[00:00:00] Speaker 03:
6-1455, palmetto pharmaceuticals versus AstraZeneca.

[00:00:26] Speaker 03:
Mr. Isaacson, please proceed.

[00:01:11] Speaker 00:
May I please the court.

[00:01:12] Speaker 00:
We are here today because the district court incorrectly attached two state of mind requirements to our claims.

[00:01:19] Speaker 00:
These are recognized need and intentional purpose.

[00:01:22] Speaker 00:
These are phrases that do not appear anywhere in our patent or our prosecution history.

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In contrast, before the district court, we made two different proposals.

[00:01:31] Speaker 03:
Your problem is Janssen.

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And it's like I look back at the dates.

[00:01:35] Speaker 03:
Janssen was signed in 2003, your patent issued in 2002.

[00:01:38] Speaker 03:
You didn't see it coming in like a freight train.

[00:01:41] Speaker 03:
It has the same subject in need of language.

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I understand.

[00:01:45] Speaker 03:
That's why it doesn't appear in your spec.

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That's why it doesn't appear in your prosecution history.

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And you know what?

[00:01:50] Speaker 03:
I may not even agree with the way Jansen was decided.

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But I am definitely and clearly bound by it.

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So that's your problem.

[00:01:57] Speaker 03:
So why don't you just start your argument and end your argument with why Jansen doesn't hold you to the same outcome that was reached in Jansen.

[00:02:06] Speaker 00:
First, no intent for direct infringement is the norm.

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And intent is the exception.

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And as you noted, Janssen came out after we issued.

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And we have to look at the facts and circumstances of Janssen in our case.

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So first, going straight to Janssen, a different issue was before this court in Janssen.

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And if you look at the beginning of page 1333, where the court defined the issue.

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And the issue there was the party's quote,

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dispute how the treating or preventing phrase, and to a human in need thereof phrase, should be read.

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The issue reduces to whether such a human, that human being, the person being treated, must know that he is in need of either treatment or prevention of that condition.

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In Janssen, that person was the vitamin person consumer.

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The person on the street goes in and buys some vitamin B supplement.

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They have no medical education to know whether they have macrocytic megaloblastic anemia.

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So it was a way for the district court and then this court affirmed to find that the consumers and Rexall drug source did not have liability.

[00:03:25] Speaker 01:
Throughout that Janssen argument, starting at 21 and running on for maybe 10 pages,

[00:03:34] Speaker 01:
In various iterations, you make the argument that the district court erred when it construed the disputed limitations to, quote, require an intent in various ways.

[00:03:46] Speaker 01:
Here's my problem with that.

[00:03:48] Speaker 01:
In the hearing before the special master, JA 21016, you argued the person practicing claim one, quote, must intend to treat a subject who is at risk for cardiovascular disease and adverse

[00:04:04] Speaker 01:
events.

[00:04:06] Speaker 01:
At 20775, in the joint proposed claim construction chart, you acknowledged that the disputed limitations, quote, require an intent, close quote.

[00:04:18] Speaker 01:
When you objected to the special master's constructions at 21278, you didn't dispute that claim one required some intent, but instead, quote, agreed with AstraZeneca's counsel.

[00:04:30] Speaker 01:
The issue here is intent to do what?

[00:04:34] Speaker 01:
close quote.

[00:04:35] Speaker 01:
How can you fairly state that you haven't waived the no intent argument?

[00:04:38] Speaker 00:
Sure.

[00:04:40] Speaker 00:
We had initially, we had proposed two constructions.

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The first was no intent.

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The second was, if there is to be intent, it shouldn't be a dual intent requirement.

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It should be a single intent requirement concerning provision of a benefit to the patient.

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The term benefit is very important to our second construction.

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And it's a term that AstraZeneca barely mentions.

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But if I could get to what we discussed

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with the district court when we opened up with our brief at 21046.

[00:05:11] Speaker 00:
Right there, we started with, and I'll quote, Palmetto disagrees with one highly significant aspect of the special master's report recommendation, the legal interpretation of the decision in Janssen and its application to the claims in Palmetto's US patent.

