[00:00:00] Speaker 01:
Our final case for argument today is 24-2351, Regeneron versus Mylan.

[00:00:06] Speaker 01:
Mr. Burl, please proceed.

[00:00:09] Speaker 02:
Thank you, Your Honors.

[00:00:10] Speaker 02:
May it please the Court, David Burl on behalf of Regeneron.

[00:00:14] Speaker 02:
The Beckton-Dickinson case sets forth an implication or presumption that is frequently and readily rebutted, not an ironclad rule.

[00:00:25] Speaker 02:
That presumption does not operate independently of, much less override or supplant, the usual rules for construing claims that courts have applied consistently for decades.

[00:00:36] Speaker 00:
But counsel, you're here under preliminary injunction rules.

[00:00:42] Speaker 00:
Indeed.

[00:00:43] Speaker 00:
And as the court said, appendix 29, there's a substantial question of non-infringement.

[00:00:53] Speaker 00:
does not contain a buffer.

[00:00:57] Speaker 00:
And that is a limitation of the claim.

[00:01:00] Speaker 00:
Apparently, a buffer is not needed here because of the qualities of the VGF antagonist.

[00:01:09] Speaker 00:
And so we're stuck with the existence of a substantial question of non-infringement.

[00:01:16] Speaker 00:
And how can you win on the preliminary injunction?

[00:01:22] Speaker 02:
The court's ruling as to non-infringement by its own terms depended on a single issue of claim construction.

[00:01:29] Speaker 02:
The court ruled that buffer must be met by a separate ingredient in the accused product from the veg F antagonist, the aflibersept.

[00:01:39] Speaker 02:
This court has ruled repeatedly that that question is a matter of claim construction, and the court below said so too.

[00:01:46] Speaker 02:
That question, even on a motion for preliminary injunction, is reviewed de novo by this court.

[00:01:51] Speaker 02:
And for example, in the Luminarra case that we cite on page 27 of our brief, it's clear that where a denial of a preliminary injunction or grant depends on an erroneous claim construction, that denial or grant has to be vacated and it has to be reversed.

[00:02:07] Speaker 02:
So this is a de novo matter of law for the court.

[00:02:11] Speaker 02:
And there is no decision of this court, not one, that applies the Becton-Dickinson presumption without resolving a matter of claim construction as to the scope or meaning of claims that is raised by the parties.

[00:02:25] Speaker 04:
Not a single one.

[00:02:26] Speaker 04:
But the court here did resolve the relevant claim construction, which is, do we need to have a buffer separate from the VEGF antagonist?

[00:02:36] Speaker 04:
It didn't go on to do a full-blown construction of buffer because it had already decided what was material and in dispute, which is, do they have to be separate or do they not?

[00:02:46] Speaker 02:
But the question of whether the limitation is separate or overlapping, as the court phrased it, depends on the meaning of buffer.

[00:02:54] Speaker 02:
This court repeatedly, from the Google EcoFactor case to the

[00:02:58] Speaker 02:
linear technology case to Bot 8 to Sketsco, applies the Bechtin presumption by first looking at what the claim language means.

[00:03:06] Speaker 04:
And the court here did that over 40 pages, going through the Phillips analysis, looking at the claim language, the dependent claims, the specification, the prosecution history.

[00:03:16] Speaker 02:
Those 40 pages, respectfully, Your Honor, addressed a different question.

[00:03:20] Speaker 02:
What the court did was it started with the Bechtin presumption and says, I'll presume that these are separate limitations.

[00:03:26] Speaker 02:
and then asked whether there was a specific disclosure in the specification such as an example wherein the VEGF antagonist, a flibbersept, was serving as a buffer.

[00:03:37] Speaker 02:
That gets it exactly wrong, as this court said in Skedcoat.

[00:03:41] Speaker 02:
That turns this court's precedent on its head because claim construction must begin

[00:03:46] Speaker 02:
with the question of what is the ordinary meaning of buffer.

[00:03:49] Speaker 02:
And through 40 pages, the district court never addressed that question.

