[00:00:02] Speaker 00:
and setting this up as a plus panel.

[00:00:05] Speaker 00:
The case this morning is 17-2473, Nugo Pharmaceuticals versus Dureti.

[00:00:13] Speaker 00:
You all are split in time.

[00:00:16] Speaker 00:
So you're first.

[00:00:19] Speaker 00:
We'll run the clock at your full time, which includes your rebuttal, and then so you'll have to keep track of saving your rebuttal.

[00:00:25] Speaker 00:
Please proceed.

[00:00:26] Speaker 00:
Good morning.

[00:00:36] Speaker 02:
May it please the court.

[00:00:38] Speaker 02:
Let me ask you a housekeeping question.

[00:00:40] Speaker 02:
Do you agree with the cross-appellant's assertion in the red brief that if we accept their construction of essentially any, then the product would infringe?

[00:00:52] Speaker 01:
So your honor, Mr. Pollack was set to talk about the cross-appellant issues in this case.

[00:00:57] Speaker 02:
OK.

[00:00:58] Speaker 01:
OK.

[00:01:00] Speaker 02:
Go ahead.

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

[00:01:03] Speaker 01:
There are three unchallenged factual findings in this case that highlight the district court's error in analyzing written description of the effective use of an uncoded PPI.

[00:01:11] Speaker 01:
First, the district court found that the specifications of the patents provided no information regarding the effective use of an uncoded PPI.

[00:01:19] Speaker 01:
Second, the court found that the missing efficacy information was not inherent in the disclosed formulations.

[00:01:25] Speaker 01:
And third, in holding the claims not obvious,

[00:01:28] Speaker 01:
The district court found that skilled artisans would not have thought that uncoded PPIs would work as resided in the claims.

[00:01:33] Speaker 00:
Okay.

[00:01:35] Speaker 00:
You know, we've had not a huge number, but we have some number of cases for written description and enablement, and there's some confusion in terms of the overlap.

[00:01:44] Speaker 00:
But in a recent case, Judge Lurie wrote in the Alcon case, which seems to sort of parallel this, because the claim talked about

[00:01:55] Speaker 00:
PECO would enhance the chemical stability.

[00:01:58] Speaker 00:
So there's some result claimed.

[00:02:01] Speaker 00:
And he concludes, written discretion is not apt here.

[00:02:07] Speaker 00:
It's about whether, he doesn't say that, but it says it's about whether the skilled reader of patent disclosure can recognize that what was claimed corresponds to what was described.

[00:02:16] Speaker 00:
It is not about whether the patentee has proven to the skilled reader that the invention works or how to make it work.

[00:02:23] Speaker 00:
which is an enablement issue.

[00:02:25] Speaker 00:
Why doesn't that speak to the fact that, at best, this is an enablement question?

[00:02:31] Speaker 00:
When we're talking about whether it works, whether it's therapeutically effective, that's the result.

[00:02:37] Speaker 00:
That's how it works.

[00:02:38] Speaker 00:
That feels like enablement, not written description.

[00:02:42] Speaker 01:
Right.

[00:02:42] Speaker 01:
And I think there is, I think as Your Honor alluded to, there may be some confusion between referring to enablement and referring to written description in situations like this.

[00:02:51] Speaker 01:
And I think part of that

[00:02:53] Speaker 01:
stems from the fact that a lot of the enablement cases, like the one you're referring to, like the Rasmussen case, the enablement issue is framed in terms of utility.

[00:03:05] Speaker 01:
And in a case like this, where the functional languages in the claims actually speaks to effectiveness, if you're talking about whether the claims work, it might sound like both

[00:03:18] Speaker 01:
the utility requirement is brought in.

[00:03:22] Speaker 00:
Well why is, whether PECA would enhance the chemical stability, why is that not enhancement, why is that not improvements in the enhancement and not just utility?

[00:03:35] Speaker 01:
Well I think it was utility and I think it's also a limitation in the claims that has to be described by the specification under the written description requirement.

[00:03:42] Speaker 01:
So in this case we have these efficacy limitations.

[00:03:45] Speaker 01:
They are affirmative limitations in the claims and they happen to

[00:03:48] Speaker 01:
point to efficacy as the function, so it does some binding activity.

[00:03:53] Speaker 01:
It's actually efficacy.

[00:03:54] Speaker 01:
So it sounds like utility in a lot of ways, but it is a claim limitation that's recited in these claims that has to be described.

[00:04:01] Speaker 00:
And in this case... Well, how would you describe it?

[00:04:03] Speaker 00:
Give us an example.

[00:04:04] Speaker 00:
I think you've recognized that our cases speak to the fact that you don't need all this experimental data in the written description.

[00:04:10] Speaker 00:
So give me a few examples of how one would adequately describe this therapeutic

[00:04:17] Speaker 00:
in whatever language is in the question.

[00:04:20] Speaker 01:
Sure.

[00:04:20] Speaker 01:
So a lot of the cases talk about experimental data.

[00:04:22] Speaker 01:
I think that's pretty clearly enough in most cases.

[00:04:26] Speaker 00:
But not required?

[00:04:27] Speaker 01:
Not required, no.

[00:04:28] Speaker 01:
The cases have said that's not an absolute requirement.

[00:04:31] Speaker 01:
It is a factual question.

[00:04:33] Speaker 01:
And there is some spectrum between having conclusive experimental data and having no information.

[00:04:41] Speaker 01:
And there is some line that can be drawn in between there where it's enough or it's not enough.

[00:04:44] Speaker 01:
And that's going to depend on the context of the case.

[00:04:46] Speaker 01:
I don't think you have to draw that line in this case, because what we have here is no information.

[00:04:50] Speaker 03:
What about a theory?

[00:04:52] Speaker 01:
Excuse me, Aaron?

[00:04:53] Speaker 03:
What about a theory, some type of a theory as to why uncoded PPI would be therapeutically effective?

[00:05:01] Speaker 01:
Yeah, I think that's something that a fact finder could find suffices in certain cases, as we reference in the briefs.

[00:05:08] Speaker 01:
That's not there in this case, as the district court found.

[00:05:10] Speaker 03:
So what would that theory look like?

[00:05:12] Speaker 03:
Something like the fact that if you release a little bit of uncoded PPI, along with your NSAID, your NSAID is protected in the course of the fact that you haven't released enough PPI to have it totally degraded, right?

[00:05:29] Speaker 03:
The theory would somehow address the fact that they recognize that uncoded PPI, in the words of the patent, can be destroyed.

[00:05:38] Speaker 01:
I think that's right.

[00:05:39] Speaker 01:
I think that could be something that the inventor could have put in the specification.

[00:05:42] Speaker 01:
I think that actually... Well, we need that.

[00:05:45] Speaker 00:
I mean, we've had a number of cases where they don't look to exactly the language in the specification, but they rely on a person skilled in the arts testimony as how he would have understood the invention.

[00:05:57] Speaker 00:
So I think there's not that much in the district court opinion about that, but I think there are some references.

[00:06:04] Speaker 00:
This, of course, we all know is a question of fact.

[00:06:06] Speaker 00:
And there are some references to whether or not that a person skilled in the art would have understood that they had this.

[00:06:16] Speaker 00:
Isn't that sufficient without actual language in the written description?

[00:06:20] Speaker 01:
Well, I think there are some cases that have found that.

[00:06:23] Speaker 01:
Again, in this case, we have affirmative findings by the district court that there is no information in the specification about this limitation.

[00:06:30] Speaker 01:
This effectiveness was not inherent in the formulation, so you can't impute it that way.

[00:06:34] Speaker 01:
And we have affirmative findings that a person skilled in the art would not have thought this was going to work.

[00:06:38] Speaker 00:
Well, except there is an appendix page 80 of her opinion.

[00:06:43] Speaker 00:
And it's kind of confusing because it's not in the written description.

[00:06:47] Speaker 00:
I don't think that may be wrong.

[00:06:49] Speaker 00:
I don't think it's in the written description portion.

[00:06:51] Speaker 00:
I think it's more when she's talking about enablement, which is why I didn't see it.

[00:06:54] Speaker 00:
But in any event, she does make a finding that says sort of in the middle of the page, appendix 80, testimony from both sides at trial indicated

[00:07:04] Speaker 00:
that a faceta at the time of the invention would have accepted that a combination of an NSAID and a PPI would be effective for treating pain and conditions like arthritis.

[00:07:16] Speaker 00:
Does that go to whether or not it's therapeutically effective?

[00:07:21] Speaker 00:
Or is this something else?

[00:07:23] Speaker 00:
Or is your argument that the sites we can quibble, or we can just debate whether or not the site she gives for that really

[00:07:31] Speaker 00:
do what she says they do.

[00:07:32] Speaker 00:
But in any event, what's your reaction to that?

[00:07:34] Speaker 01:
So I would argue that this is something different entirely.

[00:07:38] Speaker 01:
I think this goes to utility.

[00:07:39] Speaker 01:
And so what the Court is talking about here is effectiveness for treating pain in conditions like arthritis, so pain and inflammation.

[00:07:46] Speaker 01:
That's what the anti-inflammatory does.

[00:07:50] Speaker 01:
That was prior, well-known in the art, that if you give an anti-inflammatory in a formulation like this, that is going to treat pain.

[00:07:57] Speaker 03:
Well, is this Kibbe's testimony she's talking about?

[00:08:00] Speaker 01:
I would have to double check on that, Your Honor.

[00:08:06] Speaker 01:
I'm not sure which expert this is.

[00:08:07] Speaker 03:
But I can get that for you.

[00:08:09] Speaker 03:
Kibbe is the patentee's expert, right?

[00:08:13] Speaker 01:
Kibbe was our expert.

[00:08:15] Speaker 01:
Your expert.

[00:08:18] Speaker 01:
Yeah.

[00:08:19] Speaker 01:
So this reference to pain doesn't have anything to do with the PPI.

[00:08:22] Speaker 01:
And I think this gets to the utility issue, where somebody would know that this formulation, even if you don't think the PPI is going to work,

[00:08:29] Speaker 01:
it's going to have some level of utility because it still will treat pain and inflammation.

[00:08:33] Speaker 00:
Okay, so let's get to, do we agree that her analysis of written description is like on 81 to 83?

