[00:00:00] Speaker 03:
Good morning, ladies and gentlemen.

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As you have no doubt noticed, Judge O'Malley is not here due to a recent injury.

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But she is listening in and watching us.

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And she'll fully participate in the decision of the case.

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We have six cases this morning, five patent cases.

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either from the PTAB or from the district court.

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And a case from the Court of Federal Claims, which is not being argued, will be submitted on the briefs.

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We're going to hear three arguments and then take a short break and then return for Dr. Faulk and Salix.

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The first case is Anjan B. Sandoz.

[00:00:58] Speaker 03:
2018, 1551, 1552.

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Mr. Groombridge.

[00:01:08] Speaker 01:
Good morning, Your Honors, and may it please the Court.

[00:01:13] Speaker 01:
So I want to start with the 878 patent.

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And we have two categories of complaints about what happened in the district court there.

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First of all, that the district court made errors of claim construction.

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And secondly, that the district court disregarded the evidence that we submitted, principally the declaration of our expert, Dr. Wilson.

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And while I'm going to focus largely on the claim construction issues, I want to lay out at the beginning in summary form what it was that Dr. Wilson showed.

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He went through in great detail

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Isn't the first basic question whether wash precedes elution?

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That's the first claim construction question, absolutely, Your Honor.

[00:02:00] Speaker 01:
And the dispute there boils down to does that mean that at any given point in the column wash precedes elution?

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Or does it mean that everywhere in the column all washing must be finished before any elution starts?

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Well, the claims don't get into that kind of detail.

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And they do talk about

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are supplying a refold solution, and then washing, and then eluting.

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And that's what the specification says.

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You wash, and then after that, you elute.

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And why isn't it as simple as that?

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And the reason, Your Honor, it is, at any given point in the column, absolutely as simple as that.

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But remember, the column takes the material a certain amount of time.

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Let's say 10 minutes.

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That's in Dr. Wilson's declaration.

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from the time it enters at the top to the time it exits at the bottom.

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And there is no reason whatsoever why washing cannot be occurring at the bottom of the column when eluting starts at the top of the column.

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So if we look at any given place, washing precedes eluting.

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And what that means is we avoid commingling.

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But there is absolutely no requirement that all washing be finished everywhere before any eluting start anywhere.

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That's simply not necessary.

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And in fact, the patent teaches to the contrary in example three.

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Now, the only reason that was ever given by the district court or by Sandoz for washing having to be finished before eluting takes place.

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The court reason that the washing and eluting steps occurred simultaneously because if that didn't happen, then the proteins that separate

[00:03:46] Speaker 02:
during the washing would bind again.

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Was the court wrong on that?

[00:03:51] Speaker 01:
I don't think the court's wrong if you look at any given place in the column.

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In other words, I think that the problem with the construction is it's ambiguous as to whether we're talking about a particular spot in the column or everything that's happening across the column at all.

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And so the court's completely right and there was never any disagreement that, of course, we have to wash before we elute.

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If we did the two at the same time, everything would come out and there would be no separation.

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But what is going on, and I mean this is illustrated by the diagram that's on page three of the gray brief, not that I want us to go there, but it shows there's no, the only reason that was ever advanced for the temporal separation was to avoid co-mingling.

[00:04:31] Speaker 01:
Well we can avoid co-mingling as long as we say that we're talking only about a specific spot in the column.

[00:04:36] Speaker 02:
Put co-mingling aside, you do agree you have to wash before you elute.

[00:04:39] Speaker 01:
Absolutely.

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And we never disputed that in any way.

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Would you agree that those are two distinct steps?

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At any point in the column, they're two distinct steps.

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So first of all, you wash.

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I mean, think about this.

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It's logical.

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The molecule of interest here for grasping finds to the column.

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And let's imagine we're talking now just to a specific place.

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and then there's wash which means fluid comes by and sweeps away the things we don't want so they can emerge out of the bottom of the column and be discarded.

[00:05:09] Speaker 03:
So what's the issue if you agree that there's separate steps and that washing precedes elution?

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What's the issue?

[00:05:17] Speaker 01:
So our expert says at any point in the column washing does precede eluting.