[00:03:53] Speaker 02:
It addressed it previously in the Formicon case and got it right.

[00:03:57] Speaker 02:
But by its own admission on page 78 of the decision, it announced

[00:04:03] Speaker 02:
I am not determining what the meaning of buffer is.

[00:04:06] Speaker 02:
So it did not conduct a Phillips analysis of what buffer means, and I think any such analysis would land exactly where we say, which is a buffer is an agent that resists changes in pH by a proton-donating or proton-accepting group, and thereby includes proteins like a fliverset.

[00:04:25] Speaker 02:
That's the conclusion the court reached the only time it undertook an actual Phillips analysis in the Formicon case itself.

[00:04:33] Speaker 02:
It didn't do it again.

[00:04:34] Speaker 02:
And by foregoing that claim construction analysis, it erred.

[00:04:39] Speaker 04:
As I read it, but help me try and see it your way, at 78, the only thing that the court is saying it's not going to go on to do is resolve the dispute as to whether if

[00:04:51] Speaker 04:
the veg-f antagonist can be the buffer, if they didn't have to be separate, then there's a dispute as to whether the buffer can be any substance or can only be an excipient.

[00:05:08] Speaker 04:
And the court is saying, I don't have to do that part of the buffer dispute, because it's irrelevant, given that I've already decided

[00:05:15] Speaker 04:
that they have to be separate anyway.

[00:05:16] Speaker 02:
But the decision that they have to be separate must be predicated on an actual Phillips foreigner construction of the plane.

[00:05:23] Speaker 04:
There's 40 pages of that.

[00:05:24] Speaker 02:
But none of it asks the question.

[00:05:25] Speaker 02:
And he never resolved the question of what does buffer mean?

[00:05:29] Speaker 02:
What is the ordinary meaning of buffer?

[00:05:31] Speaker 02:
The only time this court answered that question in West Virginia was in the Formicon case, where it said in the context of this specification, it says on page 16 of its Formicon decision, the ordinary meaning of buffer

[00:05:44] Speaker 02:
is any substance that resists changes in pH.

[00:05:47] Speaker 02:
The court avoided that question in its decision in this case.

[00:05:52] Speaker 04:
But the question of whether a separate component is required or not was never raised in Formicon, and the district court didn't have to consider it there.

[00:06:00] Speaker 02:
This issue was not raised with respect to the Beckton-Dickinson presumption.

[00:06:05] Speaker 02:
It was raised whether a protein like a flibbersept is part of the definition of buffer that was fiercely disputed and adjudicated in the Formicon case.

[00:06:14] Speaker 02:
This issue of whether Becton applies and whether the two things have to be separate indeed and the court says on page 78 of its opinion here the court need not address the proper construction of the term buffer and Declines to do so it never said here's the ordinary meaning of buffer.

[00:06:30] Speaker 02:
There was a dispute about the meaning of buffer below engines now abdicated its construction here on appeal that tries to read in a negative limitation into the ordinary I think I'm

[00:06:43] Speaker 01:
having trouble with your argument, because Bechtin creates a presumption that there are two separate things here.

[00:06:49] Speaker 01:
There is, is it, how do you say, is it VEGF or?

[00:06:52] Speaker 04:
Yes, VEGF or VEGF.

[00:06:54] Speaker 01:
VEGF, okay.

[00:06:54] Speaker 01:
So VEGF, so that there's VEGF and then there's a buffer.

[00:06:57] Speaker 01:
Two separate things.

[00:06:59] Speaker 01:
And Bechtin says that there's a presumption that that has to be satisfied by two separate things.

[00:07:06] Speaker 01:
There are eight examples and 22 embodiments in this spec.

[00:07:10] Speaker 01:
And they all use VEGF and all of them are

[00:07:14] Speaker 01:
a flipper CEP.

[00:07:15] Speaker 01:
I don't know if I'm saying that right.

[00:07:17] Speaker 01:
And all of them are a flipper CEP.

[00:07:19] Speaker 01:
And every one of them includes a separate buffer in addition to the a flipper CEP.