[00:08:42] Speaker 01:
Yes, and I see my light's gone red here, I don't want to point that out.

[00:08:47] Speaker 00:
So this is written description, 81 through 83.

[00:08:50] Speaker 00:
Correct.

[00:08:55] Speaker 00:
She says, as defendant points out, assertive patents do not address the efficacy of un-coded PPIs through experimental testing or other statements in the specification.

[00:09:07] Speaker 00:
The conclusion seems to be at 83, in light of disclosures in the specification describing the immediate release of an un-coded PPI and the potential disadvantages

[00:09:19] Speaker 00:
of enteric-coded PPI formulations, we conclude that each defendant has not shown that.

[00:09:27] Speaker 00:
Can you explain to me what she was referring to there?

[00:09:31] Speaker 00:
Yeah, so I think she was talking about- And that seems to be the ultimate conclusion.

[00:09:33] Speaker 00:
So she's saying you haven't shown that it should be invalidated for failure of written description.

[00:09:39] Speaker 01:
On 83 is what you're looking at now, correct?

[00:09:42] Speaker 02:
Yes.

[00:09:42] Speaker 01:
Yeah, so the way I read this is that she's saying,

[00:09:47] Speaker 01:
I find that there's sufficient room description in light of disclosures that there could be immediate release of a PPI.

[00:09:53] Speaker 03:
That's clear.

[00:09:54] Speaker 03:
I mean, that's example six.

[00:09:57] Speaker 01:
Yeah.

[00:09:58] Speaker 01:
And that's in the prior art.

[00:09:59] Speaker 03:
Well, I understand that.

[00:10:01] Speaker 03:
But what we're trying to focus in on now is exactly what was the district court's rationale for saying there was sufficient written description, having already said, I can't find anything in the spec about uncoded PPI being therapeutically effective.

[00:10:16] Speaker 03:
I basically find that it will be destroyed.

[00:10:20] Speaker 03:
So she says that.

[00:10:21] Speaker 03:
And then she says the potential disadvantages of enteric-coded PPI, which

[00:10:26] Speaker 03:
I presumably, I think what she means is that that model is slow to release.

[00:10:32] Speaker 01:
I think that's right.

[00:10:33] Speaker 03:
That's in column three or two.

[00:10:35] Speaker 03:
So those are the two data points.

[00:10:42] Speaker 01:
Right.

[00:10:42] Speaker 01:
So the only two data points she refers to are those, the immediate release and some reference to a perceived disadvantage and delay from an entire coding.

[00:10:51] Speaker 01:
Notably, she does not

[00:10:53] Speaker 01:
address the efficacy limitation, which are also resetted in the claims.

[00:10:56] Speaker 01:
I think she just skipped over that part and said, that doesn't require us to find otherwise.

[00:11:01] Speaker 01:
But there's no explanation there.

[00:11:03] Speaker 01:
There's nothing, no attempt to reconcile the findings on the preceding two pages where she says the specification has no information about that aspect of the claims.

[00:11:11] Speaker 00:
Well, right.

[00:11:11] Speaker 00:
That's a finding that has no explanation.

[00:11:13] Speaker 00:
That's what's odd about this.

[00:11:15] Speaker 00:
We'll ask our friend, perhaps, on the other side.

[00:11:18] Speaker 01:
Our position is that the specification required something to provide

[00:11:23] Speaker 01:
to show possession of that part of the claims, and it's just not there.

[00:11:26] Speaker 00:
Why?

[00:11:26] Speaker 00:
Is that because under her obviousness calculation, she concluded that there was skepticism about whether or not this would work?

[00:11:36] Speaker 00:
And we don't have very many cases that sort of combine the obvious analysis with the written description.

[00:11:42] Speaker 00:
So do you need that?

[00:11:44] Speaker 00:
Or do you just need someone skilled in the art to say something?

[00:11:49] Speaker 01:
Well, I think it informs the analysis, because the whole question is taken from the perspective of the person of skill in the art.

[00:11:55] Speaker 01:
So what we have here is a specification that tells that person nothing about this.

[00:12:00] Speaker 03:
What one of skill in the art would think, independent of the specification, is irrelevant.

[00:12:06] Speaker 03:
Isn't it?

[00:12:07] Speaker 03:
Doesn't there have to be a hook in the specification?

[00:12:10] Speaker 03:
There has to be something in the specification that one of ordinary skill in the art can point to and say, see that?

[00:12:16] Speaker 03:
That's what teaches me that the inventor possessed

[00:12:20] Speaker 03:
the concept that uncoded PPI could be therapeutic effective even though everybody knows that it can degrade when it's uncoded.

[00:12:29] Speaker 03:
Yeah, I think that's exactly right, Your Honor, and I think the reference to the... So isn't the question in our case is simply to take the specification and take my magic marker or my red pen and try to find something in the specification that is teaching the possession of therapeutic effectiveness of uncoded PPI.

[00:12:49] Speaker 01:
And the district court made that finding for us and said there is nothing.

[00:12:52] Speaker 03:
Well, that's a finding, but I mean, that's reading the document.

[00:12:54] Speaker 03:
I can do that independently.

[00:12:55] Speaker 03:
That's not a fact finding, right?

[00:12:58] Speaker 01:
I think that is a finding of fact, whether or not there's a disclosure in the specification.

[00:13:02] Speaker 01:
And I think the district court made that finding for us, and I don't think it's been challenged here.

[00:13:07] Speaker 03:
So that's a fact question, review here for clear error?

[00:13:12] Speaker 01:
It would be, yes.

[00:13:14] Speaker 01:
And the district court's finding is that there is, and this is on

[00:13:17] Speaker 01:
Appendix 81 and 82, that there is.

[00:13:19] Speaker 03:
Where do you see that?

[00:13:21] Speaker 03:
182?

[00:13:22] Speaker 01:
So if you look at Appendix 81, it's the passage that Chief Judge Crost was pointing to earlier, where the judge says, as defendants point out, the assertive patents do not address the efficacy of uncoded PPIs through experimental testing data or other statements in the specifications.

[00:13:37] Speaker 01:
So there's no data.

[00:13:38] Speaker 01:
There's not any other statement either.

[00:13:41] Speaker 01:
And there's a similar statement on Appendix 82 where the district court says,

[00:13:45] Speaker 03:
So does this case simply turn on the evidentiary question?

[00:13:51] Speaker 03:
If she's correct, then there's no hook.

[00:13:55] Speaker 01:
That's right.

[00:13:56] Speaker 03:
I don't really care what it's going to say.

[00:13:59] Speaker 01:
Right.

[00:13:59] Speaker 01:
That's one way to look at the case, certainly.

[00:14:02] Speaker 03:
And who's trying to?

[00:14:08] Speaker 03:
The other side has to disprove that fact-finding?

[00:14:13] Speaker 01:
Well, I think

[00:14:15] Speaker 03:
I mean, you're here on appeal.

[00:14:16] Speaker 01:
If they want to rely on something.

[00:14:18] Speaker 01:
I'm just trying to get my hands around it.

[00:14:21] Speaker 03:
You're here on appeal.

[00:14:22] Speaker 03:
You like that fact finding.

[00:14:24] Speaker 03:
You're supporting it.

[00:14:26] Speaker 03:
If the fact finding is accurate and correct, then it would seem to me that it's a real problem for the other side.

[00:14:33] Speaker 01:
I think that's right.

[00:14:33] Speaker 01:
I think it's tough to reconcile the district court's judgment on this issue with that finding that's in the record.

[00:14:38] Speaker 00:
Can I take you back to where I started, at least, which was where we draw the line between enablement issues?

[00:14:43] Speaker 00:
Because you had an enablement issue down here.

[00:14:45] Speaker 00:
You just didn't appeal it.

[00:14:46] Speaker 00:
Correct.

[00:14:48] Speaker 00:
And you mentioned, when I quoted what Judge Lurie said, which was out of area, you said, well, utility is an enablement question.

[00:14:57] Speaker 00:
But isn't the question whether the invention works for its intended purpose?

[00:15:02] Speaker 00:
And is part of its intended purpose to be therapeutically effective?

[00:15:08] Speaker 00:
So why doesn't this fall four square under the analysis for enablement and not in the description?

[00:15:14] Speaker 01:
So enablement has been framed in a couple of ways, I think.

[00:15:16] Speaker 01:
There's enough disclosure to teach somebody skilled in the art to make and use the invention.

[00:15:21] Speaker 00:
In this case, Force intended purpose, right?

[00:15:25] Speaker 00:
That's inherent in that.

[00:15:27] Speaker 01:
Or for a useful purpose.

[00:15:29] Speaker 01:
I think that's where the utility issue comes in.

[00:15:31] Speaker 01:
So it's also been framed in terms of utility.

[00:15:33] Speaker 01:
And in this case, we have what is

[00:15:37] Speaker 01:
I think everyone agrees is a fairly straightforward, simple pill structure that's disclosed in the specification.

[00:15:44] Speaker 01:
And I, I, the district court found that it wasn't really disputed that somebody skilled in the area would know how to make and use that pill based on, you know, it's in the figures in the specification.

[00:15:53] Speaker 01:
Somebody could make that.

[00:15:55] Speaker 01:
And it would, even if it wasn't disclosed as having being, there was no basis to find that it was effective for the uncoded PPI effectiveness limitations.

[00:16:07] Speaker 01:
Somebody still in there would still look at that and say, well, I know there's this anti-inflammatory in there.

[00:16:12] Speaker 01:
I know what that does.

[00:16:13] Speaker 01:
We normally give that with enteric coatings.

[00:16:16] Speaker 01:
That's how it's presented here.

[00:16:17] Speaker 01:
So it is going to treat pain and inflammation.

[00:16:19] Speaker 01:
So it's going to have this utility, one of the utilities that's talked about in the specification.

[00:16:23] Speaker 01:
It's the other one that's in the claims and is not in the specification that's the problem.

[00:16:28] Speaker 00:
Okay, why don't we go to your other side.

[00:16:30] Speaker 00:
This is the problem with splitting times, because your time is really our time, and our time is what we have questions on.

[00:16:38] Speaker 00:
So I know Jeff Wallach has at least one question for you all.

