[00:00:44] Speaker 03:
Mr. Reinus, you have reserved eight minutes for something rebuttal, correct?

[00:00:48] Speaker 01:
That's correct, Your Honor.

[00:00:49] Speaker 03:
And Mr. Fleming, you have five minutes for you split your time for ten and five?

[00:00:54] Speaker 00:
Ten for the principal, then five for rebuttal on the cross and deal.

[00:00:56] Speaker 03:
That's right, Your Honor.

[00:00:58] Speaker 03:
Okay.

[00:00:58] Speaker 03:
All right, let's get going, Mr. Reinus.

[00:01:01] Speaker 01:
Yes, thank you, Your Honor, and may it please the Court.

[00:01:04] Speaker 01:
The District Court committed multiple clear errors in failing to enter an injunction in this case.

[00:01:12] Speaker 01:
The first one was finding that there was no competition between Roche and Illumina.

[00:01:19] Speaker 01:
And the record is overwhelming that there is, in fact, direct competition.

[00:01:24] Speaker 01:
Every sale made by Roche's Harmony test is a sale lost to an Illumina-powered test.

[00:01:32] Speaker 05:
In the red break, Nereosa says that you waited two years after Harmony's launch to sue.

[00:01:39] Speaker 05:
And didn't sink an injunction until six years afterward.

[00:01:43] Speaker 05:
Why?

[00:01:44] Speaker 01:
Well, I mean, we brought the case.

[00:01:47] Speaker 01:
I mean, first of all, they launched one product, and then they changed the product when it was on the second product.

[00:01:53] Speaker 01:
But the fact is that the case took a long time because we had appeals, and it was stayed over our objection.

[00:02:00] Speaker 01:
So including lengthy IPR proceedings that we prevailed on.

[00:02:06] Speaker 01:
So basically, we faced an IPR, we argued, we made presentations of why that was irreparable harm, and the district court nevertheless entered a stay over our objection.

[00:02:17] Speaker 01:
That was most of the time.

[00:02:18] Speaker 01:
So punishing us for winning an IPR when we got way late, I mean, in that sense, it's all

[00:02:27] Speaker 01:
It's all the more important that we get the injunction.

[00:02:30] Speaker 01:
And the fact is that we did bring suit in 2012.

[00:02:33] Speaker 01:
So there was no initial delay.

[00:02:34] Speaker 01:
That's not what the record's going to support.

[00:02:36] Speaker 01:
And proceeding through trial on a busy court that stays your IPR seems hardly a basis to deny a permanent injunction.

[00:02:48] Speaker 01:
So the clear error is that there's Illumina powered tests, which are basically 80 licensees.

[00:02:57] Speaker 01:
It lets everyone do this.

[00:02:58] Speaker 01:
It's broadly distributed to technology.

[00:03:01] Speaker 01:
Roche has its own test that competes.

[00:03:03] Speaker 01:
We put in the IDEL declaration that documents specific examples of where someone's deciding whether to buy the Roche test,

[00:03:12] Speaker 01:
or to buy the solution from Illumina and bring it in-house.

[00:03:17] Speaker 01:
So they can bring it in-house, buy the equipment and platform from us, license the NIPT and serve their own, like the military, for example, where Kiesler Armed Forces is one.

[00:03:27] Speaker 01:
So the declaration that's talking about the very specific direct competition, that was ignored by the court.

[00:03:33] Speaker 01:
And the court statement that this isn't competition, just defies common sense.

[00:03:37] Speaker 01:
On top of that, one of the products that is in the record is something called ACFS, which is a kit, where they would sell, just like we do, for people to bring in-house the test themselves.

[00:03:49] Speaker 01:
If you're a large institution, you buy the sequencing or the other technology that's a platform, you buy the NIPT technology.

[00:03:59] Speaker 01:
and then you have a kit.

[00:04:01] Speaker 01:
That's direct competition, a kit versus a kit.

[00:04:03] Speaker 01:
There's no way to even get confused about that.

[00:04:07] Speaker 01:
And the district court's conclusion was because it had originally concluded that Harmony unsold any kits, not competitive.

[00:04:14] Speaker 01:
That can't be competitive either.

[00:04:16] Speaker 01:
So there's no basis at all to deny an injunction on that.

[00:04:19] Speaker 01:
That product's not been introduced in the US if they're waiting for this case to conclude.

[00:04:23] Speaker 01:
And that's direct competitive harm on an infringing product that should be stopped.

[00:04:28] Speaker 01:
The court also decided

[00:04:30] Speaker 01:
that the 794 patent that's been infringed by their homebrew solution is part of our licensing program.

[00:04:38] Speaker 01:
But it's not.

[00:04:39] Speaker 01:
We license NIPT specific technology.

[00:04:44] Speaker 01:
The 794 relates to platform.

[00:04:45] Speaker 01:
So it's platform versus platform competition.

[00:04:47] Speaker 01:
It's not that complicated to understand.

[00:04:52] Speaker 01:
It's just a clear error that she made, the court made.

[00:04:56] Speaker 01:
In addition, one of the arguments they made on the harms is the court said that it would be expensive for them now to move away from Illumina's product, platform.

[00:05:06] Speaker 01:
Well, that makes no sense.

[00:05:07] Speaker 01:
They're not using Illumina's platform.

