[00:00:02] Speaker 01:
The next case for argument is 17-2-6-0-3, Euro PEP versus Eli Lilly.

[00:00:38] Speaker 01:
If you're ready, Mr. Lucy, whenever you are.

[00:00:41] Speaker 00:
The judgment below should be vacated or reversed for three basic reasons.

[00:00:46] Speaker 00:
The first being that venue was improper in East Texas.

[00:00:49] Speaker 00:
The second being that the court's claim construction was legally improper and created an indefiniteness issue requiring a new trial.

[00:00:58] Speaker 00:
And third and most importantly, we believe the four corners of this patent specification

[00:01:03] Speaker 00:
prove the invalidity for lack of written description and enablement of this broad functional claim from which nearly all of the disclosed embodiments have been excluded.

[00:01:14] Speaker 01:
Can I just start you on the venue issue?

[00:01:16] Speaker 01:
We had a lot of cases this week.

[00:01:18] Speaker 01:
But after T.C.

[00:01:21] Speaker 01:
Heartland was decided by the Supreme Court, you all filed post-trial motions, right?

[00:01:27] Speaker 01:
We did, Your Honor.

[00:01:28] Speaker 01:
OK, and none of those reference TC Heartland or the venue issue.

[00:01:32] Speaker 01:
Am I correct about that?

[00:01:33] Speaker 00:
They did not, because the matter had been resolved pretrial with the trial judge stating that we had waived the issue no matter how TC Heartland came out.

[00:01:45] Speaker 00:
And that's at appendix 19, 928.

[00:01:48] Speaker 00:
And once your position has been made clear and it's been dispositively ruled on by the judge,

[00:01:54] Speaker 00:
You are not required to continually re-raise that sort of position.

[00:01:58] Speaker 01:
Well, you know, we have a lot of cases that implicate this.

[00:02:00] Speaker 01:
And we understand it comes up, and you know this, at claim construction, where it would have been futile to press this.

[00:02:06] Speaker 01:
In this context, though, isn't it a bit different?

[00:02:09] Speaker 01:
I mean, just Judge Bryson, before TC Heartland came out, said whichever way.

[00:02:14] Speaker 01:
Lawyers, on the other hand, constantly keep pushing on stuff that they shouldn't just because they don't want to have a waiver problem at the end of the day.

[00:02:25] Speaker 01:
It does, would it not seem reasonable to you that at least on a cautionary basis, notwithstanding what Judge Bryson may have sort of said as an advisory opinion early on, that once you had a Supreme Court decision that actually did it, you would have pressed that to the district court?

[00:02:44] Speaker 00:
I think there are two answers to that.

[00:02:48] Speaker 00:
The first you mentioned, which is this was Judge Bryson who told us this, and secondly,

[00:02:55] Speaker 00:
This court did not determine that TC Heartland was a change in the law until the Micron decision, which came after this case, was already on appeal.

[00:03:02] Speaker 03:
Isn't your real problem not that Judge Bryson said you would be doomed either way?

[00:03:10] Speaker 03:
But didn't he say you would be doomed on either way, no matter how TC Heartland came out?

[00:03:14] Speaker 03:
Because you never filed the proper motion.

[00:03:17] Speaker 03:
You didn't file an improper venue motion from the outset.

[00:03:21] Speaker 03:
You filed a convenience venue motion.

[00:03:23] Speaker 03:
That is very different.

[00:03:25] Speaker 03:
T.C.

[00:03:25] Speaker 03:
Heartland had to do with improper venue.

[00:03:28] Speaker 03:
You had never at any point in this case, until the eve of trial, argued venue was improper.

[00:03:34] Speaker 03:
And isn't that what Judge Bryson meant when he said T.C.

[00:03:37] Speaker 03:
Heartland wouldn't affect your convenience motion, because that's the only thing you filed?

[00:03:42] Speaker 00:
That's exactly the reason why the Micron decision was essential in order to change his mind.

[00:03:48] Speaker 00:
Because we filed the only motion that the law at the time allowed us to file, which was a 1404 motion showing our dissatisfaction with that venue.

[00:03:56] Speaker 00:
And therefore, we were not adopting a wait and see posture.

[00:04:01] Speaker 00:
We were on record as not wanting to be there.

[00:04:03] Speaker 00:
And it was only after Micron was decided that his view that we had waived the issue by not moving earlier became improper.

[00:04:13] Speaker 00:
And there was no point in raising it with him prior to that.

[00:04:17] Speaker 00:
Now, the facts are essentially undisputed here.

[00:04:19] Speaker 03:
I guess I'm just not following you.

[00:04:21] Speaker 03:
Was TC Heartland an improper venue case or a convenience case?

[00:04:27] Speaker 00:
It was an improper venue case.

[00:04:29] Speaker 03:
Right.

[00:04:29] Speaker 03:
So you only argued convenience.

[00:04:33] Speaker 03:
Only argued convenience all the way through till the eve of trial.

[00:04:35] Speaker 03:
In the meantime, there is TC Heartland at the Federal Circuit, TC Heartland granted cert at the Supreme Court.

[00:04:42] Speaker 03:
Then TC Heartland decided.

[00:04:44] Speaker 03:
All of these are under 14.06, which you never filed a motion in the district court under, ever, at any point.

[00:04:51] Speaker 00:
No, excuse me, Your Honor.

[00:04:52] Speaker 00:
We did.

[00:04:52] Speaker 00:
We raised the issue before Judge Bryson.

