[00:00:00] Speaker 01:
focused on generalized statements of uncertainty in the prior art, it excluded specific teachings of what would happen that pointed to reasonable expectations.

[00:00:10] Speaker 01:
Now here's the problem, none of the general statements of uncertainty accounted for the specific teachings in Kono Pleba and Lapidot

[00:00:18] Speaker 01:
as to how the gold standard, GCSF, worked to mobilize stem cells.

[00:00:24] Speaker 01:
And they couldn't have, because most of these references were published before Lapidome and Conepleva.

[00:00:29] Speaker 01:
And the ones that were published contemporaneous with it did not mention those teachings whatsoever.

[00:00:36] Speaker 01:
So it was both factual error, because the court didn't recognize the teachings of Lapidome and Conepleva.

[00:00:42] Speaker 01:
But more importantly, it was legal error, because this court has made clear that it's inappropriate

[00:00:47] Speaker 01:
to not consider the specific teachings in prior art and give more credence to generalized teachings of uncertainty.

[00:00:54] Speaker 02:
Didn't Lapidose say that the science behind stem cell mobilization is poorly understood?

[00:01:01] Speaker 02:
And the court relied on that teaching to make a finding of, wow, this is almost a mystery here of how these mechanisms work.

[00:01:13] Speaker 02:
And there are so many uncertainties and complexities here.

[00:01:16] Speaker 02:
We can all have theories and postulations, but there wasn't good grounds in this particular instance to have a level of confidence as to any given theory, at least at this point in time, in what was known.

[00:01:31] Speaker 01:
Right.

[00:01:32] Speaker 01:
So Lapidot is interesting because it went much beyond just having a theory.

[00:01:38] Speaker 01:
It provided the in vivo data and the explanation.

[00:01:41] Speaker 01:
And the bottom line problem here is these are scientists who are writing science articles.

[00:01:46] Speaker 01:
As there was testimony about the district court about this, scientists are looking for absolute certainty, which frankly was another thing the district court looked for, looked to actually have the mechanism of stem cell mobilization

[00:01:57] Speaker 01:
known and resolved.

[00:01:58] Speaker 01:
And the district court said there was no reasonable expectation of success because it wasn't resolved fully how to mobilize stem cells.

[00:02:06] Speaker 01:
But that's not what's required.

[00:02:08] Speaker 01:
What's required by the law is that there be a reasonable probability that there will be success here.

[00:02:14] Speaker 01:
So in other words, a reasonable probability that stem cells will be mobilized.

[00:02:18] Speaker 01:
So what LAPIDO did, it sets out in some background saying that there is some uncertainty out there, as all scientists would say, because this is complicated science.

[00:02:27] Speaker 01:
Lapidote then explained that the gold standard GCSF worked by reducing SDF1 in the bone marrow and breaking the SDF1 CXCR4 connection.

[00:02:39] Speaker 01:
So Lapidote not only said that, it provided in vivo and in vitro data that demonstrated that by using GCSF and using it both in vivo and in vitro.

[00:02:49] Speaker 01:
And when you put on top of that, then the teachings of Kono Plevo, which both echoed that in terms of the in vivo teaching, but then also said that one of skill in the art should seek a blocker of the CXCR4-SDF1 interaction and that that will lead to stem cell mobilization.

[00:03:05] Speaker 01:
So really, I think the court got sidetracked over this issue of there being uncertainty.

[00:03:10] Speaker 01:
And also, frankly, just apply the wrong legal standard, because this court applies the reasonable probability or the reasonable expectation of success, not certainty, which is what the district court required.

[00:03:23] Speaker 01:
The third basis for the court's reasonable expectation finding was its determination that a person of ordinary skill in the art would have believed that you would have wanted to increase CXCR4 expression on stem cells

[00:03:38] Speaker 01:
Well, that's the exact opposite of what any person of ordinary skill in the art would have done in light of the prior art.

[00:03:44] Speaker 01:
And the district court just made a fundamental clear error here.

[00:03:48] Speaker 01:
The prior art uniformly taught, and Lapidot is a great example of it, but the prior art uniformly taught that CXCR4 worked to draw stem cells into the bone marrow.