[00:05:09] Speaker 01:
That's why we're here taking your time this morning.

[00:05:12] Speaker 01:
What Roche says is what instead the district court intended

[00:05:17] Speaker 01:
was that district court instead intended to say that it would be expensive for them to buy Illumina platform, which is what they'd have to do if they were enjoined.

[00:05:26] Speaker 01:
Well, that proves our whole point.

[00:05:28] Speaker 01:
If Roche would have to buy the Illuminus solution in order to operate if they stop infringing, that's irreparable harm of the most classic form.

[00:05:39] Speaker 01:
I really think I could wax on about the importance of the right to exclude and the fundamental in a direct situation like this.

[00:05:48] Speaker 01:
Frankly, in litigation that's gone on and morphed because there's no clear answer to this, there's no stop infringing answer.

[00:05:56] Speaker 01:
But Judge Rain's opinion in the Apple case, you know, sets it forth.

[00:06:02] Speaker 01:
District courts seem to be afraid by eBay, or they just want to have products out there that people can use for this test.

[00:06:11] Speaker 01:
But the fact is that it's been demonstrated how the prices have come down.

[00:06:15] Speaker 01:
This whole NIPT technology is dramatically less expensive than amniocentesis.

[00:06:20] Speaker 01:
And there's no showing that even that's the public interest.

[00:06:24] Speaker 01:
The public interest argument that she made is, we don't continue to sell the Golden Gate product.

[00:06:28] Speaker 01:
The Golden Gate product is what the founders of ARIOSA, the infringer, developed at our company.

[00:06:36] Speaker 01:
We sold the Golden Gate product.

[00:06:38] Speaker 01:
They bought the Golden Gate product when they were developing the infringing device.

[00:06:42] Speaker 01:
They bought our product.

[00:06:45] Speaker 01:
And then they substituted out for a home brew that does the same thing.

[00:06:50] Speaker 01:
And that infringes.

[00:06:52] Speaker 01:
And we stopped selling the product when they dropped it afterwards, when they started selling a home brew.

[00:06:57] Speaker 03:
And the district court's saying that where it falls, somehow... If you stop selling the product, how can there be competition?

[00:07:05] Speaker 01:
Because we're competing over a platform.

[00:07:07] Speaker 01:
Because our sequencers compete with their assay.

[00:07:11] Speaker 01:
We sell other products that compete.

[00:07:13] Speaker 03:
No, but we're looking for direct competition where the sell by one is a loss of sell by the other.

[00:07:19] Speaker 03:
If you're not in the market for that particular platform, how can that be the case?

[00:07:24] Speaker 05:
And let me add to that question too.

[00:07:26] Speaker 05:
Sure.

[00:07:26] Speaker 05:
Because you say in your reply in the yellow break,

[00:07:31] Speaker 05:
I'm quoting, where an infringer ceases purchasing an embodying product to instead rely on an infringing home brew, there is no public interest in requiring the patent owner to continue to offer the product commercially to obtain an injunction.

[00:07:45] Speaker 05:
You don't cite any authority for that proposition.

[00:07:47] Speaker 05:
So I'd like to add that to it.

[00:07:49] Speaker 01:
I just think it's common sense that if someone knocks off what you're doing and then you stop selling your product, that shouldn't be held against you in an injunction.

[00:07:58] Speaker 05:
So you don't have any authority.

[00:07:59] Speaker 01:
No, just I'm relying on logic there for that one.

[00:08:03] Speaker 01:
On your question, Your Honor, is that there's multiple ways to perform the platform of the engine that runs the NIPT test, the platform.

[00:08:11] Speaker 01:
There's the sequencing solution that we sell, that we sell to 80 different companies.

[00:08:16] Speaker 01:
And then what they're doing is they're instead using an assay, which can perform the same identification of nucleic acids.

[00:08:25] Speaker 01:
And they're knocking off our product, which we've stopped selling.

[00:08:29] Speaker 01:
And so every sale that they make of their test, which is using the infringing platform of this assay, is one less sale of an Illumina-powered test that takes place, and our sequencing systems and our reagents and juices and all that.

[00:08:46] Speaker 01:
So I want to save time to respond, but it's just the classic injunction situation.

[00:08:53] Speaker 01:
And the judge obviously didn't want to have been strained and made multiple clear errors as a result.

[00:08:57] Speaker 03:
Well, an injunction situation could be a lot more clear than this is.

[00:09:02] Speaker 01:
I just don't think the platform versus platform is that complicated.

[00:09:06] Speaker 01:
Maybe it is.

[00:09:07] Speaker 01:
But it's just every sale of a test takes away from us because we supply the platform that allows people to operate.

[00:09:13] Speaker 01:
And in the case of ACFS, it is straightforward.

[00:09:16] Speaker 01:
They're selling a kit, platform, all the way to test.

[00:09:20] Speaker 01:
We do the same thing so people can take it in-house.

[00:09:23] Speaker 01:
They can in-house the process.

[00:09:25] Speaker 01:
It's direct competition.

[00:09:26] Speaker 01:
ACFS.

[00:09:27] Speaker 01:
It's classic.

[00:09:34] Speaker 00:
Good morning and may it please the court, Mark Fleming together with Thomas Saunders on behalf of the cross-appellants.