[00:04:55] Speaker 00:
And this is where the interaction occurred in the pretrial order before T.C.

[00:04:59] Speaker 00:
Heartland was argued and before it was decided.

[00:05:02] Speaker 00:
And we're told preemptively that he felt we had waived it, regardless of how it came out.

[00:05:08] Speaker 00:
And the whole point of Micron.

[00:05:10] Speaker 03:
I see.

[00:05:12] Speaker 03:
Because I may not have understood the facts right.

[00:05:13] Speaker 03:
And so this is very helpful.

[00:05:14] Speaker 03:
So are you telling me that you did move for Judge Bryson?

[00:05:19] Speaker 00:
We challenged venue under 1406 in the pretrial order before Judge Bryson.

[00:05:28] Speaker 03:
Where could I find that?

[00:05:31] Speaker 00:
At A2377 and 2384.

[00:05:49] Speaker 00:
And it was the colloquy on that issue that led to his ruling that we had waived it, regardless of how it came out.

[00:06:00] Speaker 03:
I'm sorry.

[00:06:02] Speaker 03:
I'm on 2380.

[00:06:03] Speaker 03:
Did you say 2384?

[00:06:04] Speaker 00:
2377.

[00:06:06] Speaker 03:
OK, sorry.

[00:06:07] Speaker 03:
2377.

[00:06:08] Speaker 00:
Which I believe is the actual pretrial order.

[00:06:12] Speaker 00:
And 2384, which I believe is in the pretrial order, also raising the same issue.

[00:06:18] Speaker 01:
So Micron did say that you don't have to have preserved it before the TC Heartland decision was rendered, right?

[00:06:26] Speaker 00:
But the legal consequence of it being it?

[00:06:30] Speaker 00:
That question is a friendly question.

[00:06:32] Speaker 01:
We'll push back on that.

[00:06:35] Speaker 01:
The thing that's most weird is that you really didn't file anything.

[00:06:40] Speaker 01:
I mean, you conceded jurisdiction under 1400 before Judge Bryce said

[00:06:44] Speaker 01:
I don't know why we were talking about T.C.

[00:06:46] Speaker 01:
Heartland, why you were talking about T.C.

[00:06:49] Speaker 01:
Heartland with Judge Bryson beforehand, but you never, ever filed anything beforehand.

[00:06:54] Speaker 01:
So even if he opined that it really didn't matter, there was nothing as Judge Moore points out.

[00:07:01] Speaker 01:
There was only the motion for 14.04.

[00:07:03] Speaker 01:
So it's hard to see that you can say,

[00:07:09] Speaker 01:
It would have been futile for us to arrange it.

[00:07:12] Speaker 01:
You never actually filed any paper.

[00:07:15] Speaker 00:
We raised the issue squarely in the pre-trial conference.

[00:07:20] Speaker 01:
Was there a ruling by Judge Bryson that we've got jurisdiction no matter how TC Heartland is decided?

[00:07:25] Speaker 00:
That is how we read the colloquy.

[00:07:27] Speaker 00:
He said you have waived it regardless of how TC Heartland is decided.

[00:07:31] Speaker 01:
Yeah, there's no order issued with regard to that, right?

[00:07:36] Speaker 00:
There is the transcript of the hearing, which is in the record.

[00:07:40] Speaker 01:
So your whole argument is predicated on the fact that it was so clear that we were going to get a Judge Brechu, even though it was never squarely presented to him, and even though it was before the Supreme Court decided the case, he absolutely decided it so that it was not incumbent upon us to in any way, shape, or form try to preserve that argument by filing

[00:08:00] Speaker 01:
something after the T.C.

[00:08:01] Speaker 01:
Hartley decision.

[00:08:02] Speaker 00:
It was presented.

[00:08:03] Speaker 00:
He did decide it.

[00:08:04] Speaker 00:
He decided it in a way that would not have been altered until the Micron decision, because until it is determined to be a change in the law, once it is determined to be a change in the law, you are not required to have anticipated it.

[00:08:18] Speaker 01:
Well, you're putting a lot of weight on Micron.

[00:08:21] Speaker 01:
I mean, I think our cases have suggested that at a minimum, the clock starts running on parties to have done something, at least

[00:08:30] Speaker 01:
when TC Heartland was decided.

[00:08:33] Speaker 01:
Micron illuminated the details of that.

[00:08:38] Speaker 01:
But I don't think parties could say that until Micron, we didn't have any obligation to do anything because the Federal Circuit had officially ruled it was a change in law.

[00:08:48] Speaker 00:
But we did do something.

[00:08:49] Speaker 00:
We squarely raised the issue in the pretrial order.

[00:08:53] Speaker 00:
It was discussed and resolved at the pretrial conference.

[00:08:56] Speaker 00:
And my point is there was no point in raising it post-trial, which I thought was the original question, because he had said it had been waived and it had not been determined to be a change in the law.

[00:09:09] Speaker 00:
It was only the determination.

[00:09:10] Speaker 00:
It was a change in the law that eliminated the waiver.

[00:09:15] Speaker 01:
I've used a lot of your time.

[00:09:16] Speaker 01:
I apologize.

[00:09:17] Speaker 01:
Why don't you move on to the written description issue or the other issues you were trying to cover?

[00:09:20] Speaker 00:
OK.

[00:09:22] Speaker 00:
On the written description issue, which we regard as basically the core

[00:09:26] Speaker 00:
problem in this case.