[00:03:58] Speaker 01:
and it prevented mobilization.

[00:04:00] Speaker 01:
So it was just fundamentally wrong and incorrect for the district court to draw the opposite conclusion.

[00:04:05] Speaker 02:
There was evidence of other stem cell mobilizers like GCFSF that increased CXCR4 expression, right?

[00:04:15] Speaker 02:
So here now we have something else, a plexiform that was known to, I guess, relatively speaking, decrease CXCR4 expression.

[00:04:28] Speaker 01:
So it was, it's not that plurixaphor would decrease the expression, and in fact Dr. Modi admitted, Dr. Modi, sorry, was Genzyme's expert, admitted that it doesn't necessarily decrease the expression.

[00:04:40] Speaker 01:
What it does is it blocks the interaction between CXO4, it's what's called the CXO4 blocker, and it blocks the interaction between that and SDF1.

[00:04:50] Speaker 01:
But so the evidence you talked about about increase CXDR4 levels.

[00:04:55] Speaker 01:
So what Lapidot found is that when GCSF was administered, SDF1 in the bone marrow was reduced.

[00:05:03] Speaker 01:
And he then looked at or the Lapidot authors looked at

[00:05:07] Speaker 01:
the stem cells that were then in the blood and said those stem cells have higher amounts of CXCR4 than they did prior to the administration of GCSF.

[00:05:15] Speaker 01:
And the reason for that, which was explained to the trial court, and there wasn't contrary testimony about this, the reason is that the stem cells essentially are compensating for the reduction in SDF1.

[00:05:27] Speaker 01:
And how they compensate for that is they express more CXCR4 because what the cells are doing essentially are looking for the SDF1.

[00:05:35] Speaker 01:
And CONO-PLEVA then provides a detailed correlation, which the district court looked at and said what that correlation suggests to a person with skill in the art, and this is at appendix page 50, suggests that there's the existence of a causal link between SDF1 and CXCR4 in terms of causing stem cell mobilization.

[00:05:56] Speaker 00:
You know, from everything we see, the stem cell science has been the subject of an enormous amount of study and research.

[00:06:07] Speaker 00:
But when you go back to the time that this invention was made, and two, you conducted the experiments

[00:06:16] Speaker 00:
How could you have confidence that it was going to proceed?

[00:06:20] Speaker 00:
I think any scientist that makes the effort to do a certain amount of work has an expectation and a hope, or else you'd really be wasting your time.

[00:06:30] Speaker 00:
But to say that this was known and predictable, isn't that extremely difficult in this science at that time?

[00:06:40] Speaker 01:
So I think before we had Lapidot and Kono-Pleva,

[00:06:45] Speaker 01:
And, you know, perhaps the suggestions in Hendrix, which we haven't really talked about, Hendrix is yet another reference that says to use a CX0R4 blocker.

[00:06:52] Speaker 01:
In fact, it says use plurixaporth to mobilize stem cells.

[00:06:57] Speaker 01:
Before those publications, I think you're right that things were more unknown.

[00:07:02] Speaker 01:
And in fact, when this court dealt with this in the Dr. Reddy's case, the prior case, this court didn't have the benefit of Lapidone and Conepleva.

[00:07:10] Speaker 01:
And this court said that the main piece missing in that case was no in vivo study which tied the CXCR4-SDF1 interaction to stem cell mobilization.

[00:07:22] Speaker 01:
This is a different case now.

[00:07:23] Speaker 01:
We have the two studies, Your Honor, that demonstrate why GCSF worked, that demonstrate that the importance of why it worked, or the mechanism by which it worked, was by getting in the middle of the SCF1-CXCR4 interaction and disrupting that interaction.

[00:07:41] Speaker 01:
So again, before those publications,

[00:07:44] Speaker 01:
there was much more uncertainty after those publications.

[00:07:48] Speaker 01:
There was a reasonable expectation of success that if you administered something to break that connection, as Kono Pleva expressly tells you to do... Or at least hope of success, which is quite different from expectation.

[00:08:01] Speaker 01:
Well, so I think there's a reasonable probability of success when you measure what those tests demonstrated and what the experts testify about.