[00:09:41] Speaker 00:
We think the injunction request is meritless because there's no infringement and there are three independent reasons for that and I'll get to that when discussing the cross-appeal.

[00:09:49] Speaker 00:
But there are other reasons to affirm the denial of the injunction.

[00:09:52] Speaker 00:
First of all, Illumina didn't prove a causal nexus between the 794 patent

[00:09:57] Speaker 00:
and the sales it wants to enjoin.

[00:09:58] Speaker 00:
In the district court, it had only a cursory footnote on the point, and it's easy to see why.

[00:10:02] Speaker 00:
Illumina doesn't use the 794 patent, it doesn't license anyone who does use it, and it didn't express any, it didn't identify any expression of interest in the 794 patent.

[00:10:12] Speaker 03:
What about his argument that this isn't about the patent or product, it's more platform oriented?

[00:10:17] Speaker 00:
So that goes, I think, to some extent to the direct competition issue.

[00:10:22] Speaker 00:
And Illumina announced, and this is not disputed, that it was going to exit the retail market so as not to be in direct competition with Ariosa.

[00:10:31] Speaker 00:
The CEO, Mr. Flatley, said we're getting out of the business of selling tests directly.

[00:10:35] Speaker 03:
Ariosa's customers, I think it's important to understand this, Ariosa's customers... Are you saying that these are arguing that there's competition downstream of testing?

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

[00:10:43] Speaker 00:
So that's the difference, right?

[00:10:44] Speaker 00:
Illumina is selling not to doctors' offices or clinics, but to large labs that are doing the testing themselves.

[00:10:50] Speaker 00:
Ariosa's market is a retail market.

[00:10:52] Speaker 00:
We provide a service for doctors' offices who collect patient samples.

[00:10:56] Speaker 00:
They don't have the infrastructure to do the tests themselves.

[00:10:58] Speaker 00:
They send us the samples in San Jose.

[00:11:00] Speaker 00:
We test them.

[00:11:01] Speaker 00:
We send the results back.

[00:11:03] Speaker 00:
Ariosa is competing not against Illumina.

[00:11:06] Speaker 00:
Notice it's important.

[00:11:07] Speaker 00:
Whenever Illumina in its briefing says, we compete, they say against Illumina powered tests, or Illumina products, or Illumina partners.

[00:11:15] Speaker 00:
Whenever Your Honor hears that, that is a euphemism for Illumina's licensees.

[00:11:19] Speaker 00:
Illumina licenses its intellectual property to these big labs that do the testing.

[00:11:23] Speaker 00:
Those are Ariosa's competitors, not Illumina.

[00:11:25] Speaker 00:
This is Active Video.

[00:11:26] Speaker 00:
It's exactly the same situation.

[00:11:28] Speaker 00:
Active Video licensed Cablevision.

[00:11:30] Speaker 00:
Cablevision sold cable services.

[00:11:32] Speaker 00:
Verizon took away Cablevision's customers.

[00:11:35] Speaker 00:
That was not irreparable harm to Active Video because all Active Video was losing was licensing revenue from Cablevision.

[00:11:41] Speaker 00:
The same thing with respect to the reagents and juices that Mr. Reinus was mentioning.

[00:11:46] Speaker 00:
Those are, if proven, they're product sales, quintessentially compensable by monetary damages.

[00:11:52] Speaker 00:
In this case, they weren't even proven.

[00:11:54] Speaker 00:
There's no identification of what they are in the opening brief.

[00:11:56] Speaker 00:
In the reply brief, there's just an undifferentiated site to 200 pages of agreements.

[00:12:00] Speaker 00:
There's no proof they can't be compensated by damages.

[00:12:03] Speaker 00:
There's no proof that they're due, if they're lost, to sales of Harmony version 2.

[00:12:07] Speaker 00:
Because again, if for some reason Harmony version 2 were to be enjoined, it's not as though a doctor is going to say, I'm going to open my own lab and provide my own testing in-house.

[00:12:16] Speaker 00:
They're just going to go to one of the other companies that is providing testing services.

[00:12:20] Speaker 00:
And to the extent there's a loss, that's a loss of licensing revenue to Illumina, not a loss of business.

[00:12:25] Speaker 05:
On page 16 of the red brief, you say today the 794 is old technology.

[00:12:34] Speaker 05:
Illumina no longer manufactures products that practices it, and quote, virtually every other provider of DNA sequencing based non-invasive prenatal testing uses different technology from that claim of the 794.

[00:12:50] Speaker 05:
And you cite us to appendix 15343.

[00:12:56] Speaker 05:
And when I went to 343, it was a plaintiff's opposition to Arios's motion for judgment as a matter of law.

[00:13:08] Speaker 05:
And I'm looking at the language you quote.

[00:13:13] Speaker 05:
And it's a statement.

[00:13:15] Speaker 05:
It's unsupported.

[00:13:17] Speaker 05:
You say CEG, docket, and so on.

[00:13:22] Speaker 00:
How on earth does that support your proposition?

[00:13:26] Speaker 00:
I think the point here, and I don't think this is disputed, Judge Wallach, is that the rest of the market, the accusation is that we are using the 794.

[00:13:35] Speaker 00:
Obviously, we don't agree with that, and I'll get to that on the cross appeal.