[00:05:24] Speaker 00:
Under the special master's construction, a finding of patent infringement hinges upon proof of the doctor's state of mind, even though patent infringement traditionally requires no such proof.

[00:05:34] Speaker 00:
Later, in our slides for the oral hearing at Joint Appendix 21168, we provided a slide discussing the Camel case.

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Camel came out after we had done our briefing.

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But nevertheless, that shows that we said, generally, there's no center inquiry.

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And that direct infringement is a certain liability offense.

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And finally, going back a little bit, and I think that this court's decision in CCS Fitness v. Brunswick Corp is

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is helpful here.

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This court looked to whether the trial court and the party court claiming waiver had previous notice of a proposed construction.

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And the court in CCI fitness found that an allegedly waived construction was raised during a previous summary judgment motion, a factor of militating against a waiver.

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Same thing happened here.

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In our joint appendix at 4131 and that at 18600, Jansen v. Rexall was briefed.

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during AstraZeneca's motion for some of the judgment non-infringement, although we agreed at that point that they didn't have to go into a construction.

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The court accepted our plain meaning of the claims and did not apply any intent requirement in its order denying summary judgment.

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You can find that at Joint Appendix 18613, footnote 7.

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That's the magistrate's recommendation, which was affirmed by the district court at Joint Appendix A,

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19162.

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So the court in AstraZeneca knew our position from the very beginning.

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A lot of these other statements we discussed come in terms of our second proposed construction of a single attempt connected to the word benefit.

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But just because we provided that second proposal didn't mean we waived our first and that this case should be looked at as like any other method of treating claim.

[00:07:31] Speaker 00:
There's no intent for the direct confrontor.

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And when we did discuss Janssen, and AstraZeneca provided a few quotes at page 17 of their brief, opening brief, we did say, yes, Janssen applies an intent to the Janssen claims.

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And if you had the facts exactly like Janssen, that might be appropriate.

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But our facts are very different.

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We've never agreed that Janssen should be applied.

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If I want to get to, I'd like to get to why we think Janssen shouldn't be applied.

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I discussed that there was a different issue at the time.

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And again, getting back to, you know, Janssen discussed whether the human must know that they need a treatment.

[00:08:23] Speaker 04:
What do you think is the principle we should take away from Janssen?

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I mean, I know you want to identify certain facts that are different from the facts here, but there seems to be a certain legal principle at stake in Janssen.

[00:08:40] Speaker 04:
And I'm just trying to figure out what you think is the right articulation and boundaries of that legal principle coming out of Janssen, a presidential opinion.

[00:08:51] Speaker 00:
I think Janssen was concerned that

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what I'm presuming is a poor person of skill at that claim, which I think is the vitamin purchasing consumer, had a very low level of skill and knowledge.

[00:09:05] Speaker 00:
They had no medical knowledge.

[00:09:07] Speaker 00:
I mean, Janssen doesn't come out and say, the person of ordinary skill is this.

[00:09:12] Speaker 00:
But I do take from that one statement of the issue at the beginning of 1333, that the person of ordinary skill in Janssen seems to be the person who's actually taking the vitamin.

[00:09:25] Speaker 00:
Okay?

[00:09:27] Speaker 00:
And ours is, our person with ordinary skill is a far different person.

[00:09:32] Speaker 00:
It's a medical doctor, board certification, cardiology, or something similar, and five years of clinical experience treating patients with cardiovascular diseases and abnormal lipid levels.

[00:09:43] Speaker 00:
So our person with ordinary skill is the treating doctor.

[00:09:47] Speaker 00:
Yes, they should have knowledge about nitric oxide that's in our patent.

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It's in the medical literature.

[00:09:53] Speaker 00:
It means that they don't have to be thinking about nitric oxide when they see a person who's older and perhaps has hypertension, risk factors, cardiovascular disease, and they prescribe a statin like Crestor.

[00:10:09] Speaker 00:
They don't need thinking about the biochemistry, because our person with already skill in the art is not a biochemist.

[00:10:16] Speaker 00:
It's a treating physician.