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The district court then said well that wasn't what I meant when I said after I meant all

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washing has to be finished before any looting starts.

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You're nitpicking the district court.

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The question is, was the judgment correct?

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The judgment was wrong.

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Because what's going on, as our experts showed, what their process does is exactly what's claimed in this patent.

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The judgment's wrong.

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And our experts showed, Phil Graston comes in, binds to the column, fluid comes by, carries away contaminants.

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You're saying they have separate

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washing and elution steps?

[00:06:00] Speaker 01:
Absolutely.

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When you look at any given point in the column, absolutely, Your Honor.

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Filgrastin binds, fluid passes down the column carrying away contaminants that are discarded, never again to be mixed with the desired substance.

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The conditions change, the filgrastin releases from the column, comes down the bottom and is collected.

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That's exactly what this patent is talking about.

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And our expert laid that out in tremendous detail.

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and the district court simply disregarded it.

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That's the fundamental problem that we have here.

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And there's paragraph after paragraph in which our expert goes through and talks about, explains why it is that feldrastant binds, why it is that specific contaminants don't bind and are swept away, why it is that the conditions change, the salt concentration increases, the feldrastant let go, comes out and is collected.

[00:06:49] Speaker 01:
It lays it out in graphic detail, the district court's

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comments on that was you're just one sentence, you're attempting to redefine Sandoz's process.

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We're not redefining it, we're analyzing it, analyzing it in tremendous detail.

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And that was wrong.

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And so the claim construction, to the extent that after means, as it must have meant, as the district court said it meant for this judgment, after means all washing must be finished before any eluting begins, that's wrong.

[00:07:19] Speaker 01:
To the extent it means

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at any given point in the column, washing proceeds eluting its right, but our evidence shows that that's exactly what happens.

[00:07:27] Speaker 02:
Putting that aside, just looking at the PAN itself, at F, washing the separation matrix and eluting the protein from the separation matrix, that seems to just read in plain English that you first have to wash a separation mix.

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It's logical.

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You have to wash the separation mix before you get into the eluting process.

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And that's exactly what happens, Your Honor.

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In other words, what our experts said is the filgrastim attaches to these beads.

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Then fluid comes, and while it's attached, fluid comes by that doesn't cause it to unattach, sweeps away the things that aren't wanted.

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Then the salt concentration goes up.

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That causes the filgrastim to release from the bead.

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and be swept out of the bottom.

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That is eluting.

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And so what is happening here is that Sandoz is doing exactly what this patent talks about.

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It is having the filgrastium attached to the column, have unwanted contaminants not attached, come out of the bottom, be disposed of, and then have the filgrastium come out afterwards because it's eluted and be collected.

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The district court said the method employed by Sandoz does not have the

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sequential washing and eluting steps required by claim seven.

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It entails continuously pumping a refold solution.

[00:08:54] Speaker 01:
And I think, Your Honor, that gets into the second of our disputes, which is about whether it is required to form a discrete washing solution outside the column and then put it in, and whether after that it's required to form a discrete eluting solution and put that in.

[00:09:13] Speaker 01:
And that's what the district court is saying there.

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Our experts said compositionally distinct washing and eluting solutions form inside the column in situ and form functions that are laid out in this patent.

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And they're not adding, it's not that three separate solutions are made at the beginning and put one after another into the column, but they form in there and they carry out the teaching of this patent.

[00:09:41] Speaker 01:
district court then said, and this is what I take to be the dispute, I think you only infringe this patent if you form a washing solution that's separate from the refold mixture and put it in, and then after that you form a different eluting solution that's separate from the mixture and put it in.

[00:10:02] Speaker 01:
And our view is that that's incorrect.

[00:10:04] Speaker 01:
There's nothing in the patent that requires that.

[00:10:06] Speaker 01:
The patent only requires that

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once the filgrast is attached that there'd be a washing in the sense that fluid carries away.

[00:10:16] Speaker 03:
What about the 427 patent?

[00:10:19] Speaker 01:
I'm happy to talk about that, Your Honor.

[00:10:20] Speaker 01:
In the 427 patent, again, we think there's an error of claim construction and we think that the term is disease-treating effective amount.

