[00:00:00] Speaker 03:
Good.

[00:00:26] Speaker 03:
Mr. Perry, I thought this was your fan club.

[00:00:49] Speaker 01:
What's going on?

[00:00:51] Speaker 01:
I'm a little disappointed, Your Honor.

[00:01:01] Speaker 03:
I'm sure Bill James is there.

[00:01:16] Speaker 03:
You too, Mr. Morton.

[00:01:21] Speaker 03:
I wrote a joint fan book.

[00:01:41] Speaker 01:
We're good.

[00:01:55] Speaker 01:
Thank you, Judge Wallach.

[00:01:56] Speaker 01:
May I please the court?

[00:01:58] Speaker 01:
During his deposition, Dr. Michael Weinblatt, Abbe's expert on the state of the art,

[00:02:05] Speaker 01:
was asked the following question and gave the following answer, and this is at page A1952.

[00:02:11] Speaker 01:
Question, would one have expected that treatment of RA, rheumatoid arthritis, as of August 1, 1995, might achieve significant examples of near remission in patients?

[00:02:26] Speaker 01:
Answer, I think it's unlikely back in 1995 that we would achieve that goal in patients with chronic rheumatoid arthritis.

[00:02:35] Speaker 01:
Later in his deposition, our client cleared this point up by asking, and Dr. Weinblatt agreed, and this is page A1964, a person of skill in the art, quote, could not have predicted at that time that near remission would have occurred in many patients.

[00:02:52] Speaker 01:
And in page A1965, quote, one of the surprises in this clinical trial was that many patients achieved a result which was near remission, end quote.

[00:03:03] Speaker 01:
These quotes from Dr. Weinblatt, this evidence is alone sufficient to require reversal of the summary judgment in this case.

[00:03:11] Speaker 01:
And let me explain why.

[00:03:13] Speaker 01:
The 120 patents, now before the court, was prosecuted after Dr. Weinblatt made this deposition.

[00:03:20] Speaker 01:
What was going on was Abbott was challenging the 442 patent, the first species patent.

[00:03:27] Speaker 01:
In discovery, Abbott presented its expert and Dr. Weinblatt's testimony, part of which I just read you,

[00:03:33] Speaker 01:
His testimony was this.

[00:03:35] Speaker 01:
He said, I, and therefore a person of skill in the art, in 1995 would have predicted a so-called Paulus 20 reduction, the standard reduction that was claimed in the 442, but I would not, and a person of skill in the art, would not have predicted.

[00:03:50] Speaker 04:
It was claimed in the 442?

[00:03:51] Speaker 01:
Your Honor, the 442 was described a significant reduction, and the disclosure said Paulus 20.

[00:03:57] Speaker 01:
It did not say Paulus 50.

[00:03:59] Speaker 01:
What was brought out in the deposition was that Dr. Weinblatt would have predicted a POLIS 20 reduction, but would not have predicted a POLIS 50 reduction.

[00:04:09] Speaker 01:
Therefore, the applicant, the patentee, Kennedy, went to the patent office, amended a pending application, and added claims specifically to claim POLIS 50 reduction, that's claim one, and near remission, that's claim 19.

[00:04:24] Speaker 04:
Your argument today is the 120 claims are

[00:04:30] Speaker 04:
patently distinct over the 766.

[00:04:32] Speaker 04:
Correct.

[00:04:33] Speaker 01:
Well, that's the ultimate ODP question.

[00:04:34] Speaker 04:
That's the ultimate ODP question.

[00:04:36] Speaker 04:
And now, but I guess the way this case has come up to us is flat or the softball.

[00:04:41] Speaker 04:
You're right, Your Honor.

[00:04:42] Speaker 04:
Whether the, essentially the issues that were litigated last year are essentially identical to what you're arguing today.

[00:04:53] Speaker 01:
That's correct, Your Honor.

[00:04:53] Speaker 01:
The district court before the evidence was even in,

[00:04:56] Speaker 01:
before the pleadings were closed, no evidence in the second case from our side or from Abbott's side.

[00:05:03] Speaker 04:
The starting point of trying to understand the relationship between this case and that case is on what I'll call a more general level.

[00:05:13] Speaker 04:
They share the same attributes in the sense that

[00:05:17] Speaker 04:
last time around, your client was trying to get a patent on a species in the sense that a smaller subset of even sicker patients that resulted and yielded an even higher, more beneficial result.

[00:05:34] Speaker 04:
And that's a little bit what's going on here in the sense that thematically,

[00:05:41] Speaker 04:
Those are the two limitations, again, that we're focused on here, where now you have more description of what that patient population is in the claim, and you have more detail about what the actual benefits that would be yielded from performing the method.

[00:05:59] Speaker 01:
Judge Chen is absolutely right.

[00:06:00] Speaker 01:
It is a narrower species of the 766 patent.

[00:06:03] Speaker 01:
And the question before this court in this appeal we submit is whether the invalidation of 442

[00:06:10] Speaker 01:
precludes us even from litigating the validity of the 120, because of course they are presumed to be separate, separately valid, they are separate claims, separately allowed, and what the district court's error here was was simply mapping the decision as to 442 onto 120 when the relevant, the whole disputed issue was what a person of skill in the art would have predicted, or unexpected results, right?

[00:06:36] Speaker 04:
Unexpected results, and in a sense, aren't we,

[00:06:40] Speaker 04:
Working in that same area again today, whether this particular species would be deemed to be unexpected results in the face of the 766 claim.

[00:06:52] Speaker 01:
We are, Your Honor.