[00:09:28] Speaker 00:
To some extent, the case is a reprise of Ariadne.

[00:09:32] Speaker 03:
I'm sorry.

[00:09:33] Speaker 03:
Can I make him go back for one second?

[00:09:35] Speaker 03:
Because I just read the Bryson transcript on this.

[00:09:38] Speaker 03:
And he expressly tells you on 19.929, this is his preliminary take on this.

[00:09:42] Speaker 03:
And we'll see how TC Hartland turns out.

[00:09:45] Speaker 03:
But that's my view of the matter.

[00:09:46] Speaker 03:
And if either of you would like to comment, I'll listen.

[00:09:49] Speaker 03:
But if you don't, we can move on.

[00:09:51] Speaker 03:
How does that not?

[00:09:54] Speaker 03:
I'm just confused about how

[00:09:56] Speaker 03:
that renders any further discussion of the issue futile.

[00:09:59] Speaker 03:
He's inviting you to tell him whether he's wrong.

[00:10:02] Speaker 03:
He's also inviting you saying, but we'll have to see how T.C.

[00:10:06] Speaker 03:
Heartland turns out.

[00:10:08] Speaker 03:
So the futility thing is ringing hollow for me.

[00:10:12] Speaker 03:
I do see earlier where he says he thinks you waived it, but then at the very end of that very discussion with him, he invites you to comment further and says, we'll have to see how T.C.

[00:10:21] Speaker 03:
Heartland turns out before we can really decide this.

[00:10:25] Speaker 00:
that he believed we had waived it no matter how it came out.

[00:10:29] Speaker 00:
And it wasn't how T.C.

[00:10:30] Speaker 00:
Heartland.

[00:10:31] Speaker 03:
But we'll have to see how T.C.

[00:10:32] Speaker 03:
Heartland comes out.

[00:10:33] Speaker 03:
And you're welcome to comment on this if you'd like.

[00:10:35] Speaker 00:
But it wasn't T.C.

[00:10:38] Speaker 00:
Heartland that changed anything.

[00:10:40] Speaker 00:
It was Micron that changed the ability.

[00:10:44] Speaker 00:
If Micron had said it wasn't a change in the law, he would have been right.

[00:10:48] Speaker 00:
We would have waived it.

[00:10:49] Speaker 00:
There was no point in raising that until Micron.

[00:10:51] Speaker 03:
I'll let you get onto your written description now.

[00:10:55] Speaker 00:
Anyway, the case is in many ways a reprise of Ariad.

[00:10:58] Speaker 00:
There was the identification of a natural phenomenon that PDE 1, 4, and 5 were in the prostate.

[00:11:05] Speaker 00:
There was a hypothesis that you could treat a variety of diseases by inhibiting those, and then a claim to a method of treatment using any molecule that inhibits them.

[00:11:16] Speaker 00:
And the problem is that's an identification of the problem to be solved.

[00:11:21] Speaker 00:
and claims all solutions to it, but does not do the hard work of actually making that invention.

[00:11:28] Speaker 00:
PDE5 inhibitors is not a class of molecules.

[00:11:31] Speaker 00:
It's not like benzodiazepines.

[00:11:34] Speaker 00:
It's a property.

[00:11:35] Speaker 00:
And it turns out that lots of things inhibit PDE5, including a lot of natural products like horn and goatweed, as you saw in the record.

[00:11:44] Speaker 00:
It is an extremely broad universe, and the record evidence

[00:11:49] Speaker 00:
Compounds that perform that function are highly structurally diverse, that there are unpredictable changes in structure with function.

[00:11:56] Speaker 00:
And it was incumbent in that circumstance to illustrate a representative number of species or a structure-function correlation so that you can envision what the universe of molecules that did these things, inhibit PDE5 and be effective to treat BPH, were.

[00:12:14] Speaker 00:
And neither one of those were in the application and, indeed, the vast bulk

[00:12:19] Speaker 00:
And this is an exceptional point in this case.

[00:12:21] Speaker 00:
The vast bulk of the molecules actually described are excluded from the claim.

[00:12:26] Speaker 00:
And since written description focuses on written description for what is included in the claim, those things cannot serve to inform.

[00:12:35] Speaker 01:
Is there a case that you can cite us that says that?

[00:12:38] Speaker 00:
We cited a whole raft of written description cases in our brief, all of which focus and actually say, is there a written description of the claimed invention?

[00:12:48] Speaker 00:
All of the 112 requirements are focused on the claimed invention.

[00:12:53] Speaker 03:
So do you think the judge below aired as a matter of law to the extent that he said the genus is defined by these 10 examples in the specification, because eight of them are expressly excluded later from the claim?

[00:13:07] Speaker 03:
There's no doubt within the genus.

[00:13:09] Speaker 03:
Everyone would agree they are within the genus, but they're later expressly excluded from the claim.

[00:13:15] Speaker 00:
This is another problem.

[00:13:16] Speaker 00:
The genus that's described is things that inhibit PDE 1, 4, and 5.

[00:13:22] Speaker 00:
There's not a single molecule identified in the specification that is said to be an inhibitor of PDE 5 and effective to treat BPH.

[00:13:32] Speaker 00:
There are a whole bunch of diseases.

[00:13:33] Speaker 00:
There are a whole bunch of PDEs.

[00:13:36] Speaker 00:
There's nothing that identifies a single molecule as falling within that genus.

[00:13:41] Speaker 03:
OK, but that's a completely different point than my question.