[00:10:29] Speaker 01:
The question is whether the term disease-treating requires this agent, what the patent defines as the chemotherapeutic agent, to be prescribed

[00:10:38] Speaker 01:
for treating, let's say, cancer as opposed to the treatment, as opposed to for the purpose of mobilizing stem cells.

[00:10:48] Speaker 03:
Are you saying that if there were no chemo agent, the claim would still make sense that treating a disease would be sufficient by administering the GCSF?

[00:11:05] Speaker 03:
Excuse me.

[00:11:06] Speaker 03:
My congestion.

[00:11:07] Speaker 01:
No worries.

[00:11:08] Speaker 01:
What we're saying, Your Honor, is that the term disease-treating effective amount is an adjectival phrase that says this is how much you apply.

[00:11:20] Speaker 01:
It's a what kind of phrase?

[00:11:21] Speaker 01:
An adjectival phrase.

[00:11:23] Speaker 01:
In other words, disease-treating and effective here modify amount.

[00:11:28] Speaker 01:
And all this is doing is this is how much you administer.

[00:11:31] Speaker 01:
It's not saying why you administer it.

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In other words, disease-treating doesn't mean that

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This must be administered for the purpose of killing cancer cells.

[00:11:42] Speaker 01:
The patent is very clear that... That doesn't seem to make a lot of sense.

[00:11:48] Speaker 01:
That's why you're doing the treatment.

[00:11:50] Speaker 01:
Can I take a run at that, Your Honor?

[00:11:52] Speaker 01:
That what the patent is saying is it starts... Because the way the claim was construed, it reads on what the patent describes in column one as a prior art.

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And in our view, that can't possibly be right.

[00:12:02] Speaker 01:
And so the patent says, look, we know that

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when you treat certain diseases with high dose chemotherapy or radiation, as part of that treatment, the treatment itself requires subsequent incorporation of hematopoietic stem cells.

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That's column one, lines 18 to 20.

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So part of the treatment is the stem cell collection, harvesting, and re-administration.

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And the pattern then says, we know

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It's been known in the art that one of the ways you can mobilize the stem cells is by administering GCSF.

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And it also says that then you could do that, harvest the stem cells, and then treat the cancer by giving chemotherapy.

[00:12:44] Speaker 01:
That's part of the prior art.

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The claim was construed to read on that description of the prior art.

[00:12:49] Speaker 01:
What the patent says, and frankly, it's hard for us to see how anyone could reach a contrary conclusion, when you read the patent, it says our invention is the discovery that when you're trying to mobilize the stem cells,

[00:13:01] Speaker 01:
If you first give the GCSF and then you give a chemotherapeutic agent, and then you harvest the stem cells, you get a much better result.

[00:13:09] Speaker 01:
You get a better yield of stem cells.

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And then you could go on to treat the cancer.

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You could treat it with chemotherapy.

[00:13:15] Speaker 01:
You could treat it with radiation, in which case there would never be a chemotherapeutic drug used for treatment of the cancer.

[00:13:20] Speaker 02:
When the claim uses the word diseases, what diseases is it talking about?

[00:13:26] Speaker 01:
In the preamble, Your Honor.

[00:13:29] Speaker 01:
I think what it's talking about

[00:13:31] Speaker 01:
in the preamble when it says a method of treating a disease requiring peripheral stem cell transplantation.

[00:13:37] Speaker 01:
I think what it's talking about is a method such as the use of high-dose chemotherapy or radiation.

[00:13:43] Speaker 01:
What diseases are talking about?

[00:13:45] Speaker 01:
Typically cancer, but the pattern's not so limited and there may very well be others.

[00:13:51] Speaker 01:
But what the classic case would be if someone has cancer, and there are certain methods of treatment that will kill

[00:14:00] Speaker 01:
all of the stem cells in the bone marrow.

[00:14:03] Speaker 01:
And therefore the patient will die if there is not a re-transplantation.

[00:14:09] Speaker 01:
And therefore the method of treatment requires this peripheral stem cell transplantation.

[00:14:17] Speaker 01:
And that's what I take the claim to be talking about.

[00:14:20] Speaker 03:
You wanted to save a couple of minutes for a bottle?