[00:08:11] Speaker 00:
So you're saying they shouldn't have run the experiments?

[00:08:14] Speaker 01:
Well, so they did run experiments.

[00:08:16] Speaker 01:
And I guess that's maybe what I'm not explaining good enough.

[00:08:18] Speaker 01:
LAPIDO and CONOPLEVA both ran experiments to find out why GCSF was working.

[00:08:25] Speaker 01:
And what they both concluded with in vivo data and some in vitro data with LAPIDO ads in vitro data is that if you disrupt the SDF1 CXDR4 connection, stem cells are being mobilized.

[00:08:37] Speaker 01:
And that's how GCSF worked.

[00:08:40] Speaker 01:
So once those studies were published,

[00:08:42] Speaker 01:
There was then a reasonable probability of success for a person of skill in the art and you know the bottom line with that and there's testimony about that this in the district court is it wasn't difficult to mobilize themselves again the district court was looking at different things it was looking at

[00:09:01] Speaker 01:
Could we get stem cells that one would know are capable of engraftment?

[00:09:05] Speaker 01:
Could we get a certain number of stem cells?

[00:09:07] Speaker 01:
Those may be different questions because the patent claims here only require the mobilizing of some stem cells that can be harvested.

[00:09:16] Speaker 01:
And GEMS line expert Dr. Modi admitted that once those stem cells are in the blood, you can harvest them.

[00:09:24] Speaker 01:
And I think, Your Honors, when you look at the district court's conclusions on motivation and the district court's conclusions when the district court evaluated the inventor's reasonable expectation of success, the findings the district court makes there are totally the opposite of what the district court made with respect to reasonable expectation of a person of ordinary skill in the art.

[00:09:46] Speaker 01:
The district court appropriately concluded that it was known in the art that the SDF-1 CXCR-4 interaction or mechanism

[00:09:53] Speaker 01:
is how stem cells were being mobilized, and that there was in vivo testing.

[00:09:58] Speaker 01:
And as I mentioned, that Hendrix points in that direction.

[00:10:01] Speaker 01:
And the district court applied the proper analysis with the inventors, because what the district court there said is we shouldn't consider, which is right, you shouldn't consider unclaimed features.

[00:10:11] Speaker 01:
If all we look at is a molecule that disrupts the CXCR4-SDF1 interaction to mobilize some stem cells that can be harvested,

[00:10:20] Speaker 01:
That was all there, and the district court made that proper conclusion with respect to the inventors.

[00:10:25] Speaker 01:
But the district court made the wrong conclusion by importing all these other limitations when the district court was addressing the person of ordinary skill in the art.

[00:10:35] Speaker 01:
I'd like to quickly just turn to some of the secondary considerations.

[00:10:40] Speaker 01:
First and foremost, the district court was looking at the wrong closest prior art

[00:10:45] Speaker 01:
The district court held that GCSF alone was the closest prior art and made all of its findings based on that.

[00:10:53] Speaker 01:
That really ignores and frankly is illogical because Conal Pleva discloses the administration of GCSF.

[00:11:00] Speaker 01:
It then discloses in vivo data about how GCSF work and then has the express suggestion to find another CXCR4 SDF1 blocker to allow more stem cells to be mobilized.

[00:11:14] Speaker 01:
And when you start looking at the secondary considerations in lidoconal pleba, they certainly carry less weight.

[00:11:21] Speaker 01:
Again, on the failure of others, the district court was looking to unclean features, including clinical success relative to GCSF, whereas the evidence demonstrated that there were numerous prior molecules that are out there that, when administered, would mobilize stem cells.

[00:11:40] Speaker 01:
But the district court ignores those

[00:11:42] Speaker 01:
And frankly, it's just improper to rewrite the claims here to something more narrow in order to save them.

[00:11:48] Speaker 01:
And then finally, on long-felt need and failure of others, the district court appropriately found that there was a blocking patent, but then did the wrong analysis when looking at that blocking patent.

[00:12:00] Speaker 01:
There was a patent that clearly blocked others, as Dr. Andreyev testified, from using Plurix before.