[00:07:24] Speaker 01:
So given that there's a presumption and given that that's the intrinsic record, why does it matter if a flipper CEP can sometimes function as a buffer and the district court's construction below in the other case is only that there's overlap?

[00:07:39] Speaker 01:
And so why does that matter?

[00:07:40] Speaker 02:
But the reason it matters is that the question for invoking the presumption of Beckton Dickinson depends on the ordinary meaning of the claim terms.

[00:07:49] Speaker 02:
And the question is, is there overlap between those ordinary meanings, or is there not overlap?

[00:07:54] Speaker 02:
Are they indeed separate?

[00:07:55] Speaker 02:
That's the issue that the court addressed in the Sketco case, where just like in this case, there was no example in the specification there where the pump

[00:08:03] Speaker 02:
and the valve were one in the same.

[00:08:04] Speaker 02:
They were always separate in the specification.

[00:08:07] Speaker 02:
In Bot 8, there was no example in the specification where the fault inspection program and the boot program were one in the same program.

[00:08:14] Speaker 02:
But the court, in those cases, asked a simple question.

[00:08:18] Speaker 02:
What is the ordinary meaning of the claim terms?

[00:08:21] Speaker 02:
That's the starting basis for any claim construction analysis, even with Beckton Dickinson.

[00:08:26] Speaker 02:
The court didn't do that here.

[00:08:27] Speaker 01:
My problem is, even if I start with

[00:08:31] Speaker 01:
The court's claims instruction of buffer already adopted.

[00:08:34] Speaker 01:
I still see a substantial problem with your infringement analysis.

[00:08:39] Speaker 01:
And I don't see why I would overturn the PI under those circumstances, overturn the decision to adopt.

[00:08:45] Speaker 02:
I think the issue arises, Your Honor, because in cases where

[00:08:49] Speaker 02:
Under a proper claim construction analysis.

[00:08:52] Speaker 02:
There is some overlap between the two claim limitations at issue We see that in Canon rubber we see that in the retractable technology didn't have 28 Embodiments which all required a separate buffer look

[00:09:04] Speaker 01:
If I say anything confidential, scream, and I'll make sure it gets stopped immediately and taken off the record.

[00:09:09] Speaker 01:
But the amount of flibbersep in the Amgen product is identical to the amount in all of the other products.

[00:09:16] Speaker 01:
It's not like they figured out, okay, we'll use the same 40, whatever it is, of a flibbersep, but hey, if we ramp it up to 60, it'll also fill the buffer function.

[00:09:26] Speaker 01:
It's the same number, and that's the number in all 28 embodiments.

[00:09:31] Speaker 01:
So you need a separate buffer.

[00:09:33] Speaker 01:
We didn't have one.

[00:09:34] Speaker 02:
No, those embodiments include a separate buffer, but the claims are not limited to that.

[00:09:39] Speaker 01:
The ordinary meaning of the term buffer is any substance... No, the claims are requiring a buffer, and the default presumption is that buffer is a separate element from the other elements in the claim.

[00:09:49] Speaker 01:
That's the default, and you have to overcome that.

[00:09:52] Speaker 02:
We have to overcome that, including by, under a traditional Phillips analysis, which the court below conducted, for example, in the Formicon case, if there's overlap between the two claim terms, as there was in can and rubber or tractable technology.

[00:10:06] Speaker 02:
I don't think even Amgen disputes the notion.

[00:10:08] Speaker 02:
that where two claim terms overlap in scope, the Bechtin presumption is either inapplicable or overcome.

[00:10:14] Speaker 02:
On page 43 of its brief, where it's trying to distinguish the Google versus EcoFactor case and the retractable technologies case, what they say there is, well, the claim language suggested that there was some overlap in those two cases.

[00:10:27] Speaker 02:
But here, the claim language doesn't explicitly do the meaning of the claims to the person of ordinary skill.

[00:10:32] Speaker 04:
Can we assume, for the sake of argument, just for a moment, that the district court followed a proper claim construction process?