[00:06:53] Speaker 04:
And last time around, the question was, was it appropriate to consider the T14 study that was disclosed and described in the specification

[00:07:05] Speaker 04:
to try to understand whether there was an unexpected result between the 442 species claim and the 766 more generic claim.

[00:07:14] Speaker 04:
And the answer is that grounds for unexpected results was rejected because what we saw was it wasn't unexpected given the fact that that was the very utility for the 766 claims.

[00:07:31] Speaker 04:
That was the basis for it, the T14 study.

[00:07:35] Speaker 04:
And so the question is, why this time around is it appropriate to look at the results of the T14 study to prove up unexpected results for this particular species in light of what was said in the last litigation?

[00:07:51] Speaker 01:
Because for two reasons, Judge Chen.

[00:07:53] Speaker 01:
First, this court in the last litigation did not foreclose all species claims.

[00:07:57] Speaker 01:
In fact, the opinion is quite clear that this is not one of those genuses that has

[00:08:01] Speaker 01:
every conceivable species was envisioned.

[00:08:04] Speaker 01:
And second, we have the testimony from the challenger's expert, this is a summary judgment case, testifying that this species, the species claimed in 120, was unexpected.

[00:08:14] Speaker 01:
That at that time, no person with skill in the art would have expected near remission.

[00:08:18] Speaker 01:
And when I stood at this podium a year ago and argued unexpected results, Judge Dyke pointed out three times, and I can give you the citations you like, that remission was not claimed in 442, which is absolutely right.

[00:08:29] Speaker 01:
We went back to the patent office and we claimed near remission in 120.

[00:08:33] Speaker 01:
And that is a significant difference because of Dr. Wineblast's testimony.

[00:08:38] Speaker 05:
Can I ask if I could see if I understand the point?

[00:08:43] Speaker 05:
In the last case, the question was whether a dosage necessary for even reduction, because the 442 claim says reduce or eliminate.

[00:08:55] Speaker 01:
Correct.

[00:08:55] Speaker 05:
Was non-obvious.

[00:08:59] Speaker 05:
unexpected in light of a claim to something therapeutically effective.

[00:09:04] Speaker 05:
The question here is whether a dosage that produces big and long lasting effects is non-obvious, unexpected in light of a claim to therapeutically effective.

[00:09:17] Speaker 05:
And those are different questions.

[00:09:19] Speaker 05:
And therefore no issue preclusion.

[00:09:22] Speaker 05:
And then you can litigate the question whether this new claim is in fact

[00:09:26] Speaker 05:
obvious or not in light of therapeutically.

[00:09:29] Speaker 01:
Absolutely right, Your Honor.

[00:09:30] Speaker 01:
And the reason for that is the testimony of Abbott's expert, Dr. Weinblatt.

[00:09:35] Speaker 01:
And in the first trial, Judge Chen and Judge Toronto, the district court issued this 107 page, 410 paragraph, 32 footnote opinion in which the word remission nowhere appears.

[00:09:47] Speaker 01:
So the unexpected result of remission

[00:09:49] Speaker 01:
was never examined in the first place.

[00:09:51] Speaker 05:
Can I just try to be precise about one thing?

[00:09:55] Speaker 05:
I use the term dosage because if, I guess I have in mind the background principle that mere new results, even spectacular new results from old steps don't create anything patentable.

[00:10:10] Speaker 05:
So this has to be a dosage necessary to produce the big and long lasting effects.

[00:10:16] Speaker 01:
Dosage may be a little imprecise.

[00:10:18] Speaker 01:
It is actually the administration of the claimed combination, including the antibody that binds to the particular site.

[00:10:24] Speaker 05:
In some language, like in amounts, et cetera?

[00:10:26] Speaker 01:
Yes, Your Honor.

[00:10:27] Speaker 01:
The easiest way to look at it is the chart.

[00:10:29] Speaker 05:
If you were doing exactly the same physical thing, it wouldn't matter what the results were.

[00:10:34] Speaker 01:
That's correct.

[00:10:35] Speaker 01:
Well, yes.

[00:10:37] Speaker 01:
Here, we are claiming a very specific method, much more specific than the 766.

[00:10:43] Speaker 01:
in a particular patient population.

[00:10:45] Speaker 05:
I'm putting aside patient population, everything except the big and long-lap.

[00:10:50] Speaker 01:
To achieve this particular result, that's right.

[00:10:52] Speaker 01:
And the binding effect of the antibody, which is claimed in claim 1 and claim 19, was not claimed in claim 766.

[00:11:01] Speaker 01:
In other words, it has been narrowed on each of those vectors in a way, again, that Abbott's expert testified would not have been expected.

[00:11:08] Speaker 04:
He didn't rely on that here, though, right?

[00:11:14] Speaker 04:
the chain of reactions that happen in terms of what binds to what?

[00:11:22] Speaker 01:
Well, we did, Your Honor.

[00:11:23] Speaker 01:
The district court said it makes no difference.

[00:11:24] Speaker 01:
The district court went through each of the three differences and said, this makes no difference, we've already litigated it.

[00:11:30] Speaker 01:
And it was just wrong on all of these, Your Honor.

[00:11:32] Speaker 01:
It says, for example, that the court already determined that the 442 claims did not yield unexpected results.

[00:11:40] Speaker 01:
Well, that's true.

[00:11:42] Speaker 01:
That was what this court affirmed.

[00:11:43] Speaker 01:
But the court never determined whether the 120 claim achieved unexpected results.