[00:10:18] Speaker 00:
And so if there is a tension between Janssen

[00:10:23] Speaker 00:
And Phillips says we start claim interpretation from the point of view of the person of ordinary skill.

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And the art is the objective baseline where claim interpretation begins.

[00:10:36] Speaker 00:
We have to start with that.

[00:10:38] Speaker 00:
Instead, what the district court did is took the vitamin patent as a template, laid it over our claims, and tried to look for things that were consistent with that.

[00:10:47] Speaker 00:
But that interpretation started with Janssen, where we think our claim interpretation

[00:10:53] Speaker 00:
needs to start with our personal ordinary skill.

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And if there is to be an intent, we need to look at the word benefit.

[00:11:00] Speaker 00:
Benefit is in our claim.

[00:11:02] Speaker 00:
It means reduction in clinical events or the risk of clinical events.

[00:11:07] Speaker 00:
That's what the treating doctor wants to do when they're giving us that.

[00:11:10] Speaker 01:
Well, your problem with that argument is that it doesn't comport with the disputed limitations terms.

[00:11:22] Speaker 01:
Where does a term of the disputed limitation refer to selection or administration of treatment based on cardiovascular risk factors?

[00:11:36] Speaker 00:
What am I referring to?

[00:11:39] Speaker 00:
He asked you where your claim has what you just said it has.

[00:11:48] Speaker 00:
was defined was construed as reduction of clinical events.

[00:11:52] Speaker 01:
The disputed limitations recite a method for treating a cardiovascular risk factor.

[00:12:04] Speaker 01:
I'm sorry, they don't.

[00:12:05] Speaker 01:
They say a method for treating a subject who would benefit from increased nitric oxide reduction in a tissue comprising administering to the subject in need of such treatment.

[00:12:16] Speaker 01:
Claim one.

[00:12:18] Speaker 01:
teaches that the treatment should be administered in an amount effective to increase nitric oxide production in said tissue of the subject.

[00:12:28] Speaker 01:
You don't mention cardiovascular in there.

[00:12:32] Speaker 00:
Clinical events are the cardiovascular events.

[00:12:41] Speaker 03:
Would you like to save the rest of your time for rebuttal, or do you have something more you want to add in your initial argument?

[00:12:49] Speaker 00:
Now, I'll be quick.

[00:12:54] Speaker 00:
All we wanted to do is to start with a standard Phillips construction.

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And we think the district court, by starting with Janssen, interfered with that.

[00:13:06] Speaker 00:
We wanted our patent to be construed on the four corners of our patent and our prosecution history.

[00:13:13] Speaker 00:
Janssen was very different in that the person with more skill in the art was different.

[00:13:17] Speaker 00:
The technology was different.

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And as this court said in the Monsanto v. Behr bioscience case, we don't use one patent against another.

[00:13:29] Speaker 00:
And in that case, the technology was the same, but the specifications were different.

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So we submit that the district court erred from the start by starting with Janssen.

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And that essentially interfered with the correct construction.

[00:13:47] Speaker 00:
And after that, I will say the rest of my time for rebuttal.

[00:13:51] Speaker 03:
OK, Mr. Sykes.

[00:14:06] Speaker 02:
Thank you, Your Honors.

[00:14:06] Speaker 02:
Christopher Sykes here on behalf of Lieutenant AstraZeneca.

[00:14:11] Speaker 02:
Let me start just with the basic point about Janssen.

[00:14:14] Speaker 02:
Janssen, of course, followed Rappaport, which had construed the same kind of method of treating language, and that's from 2001.

[00:14:20] Speaker 02:
This is a patent which is about a method of treating a patient in need.

[00:14:23] Speaker 02:
That's a very common language.

[00:14:25] Speaker 02:
It's a very well-understood language.

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And what Janssen recognized is that there is a well-understood meaning to treat a patient in need, and that is to intend to address the recognized need.

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Treating is an intentional act.

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That is what Janssen recognized.

[00:14:41] Speaker 02:
So even beginning with Phillips and Phillips' emphasis that what we look at is the meaning of the words and claims as used in the intrinsic evidence.