[00:16:42] Speaker 00:
Thank you.

[00:16:49] Speaker 00:
So you're here to talk about this.

[00:16:52] Speaker 05:
Two different issues, Your Honor.

[00:16:53] Speaker 05:
First of all, may it please the court, my name is Alan Pollack.

[00:16:55] Speaker 05:
I'm here from the Bunbunbun Law Firm, and I'm going to discuss first why the 285 patent claims lack written description for an additional reason beyond what we've just heard.

[00:17:07] Speaker 05:
As we move from the written description arguments... I'm so sorry that your co-counsel used up all your time.

[00:17:14] Speaker 02:
Will you answer my question I asked him?

[00:17:16] Speaker 05:
I certainly will, although my understanding was that pertains to the cross appeal.

[00:17:20] Speaker 05:
I was supposed to allow

[00:17:23] Speaker 05:
to speak first on that, but the answer is yes.

[00:17:26] Speaker 00:
OK, fine.

[00:17:28] Speaker 00:
Can you repeat what the question was like and put it in context?

[00:17:32] Speaker 02:
Do you agree you lose if we accept their construction of essentially any?

[00:17:37] Speaker 05:
Right, that's the claim term in the 907 patent, which is part of the cross appeal, which I thought they were going to speak to first, but I can take it in whatever order the court would like.

[00:17:47] Speaker 00:
Well, you took it.

[00:17:48] Speaker 00:
Go ahead.

[00:17:48] Speaker 05:
You answered it.

[00:17:50] Speaker 00:
Well, I don't know if you have anything more to say about that.

[00:17:54] Speaker 05:
I have plenty to say about the cross appeal you have.

[00:17:56] Speaker 05:
That, of course, is something Horizon is appealing.

[00:17:59] Speaker 05:
We won summary judgment on that issue before the district court.

[00:18:03] Speaker 05:
And I think that issue should be very straightforward, because I'm sorry, my mistake.

[00:18:07] Speaker 00:
Why don't we wait till we hear from them?

[00:18:09] Speaker 00:
It just doesn't flow right.

[00:18:11] Speaker 00:
So what else do you hear?

[00:18:12] Speaker 00:
Talk about the cross appeal.

[00:18:12] Speaker 05:
I'm here to talk about why the 285 patent

[00:18:15] Speaker 05:
is invalid for lack of written description for a different reason than we've just heard about.

[00:18:20] Speaker 05:
And this argument is specific to the 285 patent only.

[00:18:24] Speaker 05:
And it also has to do with a different aspect.

[00:18:26] Speaker 05:
The previous discussion we just heard had to do with the uncoded PPI.

[00:18:30] Speaker 05:
The discussion I'm going to offer has to do with the uncoded naproxen, the uncoded NSAID, the other component of the two active ingredient component tablet that we're talking about.

[00:18:40] Speaker 05:
The 285 patent is a follow-on patent.

[00:18:43] Speaker 05:
It spun off the 907 patent by two divisionals and a continuation in part.

[00:18:49] Speaker 05:
It issued two years after this case began and eight years after the 907 patent issued.

[00:18:55] Speaker 05:
The point of the patent is preventing NSAID release, unsafe NSAID release.

[00:19:02] Speaker 05:
There is no other point.

[00:19:04] Speaker 05:
The patent presents only one way to do this, as explained by the inventor at trial.

[00:19:08] Speaker 05:
The whole point of the idea here is to get acid inhibition

[00:19:12] Speaker 05:
Before the administration of the NSAID, there is no dispute that the 285 patent claims cover tablets that do not do this.

[00:19:21] Speaker 05:
They cover tablets that release large amounts of naproxen before any acid inhibition.

[00:19:28] Speaker 05:
The whole point of the idea here is undermined by releasing a large amount of NSAID first.

[00:19:35] Speaker 00:
Is this the issue that, I'm sorry, there's so many issues in this case.

[00:19:37] Speaker 00:
Is this the one where we get into the word comprising?

[00:19:41] Speaker 05:
Yes.

[00:19:42] Speaker 03:
The uncoded NSAID gets in via the comprising clause.

[00:19:46] Speaker 05:
Yes.

[00:19:47] Speaker 05:
Right.

[00:19:48] Speaker 03:
And the district court resolved your challenge here by saying not to worry, not to worry.

[00:19:55] Speaker 03:
The notion that you would have coded naproxen is simply a preferred embodiment.

[00:20:03] Speaker 05:
That's exactly right.

[00:20:04] Speaker 03:
And because it's a preferred embodiment, other embodiments, i.e.

[00:20:08] Speaker 03:
those that would enable

[00:20:11] Speaker 03:
even an unlimited amount of uncoded and approximate, they are not preferred embodiments.

[00:20:16] Speaker 03:
You only need to describe the preferred embodiment.

[00:20:19] Speaker 05:
Right.

[00:20:19] Speaker 05:
That's exactly correct.

[00:20:21] Speaker 03:
And so on the decision tree, if she's right, if the district court was correct, that it's only a preferred embodiment as opposed to the entire invention, then you lose.

[00:20:35] Speaker 03:
Because the law only requires you to describe the preferred embodiment.

[00:20:41] Speaker 05:
I think the conclusion might... So how do I decide?

[00:20:44] Speaker 03:
Is this a claim construction issue?

[00:20:46] Speaker 05:
It is not a claim construction issue.

[00:20:48] Speaker 05:
The 285 patent was construed, actually, at the trial.

[00:20:50] Speaker 03:
I understand it's not a claim construction, but you're telling me that the district court was wrong because the invention is drawn solely to this coordinated release and a coordinated release that disallows any uncoded

[00:21:08] Speaker 05:
That's correct, Your Honor.

[00:21:09] Speaker 03:
And I think the reason why... Why aren't you raising a claim construction issue up here?

[00:21:14] Speaker 03:
How do I go about undoing what she did?

[00:21:18] Speaker 02:
Yeah.

[00:21:18] Speaker 02:
How could a specification cover all potential features not required but merely allowed based upon the use of comprising?

[00:21:28] Speaker 05:
I think the answer to that question is that this specification is about one way to do something.

[00:21:34] Speaker 05:
And that way is to control unsafe and said release.

[00:21:37] Speaker 05:
That's the point of the patent.

[00:21:38] Speaker 05:
There's really no other point.

[00:21:40] Speaker 05:
The issue that I think allows us to talk about this as an unclaimed limitation is that we do not say that there's a requirement to disclaim or to negatively claim any possible feature that could be a problem for the invention.

[00:21:57] Speaker 05:
That's the analysis that Horizon suggests.

[00:22:01] Speaker 05:
But that's not the case at all here, and I can give you a specific example why that is.

[00:22:06] Speaker 05:
It is not our position that the written description requirements require, say, a negative limitation for arsenic.

[00:22:11] Speaker 05:
I think we can all agree that if you included arsenic in this tablet, that would be a bad thing.

[00:22:16] Speaker 05:
But we do not argue that written description is transgressed or not satisfied because there's no affirmative, no claim element saying don't put arsenic in this tablet.

[00:22:28] Speaker 05:
Because this invention has nothing to do with arsenic.

[00:22:31] Speaker 05:
but it has everything to do with preventing unsafe NSAID release.

[00:22:34] Speaker 05:
That's the whole point here.

[00:22:36] Speaker 03:
And if you have claims that sweep in... Insider NSAID and the patent does allow a certain amount of line-coded NSAID.

[00:22:43] Speaker 05:
I think that there's room, certainly if we look at the 907, the NSAID coding term... Haven't you walked right into her preferred embodiment?

[00:22:50] Speaker 05:
No, I don't think that's correct.

[00:22:52] Speaker 03:
I think that whether... Why isn't an embodiment that has a little bit of line-coded NSAID just another embodiment?

[00:23:00] Speaker 05:
First of all, there's no description in the specification of that.

[00:23:02] Speaker 03:
I understand that, but my point is that it isn't required.

[00:23:07] Speaker 03:
Her analysis is that if you have an invention that has several embodiments, one embodiment is that there's no inset at all in the formulation.

[00:23:18] Speaker 03:
The other one is there's a dab, a little bit.

[00:23:22] Speaker 03:
And you wouldn't argue that an entirely uncoded inset would be within the embraced invention, right?

[00:23:28] Speaker 05:
Two responses to that.

[00:23:30] Speaker 05:
I agree that some small amount, a minimal amount of NSAID release before... That's what we're talking about.

[00:23:34] Speaker 03:
We're not talking about an absolutely entirely un-coded NSAID.

[00:23:39] Speaker 05:
I think the invention can tolerate a small, minimal amount of NSAID release, but there is no disclosure in the specification at all about that at all.

[00:23:47] Speaker 03:
Well, I understand that, but I mean, if that is yet another embodiment, but not the preferred embodiment, then the law, I think, wouldn't require description.

[00:23:58] Speaker 03:
of the lesser embodiment.

[00:24:01] Speaker 05:
Well, I don't agree that it's an embodiment at all.

[00:24:04] Speaker 05:
There's no suggestion in the specification that the invention can tolerate.

[00:24:08] Speaker 03:
Well, it becomes an embodiment by virtue of the comprising clause.

[00:24:14] Speaker 03:
Doesn't it?

[00:24:16] Speaker 05:
As the claim was construed, it allows unlimited amounts of uncoded.

[00:24:19] Speaker 03:
I understand she did that.

[00:24:21] Speaker 05:
Right.

[00:24:22] Speaker 05:
So I don't know.

[00:24:22] Speaker 03:
And that doesn't seem to square with what you think the invention is or anybody else.

[00:24:27] Speaker 05:
That's correct.

[00:24:28] Speaker 05:
That's the basis of our written description decision.

[00:24:30] Speaker 05:
But I don't think whether coordinated release as a concept can tolerate a small amount of NSAID release doesn't really address... You're not asking her.

[00:24:39] Speaker 03:
You're not saying that the patent has to describe absolutely totally un-coded NSAID.

[00:24:48] Speaker 03:
I'm saying... She says there's no limit on the amount of un-coded NSAID that could be in here.

[00:24:54] Speaker 05:
That's right.