[00:11:47] Speaker 01:
And our whole point in a collateral estoppel case, it's simply too glib and too flip to say it's deja vu all over again, as my friend Mr. Morin does.

[00:11:55] Speaker 01:
What we have to do is look at the actual claims.

[00:11:57] Speaker 01:
And here we have claims allowed by the office during this litigation.

[00:12:01] Speaker 01:
We submitted all the briefs, all the trial transcripts, all the public documents from this litigation to the patent office.

[00:12:08] Speaker 01:
and got those narrowed claims specifically in light of the arguments that Abbott was making against the 442.

[00:12:14] Speaker 01:
Because remember, the first time around, what Abbott tried to do was broaden the 442 so that it maps straight onto the 766 and said these are essentially the same thing.

[00:12:22] Speaker 01:
That was a successful strategy.

[00:12:24] Speaker 01:
While they were trying that strategy, we went and said, okay, let's get a very narrow patent, a very, very narrow patent, which is the 766.

[00:12:31] Speaker 01:
Claim 19 of the 766 is very narrow.

[00:12:34] Speaker 04:
But in the end, I thought that the last litigation ultimately held that

[00:12:40] Speaker 04:
You can't rely on the results of the T14 study disclosed and described in 766 to establish unexpected results for those claims.

[00:12:49] Speaker 04:
And so I'm trying to understand why on this go around to the 120 claims, it's okay to rely on the information and the results of the T14 study for unexpected results.

[00:13:04] Speaker 01:
Your Honor, we have to rely on the T14 study because all the claims have to be supported by the specification.

[00:13:09] Speaker 01:
It's a common specification because it's a continuation patent.

[00:13:13] Speaker 01:
We are not relying on T14.

[00:13:14] Speaker 01:
T14 is the results.

[00:13:16] Speaker 01:
The factual question for 120 is, were those results unexpected as of August 1, 1995?

[00:13:23] Speaker 01:
The answer given by Abbott's expert, the factual answer, this is a grand inquiry, this is a factual inquiry.

[00:13:28] Speaker 04:
This is unexpected in light of the claims in 766.

[00:13:32] Speaker 01:
Yes, Your Honor.

[00:13:33] Speaker 04:
And the utility and the basis for the 766 claims is the very same information in the T14 study.

[00:13:43] Speaker 04:
That's ultimately what we arrived at last year.

[00:13:46] Speaker 01:
Well, that's what you arrived at as a patient population.

[00:13:48] Speaker 01:
The court never considered unexpected results as to outcome, patient outcome, which is why Dr. Weinblatt's testimony is so critical.

[00:13:56] Speaker 01:
Which my friend doesn't want to talk about.

[00:13:58] Speaker 01:
They address it in one sentence at their brief, page 52 and 53, and all they say is, well, he was talking about something else.

[00:14:03] Speaker 04:
But I thought in the last opinion we did look at it in terms of efficacy and improved health.

[00:14:08] Speaker 01:
You're only at the significant reduction, Your Honor, and because 766 claimed that the way that the court construed the 766 claim of therapeutic benefit was a significant reduction, which was what was claimed in 442, they were the same.

[00:14:20] Speaker 01:
Here what's claimed is,

[00:14:22] Speaker 01:
near-emission or Paulus 50.

[00:14:24] Speaker 01:
Absolutely not claimed.

[00:14:25] Speaker 04:
In fact, if you look at the undisputed facts in this case... Not recited in the 442 claim.

[00:14:29] Speaker 04:
Correct.

[00:14:30] Speaker 04:
But nevertheless, that is, again... Supported by the same specification.

[00:14:34] Speaker 04:
Information from the T14 set.

[00:14:37] Speaker 01:
But if that's the answer, Your Honor, then you could never have a species claim in a continuation patent because it always has to be supported by the specification.

[00:14:43] Speaker 01:
And the court also ruled in that same opinion that a genus patent does not preclude a species patent, which has always been the law.

[00:14:49] Speaker 01:
And the question is whether this species, the 120 species, is one that would have been envisioned by a person of skill and the art at the time.

[00:14:56] Speaker 01:
The court said one thing as to 442, we submit there's a different answer for 120.

[00:14:59] Speaker 04:
I don't think the opinion last year necessarily foreclosed any reliance on any aspect of the spec.

[00:15:06] Speaker 04:
But what it did talk about is for this particular case, this particular section of the patent, it's not going to be permitted to use that to establish unexpected results over the 766 claim, especially given that this is the very study that your client relied on in prosecution history to overcome a rejection, to get the 766.

[00:15:34] Speaker 01:
And to get the 120 on precisely this point, because let me try it this way, Judge Chen.

[00:15:39] Speaker 01:
The results are what the results are.

[00:15:40] Speaker 01:
It's a clinical study.

[00:15:41] Speaker 01:
The question is whether those results would have been expected by a person of skill in the art.

[00:15:45] Speaker 01:
As an issued patent, it's Abbott's burden to prove by clear and convincing evidence that a person of skill in the art in August of 95 would have expected the T14 results.

[00:15:55] Speaker 04:
You're down to a minute, Mr. Perry.

[00:15:56] Speaker 01:
Dr. Weinblatt testified that he and others would not have, and that's enough to get his past summary judgment and a trial

[00:16:02] Speaker 01:
All we want is a trial to prove these points.

[00:16:05] Speaker 01:
You and I are discussing the merits of the case, which the judge cut off on McLeod or Elstaffer, really.

[00:16:11] Speaker 01:
Thank you.

[00:16:26] Speaker 00:
Go ahead, Mr. Moran.

