[00:00:00] Speaker 02:
0-3, Aventus versus Miley.

[00:01:02] Speaker 02:
We're ready whenever you are.

[00:01:03] Speaker 00:
Thank you, Your Honor.

[00:01:04] Speaker 00:
May it please the court?

[00:01:05] Speaker 00:
Your Honors, at minimum, this case should be remanded in light of aqua products for the board to consider the patentability of the proposed amended claims under the proper burden of proof.

[00:01:15] Speaker 00:
We submit, though, Your Honors, any further adjudication of those claims should be done so not only under the proper burden, but also under the proper claim construction.

[00:01:26] Speaker 00:
And that is with the preambles limiting.

[00:01:29] Speaker 03:
Let me ask you about this preamble.

[00:01:32] Speaker 03:
Is it your position that the preamble is just further defining the patient population, or is it your position that the preamble also describes the purpose for practicing the method?

[00:01:45] Speaker 00:
The purpose, Your Honor, under Janssen, that when the preamble sets forth the purpose of the method and the body of the claim directs at that method to be directed to a patient in need, it is a statement of intentional purpose for which the claim

[00:01:59] Speaker 03:
But in Janssen, at least, and I think that the argument on the other side is that in Janssen, the thought was that a need was helping to define the patient population, which was described in the preamble.

[00:02:17] Speaker 03:
Here we've got the preamble, we have the in need of language, and then we've got a separate description, a detailed description of the patient population.

[00:02:26] Speaker 00:
I disagree with the notion that

[00:02:28] Speaker 00:
that the language in Janssen, that claim, defined the patient population any further.

[00:02:34] Speaker 00:
The preamble of that claim is treating or preventing pernicious anemia.

[00:02:39] Speaker 00:
So it doesn't define patients with anemia.

[00:02:42] Speaker 00:
I think the suggestion from my land was, during prosecution history, there was a preamble directed to treating anemia in general.

[00:02:53] Speaker 00:
And the examiner said that that is not commensurate with the scope of your unexpected results.

[00:02:59] Speaker 00:
So the claims were issued when that specific type of anemia was chosen.

[00:03:07] Speaker 02:
But I don't understand.

[00:03:09] Speaker 02:
I mean, the reason, before the district court, you argued that all people, all humans are in need of preventing anemia.

[00:03:21] Speaker 02:
this language was supposed to connect this particular anemia to the patient population you were treating, right?

[00:03:31] Speaker 00:
That was Mylan's argument that all patients are in need of increasing survival.

[00:03:36] Speaker 00:
That is not our position before or here.

[00:03:44] Speaker 00:
The idea that we're all in need of a method of increasing survival is true just by our mortality.

[00:03:49] Speaker 00:
But just as in Janssen, we're all in need of a method of preventing anemia.

[00:03:53] Speaker 00:
We all need vitamin B12.

[00:03:54] Speaker 00:
Sometimes we get it through the food we eat.

[00:03:58] Speaker 00:
But just because we don't.

[00:03:59] Speaker 02:
But I thought the limitation was for purposes of limiting that, right?

[00:04:04] Speaker 02:
The limitation was construed to limit the population, right?

[00:04:07] Speaker 00:
In Janssen?

[00:04:08] Speaker 00:
Yes.

[00:04:10] Speaker 00:
Not the population of patients that can

[00:04:13] Speaker 00:
that can receive the claimed composition, the mixture of folic acid and vitamin D12.

[00:04:18] Speaker 00:
It defines patients who have anemia that are treated that way and also patients who are taking that vitamin combination for prevention of anemia.

[00:04:30] Speaker 02:
So what is the import of the language in need of?

[00:04:34] Speaker 00:
In need of in Janssen imports this intentional purpose requirement.

[00:04:39] Speaker 02:
Which is?

[00:04:40] Speaker 02:
Why don't you explain it in English?

[00:04:41] Speaker 00:
So in Janssen, Rexol had a vitamin D12 and folic acid combination.

[00:04:50] Speaker 00:
And what the court held was for purpose of his infringement, if that combination was taken by a patient without a recognized need of treating and preventing anemia, that is not direct infringement of that claim.

[00:05:05] Speaker 00:
So unless you have the patient in that case, here we're talking about the physician's intent,

[00:05:10] Speaker 00:
The patient in that case, if they are not taking folic acid and vitamin B12 with the claimed amounts for the purpose of treating or preventing anemia, if they're taking... I'm going back to Judge O'Malley's, which I think she was getting there.