[00:12:06] Speaker 01:
But the district court flipped the blocking patent analysis that this court has used in the court and other cases on its head

[00:12:12] Speaker 01:
Instead, it was speculative that others would have come up with the invention but for the blocking patent.

[00:12:17] Speaker 01:
But that's not the analysis.

[00:12:19] Speaker 01:
This court's analysis is applied that if there is a blocking patent, then it's speculative that a long-filled need or failure of others is due to any other reason other than the blocking patent.

[00:12:31] Speaker 01:
And then finally, on the Andreiff letter, the Andreiff letter is clear evidence of simultaneous invention.

[00:12:37] Speaker 01:
Again, I think the district court made multiple mistakes of fact when evaluating the Andreiff letter.

[00:12:43] Speaker 01:
It also inappropriate applied in an intent element.

[00:12:47] Speaker 01:
And it's either an anticipatory reference or it's certainly simultaneous invention, which again, weighs in light of the obviousness of the claims.

[00:12:56] Speaker 01:
So if there are no further questions, I'll reserve my time.

[00:12:58] Speaker 01:
Thank you.

[00:13:07] Speaker 00:
Mr. Berghoff.

[00:13:08] Speaker 03:
Good morning, Your Honors.

[00:13:10] Speaker 03:
May it please the Court?

[00:13:12] Speaker 03:
You can affirm here based solely on the issue of reasonable expectation of success, and I'll start there.

[00:13:19] Speaker 03:
I want to clarify a point made by counsel.

[00:13:25] Speaker 03:
The district court here made numerous findings concerning the absence of a reasonable expectation of success.

[00:13:34] Speaker 02:
What about the ground of no reasonable expectation of success because there is no reasonable expectation of successful stem cell engraftment?

[00:13:41] Speaker 02:
That's going beyond the scope of the claim, isn't it?

[00:13:46] Speaker 03:
Grafman is not in the claim, Your Honor.

[00:13:49] Speaker 02:
That is correct.

[00:13:49] Speaker 02:
All we're talking about here is mobilization of stem cells into the blood.

[00:13:54] Speaker 03:
That's correct.

[00:13:55] Speaker 03:
And the district court made a specific finding on the lack of reasonable expectation of success without any reference to engraftability of the

[00:14:05] Speaker 03:
of the stem cells.

[00:14:07] Speaker 03:
If I could refer your honor to the appendix, page 76, paragraph 112, this is one of several findings, factual findings by the district court on reasonable expectation of success.

[00:14:24] Speaker 03:
The court said it should not be lost on those of us looking back, if I can say in hindsight, to September 2000.

[00:14:31] Speaker 03:
The person of ordinary skill of the art would not have had a reasonable expectation.

[00:14:35] Speaker 03:
the use of Polixaphora as a stem cell mobilizer would succeed.

[00:14:39] Speaker 03:
Again, this is actually repeating another similar finding at

[00:14:45] Speaker 02:
Appendix 6263 So you're not defending the no expectation of engraftment?

[00:14:54] Speaker 02:
Ground of no reasonable expectation of success you prefer to focus on other grounds of no reasonable expectation of success articulated by the judge I will I would like to do both and if I could okay.

[00:15:06] Speaker 02:
Well, how about the one that?

[00:15:09] Speaker 03:
First yeah, and then we'll come back to this to this point

[00:15:13] Speaker 03:
Engraftment is an implicit part of the claims.

[00:15:17] Speaker 03:
Institute Pasteur says when the motivation of the person of ordinary skill in the art looking at the prior art is focused on a particular goal and the court here found that the motivating force of the person of skill in the art was to find a better stem cell mobilizing agent than GCSF.

[00:15:39] Speaker 03:
And with that goal in mind, Institute Pasteur says, when you come to the no reasonable expectation of success analysis, you can't then lower the goal to something other than what the person of skill in the art was looking at.

[00:15:53] Speaker 03:
And engraftability, there's no point in mobilizing and certainly no point in harvesting stem cells that won't engraft.

[00:16:03] Speaker 02:
They're non-viable.