[00:14:49] Speaker 04:
The law is the law, but why is our case law allowed for a knowledge component in a patent claim or some state of mind?

[00:15:05] Speaker 04:
a little peculiar.

[00:15:06] Speaker 04:
Typically, a method step requires a certain series of actions.

[00:15:13] Speaker 04:
And the product claims are tangible concrete things.

[00:15:17] Speaker 04:
And now here, we have a method claim about taking some actions, but taking some actions also with

[00:15:27] Speaker 04:
while you're thinking something inside your head.

[00:15:30] Speaker 02:
Well, I believe it's not that uncommon to see method claims that are purposeful, that require them to achieve a purpose.

[00:15:37] Speaker 02:
And that's important, particularly in this context.

[00:15:40] Speaker 03:
You can achieve a purpose without knowing.

[00:15:43] Speaker 03:
Let me give you an example.

[00:15:45] Speaker 03:
All right.

[00:15:45] Speaker 03:
My son, he had a rash on his face recently.

[00:15:48] Speaker 03:
This is not a made up story.

[00:15:49] Speaker 03:
He had a rash on his face recently.

[00:15:51] Speaker 03:
I took him to the doctor for the rash because it was red and it bothered him, little irritated.

[00:15:55] Speaker 03:
It also itched.

[00:15:56] Speaker 03:
He never mentioned that to me or the doctor.

[00:15:58] Speaker 03:
Well, the doctor gave him a steroid, cleared the rash up.

[00:16:00] Speaker 03:
You know what else the steroid had contained within it?

[00:16:02] Speaker 03:
Some sort of anti-cortisone type thing that also removed the itch.

[00:16:06] Speaker 03:
And Billy says, this medicine is great.

[00:16:08] Speaker 03:
It doesn't itch anymore.

[00:16:10] Speaker 03:
So he was the subject in need of an anti-itch cream.

[00:16:14] Speaker 03:
He hadn't communicated that to me.

[00:16:15] Speaker 03:
He's a child or his doctor.

[00:16:17] Speaker 03:
The doctor gave him a steroid, which cleared up the rash.

[00:16:19] Speaker 03:
It also happened to take care of his need

[00:16:22] Speaker 03:
for something to clear up the itching.

[00:16:24] Speaker 03:
So the doctor performed a method that would fall on all fours if this were a claim for a subject in need of an anti-itch cream.

[00:16:31] Speaker 03:
Billy had the itch, he was such a subject, and it effectively reduced the itch.

[00:16:37] Speaker 03:
Why wouldn't that be an infringement of this claim?

[00:16:41] Speaker 03:
Why does it have to be that he knew and the doctor knew when prescribing the treatment that it was all this cream was going to treat the edge?

[00:16:48] Speaker 02:
I would say that shows exactly why it's important to distribute method of treating claims that way.

[00:16:52] Speaker 02:
Because of course, part of the idea of patent law is promoting research on new uses for medicines that are already in use.

[00:16:57] Speaker 03:
But patent law is strict liability.

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You're dead in the water whether you know you're infringing or not.

[00:17:02] Speaker 02:
Which would also mean that if you believe you have a new use, say, for statin,

[00:17:06] Speaker 02:
But it's been used before.

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Even if not knowingly used that way before.

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If it had been administered to a person who was non-hyperlipidemic under their construction, it's anticipated.

[00:17:19] Speaker 02:
The way you claim new treatments is that a doctor who maybe has been administering it to patients unbeknownst to him or her in a way that would affect that treatment never recognized it.

[00:17:31] Speaker 02:
Now somebody comes along and says, you know what?

[00:17:32] Speaker 03:
Well, that couldn't render it invalid.

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And the reason it couldn't render it invalid is you have to have prior known or public use.

[00:17:38] Speaker 03:
It has to be publicly accessible and known.

[00:17:41] Speaker 03:
I'm trying to think of how that could be prior art that would invalidate a statin.

[00:17:44] Speaker 02:
Inherent anticipation, Your Honor.

[00:17:45] Speaker 02:
If, for example, this claim was simply directed to giving a statin to a person, and look, it has this effect.