[00:05:26] Speaker 02:
I can get my brain around that.

[00:05:28] Speaker 02:
It seems somewhat different in this claim, where it's not, as in Janssen, a method of treating, preventing a particular disease.

[00:05:38] Speaker 02:
but a method of increasing survival to a patient in need that of.

[00:05:45] Speaker 02:
In other words, someone who needs to increase their survival.

[00:05:50] Speaker 02:
Well, isn't that the entire world?

[00:05:53] Speaker 00:
Well, I think that's the point when we come to, after there's a decision on whether the preamble is limiting, there's the question of, well, what is the construction of that preamble?

[00:06:05] Speaker 00:
I think just

[00:06:06] Speaker 00:
Just because of the fact that we're talking about increasing survival and we're humans, we think, well, this is yes, this is what we all need.

[00:06:12] Speaker 00:
But keep in mind, Your Honor, before the invention here, no one treated these particular patients with the intent of increasing their survival.

[00:06:21] Speaker 00:
That is the invention here.

[00:06:23] Speaker 00:
This is the first- I'm going to interrupt you for a minute.

[00:06:26] Speaker 04:
I mean, are you then, through your argument, you're further defining the patient need thereof with the wherein limitation at the end of the claim?

[00:06:35] Speaker 04:
You've got a wherein the patient has castration resistant or hormone refractory, fantastic prostate cancer.

[00:06:41] Speaker 04:
I mean, how does that play into this language with the patient need thereof?

[00:06:48] Speaker 04:
Or does it not at all?

[00:06:50] Speaker 00:
It doesn't, Your Honor.

[00:06:51] Speaker 00:
It does not.

[00:06:54] Speaker 00:
Right.

[00:06:55] Speaker 00:
So that defines the patient as having dositaxel resistant metastatic castration resistant prostate cancer.

[00:07:02] Speaker 00:
What the need thereof is the antecedent basis for that is in the preamble, not in the wearer.

[00:07:08] Speaker 03:
So what you're saying is that that patient population that you defined before this point never would have gotten any treatment because there's no hope of cure.

[00:07:18] Speaker 03:
Is that right?

[00:07:20] Speaker 00:
Those patients got treatment, but they got treatment for palliative purposes.

[00:07:24] Speaker 03:
So just to keep them comfortable.

[00:07:26] Speaker 00:
Keep them comfortable.

[00:07:27] Speaker 00:
Yes, that's true for all medications.

[00:07:29] Speaker 00:
You're either taking a drug to increase your survival or make you feel better.

[00:07:34] Speaker 03:
So why does this drug, and this is just more of my understanding of the background, why does this drug do more than increase their comfort level?

[00:07:46] Speaker 00:
Well, the science behind that, I'm not sure anybody knows.

[00:07:49] Speaker 00:
But the issue here is, and what's borne out all over the prior art, is

[00:07:55] Speaker 00:
You can give a drug to a patient with metastatic prostate cancer, and you can reduce their tumors.

[00:08:00] Speaker 00:
You can drop their PSA level.

[00:08:02] Speaker 00:
That doesn't mean they're going to live any longer.

[00:08:05] Speaker 00:
Those are not surrogates for one another, as both experts in this case agree.

[00:08:10] Speaker 00:
What's the difference here is now having now for the first time a method of treating these patients where you can actually prolong the life of those patients.

[00:08:21] Speaker 04:
Can I ask you on that, when you're talking about increasing survival,

[00:08:25] Speaker 04:
How is that measured?

[00:08:26] Speaker 04:
Like, is it a couple of days?

[00:08:28] Speaker 04:
I assume it has to be statistically relevant.

[00:08:30] Speaker 04:
Could you just speak to that for a minute?

[00:08:33] Speaker 00:
Yeah, well, it's measured in prolonging the life of the patient as to the standard of care for palliative purposes or no treatment at all.

[00:08:42] Speaker 00:
So the specific boundaries of when do you know whether you're actually prolonging the life of the patient, I'm not sure that is defined as a certain number of days

[00:08:54] Speaker 00:
or a certain number of months.

[00:08:55] Speaker 00:
We do have established circumstances from Milan's expert.

[00:09:01] Speaker 00:
He says, if I give a patient cabazitaxel, which is the drug that is the basis of the claims, if I give that drug to a patient for five cycles and they're still alive, I prolong their life, because they would have been already dead.

[00:09:15] Speaker 00:
Now, do we know for sure for certain whether it was the drug that lived them long?

[00:09:21] Speaker 00:
No.

