:
PTAB found that 45 days taken daily would be within the scope of the claims.

[00:24:48] Speaker 04:
Yes.

[00:24:49] Speaker 04:
No, I do not dispute that.

[00:24:50] Speaker 03:
OK, just want to make sure.

[00:24:52] Speaker 04:
So in terms of where Whitaker teaches 45 days,

[00:25:06] Speaker 03:
Whitaker teaches daily administration.

[00:25:08] Speaker 03:
There's no doubt about that.

[00:25:09] Speaker 03:
But I thought it said as long as the patient suffers from ED.

[00:25:12] Speaker 03:
Right.

[00:25:12] Speaker 03:
Without a particularized time frame.

[00:25:14] Speaker 04:
Right.

[00:25:14] Speaker 04:
And that's going to come up again in the next argument.

[00:25:16] Speaker 04:
We're just going to focus, I think, on that issue.

[00:25:19] Speaker 04:
But on page 21 of the opinion, appendix page 21, the board recognizes that Whitaker expressly teaches once daily dosing, teaching that the treatment should last as long as the rectal dysfunction continues, and expressly teaches time periods of 8 to 12 weeks.

[00:25:35] Speaker 04:
And the better responsiveness comes with more time.

[00:25:39] Speaker 04:
And what we know from Whitaker is that what we know from the experts in this case, Your Honor.

[00:25:45] Speaker 03:
Am I misunderstanding?

[00:25:46] Speaker 03:
I thought the 8 to 12 weeks were in Montorsey.

[00:25:48] Speaker 03:
Is that in Whitaker?

[00:25:50] Speaker 04:
They both have.

[00:25:51] Speaker 04:
That's example 6 of Whitaker.

[00:25:53] Speaker 04:
Whitaker example 6 is 8 to 12 weeks.

[00:25:54] Speaker 04:
There's a separate Montorsey Disclosure of similar length time periods.

[00:25:58] Speaker 04:
And so what Whitaker is teaching is Whitaker is teaching to take as long as the

[00:26:06] Speaker 04:
condition persists, and that is on page 5609, and what both experts in the case said is there's only one understanding, a person with a foregrooming skill would only understand as long as the patient suffers from ED to have one meaning, that it would be a time period of at least months.

[00:26:23] Speaker 04:
And so of course it doesn't literally say 45 days, but

[00:26:26] Speaker 04:
ED was understood to be a long-term, if not a lifetime condition, absent some change to your body.

[00:26:33] Speaker 04:
And therefore, if you treat it as long as a patient suffers from erectile dysfunction, you're treating it essentially indefinitely.

[00:26:40] Speaker 04:
But what both experts agreed is that it would be a time period of at least months.

[00:26:44] Speaker 04:
At least months is certainly not less than 45 days.

[00:26:48] Speaker 00:
And that's Bevilaco and Goldstein that you're relying on?

[00:26:50] Speaker 04:
Correct, Your Honor.

[00:26:57] Speaker 00:
So if I can, Your Honor.

[00:27:00] Speaker 00:
If you could just briefly address the arrest regress issue that Ms.

[00:27:06] Speaker 00:
Davidson started off with.

[00:27:08] Speaker 04:
So under the broadest reasonable construction, there's no error in finding that arrest or regress is an inherent step of the process, that it results from the step.

[00:27:21] Speaker 04:
There's only one thing you do.

[00:27:23] Speaker 04:
You only give a pill, and the arrest or regress happens.

[00:27:27] Speaker 04:
whether the arrest being stopped or slow or whatever it means, it's still properly construed under the broadest reasonable interpretation to be the result of the one and only affirmative step in the claim is give a pill.

[00:27:40] Speaker 04:
And therefore, this is consistent with LA Biomed's infringement allegations in the related district court case that are in the record here, too, that by instructing users to take Cialis, which is the same tetanol-filled drug as in Whitaker and Horst,

[00:27:55] Speaker 04:
that taking that daily will result in the arresting and regressing of erectile dysfunction.

[00:28:03] Speaker 00:
What if the patent drafter at least, let's assume, had the view that it only worked a third of the time and therefore wanted to limit the scope of the claim just to those cases in which it was actually effective?

[00:28:16] Speaker 04:
Because the only teaching

[00:28:18] Speaker 04:
in the patent is that if you do it, this result happens.

[00:28:22] Speaker 04:
You have to take that as a mission and read it that way.

[00:28:25] Speaker 04:
And it's reinforced by the district court case where they said taking it will result in the arresting or regressing.

[00:28:32] Speaker 04:
And it doesn't matter exactly what arresting or regressing means to find that it's the inherent result of

[00:28:38] Speaker 04:
the method that's taught, which is only taught as to be a one-step method.

[00:28:42] Speaker 03:
Can I ask one more question?

[00:28:44] Speaker 03:
Yes, please.