[00:13:38] Speaker 00:
But the rest of the market is Illumina licensees who do not use, and Mr. Reines I think said this this morning, they don't use the 794, they use what they call the NIPT patent pool.

[00:13:48] Speaker 00:
Now Mr. Reines was accusing Judge Ilston of misunderstanding the 794 as being part of the patent pool.

[00:13:53] Speaker 00:
You're not answering my question.

[00:13:54] Speaker 00:
I apologize.

[00:13:55] Speaker 05:
And my question is, how did you cite this page for that proposition?

[00:14:01] Speaker 00:
Well, we were citing, so beginning at line three, as just one, so first of all, this is their opposition, not our brief.

[00:14:08] Speaker 00:
Line three of this page says, as just one example, it is undisputed that Illumina and virtually every other provider of DNA sequencing-based non-invasive prenatal testing uses random sequencing techniques that, unlike Arios's Dancer technique and the 794 patent, do not target specific sequences.

[00:14:26] Speaker 00:
So that's what we were referring to.

[00:14:27] Speaker 00:
And again, I don't think it's disputed, that they have a program that does not involve- You answered my question.

[00:14:32] Speaker 00:
Thank you, Your Honor.

[00:14:33] Speaker 00:
I was just trying to pivot it back to the main point.

[00:14:36] Speaker 05:
Because when I went to it, I didn't realize it was their session.

[00:14:40] Speaker 00:
I apologize.

[00:14:40] Speaker 00:
This is plaintiff's opposition to Arios's motion.

[00:14:43] Speaker 00:
We should have made that clear, and I hope I have.

[00:14:46] Speaker 00:
You're at your 10-minute mark.

[00:14:49] Speaker 00:
Thank you.

[00:14:50] Speaker 00:
I was hoping I could have 10 minutes to present our cross-appeal, and then I'd have five minutes for rebuttal on the cross-appeal.

[00:14:55] Speaker 00:
You still have time.

[00:14:56] Speaker 00:
Thank you very much, Your Honor.

[00:14:57] Speaker 00:
So with the Court's permission, unless there are more questions about the injunction, I would move to the cross-appeal, which is, of course, the injunction issue falls away if there's no infringement.

[00:15:05] Speaker 00:
And there are three independently sufficient reasons why there's no infringement.

[00:15:11] Speaker 00:
The first comes from claim elements E and F.

[00:15:13] Speaker 00:
And E requires taking the modified probes, which is a claimed term.

[00:15:17] Speaker 00:
amplifying them using PCR, polymerase chain reaction, and forming different amplicons.

[00:15:23] Speaker 00:
And the district court construed that to mean amplification products of each of the different modified probes.

[00:15:28] Speaker 00:
And that's important because the modified probes are the big probes, the long probes that include the full sample as well as the universal priming site, which is necessary in order to amplify them.

[00:15:40] Speaker 00:
And then step F says, you immobilize said different amplicons.

[00:15:44] Speaker 00:
Now, there's no factual dispute about how our product operates, how Harmony version 2 operates.

[00:15:49] Speaker 00:
What gets immobilized is not an amplification of any of the modified probes, but a different thing called a readout cassette, which doesn't have any of the target sequence in it.

[00:15:59] Speaker 00:
It doesn't have a universal priming site.

[00:16:01] Speaker 00:
It's a completely different technology, which is why the district court did not suggest that there was any kind of literal infringement here.

[00:16:07] Speaker 00:
Illumina didn't draft claims directed to immobilizing and detecting fragments of amplicons formed in step E.

[00:16:13] Speaker 00:
have done that, but instead it claimed immobilizing and detecting said different amplicons, and those are the things that are amplified in step E. Notably, there's no example in the patent whatsoever that contemplates immobilizing anything other than the full big modified probes, and Illumina has never denied that.

[00:16:30] Speaker 00:
So this fight is about the doctrine of equivalence, and the most one could say

[00:16:34] Speaker 00:
is that the readout cassettes perform the same function as the said different amplicons do in the claims, but there is nothing about their being done in the same way or about it being done with the same results.

[00:16:44] Speaker 00:
So this is a case of an utter lack of proof.

[00:16:46] Speaker 00:
The other side has nothing beyond conclusory assertion.

[00:16:49] Speaker 00:
In result, they're different because the process works with the Harmony V2 process when you use the readout cassettes.

[00:16:56] Speaker 00:
It does not work when you use the full big amplicons because if you were to put them together on this dense array,

[00:17:01] Speaker 00:
it would create something called steric hindrance, where the molecules interfere with each other, and they can't bind.

[00:17:07] Speaker 00:
Dr. Oliphant testified to this without any contradiction.

[00:17:09] Speaker 05:
I have a question about a sign or a stopper.

[00:17:12] Speaker 05:
Oh, all right.

[00:17:13] Speaker 05:
Yes, Your Honor.

[00:17:14] Speaker 05:
And specifically, on page 54 of the red brief, in a footnote, you reference Dr. Oliphant and Stoltnagel.

[00:17:29] Speaker 05:
Yes.

[00:17:31] Speaker 05:
making no general representation about the validity of future claims.

[00:17:38] Speaker 05:
That oath that Illumina required its employees to execute, which they did, weren't they the officers of the corporation at that point?