[00:09:22] Speaker 00:
Physicians can reasonably determine that because of that drug, that patient is still alive.

[00:09:28] Speaker 04:
So in understanding the meaning of this preamble, it's telling us that this drug is being given for purposes of increasing survival.

[00:09:37] Speaker 04:
It's not as if it's only going to be infringed if somebody's life is actually increased.

[00:09:42] Speaker 00:
That's correct, Your Honor.

[00:09:43] Speaker 00:
It's the intent requirement, not that you have to have a specific finding that you actually have prolonged the life.

[00:09:50] Speaker 00:
to determine whether you're practicing the claims or not.

[00:09:52] Speaker 03:
The patient population, as defined in the wherein clause, would not receive this drug if all the doctor was doing is trying to make them comfortable while they were dying, while they were in hospice, for instance.

[00:10:08] Speaker 00:
Before or after the results of the study?

[00:10:13] Speaker 00:
Are there other purposes for administering this drug combination?

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

[00:10:19] Speaker 02:
To the same patient population?

[00:10:21] Speaker 00:
To the same patient population.

[00:10:22] Speaker 00:
You could conceivably give it room.

[00:10:24] Speaker 02:
The only slicing and dicing you're doing here is that it's the same patient population.

[00:10:29] Speaker 02:
It's the same drug.

[00:10:31] Speaker 02:
They're all in need of something, but you're saying the other claim dealt with palliative care.

[00:10:37] Speaker 02:
So we're claiming a new, not even use, it's the same use, a new result

[00:10:45] Speaker 02:
or something.

[00:10:46] Speaker 00:
Well, that's why I wanted to be careful with Judge O'Malley's question, whether we're talking beforehand or afterhand.

[00:10:51] Speaker 00:
Before the results of the tropics study group, before this patent issued, no patient would have been treated with this drug.

[00:10:59] Speaker 03:
With this drug at all?

[00:11:00] Speaker 00:
With this drug at all.

[00:11:02] Speaker 00:
It wasn't as if it was treated, if the idea was we would use this for some other purpose and now we're coming up with a new use.

[00:11:09] Speaker 00:
We have come up with data that supports its use

[00:11:14] Speaker 00:
At all.

[00:11:14] Speaker 00:
Beforehand, you didn't have sufficient data to conclude whether the benefits of the drug outweigh the risk of harm.

[00:11:21] Speaker 02:
But that's the issue of the three drug regimen, right?

[00:11:23] Speaker 02:
That's a sort of a different issue than what you were talking about with Capri.

[00:11:26] Speaker 02:
Well, I've been thinking about it differently.

[00:11:27] Speaker 00:
This is the issue with cabazitaxel itself.

[00:11:30] Speaker 00:
So the actual taxing chemotherapy, which, as we all know, has great risks involved.

[00:11:37] Speaker 00:
In the first phase one clinical studies, a patient died because of the drug.

[00:11:44] Speaker 00:
So when you're giving chemotherapy to these patients, you're putting them at risk of serious harm or death.

[00:11:51] Speaker 00:
So if you do not have sufficient clinical data from which to determine that the benefit you get from the drug outweighs that risk of harm, you don't give it to that patient.

[00:12:05] Speaker 02:
Can I just, literally, reading the in need of, I mean, it seems to me the board is right, that virtually all terminally ill patients defined in the claim need increased survival.

[00:12:17] Speaker 02:
So the only thing that gets you maybe towards where you want to go is this intent requirement that's globbed off.

[00:12:25] Speaker 02:
Not the use of, but that they intended to use it for a particular purpose.

[00:12:30] Speaker 00:
Am I right?

[00:12:31] Speaker 00:
The specific, the claims were drafted

[00:12:34] Speaker 00:
with Janssen in mind, with the specific idea that it would incorporate this specific intent element.

[00:12:43] Speaker 00:
That these claims are limited to situations where the physician administers the claim drug combinations with the specific intent to prolong the life of the patient.

[00:12:54] Speaker 03:
The word intent seems weird, meaning the purpose of practicing the method.

[00:12:59] Speaker 03:
Is that what you're talking about?

[00:13:00] Speaker 00:
The purpose, yes.

[00:13:01] Speaker 03:
The purpose for practicing the method.

[00:13:03] Speaker 03:
And I guess what Judge Prosis is getting at is once you have the drug and once you know that this is the result that the drug gives, why does having a purpose change the scope of the claim?

[00:13:22] Speaker 00:
Right.