[00:28:44] Speaker 03:
Of course.

[00:28:44] Speaker 03:
I want to come back to Whitaker for a second, only because the example six, I remember why now I was having some concern about it.

[00:28:53] Speaker 03:
And it's the question of whether it teaches daily dosage, given that example six includes a table.

[00:28:59] Speaker 03:
I don't actually, for some reason, have Whitaker here with me, which is a mistake on my part.

[00:29:02] Speaker 03:
But my recollection is that it's a chart.

[00:29:05] Speaker 03:
that says something like less than 30%, 30% to 70% or 70% or more and that how is it that that teaches daily when it's reporting results clearly of patient compliance at less than 100% and in fact the chart doesn't actually say 100% anywhere on it.

[00:29:22] Speaker 03:
So there's no evidence that any of the participants in that 8 or 12 week study actually were in fact administering the dose daily 100% of the time.

[00:29:31] Speaker 04:
Sure, but we're not talking about inherency of example 6.

[00:29:34] Speaker 04:
We're talking about what does Whitaker suggest?

[00:29:38] Speaker 04:
It suggests cheating patients daily as long as the condition persists.

[00:29:43] Speaker 03:
No, but the claims require continuous treatment for 45 straight days.

[00:29:46] Speaker 03:
I understand.

[00:29:47] Speaker 03:
And there's no doubt that some of these, like the 12 and the 6-week study in Montorsi, and then again, I'm having concerns about the

[00:29:53] Speaker 03:
eight or 12-week study in Whitaker because they're clearly not daily, like they're five days a week on weekdays but not weekends or something like that.

[00:30:01] Speaker 03:
And the claims require daily, continuous, everyday administration and that these references teach long-term administration but not necessarily daily.

[00:30:11] Speaker 04:
Okay.

[00:30:11] Speaker 04:
The preferred treatment in Whitaker on page 7, which is appendix page 5609, the preferred treatment is daily as long as the patient suffers.

[00:30:22] Speaker 04:
And so there's a preferred treatment of treating your patient daily.

[00:30:26] Speaker 04:
That's what Whitaker prefers.

[00:30:28] Speaker 04:
Example six seems to be a building block of how they got to that.

[00:30:30] Speaker 04:
They found that if you took it 30% of every day, you got some improvement.

[00:30:35] Speaker 04:
If you took it 60% of every day, you got more improvement.

[00:30:37] Speaker 04:
If you take it 70 or more percent of the day, you get more improvement.

[00:30:40] Speaker 04:
And that led to the conclusion that we should instruct people to take it every day.

[00:30:47] Speaker 04:
is whether example six need not be a disclosure that people took it every day, because that would only be relevant if it was a question of inherent anticipation.

[00:30:58] Speaker 04:
Here, the question is, what does the reference suggest doing?

[00:31:01] Speaker 04:
The reference suggests taking it daily for an extended period of time.

[00:31:05] Speaker 04:
How do we know it's extended?

[00:31:06] Speaker 04:
We know it's extended because it says as long as the patient suffers, which is at least months, both experts agree.

[00:31:14] Speaker 04:
And we know that in context,

[00:31:16] Speaker 04:
that they were doing eight and 12-week clinical trials.

[00:31:19] Speaker 04:
So they're not thinking very short term.

[00:31:26] Speaker 00:
Well, go ahead.

[00:31:28] Speaker 00:
No, no, go ahead.

[00:31:28] Speaker 00:
Please, go ahead.

[00:31:29] Speaker 00:
Briefly, where in Montorsi is there a reference to 8 to 12 weeks?

[00:31:33] Speaker 00:
Is it in the discussion of one of the studies?

[00:31:36] Speaker 04:
It's earlier in the background.

[00:31:39] Speaker 04:
The Montorsi studies are not daily studies.

[00:31:43] Speaker 04:
They're on-demand studies.

[00:31:44] Speaker 04:
The way the board seems to have relied on that is that Montorsi is also thinking long-term.

[00:31:51] Speaker 04:
But the Montorsi studies

[00:31:52] Speaker 03:
But the Montorsi study is saying, I think it's on 5598, and it's 12 weeks or six months.

[00:31:57] Speaker 03:
It's not eight weeks.

[00:31:58] Speaker 03:
I misspoke when I said eight weeks.

[00:31:59] Speaker 03:
I think I was confusing them, maybe.

[00:32:01] Speaker 03:
I don't know.

[00:32:02] Speaker 03:
But in any event, it says not more than once daily, right?

[00:32:06] Speaker 03:
Isn't that what it says on 5598?

[00:32:08] Speaker 04:
In Montorsi, I think that's correct.

[00:32:10] Speaker 03:
Yeah, not more than once daily.

[00:32:11] Speaker 04:
Right.

[00:32:12] Speaker 03:
And so the Montorsi study is not a study... Doesn't that expressly suggest to you you can take it less, certainly less than daily?