[00:17:51] Speaker 04:
Dr. Stoltenegel certainly was.

[00:17:53] Speaker 04:
I don't remember clearly about Dr. Alphen, but I'm... And that was then prepared under his direction and control, right?

[00:18:01] Speaker 04:
You mean the text of the oath?

[00:18:02] Speaker 00:
Yes.

[00:18:03] Speaker 00:
I'm not sure the record says anything about that.

[00:18:05] Speaker 05:
Well, what I'm driving at is, isn't it proper to construe it against them, given that they're responsible for its language?

[00:18:15] Speaker 00:
To the extent there were an ambiguity in it, then I suppose it might be.

[00:18:18] Speaker 00:
But I don't think this language is in any way ambiguous.

[00:18:21] Speaker 00:
It says the Sinors believe themselves to be the original inventors of the invention disclosed and claimed in said application.

[00:18:28] Speaker 00:
And there's, I don't think, any reasonable dispute that what was disclosed and claimed in the application at the time this document was executed is not what was claimed in the ultimate patent, which went through significant changes and became much broader at the time that it was actually issued long after Dr. Stoltz-Negrel and Oliphant had executed their

[00:18:49] Speaker 00:
assignment.

[00:18:50] Speaker 00:
And that's why we think this is a situation where a sign or estoppel is not properly applied, because what they're trying to do is take a representation about a narrow invention that required perfect complementarity and extend it to a much broader claim that subsumes substantial complementarity and not limited to perfect complementarity, which implicates different invalidity contentions.

[00:19:12] Speaker 00:
So that's why we rely on that.

[00:19:13] Speaker 00:
And we don't think there's any ambiguity that would require construing anything against them.

[00:19:17] Speaker 00:
If I could return to infringement, the issue about immobilizing the amplicons is important because it works on the one hand when you have the small readout cassettes which can fit together and they don't have the steric hindrance problem.

[00:19:32] Speaker 00:
Notably, Illumina's own expert, Dr. Cooper,

[00:19:34] Speaker 00:
said he had no basis to agree or disagree with Dr. Oliphant on this.

[00:19:37] Speaker 00:
So this is something where we would say we're entitled to judgment as a matter of law.

[00:19:42] Speaker 00:
Similarly, with respect to the reductus sets being immobilized during the detection step.

[00:19:48] Speaker 00:
That is something the claims specifically require.

[00:19:50] Speaker 00:
They say detecting said different amplicons immobilize to said second solid support.

[00:19:55] Speaker 00:
Immobilize modifies amplicons.

[00:19:57] Speaker 00:
They have to be immobilized at the time of detection.

[00:19:59] Speaker 00:
Again, there is no dispute that in our system, the amplicons are not immobilized at the time of detection.

[00:20:05] Speaker 00:
They have been washed away.

[00:20:06] Speaker 00:
So we're at the very least entitled to Jamal on this.

[00:20:09] Speaker 00:
But if we don't get Jamal, we're entitled to a new trial where we have a properly instructed jury that is told that the amplicons have to be immobilized at the time of detection.

[00:20:19] Speaker 00:
That's a request we made.

[00:20:20] Speaker 00:
The district court acknowledged it, but did not rule on it.

[00:20:22] Speaker 00:
So at the very least, we need a new trial on that one.

[00:20:25] Speaker 00:
If I might just take a moment, Your Honor, to deal with the final issue of non-infringement.

[00:20:29] Speaker 00:
Again, each of these is sufficient in and of itself to direct judgment as a matter of law of non-infringement.

[00:20:35] Speaker 00:
The first two elements of the claim, the first two limitations, have to be done in order.

[00:20:39] Speaker 00:
You first have to have sample strands attached to a substrate, and then they are contacted by the probes.

[00:20:46] Speaker 00:
And they have to be single-stranded when they're attached, and then all three probes have to connect with them and hybridize.

[00:20:51] Speaker 00:
That is the opposite of what happens in our product.

[00:20:53] Speaker 00:
In our product, the samples are swimming around in the solution.

[00:20:56] Speaker 00:
They have over a million probes per sample strand sitting there in solution.

[00:21:00] Speaker 00:
They contact each other, and then, and only then, are they attached to the substrate.

[00:21:04] Speaker 00:
It is the exact opposite.

[00:21:06] Speaker 00:
So Illumina's infringement theory depended on speculation.

[00:21:09] Speaker 00:
They say there's some sample strands that remain unattached in the solution.

[00:21:13] Speaker 00:
They then get bound down to the array.

[00:21:15] Speaker 00:
And then all of a sudden, and they've never explained how or why, all three probes attach to them at once in the very short period that is left.

[00:21:22] Speaker 00:
And there is absolutely no evidence that no one has ever seen this happen.

[00:21:26] Speaker 00:
There's no reason to think that it would happen.

[00:21:28] Speaker 00:
There's certainly no reason to think that a strand that remained unattached for two hours during the hybridization period that is specifically designed to have the probes contact them, that somehow all of a sudden, once they are weighed down,

[00:21:39] Speaker 00:
All three of them would attach in the short period before the probes are washed away.

[00:21:43] Speaker 00:
And notably, our experts said without contradiction that the strands would be far less likely to bind once they were weighed down with the beads and attached to the substrate.