[00:13:22] Speaker 00:
So those cases, so like the Inre Montgomery case, the King Pharmaceutical case, the Bristlemire-Squibb case, those are anticipation cases.

[00:13:30] Speaker 00:
So those are anticipation cases where you're talking about known methods, known processes.

[00:13:39] Speaker 00:
So you have a method that's in the prior art that the public has the benefit of, and now you're claiming a result that is inherent to that method.

[00:13:48] Speaker 00:
Here, the method is not in the prior art.

[00:13:52] Speaker 00:
We are not in the world of anticipation.

[00:13:54] Speaker 00:
This is not a question of inherency.

[00:13:56] Speaker 00:
This is a question of obviousness.

[00:13:58] Speaker 00:
We have combinations.

[00:14:00] Speaker 00:
of four different references to put together all of the limitations of these claims.

[00:14:05] Speaker 00:
So it's not that this is claiming a new use of a known method.

[00:14:11] Speaker 00:
This is a new method.

[00:14:13] Speaker 02:
Well, you're saying it's a new method, but a necessary piece of that is you're saying it's used the intent or the purpose, as Judge O'Malley said, is for increasing survival and not for palliative care.

[00:14:27] Speaker 00:
That was the proposed limitation.

[00:14:30] Speaker 00:
And in the motion to amend, the patent owner expressly relied on that added limitation to distinguish the claims from the priority.

[00:14:40] Speaker 02:
Since increasing survival in this context, we're not talking cure here, right?

[00:14:44] Speaker 02:
Increasing survival is just managing to prolong life.

[00:14:49] Speaker 02:
Isn't there an overlap in a lot of circumstances in these cases between increasing survival and palliative care?

[00:14:57] Speaker 00:
There isn't, with any of the prior art, there is no evidence of anything before the claimed method of use for these particular patients after they have failed dose of taxil treatment that any of the known drug therapies or any of the therapies that had gone into phase three clinical studies prolong the life of the patient, any patient.

[00:15:23] Speaker 00:
I mean, these are statistical analyses.

[00:15:26] Speaker 04:
I think her question is different.

[00:15:27] Speaker 04:
She's saying, would it be that this drug, if administered, would not only extend life, but also provide palliative care?

[00:15:36] Speaker 00:
It could.

[00:15:37] Speaker 00:
You could have those two purposes at the same time.

[00:15:42] Speaker 00:
But for both of those purposes, you need actual clinical data that supports

[00:15:48] Speaker 00:
that use, right?

[00:15:50] Speaker 00:
A physician does not administer a drug for a specific purpose without clinical data supporting that intent.

[00:16:01] Speaker 03:
And so the danger here with respect to this drug is you're saying that up to this point no physician would have used this drug for purposes of just making someone comfortable because of all the risks that are involved.

[00:16:18] Speaker 00:
They would neither have done it for that purpose, nor would they have done it for the purpose of increasing survival.

[00:16:23] Speaker 00:
Yes, your honor.

[00:16:27] Speaker 02:
Why don't we hear from the other side?

[00:16:35] Speaker 01:
All right, thank you.

[00:16:35] Speaker 01:
Hello.

[00:16:36] Speaker 01:
May I please the court?

[00:16:40] Speaker 01:
This court should affirm the board's decision on all three of the issues raised by

[00:16:46] Speaker 01:
Aventus in this appeal first.

[00:16:48] Speaker 02:
OK, can I just go to what we were just talking about with your friend, just to keep the chain of thought going?

[00:16:53] Speaker 02:
Why is it not the case that if indeed this language inserted in the claim limits it to the use for purposes of increasing survival, i.e.

[00:17:06] Speaker 02:
prolonging life, as opposed to palliative care, why isn't that an actual limitation?

[00:17:12] Speaker 02:
I mean, there hasn't been an obviousness determination or whatever.

[00:17:15] Speaker 02:
But why isn't that different than the other ordinary use, which was palliative care?

[00:17:22] Speaker 01:
That is different because in the Bristol Myers case, the BMS case was specifically on point here.

[00:17:28] Speaker 01:
There is no difference in the steps you perform as a result of having increased survival in the preamble or not as a limitation.

[00:17:38] Speaker 01:
There is no difference in how you practice the claimed method.

[00:17:42] Speaker 03:
Isn't there a difference in whether you would perform the steps at all?

[00:17:46] Speaker 01:
In fact, there's not.

[00:17:47] Speaker 01:
The suggestion that there would be no patient that would have been treated with this drug, cabazitaxel, without having the clinically significant data that showed an increase in survival is incorrect.