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Well, it has that effect whether you attend it or not.

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So if the statin was administered to a non-hyperlipidetic patient in the past,

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And now we know it can be used to treat some condition before.

[00:18:03] Speaker 02:
Well, if the person had the condition before the patent was filed, that would be inherent anticipation.

[00:18:08] Speaker 02:
It's because the claim itself requires the doctor to intend the effect that allows you to patent new uses.

[00:18:15] Speaker 02:
That's why this language is quite common in method of treating patents, because what it says is it's not that people haven't received the drug before, but now the drug is being used for a new purpose.

[00:18:28] Speaker 02:
And I think Janssen and Rappaport

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recognize it, that that's a very important aspect of method of treatment claims.

[00:18:34] Speaker 02:
It says not simply, now a new drug has been developed.

[00:18:38] Speaker 02:
Well, fine, get a drug substance patent.

[00:18:40] Speaker 02:
But how do you claim new treatments?

[00:18:42] Speaker 02:
And that's this case.

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There's no claim here that Palmetto invented stats.

[00:18:46] Speaker 02:
The claim here is that they came up with a new way of using it.

[00:18:50] Speaker 02:
A new way of using it.

[00:18:51] Speaker 02:
And specifically, to use it for the specific purpose of raising NL.

[00:18:56] Speaker 02:
rather than lowering cholesterol.

[00:18:58] Speaker 02:
That's a purposeful act.

[00:19:00] Speaker 03:
Well, you're fighting a very good fight, by the way, but you're fighting a harder fight than you need to.

[00:19:04] Speaker 03:
Because isn't all of my logic shut down by Janssen?

[00:19:07] Speaker 02:
It is.

[00:19:07] Speaker 03:
I mean, that's the real thing.

[00:19:08] Speaker 03:
Regardless of, I mean, that's why when I started with him, I said, whether I agree with Janssen or not, I got to obey it.

[00:19:13] Speaker 02:
It absolutely shut down by Janssen.

[00:19:15] Speaker 02:
And Janssen is good law, and it's important law in this area.

[00:19:18] Speaker 03:
All law is good law.

[00:19:20] Speaker 02:
Fair enough, you're out of it.

[00:19:21] Speaker 02:
Is it?

[00:19:22] Speaker 02:
But in this case, it really comes in.

[00:19:25] Speaker 02:
And of course, once we get to the intent, I would point out that both the special master and the district judge here found that they had not preserved an argument that there's no intent.

[00:19:34] Speaker 02:
And they clearly didn't.

[00:19:36] Speaker 02:
Their objections to the report and recommendation of the special master said specifically, and Your Honor Judge Walke, you pointed this out at 821-048, that the correct, properly constituted requires intent.

[00:19:47] Speaker 02:
They admit in their brief that Rappaport and Janssen require intent.

[00:19:52] Speaker 02:
So we're dealing here with what intent?

[00:19:54] Speaker 02:
And Phillips says, look at the language of the claim and the specification, the intrinsic evidence.

[00:19:59] Speaker 02:
So the language of the claim here is not reduction of cardiovascular risk.

[00:20:03] Speaker 02:
They're very specific words.

[00:20:04] Speaker 02:
And it's a subject who would benefit from increased nitric oxide production in a tissue, comprising administering to the non-hyperlipidemic subject in need of such treatment

[00:20:14] Speaker 02:
a statin in an amount effective to increase nitric oxide production.

[00:20:18] Speaker 02:
The claim beats you over the head with the fact that the purpose here is specifically to raise nitric oxide.

[00:20:24] Speaker 04:
Is there some very tight, close correlation between increasing nitric oxide production and, you know,

[00:20:32] Speaker 04:
helping people with cardiovascular disease or hypertension?

[00:20:35] Speaker 02:
I would say there's dispute between the parties at that.

[00:20:37] Speaker 02:
Maybe almost a one-to-one correlation?

[00:20:40] Speaker 02:
I don't believe so, Your Honor.

[00:20:41] Speaker 02:
There's some dispute over that between the parties, but that's an infringement issue.