[00:21:50] Speaker 00:
That's on page 2394.

[00:21:53] Speaker 00:
So for any of one of those three reasons, we respectfully submit the judgment of liability should be reversed.

[00:21:59] Speaker 00:
And if that happens, then there is no need to consider the injunction because there wouldn't be an injunction.

[00:22:03] Speaker 00:
At the very least, the denial of the injunction should be affirmed.

[00:22:06] Speaker 00:
And I'll reserve what's left of my time for rebuttal.

[00:22:12] Speaker 01:
Thank you, Your Honor.

[00:22:12] Speaker 01:
The fact of competition is simply demonstrated by APPX 10363, where they list competition.

[00:22:21] Speaker 01:
And they say, Illumina, very large player with fast growing testing strategy based on enabling labs to run VeriSeq, which is the competition.

[00:22:30] Speaker 01:
It's VeriSeq in harmony.

[00:22:32] Speaker 01:
And beyond that is a detailed declaration

[00:22:37] Speaker 01:
at A10024 that talks about specific competitive situations.

[00:22:44] Speaker 01:
I mentioned the military.

[00:22:45] Speaker 01:
People are considering we're either going to bring it in-house and get the Illumina solution, which is a huge business opportunity for Illumina to sell sequencers and juice,

[00:22:55] Speaker 01:
Or we're just going to send the test out and Ariosic can perform the test for us.

[00:22:59] Speaker 01:
So we bring it in or do we send it out?

[00:23:02] Speaker 01:
Direct competition.

[00:23:03] Speaker 01:
And there's just pages of direct irreparable harm showing that was ignored totally that just can't... I just ask you please to just look back at the record.

[00:23:13] Speaker 01:
It's not that hard to figure out that there's direct competition here.

[00:23:16] Speaker 01:
They admit it.

[00:23:17] Speaker 01:
I give you a direct corporate strategy document and your specific examples.

[00:23:21] Speaker 03:
Is the competition with the Luna or is it with the licensees?

[00:23:24] Speaker 01:
It's with the licensees, but that's where the difference from active video applies.

[00:23:28] Speaker 01:
In active video, it was a license, a naked patent license and a naked patent license.

[00:23:33] Speaker 01:
So this court said, well, the royalty, if you're not getting royalty from this one, you can get the royalty from that one.

[00:23:38] Speaker 01:
In this case, what

[00:23:40] Speaker 01:
Council candidly admitted is what we're missing is sequencer sales, juice sales, relationships.

[00:23:46] Speaker 01:
And what Idle explains is if people buy our solution to do their own NIPT tests, they can do cancer, they can do other things.

[00:23:54] Speaker 01:
Getting in the door at these clinical labs at Walter Reed to sell them your box of your sequencing system and then on top of that let them do the different applications is huge opportunities.

[00:24:05] Speaker 01:
This is big business and we're being

[00:24:07] Speaker 03:
Isn't that different, you know, going to John Hopkins and making a sale there versus making a sale through some drug store?

[00:24:16] Speaker 01:
It's not a drug store.

[00:24:17] Speaker 01:
That's just false.

[00:24:18] Speaker 01:
People at Walter Reed, if they're not, if Walter Reed doesn't have this, it's not trivial to have this in house, are sending out the test to Ariosa.

[00:24:26] Speaker 03:
They're sending it to Roche.

[00:24:28] Speaker 03:
What I meant to say is that you have

[00:24:31] Speaker 03:
You have sales or a license to a testing facility versus retail sales.

[00:24:37] Speaker 03:
Is that what's going on here?

[00:24:40] Speaker 01:
You can think of anything anyone does with our products as retail sales.

[00:24:44] Speaker 01:
When people buy the Illumina solution, they're running the test themselves for themselves or they're running the test to sell in competition

[00:24:52] Speaker 01:
with harmony.

[00:24:54] Speaker 01:
So there's harmony, and then there's the Illumina power test.

[00:24:57] Speaker 01:
And there's just head-to-head competition.

[00:24:59] Speaker 01:
But we're not just losing a royalty.

[00:25:01] Speaker 01:
We're losing the relationships of selling the sequencers and selling the juice.

[00:25:05] Speaker 01:
And that's why we were able to submit an extensive declaration giving comparative situations at 10024 that squarely fall within what Judge Raina was saying in the Apple case.

[00:25:18] Speaker 01:
Let me also say one thing.

[00:25:20] Speaker 01:
Can I ask you a question?

[00:25:21] Speaker ?:
Sure.

[00:25:21] Speaker 02:
I'm going to take you away a little bit, but it's very narrow.

[00:25:25] Speaker 02:
If we agree with you that substantial evidence supports no anticipation on the 794, do we need to reach the assigner or stop the motion?

[00:25:34] Speaker 02:
No.

[00:25:35] Speaker ?:
OK.

[00:25:35] Speaker 01:
and you don't need to read it.

[00:25:36] Speaker 01:
There's also IPR estoppel here, because they didn't make this argument, but you don't need to reach that either.

[00:25:41] Speaker 01:
And there's overwhelming evidence.

[00:25:43] Speaker 01:
But let me address the infringement, unless there's anything else on the injunction.

[00:25:48] Speaker 01:
I just ask you please look at the record.