[00:14:22] Speaker 03:
Absolutely, Your Honor.

[00:14:23] Speaker 03:
We'll save it for you.

[00:14:24] Speaker 03:
Thank you.

[00:14:33] Speaker 00:
Good morning, Your Honors, and may it please the Court.

[00:14:35] Speaker 00:
Diane Maynard on behalf of Sandoz.

[00:14:37] Speaker 00:
The District Court correctly concluded that Sandoz's one-step, one-solution process does not infringe Amgen's three-step, three-solution method.

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And there's at least three independent ways this Court could affirm.

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And the first is Amgen should not be allowed to make its claim construction arguments in this Court.

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It strategically chose not to respond

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to the claim construction arguments during the claim construction proceedings in the district court, the district court concluded it made no response.

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And Sandoz expressly teed up the question of separate steps, that the washing step had to be separate from the eluding step.

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And the district court agreed with us.

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At A46, the district court held the steps cannot occur simultaneously.

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And then at summary judgment, contrary to the

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the premise of Amgen's appeal brief here at summary judgment, the district court applied that construction and held the Amgen, excuse me, that Sandoz's one step, one solution process, whereas your honor mentioned it's just a matter of continuously applying refold solution, does not practice the claims as interpreted by the claim construction order.

[00:15:53] Speaker 00:
So under this court's precedent, that should be the end of this appeal.

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Amgen did not press its claim construction arguments at the proper time, and it shouldn't be allowed to come to this court and contend that the district court made an error.

[00:16:06] Speaker 03:
But on the merits?

[00:16:07] Speaker 00:
On the merits, Your Honor, the claim construction is correct.

[00:16:10] Speaker 00:
So if one looks at the claim constructions that aren't challenged, the step of washing the separation matrix was interpreted to mean, and this is at appendix 44 to 45, carryover, adding a solution

[00:16:26] Speaker 00:
to the separation matrix to remove materials in the refold solution while preserving binding of the protein to be purified.

[00:16:35] Speaker 00:
Adding a solution to remove materials from the refold solution.

[00:16:39] Speaker 00:
So that is, just by definition, that has to be a different solution than the refold solution while preserving binding of the protein.

[00:16:48] Speaker 00:
And then the next step, the next step is applying a solution, applying a solution, and that step

[00:16:56] Speaker 00:
must come after the step of adding a solution to wash.

[00:17:01] Speaker 03:
And where are you?

[00:17:03] Speaker 00:
So I'm reading you the claim constructions for washing, which is at appendix 44 to 45 at the bottom, Your Honor.

[00:17:14] Speaker 00:
So it's a carryover.

[00:17:15] Speaker 00:
In sum, the phrase must be construed.

[00:17:18] Speaker 00:
And the judge adopts part of Amgen's proposal and part of Sanders' proposal for the washing.

[00:17:25] Speaker 00:
But the key point, Judge Lurie, is that the focus on the washing step is adding the solution.

[00:17:33] Speaker 00:
Adding the solution.

[00:17:34] Speaker 00:
And only after you add the solution and all of the washing solution, because the step can't occur simultaneously with the eluting solution, applying the eluting solution occurs after and is a separate step.

[00:17:50] Speaker 03:
Well, that's what the patent says.

[00:17:52] Speaker 00:
That's what the patent says.

[00:17:53] Speaker 00:
Exactly.

[00:17:54] Speaker 03:
Now, what about example three?

[00:17:56] Speaker 00:
So example three is not inconsistent with that construction genre.

[00:17:59] Speaker 00:
So example three includes adding a refold solution, then adding, so we're on A76 in, let me see, let me, sorry, I beg your pardon, A76, column 20, line 34.

[00:18:25] Speaker 00:
So starting up at line 27, the refold solution is added.

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And then picking up at line 34 on column 20, after loading, the column was washed.

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And then it gives the components of that first washing solution.

[00:18:45] Speaker 00:
Then it was washed with an additional washing solution.

[00:18:47] Speaker 00:
It gives components for a different washing solution.

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The protein of interest was recovered from the resin by gradient elution.

[00:18:56] Speaker 00:
And then it talks about a third solution.