[00:13:45] Speaker 03:
My question was, do you think he aired as a matter of law to the extent that he looked at the 10 example species, molecules disclosed in the spec, even though they are within the genus, do you think he aired as a matter of law in looking at those because they are then excluded from the claim?

[00:14:06] Speaker 00:
I disagree that they are within the claimed genus.

[00:14:09] Speaker 00:
And yes, he did air as a matter of law.

[00:14:12] Speaker 00:
by looking at things that were expressly excluded from the claim as representative species of what is included.

[00:14:20] Speaker 00:
They simply are not.

[00:14:23] Speaker 00:
And I think the record is clear.

[00:14:24] Speaker 00:
There's no structure-function correlation.

[00:14:26] Speaker 00:
The Tekasi article at 16.019 says there's little information on the structure-activity relationships because even the most potent inhibitors have very diverse molecular structure, making identification of the most important sites

[00:14:42] Speaker 01:
We're almost completely out of time.

[00:14:46] Speaker 01:
If you want to make one more point, either I'm at description, or I don't recall if indefiniteness was listed in what you wanted to cover this morning.

[00:14:52] Speaker 00:
Well, the core problem here, and the reason the case has to go back, and the reason if it goes back, it should go back to Indiana, is that the claim construction that was made here simply read into the claim a bunch of words that are simply not there.

[00:15:11] Speaker 00:
Compound had to be selective.

[00:15:13] Speaker 00:
It said it had to be selective for PDE 1 through 4, even though 1 through 7 were known at the time.

[00:15:19] Speaker 01:
So was your argument on claim construction or on indefiniteness, that the claim is indefinite?

[00:15:22] Speaker 01:
Both.

[00:15:23] Speaker 00:
The claim construction was wrong, and it infected every aspect of the trial.

[00:15:27] Speaker 00:
The jury was given the wrong construction.

[00:15:29] Speaker 00:
There's prior art we would have presented if the construction had been different.

[00:15:34] Speaker 00:
It greatly altered.

[00:15:35] Speaker 01:
Suggesting that there is a construction sort of cuts against the argument that this claim was indefinite, right?

[00:15:42] Speaker 00:
No, because the construction given it is what created the indefiniteness.

[00:15:47] Speaker 00:
If it simply said PDE5 inhibitor, both parties said, yeah, that's something that inhibits PDE5.

[00:15:55] Speaker 00:
He now said it has to inhibit it in an amount that's 20 or more times more effective than 1 through 4.

[00:16:03] Speaker 00:
And the evidence, which we cited in our brief, was all over the lot that when you

[00:16:07] Speaker 00:
vary the conditions under which that test is done, you get different results.

[00:16:10] Speaker 00:
That's a classic indefiniteness problem.

[00:16:12] Speaker 01:
OK.

[00:16:12] Speaker 01:
Let's hear from the other side.

[00:16:14] Speaker 01:
OK.

[00:16:15] Speaker 01:
Thank you.

[00:16:24] Speaker 02:
May it please the Court, Your Honor.

[00:16:25] Speaker 02:
Just turning to the issue of venue right away, the key element there is that what Judge Bryson said is exactly what Judge Moore noted.

[00:16:33] Speaker 02:
I just wanted to put on the record that that's my take on this.

[00:16:36] Speaker 02:
And we'll see how TC Heartland turns out.

[00:16:39] Speaker 02:
But that's my view of the matter.

[00:16:41] Speaker 02:
For an order for the issue to be even remotely, rightly ready for this court to consider on appeal, it was necessary for Lilly to have raised it in its post-trial motion.

[00:16:51] Speaker 01:
An additional argument, which is we're not using the cutoff date.

[00:16:56] Speaker 01:
Once TC Heartland issued, there was still time to file a post-trial motion on this.

[00:17:02] Speaker 01:
He's arguing the clock starts to run from micron.

[00:17:07] Speaker 01:
That's the way I understood this argument.

[00:17:09] Speaker 01:
Did you understand it differently?

[00:17:10] Speaker 02:
I don't believe that's true, Your Honor.

[00:17:12] Speaker 02:
I think the point is that once T.C.

[00:17:15] Speaker 02:
Hartland comes out, there is this open question.

[00:17:19] Speaker 02:
to characterize it a free for all, where people are rushing to now take advantage of what TC Heartland says.

[00:17:25] Speaker 02:
And so the question before various district courts is, now that TC Heartland has been decided, and there is this new principle associated with improper venue,

[00:17:34] Speaker 02:
Is that a change in the law or not?

[00:17:36] Speaker 02:
And there was a split.

[00:17:37] Speaker 02:
Different district courts ruled differently.

[00:17:39] Speaker 02:
But what is consistent in every instance is that the parties involved, once T.C.

[00:17:44] Speaker 02:
Heartland came out, for improper venue.

[00:17:47] Speaker 02:
And I believe, in fact, in Micron, one of the inherent powers that was associated with the determination of improper venue was, has the party been lying in wait?

[00:17:57] Speaker 02:
Has it been strategic in waiting to raise this issue?

[00:18:01] Speaker 02:
And that kind of a delay,

[00:18:03] Speaker 02:
post-TC Heartland was a relevant consideration.

[00:18:08] Speaker 02:
So the clock starts with TC Heartland.

[00:18:10] Speaker 02:
And by not raising it in the post-trial motion, Lilly has deprived this court of the opportunity to actually consider a fully briefed issue.

[00:18:18] Speaker 02:
We don't know how Judge Bryson would have ended up ruling on it.