[00:18:02] Speaker 01:
In fact, there were three drugs that are all taxanes that are related.

[00:18:06] Speaker 01:
The oldest one, paclitaxel, is not actually approved to treat prostate cancer.

[00:18:11] Speaker 01:
But it's used to do so.

[00:18:13] Speaker 01:
It's used off label.

[00:18:14] Speaker 01:
Similarly here, in this case, cabazitaxel was used.

[00:18:19] Speaker 01:
It was being used.

[00:18:20] Speaker 01:
It had been used in the phase one clinical study.

[00:18:22] Speaker 01:
It had been used in the phase two clinical study.

[00:18:26] Speaker 01:
And it was used in phase two clinical studies.

[00:18:27] Speaker 04:
But these are just clinical studies, right?

[00:18:29] Speaker 01:
That's right.

[00:18:29] Speaker 04:
I think what he said was that without having clinical studies, it wouldn't have been provided to a patient.

[00:18:34] Speaker 04:
That's what I heard him to be saying.

[00:18:37] Speaker 04:
So I don't think he said something inconsistent with what you just said.

[00:18:40] Speaker 04:
Am I missing something?

[00:18:42] Speaker 01:
He was drawing a very fine line between

[00:18:44] Speaker 01:
When are we talking about?

[00:18:46] Speaker 01:
In the doctor's mind, does the doctor yet have the clinical results?

[00:18:51] Speaker 01:
And he's supposed on day minus one, when the doctor doesn't have the clinical results, that the doctor cannot practice this method because the doctor doesn't possess those results in his or her mind.

[00:19:03] Speaker 01:
On day plus one, after the results, now suddenly something's changed.

[00:19:07] Speaker 01:
And that doctor's mind makes a difference.

[00:19:10] Speaker 01:
That cannot be the kind of limitation

[00:19:13] Speaker 01:
that this preamble language was meant to include in this claim.

[00:19:19] Speaker 04:
How do you distinguish Janssen?

[00:19:21] Speaker 04:
Is it that you don't see the treating or preventing anemia language is actually being interpreted to require that purpose?

[00:19:29] Speaker 01:
Exactly right.

[00:19:30] Speaker 01:
The anemia to be treated was a limitation of the claim.

[00:19:34] Speaker 01:
That's the holding of Janssen, that the treatment of a specific type of anemia, which I won't try and pronounce, but the pernicious anemia

[00:19:44] Speaker 01:
had to be the point of treatment.

[00:19:47] Speaker 01:
And as Judge O'Malley suggested earlier, it's just where in the claim does the language appear?

[00:19:52] Speaker 01:
Here we have the docetaxel-resistant metastatic castration-resistant prostate cancer in the body of the claim.

[00:20:04] Speaker 01:
So this pramble language doesn't add anything.

[00:20:07] Speaker 01:
It doesn't give life-meaning vitality to the claim.

[00:20:10] Speaker 03:
BMS, I thought one of the major problems there was that they were proffering one construction for infringement and a different construction for claim construction.

[00:20:21] Speaker 03:
If this party wants to limit themselves so dramatically for purposes of infringement that says, you know, unless this is the purpose for which you're practicing the method, you can't be infringing, then doesn't the patentee have the right to limit their claim?

[00:20:36] Speaker 01:
They could have done so, but they didn't.

[00:20:38] Speaker 01:
The language that they chose

[00:20:39] Speaker 01:
simply using the phrase increasing survival and then putting the thereof, indeed thereof claim right after it as part of the body of the claim really doesn't import the kind of limitation that my colleague on the other side is suggesting.

[00:20:54] Speaker 02:
How could they have done this?

[00:20:55] Speaker 01:
They could have used words like clinically significant, statistically.

[00:20:59] Speaker 02:
Tell me what you're doing to the claim.

[00:21:01] Speaker 02:
A method of increasing survival?

[00:21:03] Speaker 02:
Are you talking about putting that in the preamble language or in the claim?

[00:21:06] Speaker 01:
The amendment includes in the preamble a method of increasing survival.

[00:21:12] Speaker 01:
They could have added into that preamble language like clinically significant, statistically significant, some kind of language like that.

[00:21:21] Speaker 04:
And then that would have differentiated it for you.

[00:21:25] Speaker 01:
Absolutely.

[00:21:26] Speaker 01:
And the problem with that is that that cannot be a limitation because the statistically significant data come from a population study.