[00:32:20] Speaker 04:
That study in Montorsi,

[00:32:23] Speaker 04:
gives you some time frame for how long, but it's on page 5597 where they're taking an administrative nightly, that's the suggestion for doing it daily, i.e.

[00:32:35] Speaker 04:
nightly.

[00:32:35] Speaker 00:
But that doesn't, isn't accompanied by a duration factor, right?

[00:32:40] Speaker 00:
It seems to be indefinite, Your Honor.

[00:32:42] Speaker 04:
Okay, well.

[00:32:43] Speaker 04:
Indefinitely open, not indefinitely, not lacking meaning.

[00:32:46] Speaker 04:
As long as the patient is symptomatic.

[00:32:47] Speaker 04:
Right, and which Dr. Goldstein says if you have ED due to aging, it's the rest of your life.

[00:32:57] Speaker 01:
And with all of these issues, we're getting to the cross appeal as well.

[00:33:02] Speaker 01:
So I think that by the time you finish, we'll get to probe everything.

[00:33:08] Speaker 01:
So still on your appeal, let's continue with the rebuttal.

[00:33:15] Speaker 02:
Thank you, Your Honor.

[00:33:15] Speaker 02:
Turning to Montorsi.

[00:33:18] Speaker 02:
So the central statement in Montorsi that Lilly has relied on is the one on page 5597

[00:33:24] Speaker 02:
saying, these data have opened the door to further study investigating the possible dosage of sildenafil to be administered daily at bedtime to prevent or treat ED in the elderly patient.

[00:33:36] Speaker 02:
And that's referring to a one-night sildenafil study.

[00:33:40] Speaker 02:
But I think what's critical to understand about that statement is it's an invitation to investigate, which is not a proper basis for an obvious determination.

[00:33:50] Speaker 02:
And as for the other study to which the board referred in its decision in Montorsi, that is, as opposing counsel admitted, an as needed study.

[00:34:00] Speaker 02:
And that instruction to take not more than once daily simply meant if you have an opportunity to have sexual intercourse more than once daily, you are not allowed to take a second pill.

[00:34:13] Speaker 02:
But otherwise, the instruction was simply to take sildenafil an hour before sexual activity.

[00:34:21] Speaker 00:
Well, but Whitaker does have, does it not, the reference, the definition of day and daily.

[00:34:28] Speaker 00:
And then on page seven of Whitaker talks about preferably daily.

[00:34:35] Speaker 00:
In that reference, it's referring to three or more days, but that is, it seems to me that that nails down the daily part of the question, does it not?

[00:34:45] Speaker 02:
I think, Your Honor, that daily is an interval.

[00:34:50] Speaker 02:
It's an instruction, for example, in Whitaker.

[00:34:54] Speaker 02:
Whitaker describes daily as about once per 24 hours.

[00:34:58] Speaker 00:
Well, that's a pretty normal definition of daily.

[00:35:02] Speaker 02:
But what it doesn't give you is how many times and for how long.

[00:35:07] Speaker 02:
So daily is not a duration.

[00:35:09] Speaker 00:
Well, it says more preferably one time per 24 hours.

[00:35:16] Speaker 00:
So it doesn't give you duration, but it does tell you

[00:35:19] Speaker 00:
once a day, it seems to me.

[00:35:22] Speaker 00:
Right.

[00:35:22] Speaker 02:
But I think if you look further in Whitaker, it becomes evident why daily doesn't necessarily correspond to a duration, for example, of at least 45 days.

[00:35:33] Speaker 02:
So Whitaker does say, effectively, that treatment may be intermittent, that you can skip every fourth dose.

[00:35:41] Speaker 02:
If you look at example six, it's clear that the study subjects in that example

[00:35:46] Speaker 02:
are not taking it consistently every single day.

[00:35:50] Speaker 02:
So daily is not a teaching of how many times and for how long.

[00:35:54] Speaker 02:
It's simply the interval.

[00:35:56] Speaker 02:
And that's crucial because Whitaker also indicates that you can have intermittent daily treatment.

[00:36:10] Speaker 02:
And regarding months, if not longer,

[00:36:14] Speaker 02:
Your Honor, Dr. Bivalakwa's testimony that daily, as long as the patient may suffer from erectile dysfunction, Dr. Bivalakwa's testimony about months, if not longer, is simply not relevant to that.

[00:36:28] Speaker 02:
What his testimony concerned was non-pharmaceutical intervention, like diet, like exercise, like quitting smoking, and how long that might take to resolve ED symptoms.

[00:36:38] Speaker 02:
That doesn't cast any light on the duration in Whitaker of that treatment.

[00:36:46] Speaker 01:
If there are no other questions, I'll stop there.

[00:36:50] Speaker 01:
Well, I think we're okay on your appeal.

[00:36:55] Speaker 01:
So that case is submitted.