[00:24:54] Speaker 03:
It could be entirely un-coded, which makes you wonder what she's talking about.

[00:24:58] Speaker 03:
That's the effect of the Comprising Clause.

[00:25:01] Speaker 03:
Right, but I think... She didn't choose to draw a limit on the amount of un-coded NSAID looking at what the invention is all about and looking about this coordinated release and the rest, right?

[00:25:12] Speaker 05:
Yes, that's correct.

[00:25:13] Speaker 05:
But I think... What do we do with it?

[00:25:16] Speaker 05:
I think you have to find that there's no written description here, because of the breadth of claims.

[00:25:20] Speaker 03:
No written description of what?

[00:25:21] Speaker 05:
For the 285 patent claims, because... Exactly what?

[00:25:25] Speaker 05:
No written description of a little bit of... No written description of tablets that release a substantial amount of NSAID below pH 3.5.

[00:25:38] Speaker 05:
And these claims clearly read on that.

[00:25:39] Speaker 05:
That's clearly not the invention.

[00:25:41] Speaker 05:
If you look at the picture that's on page 53 of the yellow brief,

[00:25:44] Speaker 05:
There's an example of a tablet that fits that description.

[00:25:46] Speaker 03:
The claims read on something that's not the invention.

[00:25:48] Speaker 03:
Excuse me?

[00:25:49] Speaker 03:
The claims read on something that's not the invention, and you have a requirement to describe what's not the invention.

[00:25:57] Speaker 05:
Well, I think... This is what you said.

[00:25:59] Speaker 00:
Well, no, but you're saying she's wrong because she concluded that the claims read on that.

[00:26:06] Speaker 05:
No, I think the error that the district court made is that it made a sharp distinction between limitations that were required and permitted.

[00:26:14] Speaker 05:
That seemed to be a very important point for the district court, which I think the district court got wrong.

[00:26:18] Speaker 05:
I think the district court's interpretation was that any element of a claim that's not required but permitted does not need written description at all.

[00:26:28] Speaker 05:
And I think that's why she made the findings that she did.

[00:26:31] Speaker 00:
Yeah, but that brings us back to your earlier hypothetical, which you recognized would put us all in a ridiculous situation, which is the same would apply to comprising, and we know it doesn't include arsenic.

[00:26:42] Speaker 00:
Right.

[00:26:44] Speaker 00:
Well, anything at some later date in the arrangement analysis where you're saying the fact that it has this additional thing doesn't take it out, you've got this comprising line.

[00:26:56] Speaker 00:
The patent owner would have had to describe that in the invention 15 years earlier when he was drafting the claim.

[00:27:03] Speaker 00:
It's kind of hard to see how that would work.

[00:27:04] Speaker 00:
Well, I think... Under your analysis, anything that falls within the

[00:27:10] Speaker 00:
comprising that isn't precisely claims, still has to have a written description.

[00:27:14] Speaker 05:
Anything that's a central part of the invention.

[00:27:17] Speaker 00:
Here, as I mentioned, the only point this patent... Well, it's hard to think that something that's not even referred to in the claims that comes under the comprising language is a central part of the invention.

[00:27:29] Speaker 05:
That's just hard to... Well, for this particular patent, I don't think it should be that difficult, given that it doesn't have any purpose other than preventing unsafe and said release.

[00:27:39] Speaker 05:
That's the only disclosure this patent specification has.

[00:27:42] Speaker 00:
So it seems to me, going back to where Judge Cleverger started, this seems to me an issue that should have been sussed out during claim construction.

[00:27:50] Speaker 00:
You are saying this should not come under the claim here, because the claim is directed towards exactly something else.

[00:28:00] Speaker 00:
And maybe proof of that is that there's, we're not talking about written description.

[00:28:04] Speaker 00:
And when we do a Phillips analysis, we look at what the spec says.

[00:28:07] Speaker 00:
So that would have been an argument,

[00:28:09] Speaker 00:
to be resolved at claim construction.

[00:28:11] Speaker 00:
Maybe you would have lost and had to appeal it here.

[00:28:14] Speaker 00:
But this seems like we're talking about a claim construction dispute.

[00:28:17] Speaker 05:
Well, I would disagree, Your Honor, respectfully.

[00:28:19] Speaker 05:
I think that that's a stretch too far.

[00:28:21] Speaker 05:
If you look at the words of this claim, I'm not quite sure how- What's a stretch?

[00:28:24] Speaker 00:
What I'm saying or what she said?

[00:28:26] Speaker 05:
No, that this is a claim construction issue.

[00:28:28] Speaker 05:
The reason for that is if you look at the words of this claim, I'm not quite sure which words you'd actually have to change and what modifications you'd have to be.

[00:28:37] Speaker 05:
I understand this court has a-

[00:28:39] Speaker 05:
This court can read your claim construction, but I think we can't just take the words of the claim and make them anything else.

[00:28:47] Speaker 05:
What you would really have to do to have this patent track the specification as it should have done is make these claims like the 907 claims.

[00:28:56] Speaker 05:
You'd have to add in something like the end said coding term from the 907, which is the source of the question that Judge Wallach raised a while back.

[00:29:03] Speaker 05:
I don't know that, as I said, I think that's a stretch too far.

[00:29:07] Speaker 05:
Are you going to suggest that it has no release at all?

[00:29:12] Speaker 05:
In other words, impute the word it when it says inhibits the release, inhibits its release, it meaning the surrounded end set or the end set in the core.

[00:29:22] Speaker 05:
Are you going to suggest that there's absolutely none of that?

[00:29:24] Speaker 05:
Are you going to put in the word essentially?

[00:29:26] Speaker 05:
What exactly is the change that would be proposed?

[00:29:30] Speaker 05:
As I said, I think that's forcing the words to take on a meaning too different from what they clearly are.

[00:29:37] Speaker 05:
That's not the regimen that was conducted in the seven different written description cases that we've provided.

[00:29:44] Speaker 05:
That issue could also apply to the ICU medical case.

[00:29:48] Speaker 05:
That was the case with the spiked valves.

[00:29:50] Speaker 05:
The same question could be raised there.

[00:29:52] Speaker 05:
Why wasn't instead of, excuse me, that was a case before this court where claims weren't validated on written description grounds because the claims were written in the absence of any type of a limitation that discussed spikes.

[00:30:04] Speaker 05:
Apparently the specification in that case

[00:30:06] Speaker 05:
talked about vowels with spikes.

[00:30:08] Speaker 05:
And this court decided that those claims were improper because they didn't have, at least the so-called spikeless claims, lacked written description.

[00:30:16] Speaker 05:
They didn't write in a spike to those claims.

[00:30:19] Speaker 05:
And we have six other cases exactly like that.

[00:30:22] Speaker 00:
Okay.

[00:30:23] Speaker 00:
Time's up.

[00:30:23] Speaker 00:
We'll reserve some rebuttal.

[00:30:26] Speaker 00:
Thank you.

[00:30:41] Speaker 06:
Good morning and may it please the court.

[00:30:43] Speaker 06:
I'd like to just quickly respond to some of the comments that were made by my colleague.

[00:30:49] Speaker 03:
What issue?

[00:30:50] Speaker 03:
Are we talking now about PPI or about an approximate?

[00:30:53] Speaker 06:
Well, I'll start with PPI, then I'll talk about an approximate.

[00:30:57] Speaker 06:
But I would like to first start with the concept of written description and what's required.

[00:31:01] Speaker 06:
And I do believe the Alcon case, the court noted, is controlling on this case in the sense of

[00:31:07] Speaker 06:
You must look at whether the patent discloses that the inventor was in possession of the claimed invention was actually specific.

[00:31:13] Speaker 00:
Okay, let me ask you about that.

[00:31:14] Speaker 00:
If you take the claim language, and it's sort of like what we were required to do all the time with statutory construction.

[00:31:21] Speaker 00:
We need to give every word meaning.

[00:31:24] Speaker 00:
How would the written, do you say, this written description describes the claims if you ignore the, we could all agree, if you ignore the words therapeutically effective.

[00:31:36] Speaker 00:
So what more beyond, wouldn't the written description map on exactly to the way the claims are written in the absence of therapeutically effective?

[00:31:47] Speaker 00:
So therefore, it strikes me that even under a rubric of statutory construction, we need to give meaning to those words, which I'm sure you do by putting them in the claim.

[00:31:56] Speaker 00:
So the question is, for every claim limitation, we need a written description.

[00:32:02] Speaker 00:
What is there in the written description that deals with the addition of those words, leaving aside everything?

[00:32:09] Speaker 00:
There's no dispute.

[00:32:09] Speaker 00:
Everything else in the claim language is covered by the written description.

[00:32:13] Speaker 00:
So where do we get the description for those three words in the spec?

[00:32:17] Speaker 06:
Well, I think with respect to the uncoded PPI and the therapeutically effective amount, if you look to, and I'm referring to A206.

[00:32:26] Speaker 03:
Are we talking about the 285?

[00:32:28] Speaker 03:
The 285 PAC specification.

[00:32:29] Speaker 03:
I'll use this reference.

[00:32:31] Speaker 03:
So give us a column in line.

[00:32:32] Speaker 06:
If you look at claim column 8 of 8206, column 8, beginning in line 5, there's a description about what the therapeutic effective amounts are for purposes of this claimed invention.

[00:32:49] Speaker 00:
It tells the reader... Those amounts are also in the claim.

[00:32:53] Speaker 00:
They're in claim 5, aren't they?

[00:32:54] Speaker 00:
Correct.

[00:32:54] Speaker 00:
Okay, so that's what... Going back to my question.

[00:32:57] Speaker 00:
Everything in the claim, this would be, this is support for a different claim limitation.

[00:33:04] Speaker 00:
How is this support for something other than the claim limitation, which is?

[00:33:08] Speaker 06:
Well, it's disclosing that there should be a therapeutic amount of the PPI.

[00:33:13] Speaker 00:
Where does it, what you're saying, proton pump inhibitors, we need the sentence.

[00:33:18] Speaker 06:
Or should be present in an amount.

[00:33:21] Speaker 00:
It doesn't say anything about therapeutically effective?

[00:33:24] Speaker 06:
It will typically be present at about 5 to 600 milligrams.