[00:21:36] Speaker 01:
And what we're talking about here in the claim is an individual patient.

[00:21:39] Speaker 01:
So we would run into all kinds of 112 problems if they tried to insert that into this language here.

[00:21:47] Speaker 01:
There would be an indefinite problem.

[00:21:49] Speaker 01:
There would be a written description problem.

[00:21:50] Speaker 01:
There would be an enablement problem.

[00:21:51] Speaker 03:
There might be a problem with written description or enablement from their use of the term survival and how that should be contemplated.

[00:22:00] Speaker 03:
But that's not the same as whether or not it's limited, right?

[00:22:04] Speaker 01:
Well, I think that it can't be limiting because as both sides expert testified, when a doctor gives this drug to a patient, that doctor has no idea whether this patient is going to benefit in terms of overall survival.

[00:22:18] Speaker 04:
I'm sorry to interrupt you, but that's not the inquiry for determining whether a preamble breathes life and breath into a claim, right?

[00:22:27] Speaker 04:
Isn't that the proper inquiry that we're supposed to be looking at?

[00:22:30] Speaker 01:
Absolutely.

[00:22:31] Speaker 01:
The preamble here, does it give life and breath

[00:22:33] Speaker 01:
to the claim as a whole.

[00:22:36] Speaker 01:
And the claim as a whole defines the patient population as metastatic castration resistant prostate cancer patients who have progressed during or after dositaxel.

[00:22:47] Speaker 01:
Those patients are, by definition, patients in need of increased survival.

[00:22:53] Speaker 01:
So there's nothing more that this additional language in the preamble adds by way of limitation.

[00:22:59] Speaker 03:
But they're also in need of other things, right?

[00:23:03] Speaker 03:
increased survival would be great, but they're also in need of palliative care, right?

[00:23:08] Speaker 01:
Absolutely.

[00:23:08] Speaker 01:
Yes.

[00:23:09] Speaker 01:
These patients are suffering from terminal cancer.

[00:23:12] Speaker 01:
There has not been a cure found for this cancer.

[00:23:14] Speaker 01:
So these patients are inevitably going to continue to suffer with the disease and ultimately die from the disease or complication of that disease.

[00:23:25] Speaker 02:
What I understand your friend to be saying was that

[00:23:29] Speaker 02:
Before this amendment, the suggestion was that anybody prescribing this was for the purpose of palliative care of a terminally ill patient, and that this is a different purpose.

[00:23:41] Speaker 02:
Increased prolonging life is a different purpose than existed previously.

[00:23:46] Speaker 01:
I don't think that's right.

[00:23:47] Speaker 01:
I think that the clinical studies... Is that right?

[00:23:49] Speaker 02:
That he's not arguing that or that it's factually incorrect?

[00:23:52] Speaker 01:
I think it's factually incorrect.

[00:23:53] Speaker 01:
I think that those who were conducting the phase one study, for instance, had

[00:23:59] Speaker 01:
as one of the purposes of their study, this is the META reference, had as an explicit purpose of that study to seek preliminary indication of anti-cancer activity.

[00:24:11] Speaker 01:
They were doing the administration of cabazitaxel for the purpose of detecting anti-cancer activity.

[00:24:18] Speaker 03:
Right, so they wouldn't infringe.

[00:24:22] Speaker 01:
That equates to survival.

[00:24:25] Speaker 01:
The anti-cancer activity demonstrated there.

[00:24:28] Speaker 03:
That equates to survival or it

[00:24:29] Speaker 03:
to a cure.

[00:24:31] Speaker 01:
Not a cure.

[00:24:33] Speaker 01:
Not a cure.

[00:24:34] Speaker 02:
That was to increase survival?

[00:24:36] Speaker 01:
The anti-cancer activity demonstrated in the phase one trial plus in the phase two trial which was in the context of mesostatic breast cancer also showed anti-cancer activity and then this drug went into a phase two.

[00:24:53] Speaker 04:
When you say anti-cancer activity are you talking about

[00:24:56] Speaker 04:
reduced tumor growth, reduced tumor size.

[00:24:59] Speaker 04:
What are you talking about?

[00:25:00] Speaker 01:
In those studies, there was indication of both.

[00:25:03] Speaker 01:
There were lower levels of PSA.

[00:25:06] Speaker 01:
There were also reductions in tumor size.

[00:25:10] Speaker 02:
And I think your friend referenced those.

[00:25:11] Speaker 02:
And those are for purposes of increasing survival, not curing.

[00:25:15] Speaker 01:
Right.