[00:10:38] Speaker 04:
Is there anything in the intrinsic evidence that you point to that would overcome the Becton presumption of separateness?

[00:10:45] Speaker 02:
I think the intrinsic evidence is that buffer is recited and claimed broadly in the intrinsic record.

[00:10:51] Speaker 02:
It doesn't say a buffer needs to be an excipient.

[00:10:54] Speaker 02:
It doesn't say it must be only phosphate.

[00:10:57] Speaker 00:
It says it's anything.

[00:10:58] Speaker 00:
The claim says a buffer.

[00:11:00] Speaker 00:
The interim product doesn't need a buffer because the VG

[00:11:05] Speaker 00:
EGF antagonist itself has buffering properties, but it isn't a buffer.

[00:11:13] Speaker 02:
Well, I believe it is a buffer.

[00:11:15] Speaker 00:
It's a B-E-G-F antagonist.

[00:11:17] Speaker 02:
It's a VEGF antagonist and it's a buffer.

[00:11:19] Speaker 02:
Under the only Phillips analysis the district court ever conducted, it is a buffer.

[00:11:24] Speaker 02:
The court looked at the intrinsic record in that case and found that in view of the specification and the ordinary meaning of buffer, that what it meant was any substance, not just an excipient with a negative limitation, any substance that resists changes in pH by a proton donating or accepting, including proteins like aflibrosept, including histidine-containing proteins.

[00:11:44] Speaker 01:
Okay, should you save some time for a bottle, maybe?

[00:11:46] Speaker 02:
Yes, Your Honor, thank you.

[00:11:47] Speaker 01:
That's it, Mr. Laskin.

[00:12:01] Speaker 03:
Thank you, may it please the Court.

[00:12:03] Speaker 03:
As a matter of ordinary Phillips claim construction analysis, ordinary understanding, an inventor's decision to list out different elements separately creates a clear implication or presumption that those elements are distinct components of the patent invention.

[00:12:20] Speaker 03:
And the district court here does not merely find that the claims separately list out four structures as necessary components, raising the presumption that those separately listed structures are separate.

[00:12:31] Speaker 03:
But it went on to find that every indication of meaning in the specification, Regeneron's own representations, the extrinsic record, points exactly the same way, that those four separately listed structures are separate structures.

[00:12:46] Speaker 03:
If I could start with the inventions nature, I mean here that presumption is particularly powerful because this invention is not merely a formulation.

[00:12:55] Speaker 03:
It's not merely a formula, a recipe in essence that comes to your ingredients.

[00:12:59] Speaker 03:
It takes a known active ingredient, a flavorcept that is no longer patented and it says we're going to have a patent because we have stabilized it.

[00:13:06] Speaker 03:
We have a stabilizing formulation and that stabilizing formulation is

[00:13:10] Speaker 03:
four ingredients, the Flavorcept itself, and three additional ones.

[00:13:14] Speaker 03:
A skilled artist in looking at this and saying, gee, this is a stabilizing patent for a Flavorcept isn't going to read a Flavorcept and those three additional ingredients to mean a Flavorcept plus two.

[00:13:24] Speaker 04:
You write in your red brief that nothing in the intrinsic record hints that a single component can satisfy multiple recited elements.

[00:13:31] Speaker 04:
And that may be true.

[00:13:32] Speaker 04:
But is there anything in the intrinsic record that demonstrates that the patentee did not intend to claim

[00:13:38] Speaker 04:
the full broad scope of the plain and ordinary meaning of buffer.

[00:13:43] Speaker 03:
Even apart from the presumption that Beckton gives, absolutely.

[00:13:47] Speaker 03:
There's, I'm going to point to three specific things in the specification.

[00:13:50] Speaker 03:
The first, if you look at the specification, it describes the VEGIF antagonist separately from the buffer.

[00:13:55] Speaker 03:
If you look on page 96 of the record, column 6, there's a bunch of lines described.

[00:14:00] Speaker 04:
That's not anything like words of exclusion.