[00:33:26] Speaker 00:
What column and line?

[00:33:27] Speaker 00:
Column A, line 5 or 6.

[00:33:30] Speaker 06:
Line 5 and 6?

[00:33:31] Speaker 03:
Yeah.

[00:33:32] Speaker 03:
Yeah.

[00:33:33] Speaker 03:
OK.

[00:33:33] Speaker 03:
OK.

[00:33:34] Speaker 06:
And that's telling the skilled artisan this is what you should use in the claimed invention.

[00:33:38] Speaker 00:
Yeah, but that's what all the claims.

[00:33:40] Speaker 00:
Again, going back to my premise of you're reading all the claims, if you took out the word therapeutically effective from the claim language,

[00:33:48] Speaker 00:
this would still make perfect sense.

[00:33:50] Speaker 00:
This is still going to the claim that is a limitation other than the one I'm talking about.

[00:33:56] Speaker 00:
So do you understand my question?

[00:33:57] Speaker 00:
Yeah.

[00:33:58] Speaker 06:
And I think there are two other parts of the specification that address that issue.

[00:34:02] Speaker 06:
First, if you look at, and I'll go back now to column two, which is at eight.

[00:34:07] Speaker 03:
Coming into this conversation, you are disagreeing with the district court's findings that there's nothing in the spec that deals with efficacy and uncoded PPI.

[00:34:19] Speaker 06:
I'm agreeing with the district court that there is no experimental data about efficacy.

[00:34:24] Speaker 03:
No, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no, no,

[00:34:43] Speaker 03:
I think what we know by way of background is that uncoded BPI, and I think in the words of the patent, can be destroyed in the stomach.

[00:34:54] Speaker 03:
And we know that at least some people in the prior art thought that you wouldn't use uncoded BPI for that very reason.

[00:35:01] Speaker 03:
Because if it's going to be destroyed, if it's destroyed, it can't have any therapeutic effect, right?

[00:35:05] Speaker 03:
If it gets destroyed in the stomach before it has a chance to do anything to deal with pH.

[00:35:10] Speaker 03:
OK, so you have that problem.

[00:35:12] Speaker 03:
So you say to yourself, OK, where is there something in this patent that teaches me that the uncoded PPI will not be destructive?

[00:35:22] Speaker 03:
It will have a therapeutic positive effect.

[00:35:25] Speaker 03:
So what I want you to do is to start with column one or whatever.

[00:35:28] Speaker 03:
I've got my red pen out.

[00:35:30] Speaker 03:
And just point to the language, other than the recitation of the claim language.

[00:35:34] Speaker 03:
Because in ipsis furbus, just recitation of the claim language is not enough.

[00:35:39] Speaker 06:
Well, I'd first point to A203, at the appendix A203 of the 285 patent.

[00:35:46] Speaker 06:
The skilled artisan walks through the background of some of what you just described.

[00:35:50] Speaker 06:
The line, the column and line.

[00:35:55] Speaker 06:
Starting at column one, in line 48, the inventor provides background about longer acting

[00:36:07] Speaker 06:
acid inhibitors, blasting acid inhibitors such as proton inhibitors and talks about that and then walks through through to column two line 11 the downsides of those longer acting coded proton pump inhibitors and specifically I direct you to column two at line four

[00:36:34] Speaker 06:
through seven, which the district court included in her opinion at page 64 of her opinion, at appendix 83.

[00:36:43] Speaker 03:
Right.

[00:36:43] Speaker 03:
She says that the disadvantages are part of why she thinks she would use uncoded PBI.

[00:36:50] Speaker 06:
Right.

[00:36:50] Speaker 06:
And that the inventor says to the public, yes, the prior art thought you needed to coat them.

[00:36:56] Speaker 06:
I believe you shouldn't coat them, because that results in deleterious effects.

[00:37:02] Speaker 06:
And I want to

[00:37:04] Speaker 06:
Then the inventor goes on to say, in the summary of the invention, in column three, starting around line 16, that I want to actively raise the intragasic pH to levels associated with less risk.

[00:37:19] Speaker 06:
That the inventor is saying, I'm doing something different from the prior art.

[00:37:23] Speaker 06:
I want to actively raise and have, and then the patent goes on, as she noted, and repeatedly talks about,

[00:37:30] Speaker 06:
making that uncoded PPI immediately released.

[00:37:32] Speaker 06:
And the inventor's telling the public that that's going to work.

[00:37:35] Speaker 06:
Notwithstanding what people might have thought in the prior art, that is going to work.

[00:37:39] Speaker 06:
That is an invention.

[00:37:40] Speaker 00:
Tell me, okay, I'm looking for that is, where is he telling them that is going to work?

[00:37:49] Speaker 06:
In that same column, he's saying that you will be reducing the risk of GI side effects.

[00:37:55] Speaker 06:
Give me a line, please.

[00:37:56] Speaker 06:
A column three, starting at line

[00:37:59] Speaker 06:
11, the present invention is based on the discovery of a new method for reducing the risk.

[00:38:06] Speaker 06:
That method involves a coordinated pharmaceutical composition that combines an agent that actively raises intragasic pH.

[00:38:17] Speaker 06:
And by that meaning, as further described in the patent, immediate release.

[00:38:21] Speaker 06:
She pointed, the district court judge pointed to that specific

[00:38:25] Speaker 06:
discussion earlier in column two about the downside.

[00:38:30] Speaker 06:
of coding.

[00:38:31] Speaker 00:
Wait, and she referred to this?

[00:38:33] Speaker 06:
Not to this section.

[00:38:34] Speaker 00:
She didn't refer to this?

[00:38:35] Speaker 00:
Correct.

[00:38:36] Speaker 00:
And you're saying she referred to the stuff in Plane 2, but that was in connection with Column 2?

[00:38:41] Speaker 00:
No, in Column 2.

[00:38:43] Speaker 00:
Column 2, the down shot?

[00:38:44] Speaker 00:
That was the obvious analysis where she found this was non-obvious because there was skepticism in the field.

[00:38:50] Speaker 06:
Well, District Court pointed to that in the written description discussion at Appendix 83, page 64.

[00:38:57] Speaker 03:
Is there anything else?

[00:39:00] Speaker 03:
in the specification that talks to the therapeutic effectiveness of uncoded PPI, especially in the fact that we know that uncoded it can be destroyed.

[00:39:12] Speaker 06:
The specification does not discuss the destruction of uncoded PPI.

[00:39:19] Speaker 06:
The specification tells the skilled artisan that the PPI will function in the claimed invention.

[00:39:26] Speaker 00:
Okay, before you went to Judge Clevis' question, you were referring us to, and the district court said that at Appendix 83.

[00:39:35] Speaker 00:
So point to me where you're, in light of the disclosure describing the immediate release and the potential disadvantages.

[00:39:48] Speaker 06:
That refers to what comes in that prior paragraph above.

[00:39:52] Speaker 06:
where the district points out the specifications teaching that immediate release is explicitly distinguished from the enteric-coded formulations that delay the absorption.

[00:40:05] Speaker 06:
That the inventor is intending to create a situation in which the PPI is immediately released and will have an impact.

[00:40:13] Speaker 03:
The column two says that the reason why you post this is to avoid destruction of the PPI by the stomach acid.

[00:40:22] Speaker 06:
that that was an issue that had been identified in the prior art.

[00:40:25] Speaker 03:
I'm just saying that we have to live with that fact, is that that's the risk that you use if you have uncoded PPI.

[00:40:34] Speaker 03:
So the patent teaches that uncoded PPI can become therapeutically ineffective by its destruction.

[00:40:42] Speaker 06:
The patent teaches that the prior art believed that the PPI would be destructed

[00:40:49] Speaker 06:
would be destroyed if it was not enteric-coded.

[00:40:52] Speaker 06:
The inventor said, that's not correct.

[00:40:55] Speaker 06:
I want to use an un-coded PPI, because that will actively raise the pH.

[00:41:01] Speaker 03:
But how does he know it doesn't get destroyed?

[00:41:04] Speaker 06:
That was the inventor's belief, based on his knowledge and experience.

[00:41:09] Speaker 06:
That was the essence of the invention, is that he believed it would work.

[00:41:13] Speaker 06:
It did work.

[00:41:16] Speaker 00:
Well, the court rejected you.

[00:41:18] Speaker 00:
In the same paragraph you were just referring to, she rejected your inherency argument, right?

[00:41:24] Speaker 00:
You came forward with an inherency argument.

[00:41:27] Speaker 00:
Can we look at the appendix and some of the testimony, at least with respect to, I don't know if I can find it immediately.

[00:41:36] Speaker 00:
Okay, one of the things, but this was in the enablement thing, so I'm a little confused, but it seems that that sentence helps you when she talks about in the earlier appendix eight, she's talking about enablement, it's not written description, but she does say testimony to both sides indicated

[00:41:55] Speaker 00:
that a faceta would have accepted the combination would be effective for treating pain and conditions like arthritis.

[00:42:01] Speaker 00:
Now, do you agree with Judge Clevenger's commentary on that, that that's not what we're talking about, the therapeutically effective stuff we're talking about now?

[00:42:10] Speaker 00:
So that that doesn't help you?

[00:42:12] Speaker 06:
I think it does help in a sense of you do have to look to the four corners of the specification of what it tells when spilled in the yard, and this is evidence.

[00:42:19] Speaker 00:
She's not citing the specification here, is she?

[00:42:21] Speaker 00:
She's just, look, she's relying on

[00:42:23] Speaker 06:
testimony of experts who are saying what the specification.

[00:42:27] Speaker 00:
Well, why don't we look at what they're saying, because we're, again, on the point of treating pain in conditions like arthritis.

[00:42:36] Speaker 00:
You agree with Judge Klovenger that that's not kind of a therapeutically effective stuff we're looking for here in the claim limitation that's at issue?

[00:42:44] Speaker 06:
Well, the, no, that you are looking at the claimed combination

[00:42:50] Speaker 06:
And the claim combination of A plus B is intended to reduce the GI side effects of naproxen.

[00:42:56] Speaker 03:
So you do look.

[00:42:57] Speaker 03:
But the question is whether that uncoded PPI contributes to that.