[00:20:46] Speaker 02:
And of course, what they're actually accusing infringement is something entirely different from that, which is giving a statin to patients who are identified at risk because of yet another biochemical marker.

[00:20:56] Speaker 04:
I thought the patent spec, when it talks about

[00:20:58] Speaker 04:
You know, in the context of the patent spec, when it talks about increasing NO production, it's in the context of treating people with cardiovascular disease and hypertension problems, right?

[00:21:10] Speaker 02:
The patent spec is actually very broad in that regard.

[00:21:13] Speaker 02:
It says the only example, of course, is in vitro.

[00:21:16] Speaker 02:
There's no treatment of anybody.

[00:21:18] Speaker 02:
in the patent.

[00:21:19] Speaker 02:
There's one example of the patent, and it's an in vitro study measuring simply an increase in NO production.

[00:21:24] Speaker 04:
Am I misremembering?

[00:21:25] Speaker 04:
They didn't say anything about cardiovascular or hypertension?

[00:21:28] Speaker 02:
They did.

[00:21:28] Speaker 02:
And here's the language, which is why they were not limiting themselves.

[00:21:31] Speaker 02:
They said, stimulation of NOS in the presence.

[00:21:34] Speaker 02:
This is from column four, beginning of line 60.

[00:21:37] Speaker 02:
Stimulation of NOS in the presence of excess L arginine or other substrate precursor of native NO may be used to prevent, treat, arrest, or ameliorate

[00:21:47] Speaker 02:
any disease or condition which is positively affected by NL production.

[00:21:50] Speaker 02:
Such conditions include hypertensive cardio cerebro renovascular disease and their symptoms, as well as non-hypertensive cardio cerebro renovascular diseases.

[00:22:05] Speaker 02:
So they're saying, look, anything, and they repeat this elsewhere, anything that would be improved by increased NL, that can be done by following our method of increasing NL.

[00:22:15] Speaker 02:
They were not focused on any particular disease, including specifically not focused on cardiovascular risk or even that specific kind that's identified.

[00:22:24] Speaker 02:
They were saying, and we wouldn't argue over whether it's a valid mention, but they were saying, I've discovered that giving statins, at least with another substrate like arginine, I will increase NO production in patients.

[00:22:37] Speaker 02:
And I think that's a good thing.

[00:22:38] Speaker 02:
And there's going to be all sorts of benefits from that.

[00:22:40] Speaker 02:
That's what they're describing in the patent.

[00:22:42] Speaker 02:
You know, the title of the patent, it's not reduction of cardiovascular.

[00:22:46] Speaker 02:
It's method of stimulating nitric oxide synthesis.

[00:22:50] Speaker 02:
Throughout the specification, what they're saying is, I've discovered a way of using a statin for the purpose of increasing endoproduction in tissue.

[00:22:58] Speaker 02:
Do that, and there'll be medical benefits.

[00:23:00] Speaker 02:
And that's what they claim.

[00:23:01] Speaker 02:
But it requires a doctor to intend to do that.

[00:23:04] Speaker 02:
And they distinguish at the very beginning of patent, in column one, the old use of reducing cholesterol to the new use of increasing endoproduction.

[00:23:13] Speaker 02:
And that's what they claimed.

[00:23:14] Speaker 02:
And the special master and the discord properly recognize that.

[00:23:17] Speaker 02:
Now, that takes me to our cross appeal, which is a conditional cross appeal, which is only if the construction is reversed.

[00:23:25] Speaker 02:
And the point is, it's that construction that goes to the original claim.

[00:23:29] Speaker 02:
This is a patent that went through re-exam after our use was approved.

[00:23:35] Speaker 02:
And they removed a limitation from the claim.

[00:23:37] Speaker 02:
Original claim one required

[00:23:41] Speaker 02:
that the stat would be administered such a patient need, but also that it be administered irrespective of the subject's cholesterol level.

[00:23:48] Speaker 02:
That limitation was taken out in re-exam.

[00:23:51] Speaker 02:
As a general matter, taking limitations out of the claim in re-exam broadens the claim and is invalid.