[00:25:49] Speaker 01:
This is direct competition.

[00:25:50] Speaker 01:
We're being denied an injunction for no reason.

[00:25:53] Speaker 01:
The analysis is just flawed.

[00:25:56] Speaker 01:
And there's multiple clear errors, I hope, I've conveyed.

[00:26:01] Speaker 01:
Non-infringement, really the focus, we ran through real quick some of them, but this cleaved amplicon point.

[00:26:07] Speaker 01:
Basically, they take the amplicon and they cleave part off of it.

[00:26:10] Speaker 01:
The facts are undisputed in that sense.

[00:26:13] Speaker 01:
But what's not undisputed is that that's a step two question as to whether that satisfied the claim construction.

[00:26:19] Speaker 01:
The court's claim construction was replicated in a whole or part to yield amplification products of each of the different modified probes.

[00:26:27] Speaker 01:
That's undisputed.

[00:26:29] Speaker 01:
What they're essentially asking now is for a new claim construction that says it has to be the whole amplicon and not a cleaved amplicon.

[00:26:36] Speaker 01:
And the jury was able to look at the technical evidence in this case with expert testimony and say, we consider an amplicon that has part of it cut off to be an amplification product, which it obviously is.

[00:26:50] Speaker 01:
In fact, they're the ones in their own document at A4294 that coincidentally called their Cleveland Amplifications amplification product

[00:27:01] Speaker 01:
A4294, which is the exact thing that's in the claim construction.

[00:27:04] Speaker 01:
It's too late for them to get a different claim construction that demands that every single nucleotide be on the amplicon for it to be considered a cleaved amplicon.

[00:27:12] Speaker 01:
And that's what they're seeking.

[00:27:14] Speaker 01:
And then there's doctrine of equivalence.

[00:27:16] Speaker 01:
They have patent applications on these cleaved amplicons that call them surrogates.

[00:27:20] Speaker 01:
And we have testimony about, if you look at the Cooper testimony, that walks through the insubstantiality.

[00:27:29] Speaker 01:
The second thing that was argued was immobilization.

[00:27:31] Speaker 01:
It was very quick.

[00:27:33] Speaker 01:
I don't know if there's questions about that.

[00:27:35] Speaker 01:
But basically, if you look at the claim term, and the judge went through this multiple times, the district court said, the fact that it is immobilized, you have to recognize, because that's how the test works.

[00:27:47] Speaker 01:
But if you leave an indicator that, OK, it was immobilized, it's enough that you can tell that it was immobilized.

[00:27:53] Speaker 01:
That's all that the claim requirement states.

[00:27:57] Speaker 01:
And then on the third one about this order of steps, boy was that a superficial statement of the record.

[00:28:05] Speaker 01:
We put in extensive scientific testimony from Dr. Cooper that went through a Daubert review that was a protracted proceeding.

[00:28:15] Speaker 01:
The district court found it reliable.

[00:28:17] Speaker 01:
That's at A12003.

[00:28:20] Speaker 01:
They didn't appeal to Daubert.

[00:28:21] Speaker 01:
So they're acknowledging that it's scientific testimony that the order of steps is met.

[00:28:26] Speaker 01:
was it was reliable enough to be in and they're saying that it's somehow voodoo and then they use this common term no one's seen it well come on i mean of course no one's seen it no one's like with you know and uh... in one of these uh... crazy scientific movies where they can get down and see different nucleotides at the new at the molecular levels i want to say two words to your son

[00:28:49] Speaker 01:
For us, Asinore Estoppel, again, these people signed all the rights.

[00:28:56] Speaker 01:
They've never brought any claim to say they're not inventors.

[00:29:00] Speaker 01:
And we've demonstrated they are inventors.

[00:29:02] Speaker 01:
And they admitted they're trying to become not inventors or denying their inventorship because they want to avoid the Asinore Estoppel doctrine.

[00:29:09] Speaker 01:
They went and made homebrew to our patent.

[00:29:13] Speaker 01:
and are competing with our platform directly, and we're entitled to an injunction.

[00:29:17] Speaker 01:
The other thing I would just say, the last point I want to make is don't lose track of the supplemental damages issue.

[00:29:22] Speaker 01:
It's kind of quirky the way it came up.

[00:29:24] Speaker 01:
And the district court said she denied it, but seems to really want to grant it and let us do it on remand.

[00:29:29] Speaker 01:
There's a lot of money, because it's been a few years, and this is big sales.

[00:29:32] Speaker 01:
And so we have to just make sure that we don't lose track of the supplemental damages issue.

[00:29:40] Speaker 03:
Thank you very much, Your Honor.

[00:29:41] Speaker 03:
That concludes today's argument.

[00:29:42] Speaker 03:
I'm sorry.

[00:29:43] Speaker 00:
If I may.

[00:29:43] Speaker 03:
Yes, you may.

[00:29:44] Speaker 00:
I'll be very quick, Judge Arena.

[00:29:45] Speaker 00:
Thank you.

[00:29:46] Speaker 00:
I appreciate the opportunity.

[00:29:47] Speaker 02:
Can I just?

[00:29:48] Speaker 02:
Yes, of course.

[00:29:48] Speaker 02:
Two things.

[00:29:49] Speaker 02:
Do you agree?