[00:16:27] Speaker 00:
May it please the court, Michael Moran, on behalf of ABVI.

[00:16:31] Speaker 00:
But the starting point for the collateral stopper analysis is to compare the claims of the 442 patent, which this court has already determined to be invalid, with the claims of the 120 patent to determine what, if any, differences that there are.

[00:16:45] Speaker 00:
Kennedy here has alleged two differences.

[00:16:47] Speaker 00:
First, they say that the 120 claims, the new claims, are directed to a sicker patient population.

[00:16:54] Speaker 00:
And second, they say that they require improved efficacy.

[00:16:57] Speaker 00:
And this is the remission thing.

[00:16:59] Speaker 00:
that Mr. Perry has talked about.

[00:17:02] Speaker 00:
But before we talk about these two alleged differences, and I'll get into those in some more detail and answer also the remission point, I think it's imperative to focus the court on something Judge Toronto asked about, which is what's the same between the two patents.

[00:17:17] Speaker 00:
And that is that it is undisputed that when comparing these two patents, that in this new patent, the one that's been invalidated now by the district court, it is the exact same method

[00:17:29] Speaker 00:
of treating patients with the exact same disease that they're trying to get again.

[00:17:35] Speaker 05:
But I guess that's what I take, in fact, the claim not to be.

[00:17:39] Speaker 05:
That is, the amounts, or is it the amounts used?

[00:17:43] Speaker 05:
The doses, multiple doses.

[00:17:47] Speaker 05:
I infer that, in fact, different amounts may be required for the much better results.

[00:18:00] Speaker 00:
No, Your Honor, with due respect, I disagree.

[00:18:03] Speaker 05:
How do we know?

[00:18:03] Speaker 05:
How do we know that?

[00:18:04] Speaker 00:
And when you look at the claims themselves, they claim the same... That's what I'm doing, looking exactly at the claims.

[00:18:08] Speaker 05:
Right, they claim the same methods of treatment as... But they claim it in terms of doses wherein a certain result occurs.

[00:18:17] Speaker 05:
So that result may require a different dose from doses wherein there's a reduces or eliminates effect, mere reduction.

[00:18:28] Speaker 00:
Your Honor, two responses to that.

[00:18:30] Speaker 00:
Number one is I don't think that was ever the argument below that there's a difference in the dosing amount.

[00:18:35] Speaker 05:
They're just claiming a difference in effect.

[00:18:37] Speaker 05:
But you also have not made the argument that the effect, the efficacy is completely irrelevant to patentability because if you're doing the same thing, it doesn't matter if you say, wow, what a great effect.

[00:18:50] Speaker 05:
We've always been doing that.

[00:18:51] Speaker 00:
With due respect, Your Honor, I think that we have said that exactly.

[00:18:55] Speaker 00:
If you look at our citations, for example, Your Honor, in the brief,

[00:18:58] Speaker 00:
to the King Pharmaceutical case or to the BMS case, both of those cases stand for the proposition that if you go and you claim the same method that's already present in the prior art, then that is not, even if you claim better results, even if you claim something better happens out of it, that that is not a basis for patentability.

[00:19:14] Speaker 00:
But I would say one step beyond that, Your Honor, is that there is no question that they have tied these results of supposed remission in the previous litigation and litigated all these issues already.

[00:19:25] Speaker 00:
If I look at their blue brief,

[00:19:26] Speaker 00:
from the Kennedy I case, Your Honors, the blue brief from the last appeal that was before you all, they argued seven times that the natural result of practicing the claims that you've invalidated, the 442 patent, is remission.

[00:19:39] Speaker 00:
And I'll quote from page 58 from their blue brief in the Kennedy I case.

[00:19:43] Speaker 00:
Quote, Kennedy adduced evidence, extensive and unrebutted evidence that patients receiving the claim therapy, that's the therapy of the 442 patent that you've already invalidated,

[00:19:55] Speaker 00:
experience relief of signs and symptoms sufficient to approach disease remission.

[00:20:02] Speaker 00:
They have already said that it's the same method that you get disease remission by practicing the claims of the 442 patent.

[00:20:09] Speaker 00:
That's the same patent that this court has already invalidated.

[00:20:13] Speaker 00:
What it boils down to, Your Honor, is that the two differences that they allege, and this is even what they, they don't allege a difference in the method, Your Honor.

[00:20:20] Speaker 00:
If you look at their blue brief,

[00:20:22] Speaker 00:
In this case, let's turn to the blueprints in this case.

[00:20:25] Speaker 04:
The method steps of the 4-4-2 have different?

[00:20:28] Speaker 04:
I see Judge Toronto focusing on the 120 Claim-1 about multiple doses of the antibody.

[00:20:38] Speaker 00:
Yes.

[00:20:38] Speaker 04:
And then multiple doses of the methotrexate.

[00:20:44] Speaker 04:
Was that the same pattern of steps that was

[00:20:50] Speaker 04:
was recited in the 442?

[00:20:52] Speaker 00:
Absolutely, Your Honor.

[00:20:53] Speaker 00:
If you look at Claim 2, for example, methotrexate is given weekly.

[00:20:57] Speaker 00:
That's how the drug is administered.

[00:20:58] Speaker 00:
There's no dispute on that issue.

[00:21:00] Speaker 00:
If you look at Claim 2 of the 442 patent, I'm looking at A93 in the appendix.

[00:21:06] Speaker 00:
Claim 2 that's been invalidated is the method of Claim 1 where the antibody, the TNF antibody or fragment thereof, is administered multiple times.