[00:19:00] Speaker 00:
That third solution is the eluding solution, Judge Laurie, and it contains salt.

[00:19:05] Speaker 00:
And it is a separate solution.

[00:19:06] Speaker 00:
It's completely consistent both with the separate solutions construction of the district court and the separate steps.

[00:19:12] Speaker 00:
And either one of those, if you affirm the district court's conclusion that it requires separate steps that can't happen simultaneously, that's a basis to affirm.

[00:19:21] Speaker 00:
They don't challenge literal infringement under that.

[00:19:23] Speaker 00:
Sandoz is only applying one step, and it's a refold solution.

[00:19:27] Speaker 00:
And or if the court agrees that these have to be separate solutions, which the spec shows that they do.

[00:19:33] Speaker 00:
Every example in the spec that gives the solutions gives separate solutions for washing and eluting, which makes perfect sense under the purpose of the steps in the claim, because they do opposite things.

[00:19:46] Speaker 00:
And it's important to note that Amgen's proposals for both constructions of the washing step was adding a solution that does one thing, a function that does one thing, which was wash away the contaminants you don't want while preserving the binding of the protein.

[00:20:03] Speaker 00:
And then Amgen's solution of the second was adding a solution that does an opposite thing.

[00:20:09] Speaker 00:
It allows the protein to be released and captured.

[00:20:12] Speaker 00:
And those require two separate solutions.

[00:20:15] Speaker 00:
Nothing in the patent suggests you can do it with one solution.

[00:20:18] Speaker 00:
Certainly nothing in the patent suggests you can do it with the refold solution.

[00:20:21] Speaker 00:
And Sandoz's accused step is only continuously pumping refold solution onto the column.

[00:20:28] Speaker 02:
And those steps have to be taken in a certain order?

[00:20:31] Speaker 00:
Yes, Your Honor, they do.

[00:20:32] Speaker 00:
Because as the district court explained on A45, A46 of its claim construction order, for the reasons that you were reading,

[00:20:41] Speaker 00:
If you don't finish applying the washing solution, and so that is an unchallenged construction and means adding a solution to do all those things, you finish that step, adding all the solution to wash that washes away the contention.

[00:20:57] Speaker 02:
Is there any commingling of the solutions at any time during the phases?

[00:21:01] Speaker 00:
So the constructions and the claims don't talk about what's happening in the column.

[00:21:06] Speaker 00:
This is kind of like a red herring.

[00:21:07] Speaker 00:
The constructions that aren't challenged talk about what you're adding into the column.

[00:21:12] Speaker 00:
They focus on what you're adding into the column.

[00:21:14] Speaker 02:
And you're adding the washing solution first to do a certain thing.

[00:21:18] Speaker 02:
But the PAN is a method of what happens in the column, correct?

[00:21:22] Speaker 00:
No, Your Honor.

[00:21:23] Speaker 00:
So if you look at the steps of claim seven, which is the only claim on appeal, it's a column 22 on page A77.

[00:21:36] Speaker 00:
If you look at the steps that are at issue, well, I think one thing, stepping back for a second, if you look at the steps, it's clear that each one of them must occur in this order, and they must occur separately.

[00:21:47] Speaker 03:
So if you... It's a method of purifying a protein.

[00:21:50] Speaker 00:
Exactly, Your Honor.

[00:21:51] Speaker 00:
And it talks about expressing the protein first.

[00:21:53] Speaker 00:
That's step A. So you express the protein.

[00:21:56] Speaker 00:
Well, you don't want to break open, which is lysing, step B, the non-mammalian cell, until you finish expressing the protein in step A.

[00:22:04] Speaker 00:
And then you can't solubilize the expressed protein until after you've lysed.

[00:22:08] Speaker 00:
So each step has to go in this order, Judge Rainier, and it has to be finished before the next step.

[00:22:13] Speaker 00:
And that's what the district court concluded.

[00:22:15] Speaker 00:
But then, to your question directly, Judge Rainier, when you get down to E, F, and G, you're talking about a step that requires adding something in to the column, directly applying the refold solution to the matrix.

[00:22:29] Speaker 00:
It's not talking about what's happening.

[00:22:30] Speaker 00:
The method claimed.