[00:43:03] Speaker 06:
Right?

[00:43:04] Speaker 03:
Correct.

[00:43:05] Speaker 06:
And the testimony by the experts is that one skilled looking at this patent specification would have believed that the uncoded PPI would function as described and help protect the

[00:43:18] Speaker 03:
Where is that?

[00:43:19] Speaker 03:
Who says exactly that?

[00:43:21] Speaker 06:
It was Dr. Williams testified, and I'll get the site for that.

[00:43:26] Speaker 00:
And the testimony that she cited, the question, the answer to the question was, it would be effective for treating chronic pain.

[00:43:35] Speaker 00:
I think I have got that right.

[00:43:37] Speaker 00:
I'm not sure.

[00:43:40] Speaker 00:
I don't know.

[00:43:42] Speaker 00:
what he means by that.

[00:43:44] Speaker 00:
I mean, it's, and when she, when her citation is to line four, which leaves out the, his last comment, which is, I'm not sure.

[00:43:52] Speaker 00:
So I don't know whether she thought that was irrelevant or whatever.

[00:43:58] Speaker 00:
What do you make of that?

[00:43:59] Speaker 00:
If he concludes by saying, I'm not sure, and she didn't rely on that.

[00:44:06] Speaker 00:
She relied on his first sentence.

[00:44:08] Speaker 00:
It's a little hard to know what to do with that, right?

[00:44:11] Speaker 06:
Well, with respect to that specific testimony, it is correct that those are his words, but the issue came down to what did he interpret the specification as teaching, and was the inventor in possession of what was taught?

[00:44:28] Speaker 06:
And I think, again, that goes back to the analysis in Alcon, that you have to look at what the specification teaches the skilled artist in, and you don't have to guarantee

[00:44:36] Speaker 06:
There's no requirement under the law that you prove that it works.

[00:44:41] Speaker 00:
Well, I'm for testimony.

[00:44:42] Speaker 00:
I don't know if it's enough, but I certainly think it would be helpful to your side if we had testimony for a proceeding that the district court relied on that said, reading the specification, I am satisfied that the inventor had possession not just of this thing, but that this thing would be therapeutically effective.

[00:45:02] Speaker 00:
So can you, I don't see it in her opinion,

[00:45:06] Speaker 00:
So do you have some expert testimony that looking at the specification says, I understand.

[00:45:15] Speaker 00:
You know what I'm looking for.

[00:45:16] Speaker 06:
Where is it?

[00:45:16] Speaker 06:
Right.

[00:45:18] Speaker 06:
I don't have something specific to identify in the testimony of the experts that she did not.

[00:45:24] Speaker 00:
Well, show me something that comes close.

[00:45:26] Speaker 00:
What's your best site from the expert testimony that gets us even close to that kind of analysis of the specification?

[00:45:35] Speaker 00:
I don't know if it's outcome.

[00:45:36] Speaker 00:
There's another case where, yeah, the district court relied on the testimony of the experts, and it's hard to dislodge that question review.

[00:45:46] Speaker 00:
But I'm looking for it in the record here.

[00:45:53] Speaker 02:
I don't have a side for that, Your Honor.

[00:45:55] Speaker 02:
I'm not sure, but I'm guessing that the district court took that I'm not sure as referring to the deposition testimony, not to the

[00:46:04] Speaker 00:
That may be right, but I remain that that testimony, even if you take, I'm not sure, out of it, whether that gets you to where you need to go.

[00:46:16] Speaker 00:
All right.

[00:46:17] Speaker 00:
My colleagues may have questions, but beyond that, you might want to get to your cross appeal at some point.

[00:46:22] Speaker 06:
Correct.

[00:46:23] Speaker 03:
I'd like to just mention quickly on the encoded in the proxen issue I just wanted to mention that we do believe that... I just want to come back, circle around, because maybe I'm too being counter or too narrow-minded here, but my understanding of the law of written description is that you could have all the testimony in the world about what one of ordinary skill in the art thinks about the patent, but in order to

[00:46:50] Speaker 03:
satisfied written description, you have to point to something I call the hook.

[00:46:54] Speaker 03:
You have to point to something in the specification that the person of ordinary skill in New York can say, see whoops.

[00:47:00] Speaker 03:
And what I'm understanding, and we think we know that the recitation of the claim language in the specification doesn't suffice alone.

[00:47:10] Speaker 03:
So I was understanding you to say that basically the language that you pointed to in column three

[00:47:17] Speaker 03:
The background of the invention, we know what the background is, but the background also includes the fact that if you use uncoded PPI, you run a high risk of destroying its efficacy, right?

[00:47:37] Speaker 06:
But I also think, one, you can't, as the district court did, you can look at the disclosure at column two,

[00:47:43] Speaker 06:
which is in the background of the admission section, but in which the inventor points out the problem, and that the inventor believes, of entericotid, and believes that you should not entericotid.

[00:47:53] Speaker 03:
Right, but it's a, it's a, it's a problem, it's, it's Janus.

[00:47:57] Speaker 03:
It's looking both ways.

[00:47:58] Speaker 03:
There's a problem if you have, if you coat your naproxen with cement.

[00:48:06] Speaker 03:
It doesn't do any, it'll never, never do any good.

[00:48:09] Speaker 03:
The problem that she's talking about, as I understand it, in column one to column two is that, depending on what kind of coding you're using, and depending on how various bodies work, the ability of the body to wear off the coding is problematic.

[00:48:26] Speaker 03:
It's problematic.

[00:48:28] Speaker 03:
Not that you wouldn't use coding.

[00:48:30] Speaker 03:
It's problematic.

[00:48:31] Speaker 03:
And she points to that.

[00:48:32] Speaker 03:
And I understand that.

[00:48:34] Speaker 03:
At the same time, we have to have in mind the fact that, you know, we better be careful

[00:48:39] Speaker 03:
that you don't peel enough off to destroy the stuff, right?

[00:48:43] Speaker 03:
So there's that tension.

[00:48:45] Speaker 03:
And I think it was that tension that leads to the part of the testimony from those of ordinary skill in the art that said, this wouldn't be something to do.

[00:48:54] Speaker 03:
That's why you prevailed on 103.

[00:48:57] Speaker 03:
And so in my mind, we're looking for something hooked in the spec that shows that the patentee got it.

[00:49:03] Speaker 03:
in terms of knowing that you better be careful not to use an entirely unwanted PPI to get destroyed.

[00:49:11] Speaker 03:
And so that's what I'm looking for.

[00:49:12] Speaker 03:
It seemed to me like when you come to that, the language that you pointed to in column three is your best shot.

[00:49:19] Speaker 03:
I don't see anything else.

[00:49:21] Speaker 03:
And I'm taking the example six and throwing it aside as simply a recitation of what's in the client.

[00:49:30] Speaker 06:
And I do believe example six is a recitation of what is the claim of what we're looking at as whether the inventor was in possession of what was claimed.

[00:49:39] Speaker 06:
And you have A and B. You have the two components.

[00:49:42] Speaker 03:
And in response- And this is a situation where sort of walking in, sort of say, well, this is somebody just walking up to it, when whoever wrote these claims knew that if you claim therapeutic effectiveness, you have to disclose it.

[00:49:57] Speaker 03:
And you have to describe it.

[00:49:58] Speaker 03:
OK, they knew that.

[00:49:59] Speaker 03:
And he knows that their standard ways of doing that are with tests or with a theory of some sort that can be divine from the specification, not from the thin air, or inherency.

[00:50:15] Speaker 03:
So he knew what the rules were.

[00:50:17] Speaker 06:
And the inventor, our position is the inventor accomplished that goal.

[00:50:22] Speaker 06:
The inventor said, this is what was known in the prior art where you would enter a code.

[00:50:26] Speaker 06:
I'm saying from my invention, my inventiveness is to use an uncoded PPI even though you didn't believe it would work.

[00:50:32] Speaker 00:
So you think that constitutes a theory?

[00:50:34] Speaker 06:
I believe that constitutes a theory.

[00:50:36] Speaker 06:
And I believe that's what she, the district court, believed also through that recitation.

[00:50:39] Speaker 00:
But she didn't rely on that.

[00:50:40] Speaker 00:
Didn't we already go through that she never referenced that portion of the specification at all?

[00:50:45] Speaker 06:
Not of column three, but of column two where the inventor pointed out the problem with the prior art.

[00:50:50] Speaker 06:
And to your earlier comment, question, my colleague

[00:50:54] Speaker 06:
shared with me the testimony of Dr. Kibbe.

[00:50:58] Speaker 06:
This is Appendix 10397, where Dr. Kibbe is looking at Claim 1 and says there should be a therapeutic effective amount.

[00:51:07] Speaker 00:
Wait, wait, wait.

[00:51:08] Speaker 00:
Let me just get the page.

[00:51:11] Speaker 00:
OK, I got it.

[00:51:16] Speaker 00:
10397.

[00:51:18] Speaker 06:
And Dr. Kibbe notes that the dependent claims lay out the range.

[00:51:23] Speaker 03:
Where are you on 10397?

[00:51:24] Speaker 06:
at the line 22.

[00:51:25] Speaker 06:
And Dr. Kibbe is looking at the claims of the 285 patent and is saying that the range that is in the claims is supported by the literature to give you a range that would be therapeutically effective.

[00:51:40] Speaker 06:
So Dr. Kibbe is saying that that range that's recited in the claims and in the specification would be, which relate to an un-coded PPI, would be therapeutically effective.

[00:51:51] Speaker 00:
Yeah, but he's looking.

[00:51:53] Speaker 00:
We know that amount is claimed.

[00:51:55] Speaker 00:
He's answering.

[00:51:55] Speaker 00:
They're not looking at the specification as far as I can tell the context here.

[00:51:59] Speaker 00:
They're just reading what the claims say.

[00:52:02] Speaker 06:
And it's this expert testimony that would be therapeutically effective.

[00:52:06] Speaker 00:
No, the sentence begins, claim one says.

[00:52:11] Speaker 00:
So he's talking about what claim one says, right?

[00:52:15] Speaker 06:
And then he says then the dependent claims lay out a range.

[00:52:18] Speaker 06:
which is supported by the literature.