[00:21:15] Speaker 00:
And that's an interval of a week or weeks.

[00:21:17] Speaker 00:
So there's that multiple dosing step.

[00:21:19] Speaker 00:
Moreover, the evidence was presented last time.

[00:21:21] Speaker 00:
This is not a new issue.

[00:21:22] Speaker 00:
But in terms of the dosing amounts, Your Honor, Judge Tarano, if you look at claim one, for example, as we talked about last time, it is a dose that would cover any possible dosings of 0.01 to 100 milligrams per kilogram.

[00:21:36] Speaker 00:
All of those claims have already been invalidated.

[00:21:39] Speaker 00:
The only alleged difference in these claims that's raised on appeal here is twofold.

[00:21:44] Speaker 00:
And if you look at their table of contents,

[00:21:47] Speaker 00:
In their blue brief, you will see that.

[00:21:49] Speaker 00:
The two differences, according to them, are A, patient population, and B, efficacy.

[00:21:53] Speaker 00:
They label them that way.

[00:21:55] Speaker 00:
They characterize them.

[00:21:55] Speaker 00:
There's no difference in the method.

[00:21:57] Speaker 00:
If you look at, I think it's little i, which is their table of contents and how they characterize everything, and it's carried through to the rest of the brief as well, what you will find is that there's two differences that they say.

[00:22:08] Speaker 00:
Patient population and the efficacy of the treatment, not a difference in the treatment.

[00:22:13] Speaker 00:
When you turn to patient population, the first one, your honors,

[00:22:16] Speaker 00:
I think that we've been pretty clear on the record that given that this court invalidated the 442 patent claims under the precise definition of active disease that's now in the 120 patent claims, that there is no difference in the patient population between the invalidated claims and the claims at issue here.

[00:22:37] Speaker 00:
That leaves only one difference.

[00:22:38] Speaker 00:
And that one difference is the alleged difference in efficacy.

[00:22:43] Speaker 04:
way of concluding that because the results have been claimed differently more precisely here with the 120 claims that that demands or commands that the method steps be performed perhaps differently or that there's now a distinction in how you do the method steps?

[00:23:02] Speaker 00:
I would say the answer is no in multiple respects.

[00:23:04] Speaker 00:
First of all, there's no difference in what's set forth in the claims.

[00:23:08] Speaker 00:
in terms of the method steps.

[00:23:09] Speaker 00:
So the method is not claimed any differently.

[00:23:12] Speaker 05:
The point that I keep having in my head is when it says give amounts that produce terrific effects, those might actually be different amounts from when the earlier patent said give amounts that may produce pretty nice effects.

[00:23:33] Speaker 05:
There is a possible physical difference in the steps performed.

[00:23:40] Speaker 00:
In theory, I understand what you're saying, that different methods could yield different results.

[00:23:45] Speaker 00:
I would say three things.

[00:23:46] Speaker 00:
Number one is, the difference in method isn't claimed.

[00:23:49] Speaker 00:
If you're comparing two claims and you looked at it from an anticipation analysis, all the steps of the method are the same.

[00:23:55] Speaker 00:
But the two other important things are, first of all, going to the T14 study,

[00:24:00] Speaker 00:
In order to get their first patent, the 766 patent allowed in the first place, they relied on the same results.

[00:24:07] Speaker 00:
And they said those results were commensurate with the first patent that they already achieved, the 766 patent.

[00:24:14] Speaker 00:
They did not just look, for example, at the 20 percent Paulus criteria.

[00:24:18] Speaker 00:
They cited to the entirety of example one.

[00:24:20] Speaker 00:
And they did not just look, for example, at table two, which was 20 percent Paulus criteria.

[00:24:25] Speaker 00:
They specifically cite the Table 4.

[00:24:28] Speaker 00:
They link these results to the first patent that died a natural death after 20 years.

[00:24:33] Speaker 00:
Having gotten the first patent by saying that those are the results that you get from co-administration generally, and that's the patent that died a natural death and that we paid royalties under, they can't then come back and say, hey, we're getting largely different results here.

[00:24:47] Speaker 00:
As a matter of fact, and this is in the record, Your Honor, and we cite to it,

[00:24:51] Speaker 00:
When they got the first patent allowed in the first place, the 766 patent, they said these are the results that you would get from the practice of this method, co-administration generally, with the entire patient population.

[00:25:03] Speaker 00:
Having done that and having already relied and said that you get this results with the broader patent, the one that has expired at this point in time, their first patent to this method, they can't now double-dip and say you didn't get those results in the first place.

[00:25:15] Speaker 05:
I think the argument you just made in the last two minutes is a

[00:25:19] Speaker 05:
straight obviousness type double patenting argument, not a collateral estoppel argument.

[00:25:24] Speaker 00:
I disagree, Your Honor, for two respects.

[00:25:26] Speaker 00:
One is all of these aspects of remission and 50% were heavily in front of both the district court and this court the last time around when the district court and this court found that those were not unexpected results, that there were no unexpected results.

[00:25:41] Speaker 05:
The second reason is that the issue...

[00:25:44] Speaker 05:
Those two things that you just said at the end are different.

[00:25:46] Speaker 05:
The only question actually before the court last time was whether what the 442 said was unexpected and what the 442 said included mere reduction.

[00:26:00] Speaker 05:
So even if there were other arguments being made,

[00:26:05] Speaker 05:
The resolution of those arguments, which is actually not explicit, was not, whatever else it is, necessary to the resolution of the 442 question because that doesn't claim remission or its equivalent.