[00:18:21] Speaker 01:
Why don't you move on to written description?

[00:18:24] Speaker 02:
On written description, with respect to this idea that you can't look

[00:18:28] Speaker 02:
at the excluded compounds for purposes of written description.

[00:18:32] Speaker 02:
And let's narrow it down.

[00:18:33] Speaker 02:
There are agreed there are four compounds in that list that are considered selective and potent PDE5 inhibitors, and two of them were excluded.

[00:18:45] Speaker 02:
There's no law cited by Lilly that says that those excluded compounds cannot be representative of the larger genus that is being claimed.

[00:18:53] Speaker 01:
You take their point, right, that written description is entirely predicated on what the invention is and what is claimed in the invention.

[00:19:01] Speaker 01:
So if the claims exclude certain things, why are we looking to those excluded matters for purposes of specification support of written description?

[00:19:13] Speaker 01:
That intuitively seems right to me.

[00:19:15] Speaker 02:
Well, when you think about the fact that we are claiming here a genus of compounds,

[00:19:20] Speaker 02:
And the question for written description, we're not claiming a genus of compounds, I apologize.

[00:19:23] Speaker 02:
We're claiming a method of treatment utilizing this genus of compounds.

[00:19:27] Speaker 02:
What's important is have we disclosed a representative number of compounds reflective of the genus.

[00:19:34] Speaker 02:
And even though that genus may now have plucked out of it two specific examples,

[00:19:39] Speaker 02:
Those examples in the specification, as Judge Bryson noted, they are still available to be reflective of other members of the genius.

[00:19:47] Speaker 01:
Maybe I've got the numbers wrong.

[00:19:49] Speaker 01:
My recollection is that I thought there were eight exclusions in the claim language.

[00:19:54] Speaker 01:
And so what we were left with were only two examples in the specification that were actually included in the claims.

[00:20:00] Speaker 01:
Am I got my numbers wrong?

[00:20:02] Speaker 02:
Because you're telling me.

[00:20:03] Speaker 02:
You are correct.

[00:20:04] Speaker 02:
But what is unambiguous in the record is that there are

[00:20:07] Speaker 02:
four specific compounds that everyone agrees are selective PD-5 inhibitors.

[00:20:13] Speaker 02:
There's a list of eight excluded compounds in the claim.

[00:20:16] Speaker 01:
So what are we left with in the written description in terms of covered?

[00:20:20] Speaker 02:
In terms of members of the examples in the specification that are still available within the claim of the 124 patent, there are two available.

[00:20:30] Speaker 02:
And of those two, in fact, are those are Zappronast and MY5445.

[00:20:36] Speaker 02:
And to go to another point.

[00:20:37] Speaker 01:
And why is that sufficient to meet the written description requirement?

[00:20:41] Speaker 02:
Well, now we've got to go back to 30,000 feet and refute something that was said here by Lily, which is that as Ariad makes clear, as does LizardTech, is that the necessary level of disclosure for written description is very dependent upon what a person of skill knows about this area of technology.

[00:21:00] Speaker 02:
And the more that the person of skill brings to the table, as LizardTech points out,

[00:21:05] Speaker 02:
the less that that person has to necessarily disclose, because you don't want to have to recite all of what is known and well understood in the prior art.

[00:21:14] Speaker 01:
So there was evidence before the jury that these compounds were known in the art?

[00:21:19] Speaker 02:
Oh, Your Honor, there's an immense amount of information.

[00:21:22] Speaker 02:
Appendix 13.317, Appendix 14.253 to 254.

[00:21:26] Speaker 01:
Was there any opposite evidence?

[00:21:29] Speaker 01:
Did the jury here make a credibility determination, or was it all one sided?

[00:21:34] Speaker 02:
On this element, there was no credibility determination necessary.

[00:21:37] Speaker 02:
Even Dr. Rotella at appendix 13.791 acknowledged that there were hundreds or over a hundred known potent and selective PD-5 inhibitors in the prior art, including Tadalafel, the active ingredient in the accused product.

[00:21:52] Speaker 02:
So the background of knowledge was immense here as of 1997.

[00:21:56] Speaker 02:
Mature, well-developed field, hundreds of known compounds, prior art disclosing those hundreds of compounds that Dr. Bell went through.

[00:22:04] Speaker 02:
two specific compounds in the clinic with doses being used in humans.

[00:22:10] Speaker 03:
If I'm understanding it right, this claim is limited to a method of using an effective amount of the PDE5 inhibitor to treat BPH, right?

[00:22:21] Speaker 02:
Correct.

[00:22:22] Speaker 03:
Okay.

[00:22:23] Speaker 03:
So what does selective PDE5 inhibitor mean?

[00:22:27] Speaker 03:
The word selective, how does that impact?

[00:22:30] Speaker 02:
A selective PDE5 inhibitor is an inhibitor that inhibits PDE5 20 times more than PDEs 1 through 4, as determined by.

[00:22:39] Speaker 03:
So wait, so then you have a list.

[00:22:42] Speaker 03:
It's going to be all of these selective PDE5 inhibitors, except not including these eight.

[00:22:49] Speaker 02:
Correct.

[00:22:50] Speaker 03:
And if I understood you right, you just said two of those eight are selective PDE5 inhibitors.

[00:22:55] Speaker 03:
Are the other six not?

[00:22:57] Speaker 02:
I'm sorry, are they?

[00:22:58] Speaker 03:
Are the other six?