[00:52:21] Speaker 00:
Can I take you back to a little debate I had with your friend on the other side, which is just trying to get us around the line drawing between written description and enablement, and particularly we were talking about this paragraph in the Alcon case.

[00:52:42] Speaker 00:
So do you agree, as I understood, that the inventory works?

[00:52:46] Speaker 00:
That's the enablement thing.

[00:52:47] Speaker 00:
That's a utility requirement.

[00:52:50] Speaker 00:
But weird is that it works is one thing.

[00:52:53] Speaker 00:
It's operable.

[00:52:54] Speaker 00:
But that it works for the intended purpose of being therapeutically effective.

[00:53:00] Speaker 00:
I guess the question before us is, does that extra part also need a written description, or is that purely an enablement analysis?

[00:53:09] Speaker 00:
So can you help me on that, please?

[00:53:11] Speaker 06:
I think our position is that it is.

[00:53:13] Speaker 00:
Primarily enable them analysis analysis, but even in Alcon the district court in discussing written this way primarily In well because the facts go to both issues enablement and written description that is so weird as the fact of Whether or not it works for its intended purpose, which in this case the claims say is there to be therapeutically effective Where does that little subgroup belong under written description or under enablement?

[00:53:42] Speaker 06:
It belongs under enablement, not under written description.

[00:53:45] Speaker 06:
Alcon held that written description is about whether the skilled reader of the patent disclosure can recognize what was claimed corresponds to what I described, not about whether the patentee has proven to the skilled artisan that the envision works or how to make it work.

[00:54:00] Speaker 06:
So if written description is not about proving

[00:54:03] Speaker 06:
that it's therapeutically effective in your specifications.

[00:54:07] Speaker 03:
So no therapeutic effecting claim ever has to be described in terms of its therapeutic effectiveness?

[00:54:15] Speaker 03:
If it's enabled, you've written that you've taken, you've just took the requirement for written description of therapeutic effecting out of the law, meaning taken it away.

[00:54:26] Speaker 06:
That can't be said.

[00:54:27] Speaker 06:
I don't believe that's what the Alkin decision was attempting to do.

[00:54:29] Speaker 06:
That's what you just said.

[00:54:31] Speaker 03:
And if Alcon says that, it's wrong.

[00:54:36] Speaker 06:
If you're looking at a claimed composition, a claimed composition which has a component that should be a therapeutically effective amount, and the specification teaches you what that therapeutically effective amount would be that you should use, you've satisfied the written description that you were envisioned and were in possession of that.

[00:54:55] Speaker 06:
This is not a method of treating

[00:54:58] Speaker 00:
What work does the therapeutically effective do?

[00:55:03] Speaker 00:
The claims, not the spec, recite the amount, and they recite the result, which is therapeutically effective.

[00:55:10] Speaker 00:
What difference, you're saying the spec doesn't have to say, the spec would say the exact same thing, I think, if the words therapeutically effective result weren't also a claim limitation.

[00:55:22] Speaker 00:
Correct.

[00:55:22] Speaker 00:
Right.

[00:55:23] Speaker 00:
So it's the exact same specs.

[00:55:24] Speaker 00:
So don't you say, like, well, since you've added a claim limitation that says therapeutically effective, you need something in the written description to deal with that new limitation?

[00:55:38] Speaker 00:
You understand my query?

[00:55:41] Speaker 06:
Yes, Your Honor.

[00:55:42] Speaker 06:
But our position is that the disclosure and the specification of what an effective amount would be for the composition is the disclosure of the therapeutically effective amount.

[00:55:50] Speaker 06:
that is claimed and set forth in the claims.

[00:55:54] Speaker 00:
Now, you haven't gotten to your cross appeal.

[00:55:58] Speaker 00:
No, no, no.

[00:55:59] Speaker 00:
That's fine.

[00:55:59] Speaker 00:
But did you have anything more on any of the others?

[00:56:01] Speaker 00:
No, Your Honor.

[00:56:02] Speaker 06:
OK.

[00:56:03] Speaker 06:
On the cross appeal, given the sake of time, I'll limit.

[00:56:06] Speaker 06:
There is a relationship between the two patents.

[00:56:09] Speaker 06:
And in this case, our position is the district court's finding of non-infringement was based on erroneous claim construction regarding essentially any.

[00:56:19] Speaker 06:
and that essentially any qualified the inset that was surrounded and not any unclaimed inset that comprising would permit.

[00:56:31] Speaker 06:
And therefore, the district court should not have imposed essentially any limitation on encompassing both the coded inset and any unclaimed uncoded inset that was permitted by the

[00:56:47] Speaker 00:
Before you sit down, could I just ask you sort of on the ground what's going on in this case in these patents?

[00:56:55] Speaker 00:
So one patent is 2005.

[00:56:58] Speaker 00:
The other one is like 2013, way after that, right?

[00:57:03] Speaker 00:
I'm just wondering what's going on with this litigation has been going on for a long time.

[00:57:08] Speaker 00:
What's the expiration date?

[00:57:12] Speaker 00:
What's the track we're on here forever reaching closure on this?

[00:57:16] Speaker 06:
There are additional patents.

[00:57:17] Speaker 06:
with additional patents going on at this moment, Your Honor.

[00:57:22] Speaker 00:
That involved the same drug?

[00:57:24] Speaker 06:
Yes, in addition to these patents.

[00:57:27] Speaker 00:
So the results of this case isn't going to make any difference?

[00:57:30] Speaker 06:
No, the results of these case make a huge difference with respect to certain different parties that were involved in different cases.

[00:57:36] Speaker 06:
Some parties are no longer involved in this case that were previously.

[00:57:40] Speaker 00:
And did the 235 get backdated to the 907?

[00:57:44] Speaker 00:
Oh, I'm sorry.

[00:57:46] Speaker 00:
The 907 was the earlier path.

[00:57:49] Speaker 00:
So what's the priority date for the later path?

[00:57:52] Speaker 00:
Did it get an earlier priority date, or is it 2013?

[00:57:59] Speaker 06:
I believe the priority dates are the same for the path.

[00:58:03] Speaker 00:
So the 235 claimed priority to the 907?

[00:58:09] Speaker 00:
I mean, that's not either here or there.

[00:58:14] Speaker 06:
Yeah, if you look at the face of the 285 patent, you'll see a claim back to the 907 patent application and the application that resulted in the 907 patent.

[00:58:30] Speaker 00:
Judge Clevenger just mentioned if you wanted to cover

[00:58:33] Speaker 00:
second person on the other side.

[00:58:36] Speaker 06:
Well I think the un-coded and the proxen issue is similar to the 285 patent is similar to the issue that arises in the 907 patent.

[00:58:46] Speaker 06:
Based on our construction of the 907 patent and essentially any only limiting be coded and said that would allow for written description support for

[00:59:00] Speaker 06:
what is actually claimed, and that would encompass, in the infringement analysis, the DLT product.

[00:59:04] Speaker 03:
Well, the addiction court said, with regard to that issue, the comprising language means that there is a virtually unlimited amount of uncoded NSAID that is embraced, right?

[00:59:14] Speaker 03:
That's her finding.

[00:59:16] Speaker 03:
And that being so, then the question is, well, where is their description to cover that embodiment?

[00:59:23] Speaker 06:
Well, and, Your Honor,

[00:59:26] Speaker 06:
There is no written description for an unlimited amount, just as there's no description for arsenic as discussed earlier or concrete or anything else that could be encompassed by a comprising term.

[00:59:42] Speaker 06:
Rather, what's disclosed is the composition of the coded inset and the uncoded PPI.

[00:59:49] Speaker 06:
That is all described in the specification.

[00:59:51] Speaker 06:
And that there is written description support for all of that.

[00:59:54] Speaker 03:
And they've created, assuming, assuming you're not adding arsenic, which you're adding just a dab will do.

[00:59:59] Speaker 03:
You're adding a little bit of uncoded.

[01:00:02] Speaker 06:
And the district court noted even focusing on something defendants had said that it was a coordinated release was preferred embodiment.

[01:00:10] Speaker 06:
So it may be less preferred.

[01:00:12] Speaker 06:
to have some approximate process.

[01:00:14] Speaker 03:
Well, that's the thrust of their appeal, as I understand it, is to get me to believe that the district court was wrong in saying that coordinated release was a preferred embodiment.

[01:00:23] Speaker 03:
I'm supposed to say it was the only embodiment.

[01:00:25] Speaker 03:
That's, as I understand it, brief.

[01:00:28] Speaker 03:
That is their position.

[01:00:29] Speaker 03:
And I understand your brief to say, oh, no, no, no, that's not true.

[01:00:32] Speaker 03:
It's just a preferred embodiment, but without anybody telling me how I decide the question.

[01:00:37] Speaker 03:
How do I know whether or not a reasonable amount of uncoated naproxil is committed?

[01:00:51] Speaker 03:
How do I know?

[01:00:52] Speaker 03:
The title of the patent is coordinated release.

[01:00:55] Speaker 03:
The entire description everywhere is coordinated release.

[01:00:59] Speaker 03:
And by coordinated release, they mean acid comes before the naproxil, right?

[01:01:06] Speaker 06:
Well, and the district, the district pointed out in its decision at page 20, appendix 39, that the 285 patent specification preferably provides for coordinated release.

[01:01:17] Speaker 03:
And yes, there was a lot of... No, no, no.

[01:01:19] Speaker 03:
She's, she's the one that created the preferred embodiment in the face of a claim that says we're after coordinated release, coordinated release, and only coordinated release.

[01:01:29] Speaker 03:
And the way you get it is by releasing the acid first.

[01:01:33] Speaker 03:
It's not coordinated release, right, if you release the NSAID first, right?

[01:01:39] Speaker 06:
Well, as long as the claimed effective amount of NSAID is released second, you have coordinated release.

[01:01:45] Speaker 03:
I'm talking about coordinated release, just the concept of coordinated release.

[01:01:49] Speaker 06:
The coordinated release of the claimed components, the coordinated release of the coded NSAID and the uncoded PPI.

[01:01:58] Speaker 06:
That is, that would be coordinated release.

[01:01:59] Speaker 03:
Right, but that's coordinated release of uncoded naproxen.