[00:16:04] Speaker 02:
So are you saying your claims are limited to the method of not only mobilizing stem cells but also engrafting stem cells?

[00:16:11] Speaker 03:
They are not.

[00:16:12] Speaker 02:
No, they're not.

[00:16:12] Speaker 02:
They are not.

[00:16:12] Speaker 02:
That is implicit.

[00:16:13] Speaker 02:
But you're saying it's an implicit limitation in the clinic.

[00:16:16] Speaker 03:
It would be implicitly understood by the person of skill in the art reading the claim that the whole goal of stem cell mobilization is to mobilize and harvest stem cells that will engraft.

[00:16:31] Speaker 03:
That's the goal, that was the motivation for all the research and that would be understood to be implicit and according to Institute Pasteur,

[00:16:40] Speaker 03:
When you get to reasonable expectation of success, you don't then lower the bar to something less than.

[00:16:46] Speaker 02:
You don't lower the bar to the actual claim limitations.

[00:16:49] Speaker 02:
It's implicit in the claim, but it's not a claim limitation.

[00:16:55] Speaker 02:
It is not.

[00:16:57] Speaker 02:
You're not requiring an accused infringer to actually successfully ingratiate stem cells to infringe your claim.

[00:17:03] Speaker 02:
Correct.

[00:17:04] Speaker 02:
Your claim doesn't require it.

[00:17:05] Speaker 02:
That's correct, Your Honor.

[00:17:06] Speaker 02:
But nevertheless, you have to prove it has a reasonable expectation of success, this non-claimed limitation.

[00:17:13] Speaker 03:
No, and the district court made several findings that did not

[00:17:17] Speaker 03:
referred to in Grafman and yet found no reasonable expectation of success and if I could return to appendix page 76 of the district court's opinion found that based on the uncertainties regarding the mechanisms of stem cell mobilization

[00:17:36] Speaker 03:
And the district court had already found that everyone, including Zydus's expert, viewed the mechanisms and molecules involved in stem cell mobilization as extremely complex and uncertain.

[00:17:50] Speaker 03:
The known complexity in the art,

[00:17:52] Speaker 03:
And the fact that GCSF, SCSF, and IL-6 were known stem cell mobilizers that increased CXCR4 expression.

[00:18:03] Speaker 03:
Even if a person of ordinary skill in the art had given polyxophore a try, that doesn't mean that such a person could, at that time, have reasonably expected it would succeed in mobilizing stem cells.

[00:18:18] Speaker 03:
No reference to engraftment.

[00:18:21] Speaker 03:
just the reference to whether floryxophore would mobilize stem cells or not.

[00:18:27] Speaker 03:
And that is, without question, the key claimed feature of the asserted claims.

[00:18:34] Speaker 03:
And since the person of ordinary skill in the art, as found factually by the district court, would not have had a reasonable expectation based on the uncertainty in the art,

[00:18:44] Speaker 03:
And based on the fact that known stem cell mobilizers increased CXCR4 expression such that one wouldn't jump to the conclusion that you should go the other way.

[00:18:56] Speaker 03:
In fact, that would lower your expectation of success.

[00:19:01] Speaker 03:
Based on those factual findings alone, the district court found no reasonable expectation of success.

[00:19:07] Speaker 03:
And again, reached that same conclusion just so the record is complete at appendix pages 62 and 63.

[00:19:15] Speaker 03:
There was an abundance of riches here, Your Honors, on why there was no reasonable expectation of success.

[00:19:22] Speaker 03:
The district court also referred to the lack of engraftability.

[00:19:26] Speaker 02:
Pretty strong motivation to combine, though, right?

[00:19:29] Speaker 02:
I mean, reading through Judge Jordan's motivation analysis, it practically convinced me that the claims were obvious in light of everything that was going on with

[00:19:45] Speaker 02:
Hendricks and the new references that were relied upon here compared to Dr. Reddy's case.

[00:19:51] Speaker 03:
But the law, I think, of this court is clear that motivation to combine does not mean there's a reasonable expectation of success.

[00:19:59] Speaker 03:
And I believe it's intelligent biosystems said you can't conflate those two standards.