[00:22:32] Speaker 00:
and because it is a method claim, it's important about the how, is talking about what you're doing sort of at the top end of the column, as it were, not within the column.

[00:22:40] Speaker 00:
And what they're trying to focus on is really a red herring.

[00:22:43] Speaker 00:
There's no dispute that Sandoz only applies one solution to the column, and it's a refold solution.

[00:22:50] Speaker 03:
Tell us about 427.

[00:22:52] Speaker 00:
Well, the 427, Your Honor, disease treating amount, they want to read disease treating amount.

[00:22:58] Speaker 00:
They want you to read in the limitation from the first step

[00:23:01] Speaker 00:
into disease-treating amount.

[00:23:04] Speaker 00:
But it says disease-treating.

[00:23:06] Speaker 00:
And he said to you today that the disease is cancer.

[00:23:09] Speaker 00:
So a disease-treating amount needs to be an amount of chemotherapy to treat the cancer.

[00:23:14] Speaker 00:
And it certainly, especially, excuse me, Your Honor.

[00:23:20] Speaker 03:
I understand the problem.

[00:23:23] Speaker 03:
We're allergic to the courtroom.

[00:23:26] Speaker 00:
A85, column 10 is where claim one is of the 427.

[00:23:31] Speaker 00:
And the first limitation is administering a hematomatic, sorry about that, stem cell mobilizing effective amount.

[00:23:40] Speaker 00:
And they want this court to read stem cell mobilizing effective amount into disease treating effective amount.

[00:23:47] Speaker 00:
Well, those are two different words contrasted against each other in the same claim.

[00:23:53] Speaker 00:
And this court, that's just a bridge too far.

[00:23:55] Speaker 02:
This court doesn't rewrite it.

[00:23:56] Speaker 02:
That's one of the ways you treat the disease.

[00:23:59] Speaker 02:
I beg your pardon?

[00:24:00] Speaker 02:
His argument is that's one of the ways you treat the disease.

[00:24:03] Speaker 00:
Well, the district court interpreted the preamble, Your Honor, and they don't challenge the interpretation of the preamble.

[00:24:07] Speaker 00:
The preamble is limiting.

[00:24:08] Speaker 00:
The district court read a method of treating a disease is it's a method of treating cancer.

[00:24:15] Speaker 00:
And the district court found as fact, and that is on

[00:24:22] Speaker 00:
A26, note three, the district court found as fact that the disease being treated in this patent is the underlying cancer, that the stem cell mobilization of this patent is not a disease treating.

[00:24:34] Speaker 00:
In their reply brief, they cite their expert, but the district court credited our expert and found as fact that this is not, there are theoretically stem cell mobilizations that can actually treat an underlying disease.

[00:24:45] Speaker 00:
This does not.

[00:24:47] Speaker 00:
What you're doing here is trying to remove the stem cells from the body so that you can

[00:24:52] Speaker 00:
give the disease-treating amount of chemotherapy to treat the cancer, and then put the stem cells back.

[00:24:59] Speaker 03:
And why does this argument matter in terms of infringement, which I gather they've conceded under this interpretation?

[00:25:06] Speaker 00:
They've conceded non-infringement.

[00:25:07] Speaker 00:
The stipulation doesn't clarify why.

[00:25:10] Speaker 00:
We think there are multiple reasons why we don't infringe.

[00:25:17] Speaker 00:
The record doesn't say why this matters.

[00:25:21] Speaker 03:
didn't realize.

[00:25:23] Speaker 00:
Yes, they conceded non-infringement under this interpretation.

[00:25:27] Speaker 00:
And the interpretation is clearly right, because it says disease treating amount.

[00:25:30] Speaker 00:
So it should be an amount of disease treating chemotherapy, if the court has no further questions.

[00:25:37] Speaker 03:
Thank you, Ms.

[00:25:38] Speaker 03:
Maynard.

[00:25:38] Speaker 03:
Thank you.

[00:25:39] Speaker 03:
Mr. Broombridge has a couple of minutes for rebuttal.

[00:25:44] Speaker 01:
I will be brief, Your Honor, and I'll start with Your Honor's most recent question.

[00:25:48] Speaker 01:
Why does it matter?