[00:23:57] Speaker 02:
You're forbidden from broadening claims in re-exam, and that's an important protection for the public.

[00:24:03] Speaker 02:
You can't go back after you see a product approved and say, now I'm going to broad my claims to capture.

[00:24:08] Speaker 02:
And that's what they did here.

[00:24:10] Speaker 02:
The district court found there was no broadening by reading the term irrespective of a subject's cholesterol level to have no meaning.

[00:24:20] Speaker 02:
The court construed it to mean either hyperlimidemic or non-hyperlimidemic.

[00:24:25] Speaker 02:
And that means everyone.

[00:24:27] Speaker 02:
It literally renders that original claim limitation superfluous, meaningless.

[00:24:33] Speaker 02:
We think that's wrong.

[00:24:34] Speaker 02:
Claim limitations are not meaningless.

[00:24:36] Speaker 02:
It's also wrong in terms of the meaning of the words.

[00:24:39] Speaker 02:
Irrespective, administering irrespective of the substance cholesterol level is not telling you about the subject.

[00:24:46] Speaker 02:
It's telling you about the administration of the drug.

[00:24:48] Speaker 02:
It's an additional intent or exclusion of intent.

[00:24:53] Speaker 02:
The first was to require the doctor to intend to raise NO.

[00:24:58] Speaker 02:
The original nation also required the doctor not to intend to lower cholesterol or alter cholesterol, to administer the drug for the purpose of raising NO, not for purposes of altering cholesterol level.

[00:25:09] Speaker 02:
That was a limitation that would have prevented them from asserting infringement's case as well, because what they're accusing also shows a reduction in cholesterol.

[00:25:17] Speaker 02:
And that was pulled out.

[00:25:18] Speaker 02:
We think the district court made an error there by relying on the prosecution history from the re-exam to construe the claim to be superfluous.

[00:25:28] Speaker 02:
But it's wrong to rely on re-examination prosecution history and determine whether or not a claim is broadened in re-exam.

[00:25:38] Speaker 02:
And this court said that recently.

[00:25:39] Speaker 04:
What does the word irrespective mean to you?

[00:25:41] Speaker 02:
Irrespective means without regard to, without consideration of.

[00:25:45] Speaker 02:
That's the plain meaning of irrespective.

[00:25:47] Speaker 02:
So when the claim read as administering irrespective of the subject's cholesterol means don't consider the subject's cholesterol level when you choose to administer the statin.

[00:25:59] Speaker 02:
In fact, that limitation existed side by side in original claim two with the requirement that the subject be non-hybrid.

[00:26:07] Speaker 02:
Clearly, there's separate limitations directed to different things.

[00:26:11] Speaker 02:
The original claim, too, required the subject to be non-hyperlipidemic, but nonetheless, the administration to be without regard to the subject's cholesterol level.

[00:26:20] Speaker 02:
What does that tell you?

[00:26:21] Speaker 02:
That the doctor is not considering cholesterol level when deciding to administer the statin.

[00:26:27] Speaker 02:
It would not cover a case where the doctor decides, you know what?

[00:26:32] Speaker 02:
I'm going to administer the statin to you.

[00:26:33] Speaker 02:
both for purposes, I think you could use a boost in NO, and I'd like to bring your cholesterol down even further.

[00:26:38] Speaker 02:
That was outside the original claim.

[00:26:40] Speaker 02:
During re-exam, they took that limitation out so that it was entirely just about increasing NO.

[00:26:46] Speaker 02:
And we think they did so specifically, and not just because they submitted our labeling during re-exam for purposes of capturing that.

[00:26:54] Speaker 02:
But it doesn't matter why they did it.

[00:26:55] Speaker 02:
You're forbidden in re-exam from broadening a claim.

[00:26:59] Speaker 02:
And that's what they did.

[00:27:00] Speaker 02:
But that's our conditional cross-appeal.

[00:27:02] Speaker 02:
If the court affirms on the meaning of the preamble term on a method of treating a patient who would benefit from increased dental production, it's unnecessary to read that issue.

[00:27:11] Speaker 02:
And we think the plain meaning of that and the holding of Janssen makes it clear that the district court correct that it's through that.