[00:26:18] Speaker 00:
I actually disagree with your respect, Your Honor, for two respects.

[00:26:21] Speaker 00:
One is that both the district court and this appellate court, they relied on the so-called unexpected results that were set forth in the specification.

[00:26:29] Speaker 00:
to try to support the claims.

[00:26:30] Speaker 00:
Of course, patentees often will rely on unexpected results that are not specifically set forth in the claims.

[00:26:36] Speaker 00:
And they say these are unexpected or surprising results.

[00:26:39] Speaker 00:
They did that.

[00:26:39] Speaker 00:
They did that at the district court with 50% and with remission repeatedly.

[00:26:44] Speaker 00:
They did that in front of this court, like I mentioned, seven different times.

[00:26:47] Speaker 00:
This court rejected the notion that there were any unexpected results associated with the practice of the claims of the 442 patent.

[00:26:55] Speaker 00:
I've also read you from their Blue Breeze the last time around.

[00:26:58] Speaker 00:
how they said that remission was the natural result of claiming, of practicing the 442 patent.

[00:27:04] Speaker 00:
Given that they've said that, all they're trying to do is patent the same exact method once again, just by specifying the results in slightly different ways.

[00:27:12] Speaker 00:
If this were allowable, Judge Toronto, one could get around collateral stopple and case after case after case by simply the first time claiming 20% policy, and the next time you say at least 25%, and the next time you say at least 30%.

[00:27:26] Speaker 00:
And you keep claiming the same method again and again and again.

[00:27:29] Speaker 00:
And each time that you'd ask me the question, hey, we haven't evaluated 30% yet, you'd have to go back and you'd have to do it all over again.

[00:27:36] Speaker 00:
That is not what the law requires intercollateral estoppel.

[00:27:40] Speaker 00:
What the Bourns case says is you don't do it with the 19th century aspects of a textbook.

[00:27:45] Speaker 00:
You do it with realism and pragmaticism.

[00:27:48] Speaker 00:
And what's happening here is that they keep claiming the same method again and again and again.

[00:27:53] Speaker 00:
With respect to Dr. Weinbach's testimony that he wouldn't have expected the results at the time, that may be why they got the 766 patent in the first place, which they also based on those same results.

[00:28:04] Speaker 00:
When he looked at that and he said, I wouldn't have expected such great reactions at the time, that obviously wasn't in the context of reading the T14 study.

[00:28:12] Speaker 00:
And the imperative point, and really the only point that you need to look at to answer this entire question in this case, is that this court has already determined dispositively

[00:28:22] Speaker 00:
that you are entitled to look at the T14 study when you're looking at the obviousness of the claims and that that can't be a basis of non-obviousness.

[00:28:31] Speaker 00:
And given that that is the case, it ends the inquiry here.

[00:28:35] Speaker 00:
They're relying on the exact same study.

[00:28:42] Speaker 00:
And let me point out where that's true, Your Honors.

[00:28:45] Speaker 04:
If you look at their briefs, for example, and you have any question- When I was up there, I never put water near my work.

[00:28:53] Speaker 00:
Yes, thank you.

[00:28:54] Speaker 00:
Appreciate that, Your Honor.

[00:28:56] Speaker 00:
And if you have any question that they're doing the exact same thing that this court said you couldn't do the last time around in Kennedy 1.

[00:29:01] Speaker 00:
In Kennedy 1, you said you can't distinguish the obviousness of the second patent based on the T14 study, example 1 of the first patent.

[00:29:09] Speaker 00:
The court said that flat out.

[00:29:11] Speaker 00:
If there's any question that they're relying on the exact same data, again, which you cannot use to distinguish obviousness... Sorry, for a different proposition.

[00:29:19] Speaker 05:
I would say, but they're looking at the exact same data, though, and if it's permissible... The question is what you're using it for.

[00:29:27] Speaker 00:
I'm not sure that that's the issue.

[00:29:29] Speaker 00:
They've already used that same data from the T14 study to get the 766 patent allowed in the first place.

[00:29:35] Speaker 00:
Once they've relied on that same data, for them to go back in and act like these are surprising new results or non-obvious species within the genus has already been ruled out in the Kennedy I case.

[00:29:46] Speaker 00:
In the Kennedy I case, the court said, quote, to determine the question of obviousness, we must necessarily look at the 766 patent disclosures

[00:29:56] Speaker 00:
to assess what results were expected at the time that the 766 application was filed.

[00:30:01] Speaker 05:
Did the court in the 2014 case rule out a case of unexpected results that relied on a combination of the T14 study plus your experts' admissions, assuming that those are properly characterized?

[00:30:16] Speaker 05:
Just assume that.

[00:30:17] Speaker 00:
Well, first of all, his admissions are only... I don't want to... Okay.

[00:30:21] Speaker 05:
But it's not the same record, right?

[00:30:25] Speaker 05:
court ruled on in 2014.

[00:30:27] Speaker 00:
It was certainly the same available record.

[00:30:29] Speaker 00:
Dr. Weinblatt testified in that trial after his deposition.

[00:30:33] Speaker 00:
They had the entire record available in front of them.

[00:30:36] Speaker 00:
And Dr. Weinblatt testified in that case.

[00:30:37] Speaker 00:
But I think the Weinblatt testimony must be seen as a sound bite that my friend is using at the beginning of his argument, but can't be meaningful.

[00:30:46] Speaker 00:
When our expert, Dr. Weinblatt, has asked whether you would expect that time of result remission in that time frame, it's obviously in the context of not

[00:30:54] Speaker 00:
looking at the T14 study.