[00:20:05] Speaker 03:
A perfect example is this court's decision in the regents of the University of California versus the Broad Institute on the CAS 9, where the court found a strong motivation to combine, and yet also found that there was no reasonable expectation of success.

[00:20:24] Speaker 03:
Here, the finding on the motivation to combine is, I think I can characterize it fairly as weak, because the judge found that the person of skill in the art

[00:20:35] Speaker 03:
based on all of the uncertainties and the pointing away in the prior art, might give Plurixifor a try because of the desperate need for a better stem cell mobile officer, but would do so despite potential misgivings, despite not thinking it would necessarily work.

[00:20:54] Speaker 03:
And so the two issues are not the same.

[00:20:57] Speaker 03:
And we are not challenging the district court's finding on motivation to combine.

[00:21:02] Speaker 03:
But it certainly, in this factual record, does not lead to a finding of no expectation of success.

[00:21:09] Speaker 03:
And the district court made that factual finding.

[00:21:13] Speaker 03:
In turn, the district court's decision was also supported by a number of unexpected results.

[00:21:20] Speaker 03:
I'll just focus on two.

[00:21:21] Speaker 03:
One is that the use of chlorixaphor to mobilize stem cells results in, unexpectedly, superior stem cells.

[00:21:31] Speaker 03:
So when you practice the invention, when you use plurixaphor to mobilize stem cells, they're better.

[00:21:38] Speaker 03:
They are superior to the ones that you got with the prior art.

[00:21:41] Speaker 03:
That was unexpected as found by the district court.

[00:21:45] Speaker 03:
Secondly, the district court found it was unexpected that when you practice the claimed method, when you administer plurixaphor, it mobilizes stem cells rapidly and predictably.

[00:21:59] Speaker 03:
prior art, it might take five, seven days of daily GCSF injections for a patient to mobilize enough stem cells.

[00:22:10] Speaker 02:
Why isn't Conal Pleva the closest prior art?

[00:22:15] Speaker 02:
Conal Pleva is also describing a methodology of mobilizing stem cells using in part GCSF.

[00:22:26] Speaker 02:
So why wasn't that regarded as the closest prior argument?

[00:22:32] Speaker 03:
The Zaitis is making the same arguments that they made in their post-trial briefs on Kanaplevo being

[00:22:39] Speaker 03:
the closest prior art to your honors, but they had no evidence to support it.

[00:22:45] Speaker 03:
Both of the experts agreed that the gold standard was GCSF.

[00:22:50] Speaker 03:
That's what everybody viewed as what needed to be improved upon by the persons of skill and the art doing research in this area.

[00:22:58] Speaker 03:
And Dr. Modi, our expert, testified that based on that, GCSF was the closest prior art.

[00:23:08] Speaker 03:
And there was, as district court found, there was no evidence to the contrary put in by Cytus.

[00:23:15] Speaker 03:
So it's just a lack of proof.

[00:23:17] Speaker 03:
They bear the burden on the whole argument of invalidity.

[00:23:22] Speaker 03:
They failed to prove, if that was their goal, they failed to prove that Canoplova was the closest prior art.

[00:23:28] Speaker 03:
And then even in the post-trial briefing,

[00:23:30] Speaker 03:
They were referring to different references as the closest prior art based on what aspect of the claims they were dealing with.

[00:23:41] Speaker 03:
And that's improper under this court's case law.

[00:23:46] Speaker 03:
If there are no more questions from the panel, but I'm happy to hear.

[00:23:50] Speaker 02:
We've got another one.

[00:23:54] Speaker 02:
What about the notion of a blocking patent?

[00:23:58] Speaker 02:
when it comes to secondary consideration evidence.

[00:24:01] Speaker 02:
And in this particular instance, the judge said, well, you need to have actual hard evidence that there were scientists out there that wanted to use the patented compound but were effectively blocked from using it and experimenting with it by the patent owner in order to

[00:24:27] Speaker 02:
to say that, well, the existence of a blocking patent neutralizes any secondary consideration evidence.

[00:24:35] Speaker 02:
But our case law doesn't seem to really talk in those terms.