[00:27:17] Speaker 02:
But if it does reverse, we do have our conditional cross-appeal.

[00:27:20] Speaker 03:
Thank you, Mr. Hypes.

[00:27:20] Speaker 02:
Thank you, Your Honor.

[00:27:22] Speaker 03:
You have some rebuttal time, Mr. Isakson.

[00:27:37] Speaker 00:
First turning to the opposition points that Mr. Sipes raised, Janssen doesn't shut down our second alternative proposal at all.

[00:27:47] Speaker 00:
In fact, if anything, that proposal would be closer to what this court said in Rappaport.

[00:27:54] Speaker 00:
In Rappaport, the claim was to a method of treating sleep apnea, a disease state, and our proposal would be

[00:28:04] Speaker 00:
The doctor intends to provide the benefit that's treating clinical events and preventing, reducing the risk of clinical events.

[00:28:13] Speaker 00:
What our invention was, ultimately, to boil it down with, we were treating a new population of people who never were treated before.

[00:28:21] Speaker 00:
They were at risk for cardiovascular events.

[00:28:25] Speaker 00:
That risk could be ascertained by things like hypertension, age, family history of heart disease, et cetera.

[00:28:33] Speaker 00:
these patients were not being treated because they were not hyperlipidemics.

[00:28:39] Speaker 00:
They did not have high cholesterol, and everybody thought statins were only for reducing cholesterol.

[00:28:47] Speaker 00:
Dr. Casemeier discovered it and filed his application in 1997.

[00:28:52] Speaker 00:
In the briefing, AstraZeneca contended that Dr. Richter was first, but he wasn't because his patent applications, his early provisional applications, didn't describe the use of statins.

[00:29:03] Speaker 00:
His earliest priority date was 1999.

[00:29:06] Speaker 04:
Do you have any patent claims that are directed to treating a person with cardiovascular disease, as opposed to treating a person in need of increased NL production?

[00:29:18] Speaker 00:
You'd have to look at our dependent claims 15 through 17.

[00:29:22] Speaker 00:
We only have one independent claim.

[00:29:24] Speaker 00:
Claim one.

[00:29:24] Speaker 00:
Our dependent claims 15 through 17 discuss the treatment of various types of disease states, such as stroke,

[00:29:33] Speaker 00:
reperfusion events, which are ischemic events, when there's a cessation of blood flow.

[00:29:40] Speaker 00:
So that was Dr. Case-Meier's invention.

[00:29:43] Speaker 00:
He was the first to do it.

[00:29:45] Speaker 00:
Now, I've heard of Mr. Sipes talking a little bit about inherent anticipation.

[00:29:53] Speaker 00:
What I just want to say is we've only been in the infringement phase of this litigation.

[00:29:59] Speaker 00:
We haven't even had discovery on validity, so I don't know what

[00:30:02] Speaker 00:
why we're discussing anticipation at all at this point.

[00:30:07] Speaker 00:
And we'll have a chance to do that if we're back before the district court.

[00:30:11] Speaker 00:
So in terms of the correlation between nitric oxide, a need for nitric oxide, and one of the risk factors, elevated C-reactive proteins, you can find evidence of that on page four of our reply brief.

[00:30:26] Speaker 00:
One is AstraZeneca promotional literature.

[00:30:29] Speaker 00:
The other is a paper by Dr. Ritker.

[00:30:33] Speaker 00:
If there are any questions on that, I'll turn to their cross-appeal.

[00:30:37] Speaker 03:
If you turn to the cross-appeal, then he gets back up if you feel like you need to talk about it.

[00:30:41] Speaker 03:
You're out of time entirely.

[00:30:43] Speaker 03:
OK.

[00:30:44] Speaker 00:
We'll stand on our briefs.

[00:30:45] Speaker 03:
Very good.

[00:30:46] Speaker 03:
So you don't get any cross-appeal time.

[00:30:47] Speaker 03:
All right.

[00:30:48] Speaker 03:
That ends this case.

[00:30:49] Speaker 03:
It's taken under submission.