[00:23:00] Speaker 03:
compounds which are excluded in claim one, not selective PDE5 inhibitors?

[00:23:07] Speaker 02:
No, Your Honor.

[00:23:07] Speaker 02:
I don't believe there's any evidence to that.

[00:23:09] Speaker 03:
We've just as a- You said two of the things in the spec are definitively PDE5 inhibitors, and two of the eight excluded ones are definitively PDE5 inhibitors, correct?

[00:23:20] Speaker 02:
Correct.

[00:23:20] Speaker 03:
So what's going on with the other six?

[00:23:22] Speaker 02:
The record does not show what the specific nature of those inhibitors was.

[00:23:26] Speaker 02:
That was not part of the record or part of what the experts were.

[00:23:29] Speaker 03:
But you're saying this is really well known to everybody with skill in the arts.

[00:23:31] Speaker 03:
So why don't I get to know about those other six if it's really well known?

[00:23:35] Speaker 02:
I'd have to go back and go through the prior art to determine which of those remaining ones, what their IC50s are.

[00:23:41] Speaker 02:
And I wouldn't ever claim that because as a non-personal skill, I don't remember what was among those hundreds of PD5 inhibitors what these fell into.

[00:23:48] Speaker 03:
But for the point of confusion for me,

[00:23:50] Speaker 03:
is how is a skilled artisan going to ascertain from potentially billions of PDE5 inhibitors.

[00:23:57] Speaker 03:
And if not billions, if there's a dispute over that, I'll just say millions.

[00:24:01] Speaker 03:
So millions of PDE5 inhibitors.

[00:24:04] Speaker 03:
Now, we've got to figure out which ones are selective or not.

[00:24:06] Speaker 03:
And that's really the issue, right?

[00:24:07] Speaker 03:
Because all eight of these are PDE5 inhibitors.

[00:24:10] Speaker 03:
It's just, do they meet the selective limitation of 20 times or more effectiveness?

[00:24:15] Speaker 02:
To be clear, I believe that our position is that they are all potent and selective PDE5 inhibitors.

[00:24:20] Speaker 02:
What I'm talking about is what in terms of what's in the record, in terms of what people testify to, we have evidence on those four.

[00:24:27] Speaker 02:
So I'm sorry, but with that caveat.

[00:24:29] Speaker 03:
None of what you just said helps your case as far as I'm concerned.

[00:24:31] Speaker 03:
I'm trying to figure out.

[00:24:33] Speaker 03:
whether or not a skilled artisan has enough information based on this spec and this claim to understand the scope of the compounds that are going to be used in this method.

[00:24:46] Speaker 03:
You've given them two in the spec, only two, when there's potentially millions.

[00:24:51] Speaker 03:
Then there's eight more expressly excluded in the spec.

[00:24:53] Speaker 03:
My understanding is the record does show the reason they're excluded is they're otherwise claimed.

[00:24:57] Speaker 03:
And so you would have run into invalidity, obviousness, or anticipation problems.

[00:25:02] Speaker 03:
if you would sought to claim those.

[00:25:05] Speaker 03:
But you're telling me, but we don't actually even know among the eight that are listed here which ones would be selective PDE5 inhibitors capable of treating BPA.

[00:25:19] Speaker 03:
Too many acronyms.

[00:25:20] Speaker 02:
Too many acronyms.

[00:25:22] Speaker 03:
And so now I'm really confused because a skilled artisan is going to know out of the millions of possibilities which ones are good

[00:25:29] Speaker 03:
But you got eight here, and you can't even tell me which ones it would.

[00:25:33] Speaker 02:
Your Honor, they are, as listed in the claim, they are all inhibitors of PDE5 for purposes of this patent.

[00:25:38] Speaker 02:
My position was that I don't know their exact IC50s.

[00:25:42] Speaker 02:
And the point of dispute.

[00:25:44] Speaker 03:
So wait.

[00:25:44] Speaker 03:
So why would you write a claim that would expressly exclude something that wouldn't be included?

[00:25:50] Speaker 02:
Well, they're expressly.

[00:25:51] Speaker 03:
You told me the way the court construed this claim, I mean, is it inserted this word selective in.

[00:25:57] Speaker 03:
Not sure where that happened or how it happened, but there it is.

[00:26:00] Speaker 03:
So they inserted the word selective in, which means not all PDE5 inhibitors are going to be included.

[00:26:05] Speaker 03:
Only selective ones.

[00:26:06] Speaker 03:
Selective means 20 times or more effectiveness.

[00:26:08] Speaker 03:
I understand all of that.

[00:26:09] Speaker 03:
But then you're telling me, you've now, but you carved out of what should be included eight things.

[00:26:16] Speaker 03:
Why would you carve something out?

[00:26:18] Speaker 03:
You don't carve out of a turkey a chicken leg.

[00:26:22] Speaker 03:
You're carving a turkey.

[00:26:23] Speaker 03:
You take the turkey parts.

[00:26:25] Speaker 03:
So if you're telling me you can't

[00:26:27] Speaker 03:
There's no proof that these eight were included in the claim.

[00:26:30] Speaker 03:
Why are you expressly carving them out?

[00:26:32] Speaker 03:
When you've indicated in the record reflex, these were carved out simply because they're already claimed elsewhere.

[00:26:38] Speaker 03:
They are supposedly nonetheless helpful or indicative of the scope of the genus that one of skill and the art would understand is nonetheless covered by this claim.