[00:25:16] Speaker 01:
But now we get to the question of what would a person of skill in the art reasonably expect with a taxing that is showing this type of anti-cancer activity?

[00:25:26] Speaker 01:
a person reasonable uh... persons from that would have a reasonable expectation that you would in fact have increased survival as a result of the anti-cancer so you're just arguing that even if it's limiting it's still obvious in the alternative absolutely that would be something for uh... remand you agree with that i don't i think that there is substantial evidence here showing that we can't make that fact if we think

[00:25:53] Speaker 04:
just hypothetically, if we thought the preamble was limiting.

[00:25:55] Speaker 04:
We have to send it back to the patent office, don't we?

[00:25:58] Speaker 04:
Because we don't decide facts.

[00:26:00] Speaker 01:
I don't think so, because the board, in its decision, explicitly said that, on page 72, that to the extent the preamble may be considered limiting at all, it refers to a patient in need of increased survival.

[00:26:17] Speaker 01:
And then it talked to them.

[00:26:18] Speaker 03:
That's where it said they didn't prove that it was

[00:26:21] Speaker 03:
not obvious.

[00:26:22] Speaker 01:
So that's where the board put the burden on the wrong party.

[00:26:26] Speaker 01:
It also cites evidence of record showing that there was, in fact, anti-cancer activity.

[00:26:33] Speaker 01:
And the parentheticals that come right after that, you have the testimony of both sides' experts as well as the decoration.

[00:26:38] Speaker 02:
So we're talking about several different things.

[00:26:39] Speaker 02:
At a minimum, there's the argument that even if we accept everything you say, there's still a problem with burden shifting that doesn't comport with that.

[00:26:51] Speaker 02:
So there's a question of whether or not even accepting what you say, we would at least have to return it for the limited purpose of applying the correct burden.

[00:27:00] Speaker 02:
And there's a step before that, which is that we would, and I think Judge Stull was referring to that, that no, no, no, we're not going to determine this sort of obviousness inquiry here based on the limited information the board gave us.

[00:27:13] Speaker 02:
And so that we would necessarily have to remand it not only for the ACWA issue, but also for the obviousness return.

[00:27:20] Speaker 01:
I respectfully disagree with my colleague's suggestion that this absolutely has to be remanded in light of aqua products.

[00:27:28] Speaker 01:
This case is uniquely positioned in that the final written decision came out.

[00:27:33] Speaker 01:
About two weeks later, the court issued the aqua products on bond decision.

[00:27:38] Speaker 01:
And the board, Suspante, offered to the patent owner.

[00:27:43] Speaker 03:
Once a decision is issued, is there an obligation to seek reconsideration before you can appeal?

[00:27:48] Speaker 01:
there's no such obligation.

[00:27:50] Speaker 02:
So there's no, you're suggesting there's some sort of waiver thing that they didn't seek reconsideration.

[00:27:54] Speaker 01:
It's not waiver, but it is a factor.

[00:27:56] Speaker 01:
It's a factor then when you take into consideration the fact that in the decision, the board, although it recited the pre aqua products standard, it in fact held Mylan, the petitioner here below, to that standard.

[00:28:12] Speaker 03:
But you're saying that

[00:28:15] Speaker 03:
They had an obligation to go back to the board under what they believed to be a wrong claim construction.

[00:28:21] Speaker 03:
So they would have gone back to the board to reconsider where they placed the burden, but they still would have been stuck with the same claim construction.

[00:28:28] Speaker 03:
So it would have been an exercise in futility in their mind.

[00:28:32] Speaker 01:
I understand that that's what was perhaps going through their mind with respect to the claim construction issue.

[00:28:38] Speaker 01:
But in fact, when it comes to imposing the burden, what the board did below is it found

[00:28:44] Speaker 01:
that Mylon, the petitioner here, had persuasively established the obviousness of what was interpreted to be the claim, the preamble without a limitation.

[00:28:55] Speaker 02:
Well, why would the board have offered up for the parties to do additional briefing or to come forward if it didn't suspect that maybe there was a problem or some different analysis that would have applied if Apple was the law at the time?

[00:29:10] Speaker 01:
The board was keenly aware of the pendency of the aqua products case.

[00:29:14] Speaker 01:
In fact, on page 66 of the final written decision, they recite the burden being on patent owner and then include a citation to the in-rate aqua products case and noting that the federal circuit had granted rehearing en banc to address burdens of persuasion and production regarding motions to amend.