[00:24:40] Speaker 02:
The other side makes a point that the existence of a blocking patent presumptively neutralizes secondary consideration evidence unless the patent owner explains the contrary.

[00:24:53] Speaker 03:
I think a court decision by this court finds that whether a patent block, a blocking patent has any effect on the non-obviousness issue is very fact-specific.

[00:25:10] Speaker 03:
And especially, you need to look in the particular facts of the case in order to decide the magnitude of the diminution, I believe is a direct quote from the decision, magnitude of the diminution of the effect of the blocking patent on the long-felt need, failure of others, whatever.

[00:25:33] Speaker 03:
There was just a complete absence on Zydus' part of any direct testimony concerning the effect of the blocking patent.

[00:25:42] Speaker 02:
I thought they had one witness say they wanted to use plexifluor but they were denied access to it by the patent on it.

[00:25:49] Speaker 03:
That is correct but he never said and the reason was they had a patent on it.

[00:25:54] Speaker 03:
There was no testimony, no testimony linking anybody's lack of access to Plurixifor or lack of ability to test other CXCR4 blockers, of which there are many, to test the hypothesis that blocking CXCR4 was going to mobilize stem cells.

[00:26:15] Speaker 03:
And that testimony does not establish a connection to the prior patents owned by Genzyme.

[00:26:24] Speaker 03:
And you compare that to the testimony in the Accorda case, where the accused infringer put on an economics expert who testified in detail about how the blocking patents in that case actually blocked people from doing the research necessary.

[00:26:43] Speaker 03:
No such testimony in this case.

[00:26:45] Speaker 03:
So I don't think, especially it's such a fact-specific inquiry as held by this court in Accorda,

[00:26:52] Speaker 03:
Zytus did not carry its burden of proof on that issue.

[00:26:56] Speaker 00:
Thank you.

[00:27:03] Speaker 00:
Mr. Lajman.

[00:27:04] Speaker 01:
Thank you, Your Honor.

[00:27:05] Speaker 01:
I just have a few quick points.

[00:27:06] Speaker 01:
And I'll start with the blocking patent question and analysis.

[00:27:10] Speaker 01:
There was clear testimony by Dr. Andreyev that he couldn't get access to floryxaphor, a letter he sent in his testimony.

[00:27:17] Speaker 01:
And he said because genzyme was the only source of it.

[00:27:20] Speaker 01:
There was also a demonstration that the patent covered Plurixifor.

[00:27:25] Speaker 01:
And the district court essentially found that it was a blocking patent.

[00:27:31] Speaker 01:
It just did the wrong legal analysis.

[00:27:33] Speaker 01:
So based on Accorda and based on all the factual inquiry that Accorda says, all the factual basis was there.

[00:27:39] Speaker 01:
And the district court essentially concluded that it was a blocking patent, just did the wrong legal analysis.

[00:27:45] Speaker 01:
Just quickly, I want to address the point about the district court's various reasons of why it didn't found reasonable expectation of success.

[00:27:56] Speaker 01:
It is pure speculation to know how the district court would come out if the legal error it committed with respect to requiring engraftment was reversed.

[00:28:06] Speaker 01:
And in fact, if I can point the court to appendix 104 and 105, paragraph 41,

[00:28:12] Speaker 01:
The district court says that it made a threefold determination.

[00:28:16] Speaker 01:
And one of those determinations was the engraftment requirement.

[00:28:19] Speaker 01:
So it's pure speculation that the district court would still find there to be no reasonable expectation of success.

[00:28:25] Speaker 01:
And in fact, as positive as I did when I spoke before, that all the evidence the court found with respect to motivation and the evidence it found with respect to the inventor's reasonable expectation of success support a reasonable expectation for a person of ordinary skill here.

[00:28:41] Speaker 01:
Unless you have any other questions, I thank you for your time.

[00:28:44] Speaker ?:
Any questions?

[00:28:45] Speaker 01:
Thank you.

[00:28:45] Speaker 01:
Thank you.

[00:28:46] Speaker 00:
Thank you both.

[00:28:47] Speaker 00:
That concludes this morning's afternoon's arguments of this panel.