[00:30:56] Speaker 00:
Once you look at the T14 study, which permitted them their first patent in the first place, the 766 patent in the first place, then of course, reading the results of the study, you would anticipate the results of the study.

[00:31:08] Speaker 00:
It's tautologically correct.

[00:31:10] Speaker 00:
Once they've set forth the data in the T14 study, if you're allowed to consult that, which this court already said in Kennedy 1,

[00:31:18] Speaker 00:
Because that was the utility for which they established 766 patent in the first place.

[00:31:22] Speaker 05:
Can I ask you this question?

[00:31:24] Speaker ?:
Please.

[00:31:26] Speaker 05:
So there's a very strong background rule for, I think, pretty obvious reasons that says material in the specification of patent number one, if never before published, isn't prior art, and that can't be used.

[00:31:42] Speaker 05:
The 2014 case, the predecessor case of this one, comes along and says,

[00:31:46] Speaker 05:
Well, there's an exception to that for utility.

[00:31:50] Speaker 05:
Now, because of the way the 442 patent was written to cover any reduction, it seems to me, like your reaction, that this board did not have to parse more finely what the scope of its utility exception was, whether it was enough to establish

[00:32:13] Speaker 05:
sufficient utility for the 776-766 to have been patentable, or whether it was the full content of the specification set out T14 study with all of its details, much of which was not necessary to establish utility.

[00:32:36] Speaker 05:
Why is, and I think you're making the argument, the full study

[00:32:40] Speaker 05:
gets to be looked at.

[00:32:41] Speaker 05:
Why is that a sensible doctrinal definition of an exception to a background principle of what is, after all, not prior art?

[00:32:51] Speaker 00:
And I see you're out of time.

[00:32:52] Speaker 00:
I assume it's OK.

[00:32:53] Speaker 00:
It's a long question.

[00:32:55] Speaker 00:
OK.

[00:32:56] Speaker 00:
Your Honor, there's two answers.

[00:32:57] Speaker 00:
Number one is Kennedy, in order to get its first patent allowed, and that's what Dr. Weinblatt was talking about, looked broadly to the T14 study.

[00:33:07] Speaker 00:
Throughout the prosecution history, for example,

[00:33:09] Speaker 00:
It pointed not only to table two, it pointed to table four, which is the 50% policy.

[00:33:14] Speaker 00:
It said that these are the results that are gotten generally from the 766 patent.

[00:33:20] Speaker 00:
I think when the court talks about whether or not you're gonna decide whether there are obviousness differences, and it talks about the ability to rely on the T14 study, it is true that it leaves open the question, for example, of whether an example three or some other example that wasn't relied on to establish utility of the first patent in the first place,

[00:33:39] Speaker 00:
whether or not you could look at those.

[00:33:41] Speaker 00:
But I think with due respect, the court knows what it wrote here, but I think reading the decision, it is pretty clear that it says having relied on the T14 study, you're allowed to look at that study to discuss what the anticipated results of practicing the method would be.

[00:33:56] Speaker 00:
The second aspect I would answer to that is

[00:33:59] Speaker 00:
It was true that there was narrowing in the results from the 766 to the 442 patent.

[00:34:06] Speaker 00:
So they said you're even allowed to look at it when you're claiming slightly better results in the end of the day.

[00:34:11] Speaker 00:
And the third thing is to answer a question that Judge Chen asked relevant to that.

[00:34:16] Speaker 00:
The court did not only say that you could look at the T14 study, for example, in the question of the patient population.

[00:34:23] Speaker 00:
The court also specifically said you can look at the specification

[00:34:26] Speaker 00:
for what you would expect the results of the efficacy could be, and that's in footnote eight of the decision when you talk about the reduction of signs and symptoms.

[00:34:35] Speaker 00:
And the court specifically said we go to the specification of the 766, and we see there that it says the practice of this method is expected to reduce the signs and symptoms.

[00:34:44] Speaker 00:
That's footnote eight.

[00:34:46] Speaker 00:
There is no difference other than we're changing the patent numbers from 442 to 120, and other than we're changing the words in which the result is described,

[00:34:54] Speaker 00:
between the 442 and the 120, there's no difference between these cases, which is where I maybe somewhat glibly say it's deja vu all over again.

[00:35:02] Speaker 00:
We're just changing out the patent numbers and saying it's the same result that they're claiming again and again.

[00:35:08] Speaker 00:
If I may, Your Honor, in the end of the day, if you were going to permit this type of thing, we could go on endlessly by claiming the same method again and again, and each time giving them another bite at the apple just by slightly narrowing it.

[00:35:19] Speaker 00:
That's not what the law permits.

[00:35:20] Speaker 00:
All of these issues have been heard already and decided by the district court.

[00:35:24] Speaker 00:
and by this Court last year.

[00:35:26] Speaker 03:
Thank you, Your Honors.

[00:35:36] Speaker 01:
Thank you, Judge Wallach.

[00:35:39] Speaker 01:
As to the last point, we did not arbitrarily pick the claims of the 120 patent.

[00:35:43] Speaker 01:
They came from Dr. Weinblatt's testimony.

[00:35:46] Speaker 01:
He testified

[00:35:47] Speaker 01:
that it was unexpected to have Paulus 50 and near remission.

[00:35:50] Speaker 01:
We claimed what he testified, Abbott's expert testified, was unexpected.

[00:35:57] Speaker 04:
Just to be clear, that wasn't in the context of having knowledge of the T14.

[00:36:02] Speaker 01:
That's absolutely wrong, Judge Chen.