[01:02:08] Speaker 03:
The patent doesn't speak to terms.

[01:02:09] Speaker 03:
If you're, pardon me, coded, if you're releasing coded naproxen first, I don't see how that can.

[01:02:17] Speaker 06:
No, the coordinated release is the uncoded PPI releases first, followed by the coded naproxen.

[01:02:21] Speaker 06:
Right.

[01:02:22] Speaker 06:
And the patent doesn't speak and it does not speak to

[01:02:25] Speaker 06:
uncoded other than, as the district court noted at column four, talking about the dosage form preferably providing for coordinated release in a way that elevates the pH.

[01:02:39] Speaker 06:
So the patent is silent as to what is encompassed by comprising beyond what the inventor disclosed as his invention, which was the coordinated release of uncoded PPI and coded insects.

[01:02:57] Speaker 00:
Okay, cross-appeal.

[01:03:00] Speaker 00:
Thank you.

[01:03:00] Speaker 00:
We'll wait a few minutes if you need it.

[01:03:03] Speaker 00:
All right, so we'll restore the two minutes and the three minutes, so it's up to you what order you want to go into.

[01:03:18] Speaker 05:
Thank you, Your Honor.

[01:03:22] Speaker 05:
Very quickly, I just wanted to address first a few points regarding the cross-appeal.

[01:03:26] Speaker 05:
That's the 907 patent and essentially any claim construction.

[01:03:32] Speaker 05:
First of all, I don't think comprising in that claim gives Horizon license to make a whole tablet into just the core.

[01:03:39] Speaker 05:
The reason for that is we all should agree that the use of comprising does not abrogate other claim limitations that are there.

[01:03:46] Speaker 05:
And for the 907 patent claims, unlike the 285 patent claims, coordinated release is a defined term.

[01:03:54] Speaker 05:
It's another limitation in the claim.

[01:03:56] Speaker 05:
And I think that, as I said before, if you were to release a large amount of NSAID or naproxen first, you are going to undermine the whole point of coordinated release.

[01:04:06] Speaker 05:
That cannot be tolerated, but that would be the result of the claim construction that they are suggesting this court adopt.

[01:04:13] Speaker 05:
There are at least half a dozen claim construction rules that would be violated by that claim construction.

[01:04:17] Speaker 05:
And at the very beginning, it should be clear to everyone that any NSAID does not mean said NSAID.

[01:04:26] Speaker 05:
need to look only to the words of the claim itself.

[01:04:29] Speaker 05:
That answers all the questions we have here.

[01:04:31] Speaker 05:
But there are at least five other claim constructions that will be violated.

[01:04:35] Speaker 05:
And they're all discussed in the briefing.

[01:04:37] Speaker 05:
And I don't think I need to go through that now.

[01:04:39] Speaker 05:
But I did want to point out one other, two other issues.

[01:04:42] Speaker 05:
I recognize that the district court in this issue pertains to about the 285 written description argument and the 907 cross appeal.

[01:04:49] Speaker 05:
It is certainly correct that the district court characterized the specifications and they're both the same.

[01:04:55] Speaker 05:
as silent as to whether it could have uncoded naproxen, or whether basically some amount of naproxen can release from somewhere other than the core.

[01:05:04] Speaker 05:
I don't agree with that.

[01:05:06] Speaker 05:
I think that certainly all the embodiments are confined to coded NSAID, but there is reference in the specification, I think a column three, about the prior type of release, which was not coordinated, and it's characterized as being toxic three times.

[01:05:22] Speaker 05:
Indeed,

[01:05:24] Speaker 05:
The only safe manner the patent discloses is the inventive manner of release, which is coordinated release.

[01:05:31] Speaker 05:
So I do think that counsels, it's more than just being silent.

[01:05:34] Speaker 05:
To characterize the alternative as being toxic, to my mind, suggests a clear indication to the person not to do that.

[01:05:41] Speaker 05:
Thank you.

[01:05:46] Speaker 01:
Thank you, Your Honor.

[01:05:46] Speaker 01:
I just wanted to respond to a couple of very quick points.

[01:05:50] Speaker 03:
Deal with the theory that has now advanced to us as to why the written description teaches us that the uncoded DPI is therapeutically effective.

[01:06:04] Speaker 03:
Name me column two.

[01:06:06] Speaker 03:
Column two and column three.

[01:06:08] Speaker 01:
Sure.

[01:06:10] Speaker 03:
I didn't understand.

[01:06:11] Speaker 03:
Maybe I'm wrong.

[01:06:12] Speaker 03:
I understand Mr. Monroe to rely on the language in column three as heavily in his brief to lay that to one side.

[01:06:20] Speaker 01:
I don't recall the district court.

[01:06:21] Speaker 03:
What he's talking about is actively raising the intergastic pH.

[01:06:29] Speaker 01:
Right.

[01:06:29] Speaker 01:
So the language in column three is not specific to PPIs at all.

[01:06:34] Speaker 01:
It's talking about acid inhibitors as a general category.

[01:06:37] Speaker 01:
Nothing in there talks about PPIs doing anything.

[01:06:40] Speaker 01:
And as you may recall, this specification talks about two broad categories of acid inhibitors.

[01:06:45] Speaker 03:
Well, it says the method involves a single coordinate in front of it that combines an agent that actively

[01:06:50] Speaker 03:
raises P, and then the agent that's in the patent is un-coded PPI.

[01:06:55] Speaker 01:
Well, the patent also talks about using un-coded H2 blockers.

[01:06:58] Speaker 01:
That's the other category of acid inhibitors that are discussed throughout the patent and actually referred to as preferred.

[01:07:03] Speaker 03:
Yeah, but is your response to this column three language, well, they're not talking about PPI?

[01:07:08] Speaker 01:
Yeah.

[01:07:09] Speaker 01:
In a nutshell, yeah.

[01:07:10] Speaker 01:
This is generic language.

[01:07:11] Speaker 03:
So isn't PPI the agent that they claim?

[01:07:14] Speaker 01:
They've claimed PPIs and H2 blockers in the claims.

[01:07:16] Speaker 03:
Well, why isn't that sufficient?

[01:07:17] Speaker 03:
It says that the product

[01:07:20] Speaker 03:
The method involves the administration of a single coordinated unit dose product that combines an agent that actively raises international PH to levels associated with less risk.

[01:07:32] Speaker 01:
So, again, this language that we're talking about here is not specific to PPIs.

[01:07:37] Speaker 01:
And the district court has looked at the entire specification and made a finding that the specification here, including this language in the specification...

[01:07:47] Speaker 03:
the fact finding from the district court that she said she couldn't find anything in this fact that dealt with therapeutically effectiveness of un-coded PPI, right?

[01:07:59] Speaker 03:
Of un-coded assent-inducing agents.

[01:08:03] Speaker 03:
And so why isn't this language helpful to the other side?

[01:08:07] Speaker 01:
Well, the claims that we're talking about, the claims that are issue are about effective use of un-coded PPIs.

[01:08:13] Speaker 01:
not encoded acid inhibitors, as are talked about generically here.

[01:08:17] Speaker 03:
Is PPI an acid inhibitor?

[01:08:18] Speaker 01:
It is an acid inhibitor.

[01:08:20] Speaker 03:
So why isn't it included?

[01:08:21] Speaker 01:
Well, this could just as easily be read to be discussing the H2 blockers that are referred to as preferred.

[01:08:27] Speaker 01:
If you look at column 5, around line 44, 45, it says H2 blockers are the most preferred.

[01:08:34] Speaker 01:
And those didn't have the same baggage that the PPI inhibitor, that the PPIs have, because those are not acid sensitive.

[01:08:41] Speaker 01:
an un-coded H2 blocker would be known to be functional, even if un-coded, because it's not sensitive to acid.

[01:08:49] Speaker 03:
And again, the district court made a finding based on the specification that there is no information about the... Assume that this language had actually referred to PPI, un-coded PPI.

[01:08:59] Speaker 02:
And it does, in fact.

[01:09:00] Speaker 02:
It says that they can also be used in the next sentence, or the second sentence.

[01:09:10] Speaker 03:
either short or long-term acid inhibitors can effectively be used in the dosage forms.

[01:09:20] Speaker 01:
Well, again, I don't see... Well, again, there's no reference... There's no reference to PPIs specifically here.

[01:09:28] Speaker 01:
This is generic language talking about generic claims.

[01:09:31] Speaker 03:
Is PPI a long-acting acid inhibitor?

[01:09:34] Speaker 01:
It is.

[01:09:34] Speaker 01:
It is one, yeah.

[01:09:35] Speaker 01:
It's longer acting than the H2.

[01:09:38] Speaker 01:
This, you know, this, it might be a different question if this language supported a generic claim or a claim to H2 blockers.

[01:09:46] Speaker 01:
This language is not about PPI inhibitors.

[01:09:48] Speaker 01:
And again, the district court.

[01:09:50] Speaker 03:
Well, how do we know it's not?

[01:09:52] Speaker 01:
Well, at most, this may be a factual question, and the district court has resolved that.

[01:09:57] Speaker 01:
So I don't think it's been argued that that was.

[01:09:59] Speaker 03:
Let me ask you this question.

[01:10:00] Speaker 03:
Assuming that the language in column three to which we've been pointed, I guess for the first time today, and the district court missed it.

[01:10:07] Speaker 03:
if that expressly had decided the PPI.

[01:10:12] Speaker 01:
That may have been.

[01:10:14] Speaker 01:
That would have been a factual question for the district court.

[01:10:16] Speaker 01:
That's not the case we have here, but it's possible that a district court could think that was enough.

[01:10:21] Speaker 01:
But that's not what it says in this case, and that's not the finding we have from the district court.

[01:10:28] Speaker 00:
Thank you.

[01:10:29] Speaker 01:
Thank you, Anderson.

[01:10:32] Speaker 00:
There was very little, Mr. Monroe, there's very little said about the cross appeal, but you want to take a minute to respond or not?

[01:10:38] Speaker 00:
No, Your Honor.

[01:10:39] Speaker 00:
Thank you.

[01:10:40] Speaker 00:
We thank both sides of the case.

[01:10:44] Speaker 04:
All rise.