[00:25:50] Speaker 01:
Because the construction says that the chemotherapeutic agent must be prescribed for treating the disease.

[00:25:56] Speaker 01:
Now, in the accused instrumentality, the chemotherapeutic agent would be prescribed for stem cell mobilization, not for treating the cancer.

[00:26:06] Speaker 01:
And the district court's construction reads that out.

[00:26:10] Speaker 01:
It reads out the very invention of the patent.

[00:26:12] Speaker 01:
And so if you have a situation where you do, you attempt to practice the invention of the 427 patent,

[00:26:18] Speaker 01:
and say I'm going to use a chemotherapeutic agent as part of my mobilization regime.

[00:26:24] Speaker 01:
That's not covered by the patent under this construction.

[00:26:27] Speaker 01:
That's why we stipulate it to non-infringement.

[00:26:30] Speaker 01:
And there was a second question.

[00:26:34] Speaker 01:
Ms.

[00:26:34] Speaker 01:
Maynard talked about why are two different terms used.

[00:26:38] Speaker 01:
For GCSF, it's hematopoietic stem cell mobilizing amount.

[00:26:43] Speaker 01:
And for the chemotherapeutic agent, it's disease-treating effective amount.

[00:26:46] Speaker 01:
The answer is because, as the patent teaches, some but not all chemotherapeutic agents were known to mobilize stem cells.

[00:26:55] Speaker 01:
Thus, for the ones that weren't so known, there would be no stem cell mobilizing amount.

[00:27:00] Speaker 01:
They would work in this method by assisting, for example, by helping the stem cells mobilizing by the GCSF to get out of the bone marrow so they could be harvested.

[00:27:11] Speaker 01:
But they would not themselves be mobilizing them, and that's why a different term is used.

[00:27:15] Speaker 01:
Lastly, with respect to the 878 patent, Ms.

[00:27:20] Speaker 01:
Maynard repeatedly said that the construction was adding a solution.

[00:27:25] Speaker 01:
And I think the reason she uses the word adding is because it implies pouring the thing in at the top.

[00:27:30] Speaker 01:
The word is applying a solution.

[00:27:32] Speaker 01:
The term, as construed at appendix 48, is applying a solution.

[00:27:36] Speaker 01:
And the reason why that matters is because if we imagine any particular point in the column,

[00:27:42] Speaker 01:
as the materials running down through those beads, it is being applied at that point.

[00:27:47] Speaker 01:
And therefore, it may seem like a slight semantic difference.

[00:27:51] Speaker 01:
In fact, in our view, it's very important that the construction of the district court proposed was applying, not adding.

[00:27:57] Speaker 01:
And with that, unless there are further questions.

[00:27:59] Speaker 02:
Does it make any difference to you whether there's any type of commingling that happens during the two steps?

[00:28:08] Speaker 01:
To be clear, Your Honor, there is

[00:28:10] Speaker 01:
There is a mixing that occurs inside the column, which is the reason why the salt conditions change.

[00:28:20] Speaker 01:
There's this in essence diffusion.

[00:28:22] Speaker 01:
You start off with a column that's full of liquid with no salt.

[00:28:25] Speaker 01:
And as you pour in this refold mixture, gradually the salt concentration rises.

[00:28:30] Speaker 01:
And the reason why that matters... And that causes the proteins to unbind.

[00:28:33] Speaker 01:
Exactly, Your Honor.

[00:28:35] Speaker 01:
The co-mingling piece that we care about is at the bottom, when the stuff comes out,

[00:28:40] Speaker 01:
We want to avoid co-mingling.

[00:28:42] Speaker 01:
So first of all, what emerges is the stuff we want to get rid of.

[00:28:45] Speaker 01:
And then after a certain point, what emerges is the stuff we want to keep.

[00:28:48] Speaker 01:
And that's exactly what happens.

[00:28:50] Speaker 01:
And that's what our experts are testifying to.

[00:28:53] Speaker 03:
Thank you, counsel.

[00:28:54] Speaker 03:
Thank you to both.

[00:28:55] Speaker 03:
We'll take the case under advisement.

[00:28:56] Speaker 01:
Thank you, Your Honor.