[00:36:05] Speaker 01:
Dr. Weinblatt was retained by Abbott in this lawsuit to study the specification of the 7.6 patent and testify about the obviousness of 4.4.2.

[00:36:17] Speaker 01:
professional job he had was to testify about the T14 study and his testimony was 442 is obvious, 120 is not.

[00:36:25] Speaker 01:
That's the summary of his testimony.

[00:36:27] Speaker 01:
All of these explanations that Mr. Moran just offered, well the one sentence of explanation he just offered here in his brief, they could argue that at trial but there's no evidence on it.

[00:36:36] Speaker 04:
The only thing we have in the record...

[00:36:41] Speaker 04:
merits of the 120.

[00:36:43] Speaker 01:
No your honor he in testifying about the 442 there's nobody has testified about the 120 claims because the court entered this summary judgment order before any discovery was going to be we would go back and but but for Mr. Moore to say it was not about the t14 study is wrong because dr. Weinblatt's job was to study the t14 that was all in this patent.

[00:37:02] Speaker 01:
Judge Toronto the t14 to get to that

[00:37:04] Speaker 01:
Not all doses, not all outcomes in the T14 resulted in the 120 outcomes.

[00:37:09] Speaker 01:
For example, there was a one milligram dosage studied that did not result in remissions.

[00:37:14] Speaker 01:
It was only multiple dosing at higher outcomes.

[00:37:18] Speaker 01:
And the 442 patent, for example, claims single dosing.

[00:37:20] Speaker 01:
In fact, much of the debate we had last time I was here, we were both here, was about single administration, whether that qualified as adjunctive and so forth.

[00:37:27] Speaker 01:
120 explicitly claims multiple and explicitly claims a sufficient dose to create these

[00:37:34] Speaker 01:
unexpected results.

[00:37:36] Speaker 01:
Judge Chen, as to this prior decision, I think it's fair to read page 1380, including footnote 8 on the previous page, to say the court was looking at the specification to define the patient population as allowed and utility in the context of that.

[00:37:51] Speaker 01:
And there's a statement here, for example, that the results in the T14 demonstrate that a sicker patient would get better results.

[00:37:59] Speaker 01:
That's correct.

[00:38:00] Speaker 01:
What the court did not say and could not have said consistently with the ODP doctrine

[00:38:04] Speaker 01:
is that a person of skill in the art necessarily envisioned every outcome that might be within this specification.

[00:38:12] Speaker 01:
And what we have here is the unanswered question of what a person of skill in the art would have expected as those narrower things that were not claimed in 442.

[00:38:21] Speaker 01:
Again, as Judge Dyke pointed out last time.

[00:38:22] Speaker 01:
Now, Mr. Moran's.

[00:38:25] Speaker 05:
Can you address the, I guess, I'll call it the policy point that Mr. Moran made about

[00:38:32] Speaker 05:
a seemingly endless succession of potential claims, small and different, but all of them supported by the very same material that appeared in patent number one.

[00:38:49] Speaker 01:
Blackwater law says the initial granting allowance of a genus claim does not foreclose later species claims that have to be supported by the same specification.

[00:38:57] Speaker 01:
So that policy argument has already been resolved by this court for the last 100 years.

[00:39:01] Speaker 01:
And this court, in the last decision, wrote that in.

[00:39:05] Speaker 01:
A genus claim does not foreclose a species claim.

[00:39:07] Speaker 01:
As to the specific what's the line, here we have the 120 patent that is based on objective criteria known in the art.

[00:39:15] Speaker 01:
Paulus 20 versus Paulus 50 was what was used by clinical researchers.

[00:39:18] Speaker 01:
Remission.

[00:39:19] Speaker 05:
I'm just going to think about that.

[00:39:21] Speaker 05:
But the genus species point is not in any way limited to cases in which the support for the species was in the original claim, is it?

[00:39:32] Speaker 01:
It is in the ODP context because the second patent always has to, in a continuation application, always has to be supported by the same specification as the original patent.

[00:39:41] Speaker 01:
You can't change the specification.

[00:39:43] Speaker 05:
but establishing the expected results or not.

[00:39:46] Speaker 01:
That's the point.

[00:39:47] Speaker 01:
That is the point of inflection.

[00:39:49] Speaker 05:
External evidence.

[00:39:50] Speaker 01:
That requires external evidence.

[00:39:51] Speaker 01:
It requires expert evidence.

[00:39:53] Speaker 01:
We had a four-day trial last time, and the court wrote in footnote 12, the district court, in the last opinion that he credited Weinblatt rather than Lipski, our expert.

[00:40:02] Speaker 01:
So this time around, we said, OK, what does Weinblatt say about this new claim?

[00:40:07] Speaker 01:
And Weinblatt says, it's not expected.

[00:40:09] Speaker 01:
And that's the difference.

[00:40:11] Speaker 01:
The chain of genus versus species, you always have to be supported by the same specification.

[00:40:15] Speaker 01:
You always have the evergreening concern in the abstract.

[00:40:19] Speaker 01:
The question is, as this court wrote in the last opinion, is this species, the particular species being studied, one that would necessarily have been envisioned by a person of skill in the art, knowing everything that they knew as of August 1, 1995?

[00:40:32] Speaker 01:
We know the answer to that question.

[00:40:33] Speaker 01:
We know the answer to that question because we asked Abbott's expert, and he answered, thank you, and you know what he answered.

[00:40:40] Speaker 01:
Thank you Judge Welch.

[00:40:42] Speaker 01:
Thank you counsel.