[00:26:47] Speaker 02:
Your Honor, to be clear, I'm not saying that we don't know and it can't be determined whether or not they are selective inhibitors of PDE5.

[00:26:54] Speaker 02:
What I'm saying is that for purposes of the record that was on dispute, everyone was focused on these four PDE5 inhibitors that both experts agreed were PDE5 inhibitors.

[00:27:05] Speaker 02:
And as a result, I today, as a non-person of scale, can't tell you what the exact IC50s of those compounds were.

[00:27:12] Speaker 02:
But what is the important background to everything you just said is, is it's not just two or four or eight.

[00:27:17] Speaker 02:
It's that a person of skill can go to these articles, Cybert, Saiki, Takazi, which is art of record, and can identify what PDE5 inhibitors exist among the hundreds known at the time that are selective PDE5 inhibitors with which you can use to practice the claim.

[00:27:33] Speaker 02:
So when we talk about written description, we are not focused on these specific PDE5 inhibitors.

[00:27:38] Speaker 02:
We are focused on the entirety of the knowledge a person of scale brings to the table, which for both written description and enablement, they can literally pluck these off the shelf and use these and practice the invention because the data is out there.

[00:27:51] Speaker 02:
The IC50 data, the selectivity data is out there.

[00:27:54] Speaker 03:
So they can be plucked off the shelf by anyone of skill and the art, yet there are eight of them listed in the only real claim at issue in this case, but you can't tell me which one despite how much did you charge your client for this litigation?

[00:28:05] Speaker 03:
How many experts did you work with?

[00:28:07] Speaker 03:
You can't tell me which of these eight, the eight expressly listed in the claim, are selective.

[00:28:11] Speaker 03:
But I should be confident that a skilled artisan could figure it out.

[00:28:16] Speaker 03:
Probably $20 million of litigation in this case.

[00:28:20] Speaker 03:
You, the attorney, arguing this case, have no idea which of the only eight compounds listed

[00:28:25] Speaker 03:
meet the claim limitations.

[00:28:27] Speaker 02:
No, no.

[00:28:27] Speaker 02:
I'm saying they are selective PDE5 inhibitors under the claim that were excluded.

[00:28:32] Speaker 02:
But what I'm saying is I don't know is I don't know their IC50s.

[00:28:35] Speaker 02:
And we are not relying on them for written description because, as part of the record, the parties have narrowed it down to these four specific PDE5 inhibitors.

[00:28:44] Speaker 02:
I'm just saying, Your Honor, that there's no confusion among the parties as to what was available in the prior art, as to what was known to a person of skill in the prior art, about what qualified for an inhibitor of PD-5 under this selectivity determination or claim construction by the judge.

[00:29:03] Speaker 02:
And I will also point out when you talk about... Well, you said there's no dispute.

[00:29:06] Speaker 03:
They absolutely dispute whether

[00:29:08] Speaker 03:
the disclosure of only a couple of these things would be sufficient to convey to a skilled artist in the scope of the genus being used.

[00:29:14] Speaker 03:
I mean, isn't that the crux of their dispute?

[00:29:16] Speaker 02:
That's the crux of the dispute, but Your Honor, I would argue that that really is just an effort at a do-over on the jury's conclusions of the credibility of the experts.

[00:29:23] Speaker 02:
Yes, Dr. Rotella said, even against this background of hundreds of known compounds,

[00:29:27] Speaker 02:
and against the undisputed two that are in the patent, that a person of skill would not believe that he was in possession or that the inventors were in possession of the full scope of the invention.

[00:29:38] Speaker 02:
Dr. Bell testified otherwise.

[00:29:40] Speaker 02:
He testified about what was known in terms of the structural similarities of these compounds.

[00:29:44] Speaker 02:
He testified about how these hundreds of compounds that were known would give a person of skill adequate understanding.

[00:29:49] Speaker 02:
of what the scope of the invention was.

[00:29:51] Speaker 02:
So at its core, yes, there is a dispute.

[00:29:54] Speaker 02:
But the credibility determination that is implicit in the jury's verdict is that Dr. Bell was found credible and Dr. Rotella was found not.

[00:30:01] Speaker 03:
What was the structure?

[00:30:04] Speaker 02:
The structure is a planar fused ring structure with a flap element, which was found to be consistent among the different PDE5 inhibitors.

[00:30:11] Speaker 03:
And so every PDE5 inhibitor that has that structure is going to fall within this genus?

[00:30:17] Speaker 02:
every PD-5 inhibitor that is a selective PD-5 inhibitor has this structure.

[00:30:22] Speaker 02:
And to be clear, what's happening here is that the PD-5 inhibitor is competing with CGMP to bind to the enzyme.

[00:30:30] Speaker 02:
And what was known here in terms of these small molecules was that these structures were consistent.

[00:30:35] Speaker 02:
Their planar elements were consistent.

[00:30:37] Speaker 02:
This is very different from Amgen versus Sanofi, where we're talking about antibodies.

[00:30:42] Speaker 03:
My clerk just sent me something, and I guess we're just not entirely sure of the technology and the way that you're talking about it.

[00:30:48] Speaker 03:
I thought, and he reminded me, or he thought, and I'm parroting him, that the IC50s are how you determine whether they meet selectivity or not.

[00:30:57] Speaker 03:
Isn't that right?

[00:30:59] Speaker 02:
Correct.

[00:30:59] Speaker 02:
Selectivity is a ratio.

[00:31:00] Speaker 03:
You have no idea what the IC50s are for six of the excluded compositions, but you're nonetheless confident they're selective?