[00:29:50] Speaker 02:
I know you don't agree that substantial evidence of support

[00:29:53] Speaker 02:
the invalidity of the 794, but if we find it does, do we need to reach a sign or a stopfall?

[00:30:00] Speaker 02:
No, Your Honor, you don't.

[00:30:01] Speaker 02:
And your friend's last point, it's clear, or I just want to make sure it's clear on the record, you agree, assuming everything plays out the way

[00:30:10] Speaker 02:
it did below that they're still entitled to supplemental damages in accounting, or at least ask for it.

[00:30:16] Speaker 00:
They're entitled to ask for it.

[00:30:17] Speaker 02:
Not that they're entitled to it, but they can ask for it.

[00:30:19] Speaker 00:
So we think it's different as to pre-verdict versus post-verdict supplemental damages.

[00:30:23] Speaker 00:
OK.

[00:30:24] Speaker 00:
And that's all something Judge Ilston, I think, should be given the opportunity to address in the first place.

[00:30:28] Speaker 02:
I just want to make sure you're not going to go back now and say she already rejected all of that and she can't read.

[00:30:32] Speaker 00:
No, no.

[00:30:33] Speaker 00:
I think the right reading of what happened is that she deferred it until following this appeal to see if there ultimately was a judgment of liability at the end of it.

[00:30:40] Speaker 00:
I'd just make two points on the non-infringement, if I may.

[00:30:44] Speaker 00:
First of all, Mr. Reines is very careful to say he thinks readout cassettes are amplification products.

[00:30:51] Speaker 00:
But of course the claim and the claim construction are not satisfied simply by amplification products.

[00:30:56] Speaker 00:
It needs to be an amplification product of each of the different modified probes.

[00:31:00] Speaker 00:
That's page 15011.

[00:31:02] Speaker 00:
And that's important because the modified probes, as construed on 1509,

[00:31:07] Speaker 00:
have to contain a universal priming site.

[00:31:09] Speaker 00:
That's how they get replicated through polymerase chain reaction.

[00:31:13] Speaker 00:
That cannot happen to the readout cassettes.

[00:31:15] Speaker 00:
They do not have a universal priming site, they are not modified probes, therefore their amplification cannot make them amplicons as Illumina chose to claim them in its own claims.

[00:31:25] Speaker 00:
If they wanted to do something different, they could have tried to do it.

[00:31:28] Speaker 00:
They could have seen if they could have gotten those claims issued, but they didn't.

[00:31:31] Speaker 00:
As a result, we're not challenging the claim construction.

[00:31:33] Speaker 00:
We're perfectly content with the claim construction.

[00:31:35] Speaker 00:
The point is they don't satisfy it.

[00:31:37] Speaker 00:
And the way they're trying to convince this court that they do, or that Harmony version 2 does, is by reading out the requirement of amplification products of each of the different modified probes.

[00:31:47] Speaker 00:
That is a critical component of the claim construction.

[00:31:50] Speaker 00:
And by trying to get rid of it, they are trying to broaden the claim beyond what they actually recited.

[00:31:54] Speaker 00:
Regarding the first two limitations and the necessity of having the strands attached in the claims attached before they are contacted by the probes, which is the opposite of what we do, there's some kind of suggestion that we were required

[00:32:10] Speaker 00:
to appeal the Daubert ruling in order to appeal a Jamal denial.

[00:32:14] Speaker 00:
I know of no law that says that.

[00:32:16] Speaker 00:
The Supreme Court in Brook Group, this court in NPLAS has made very clear that if you are challenging the admissibility of expert testimony, you appeal the Daubert.

[00:32:25] Speaker 00:
But if you are challenging the sufficiency of the testimony to support a jury verdict, you appeal substantial evidence.

[00:32:30] Speaker 00:
In fact, the denial of the Daubert motion said, the judge said, I think this goes to weight rather than admissibility.

[00:32:36] Speaker 00:
We're appealing the weight.

[00:32:37] Speaker 00:
and here the expert testimony as presented to the jury is not enough to allow a reasonable jury to find infringement.

[00:32:45] Speaker 00:
He never explained why once you have the strands bound down to the array, all close to each other, all of a sudden, even though it took two hours and none, not one,

[00:32:56] Speaker 00:
of the probes bound to the strand.

[00:32:58] Speaker 00:
The moment they had, they would have become double-stranded, not single-stranded as the claims require.

[00:33:02] Speaker 00:
The moment that they get bound down, supposedly they quickly get attached to by all three probes, there is no evidence, nothing Dr. Cooper, their expert, said remotely supported that that would happen.

[00:33:12] Speaker 00:
He never explained why it would happen.

[00:33:14] Speaker 00:
The uncontradicted testimony of our expert on 2394 says it was far less likely to happen.

[00:33:20] Speaker 00:
Also, Illumina has never explained why it would happen to 100 different probes, which the claims also require.

[00:33:26] Speaker 00:
It's a complete failure of proof.

[00:33:28] Speaker 00:
We respectfully submit that the judgment of liability should be reversed, the denial of the injunction should be affirmed, and I thank the court for its time.

[00:33:34] Speaker 03:
Thank you.

[00:33:35] Speaker 03:
Thank all the parties for the arguments this morning.

[00:33:37] Speaker 03:
This court is now in recess.