[00:29:37] Speaker 01:
So they were keenly aware, even before they issued this final written decision, that that was pending and that that was a potential issue.

[00:29:44] Speaker 02:
And I think that's probably why in the language... Except that they state right before that and right after that that the owner has the burden and he's not met his burden.

[00:29:52] Speaker 01:
Right.

[00:29:53] Speaker 01:
But when you look at what they did on page 74 and 75 of the decision, in page 75, for instance, the first full paragraph begins, petitioner persuasively establishes

[00:30:08] Speaker 01:
That's Myland bearing the burden and meeting that burden of establishing the obviousness of the claims here.

[00:30:16] Speaker 01:
So the claims really can be thought of in terms of having this treatment with cabazitaxel, on the one hand, and then also another new addition from the amendment, having the pretreatment regimen.

[00:30:30] Speaker 01:
So there are those two parts, those two pieces.

[00:30:33] Speaker 01:
And the focus so far, I think, has been on the first part, on using cabazitaxel.

[00:30:38] Speaker 01:
That, the board said on page 74, right in the middle of the page, we reject the argument for the same reasons given in section 2B4 above.

[00:30:50] Speaker 01:
And 2B4 above, of course, dealt with the original claims, which only had that cabazotaxile treatment portion.

[00:30:57] Speaker 01:
That burden was unmistakably on my own.

[00:31:00] Speaker 01:
In fact, my colleague doesn't even suggest that they bore that burden.

[00:31:05] Speaker 01:
And that burden was met.

[00:31:07] Speaker 01:
as recited in the final written decision before that.

[00:31:16] Speaker 01:
Thank you.

[00:31:16] Speaker 01:
Thank you very much.

[00:31:16] Speaker 00:
Just a few points, Your Honors.

[00:31:31] Speaker 00:
On the last points on this issue of, I guess the suggestion is that

[00:31:36] Speaker 00:
the difference in burden was harmless error on the sections that Mr. Reed just pointed, Your Honors, to.

[00:31:45] Speaker 00:
The first part on page 75, this petitioner persuasively establishes all the board is saying there was that the premedication was well-known.

[00:31:56] Speaker 00:
That is not obvious.

[00:31:58] Speaker 00:
Just because the elements of the claim were well-known,

[00:32:02] Speaker 00:
does not establish that there was a specific motivation for a person of ordinary skill in the art to combine those elements with a reasonable expectation of success.

[00:32:11] Speaker 00:
That's just one point.

[00:32:12] Speaker 00:
On the point on 74, where the board rejects the amended claims for the same reasons as section 2B4, that was under a limitation where the preamples were not limited.

[00:32:28] Speaker 00:
And I do want to point out that in section 2.B.4,

[00:32:32] Speaker 00:
the board actually did find that the results of Tropic where the increasing survival were unexpected.

[00:32:39] Speaker 00:
So on the issues of the idea that even under the different burden that there should be no remand, I think those points disagree with that.

[00:32:53] Speaker 00:
Going back to the preamble issue, my colleague mentioned that the BMS case was on all points here.

[00:33:02] Speaker 00:
I just want to reiterate a point that I made in my opening comments was that in BMS, the actual steps in the claim were already in the prior art.

[00:33:13] Speaker 00:
Here, that's not true.

[00:33:15] Speaker 00:
There is no dispute that there is no single reference setting forth all of the steps of the claim.

[00:33:22] Speaker 00:
So this is not an anticipation case, again, like BMS was.

[00:33:27] Speaker 00:
This is an issue of obviousness.

[00:33:30] Speaker 00:
On the point about did the patent owner do enough to limit the claims, to seek this limitation, include this limitation, and rely on that limitation to overcome the prior art, it's not just the language of the claim I want to remind you on.

[00:33:51] Speaker 00:
They also expressly relied on that for distinguishing the invention from the prior art.

[00:33:59] Speaker 00:
This is effectively prosecution history estoppel.

[00:34:02] Speaker 00:
This is a clear and ambiguous disavowal, as Judge O'Malley was alluding to, this idea that, well, here we have the patent owner specifically limiting the claims in a way, adding limitations.

[00:34:17] Speaker 00:
And we submit that the board has no discretion to ignore that clear reliance.

[00:34:27] Speaker 02:
Thank you.

[00:34:28] Speaker 02:
Thanks both sides.

[00:34:29] Speaker 02:
The case is submitted.

[00:34:30] Speaker 02:
That concludes our procedure for this morning.

[00:34:33] Speaker 02:
All right.