[00:31:07] Speaker 02:
I'm saying that as I sit here today, I do not recall what the prior art says about their IC50s.

[00:31:12] Speaker 02:
That is correct.

[00:31:13] Speaker 03:
So you don't know whether they're selective?

[00:31:15] Speaker 02:
I, sitting here today, believe they are selective, as included in the claim.

[00:31:18] Speaker 02:
But I don't know their IC50s, because again, as the record developed, those compounds were not at issue.

[00:31:24] Speaker 03:
Does this record establish that they are selective?

[00:31:27] Speaker 02:
The record doesn't establish it either way, as I believe, Your Honor, other than the patent itself calls them out.

[00:31:34] Speaker 02:
I'm over my time.

[00:31:35] Speaker 02:
Thank you very much.

[00:31:55] Speaker 00:
Quickly in rebuttal, there's some loose language being used here.

[00:32:01] Speaker 00:
You heard the words potent and selective, potent and selective, potent and selective.

[00:32:04] Speaker 00:
The claim says selective 22, 3, and 4.

[00:32:12] Speaker 00:
And that is not described in the prior art, except possibly for a mere handful of molecules.

[00:32:19] Speaker 00:
And the fact of the matter is that a number of those molecules that are excluded don't meet that limitation from the art of record.

[00:32:27] Speaker 00:
The Seibert's publication at 17591 says that that WYN58237, which is compound I, is not 20 times selective with respect to PDE4.

[00:32:42] Speaker 00:
And the Takasi publication teaches at 16020 that dipyridamol

[00:32:48] Speaker 00:
Also, when excluded, that's compound B, is not selective versus PDE2.

[00:32:54] Speaker 00:
And the fact of the matter is the reader is left completely at sea as to what is within the scope of the claim and what the molecules are, totally befuddled by this exclusion of things that are said to work at least for something.

[00:33:13] Speaker 00:
Without a reasonable number of examples or a structure function relationship, that doesn't work.

[00:33:21] Speaker 00:
The idea of, oh, it's flat.

[00:33:24] Speaker 00:
That's just like the antibody cases.

[00:33:26] Speaker 00:
Oh, it's a lock and key.

[00:33:28] Speaker 00:
That tells you how the thing has to conform in three-dimensional space.

[00:33:34] Speaker 00:
It doesn't tell you what molecular structures give you that.

[00:33:37] Speaker 00:
It just says, well, if it fits, it works.

[00:33:39] Speaker 00:
And if it works, it fits.

[00:33:40] Speaker 00:
And that's totally.

[00:33:41] Speaker 00:
And on the last point, the word selected.

[00:33:46] Speaker 03:
I mean, you and I can second guess this all day long.

[00:33:49] Speaker 03:
I mean, I'm not capable of truly understanding it to be able to be sure whether I'm second guessing it right.

[00:33:54] Speaker 03:
But the jury found what it found, and it's a fact finding.

[00:33:57] Speaker 03:
And the expert testified that based on the two in the spec, that was enough for a skilled artisan to understand the scope of what's covered by claim one.

[00:34:07] Speaker 03:
I mean, what do I do with that?

[00:34:08] Speaker 00:
Well, what you do with that is what the courts, this court, has repeatedly done.

[00:34:13] Speaker 00:
This is why this issue of written description is decided within the four corners of the patent.

[00:34:19] Speaker 00:
Because juries get confused.

[00:34:21] Speaker 00:
They get confused as they did in Ariad by Cade is giving some- Not the juries.

[00:34:24] Speaker 03:
Guess what?

[00:34:25] Speaker 03:
We get confused too.

[00:34:26] Speaker 00:
By giving superficial, oh, yes, it's described.

[00:34:30] Speaker 00:
Oh, you would recognize this.

[00:34:31] Speaker 00:
Oh, you would recognize that.

[00:34:33] Speaker 00:
That happens in all of these cases.

[00:34:34] Speaker 00:
And we listed in our brief all the cases where this issue has been resolved.

[00:34:37] Speaker 01:
But our court has held it's a question of fact, not a mixed question of fact and law question of fact.

[00:34:43] Speaker 01:
It is.

[00:34:44] Speaker 01:
And we haven't found necessary to change that.

[00:34:49] Speaker 01:
So that's the standard of review we're living under based on it being a question of fact.

[00:34:53] Speaker 00:
But it is a question of fact based on the four corners of the patent.

[00:35:00] Speaker 00:
wildly speculative research projects of finding things that work have been repeatedly struck down on JMOL and summary judgment for that reason.

[00:35:09] Speaker 00:
And if I can make one last point, the word selective should never be in this claim.

[00:35:14] Speaker 00:
It's not there.

[00:35:15] Speaker 00:
The parent application, the 061 patent, specifically had the word selective in it.

[00:35:21] Speaker 00:
This one doesn't have selective in it.

[00:35:23] Speaker 00:
It said it was selective for PDE 4 and or 5, meaning selective doesn't mean just one PDE.

[00:35:30] Speaker 00:
And there's certainly nothing that reads into that claim the 20-fold number that came out of an assay simply looking to determine what was there.

[00:35:42] Speaker 00:
So we think the claim is wrong as a matter of law, that there needs to be a new trial no matter what.

[00:35:47] Speaker 00:
Thank you very much.

[00:35:48] Speaker 01:
Thank you.

[00:35:48] Speaker 01:
We thank both sides in the case system.