[00:14:02] Speaker 04:
Why are those not just

[00:14:05] Speaker 04:
preferred embodiments, and we know we don't narrow claims to just, you know, the disclosed embodiment.

[00:14:09] Speaker 03:
I was actually referring to something different, which is that it describes the flavor cell.

[00:14:13] Speaker 03:
It talks about the VEGIF antagonist.

[00:14:15] Speaker 03:
And it never once says, gee, the VEGIF antagonist can be the buffer.

[00:14:18] Speaker 03:
And it described buffers.

[00:14:20] Speaker 03:
One buffer, actually, talks about a phosphate buffer.

[00:14:23] Speaker 03:
And it never says, gee, the buffer can be the VEGIF antagonist.

[00:14:26] Speaker 03:
And when it actually talks about the measures, and this is the second point, when you're looking at the concentration measures, it uses two different measures

[00:14:34] Speaker 03:
One for a flibbersep, one for the buffers.

[00:14:37] Speaker 03:
So for a flibbersep, it's milligrams per milliliter.

[00:14:39] Speaker 03:
For buffers, it's millimoles per liter.

[00:14:42] Speaker 03:
And as the district court found on appendix 40, the clear implication of using those different units of measurement for those two components is the components are separate and distinct.

[00:14:50] Speaker 03:
Now, you can convert them.

[00:14:52] Speaker 03:
But if you convert one to the other, the inference gets even stronger.

[00:14:55] Speaker 03:
Because if you look, none of the listed concentrations ever overlap.

[00:15:00] Speaker 03:
So, page 47 of the appendix, the district report finds that the highest of flipper pet concentration disclosed in the patent, which is 100 milligrams per liter, is equivalent to 0.87 millimoles per liter.

[00:15:11] Speaker 03:
So that's well below.

[00:15:12] Speaker 03:
It's actually a tiny fraction of the lowest concentration of buffer disclosed, which is 5 millimoles per liter.

[00:15:19] Speaker 03:
So when you go through, everything points the same direction in that specification.

[00:15:23] Speaker 03:
And then we have each of 22 examples

[00:15:26] Speaker 03:
eight embodiments.

[00:15:27] Speaker 03:
In each and every one of those, you find that there's a vege of antagonists, plus a separate buffer.

[00:15:33] Speaker 03:
You go to what everything Regeneron said before it had our formulation.

[00:15:39] Speaker 03:
It said, the claim is full of structural limitation.

[00:15:41] Speaker 03:
It has to have a flibberset.

[00:15:43] Speaker 03:
That's a structure.

[00:15:44] Speaker 04:
Organic cosine.

[00:15:45] Speaker 04:
In the Formicon, I hope I'm pronouncing that right, case, the district court expressly construed

[00:15:52] Speaker 04:
buffer in this very claim that we're talking about.

[00:15:56] Speaker 04:
I recognize the Becton separateness dispute was not expressed and raised, but the district court's language in the Formicon construction seems pretty definitive of its view as to what on the intrinsic evidence

[00:16:12] Speaker 04:
is the only possible correct meaning of a buffer, and it seems entirely inconsistent here.

[00:16:19] Speaker 04:
So for example, and I'm sure you know it, but in the former county case, the same district judge wrote that a construction that expressly calls out a flippersept as being able to be the buffer is consistent with the claim language specification and a person of ordinary skills understanding

[00:16:35] Speaker 04:
of the term, and in fact, Regeneron's construction, which is the one that was adopted in that case, is the only construction that gives meaning to the dependent language, and it goes on from there.

[00:16:48] Speaker 04:
How can both be right?

[00:16:50] Speaker 03:
Yeah, so because in that case, the district court flatly didn't consider the Becton presumption because there in Formicon, the accused product had four distinct structures, including a traditional small molecule buffer,

[00:17:04] Speaker 03:
instantly exactly exactly and so there was no reason to consider whether or not a flip receptor could sort of do dual duty and function as the first limitation and the third limitation it just wasn't before the court but courts are allowed to go back and look at what and make decisions and you especially when the first one's on a preliminary construction and in this case the district court looked at the extensive evidence the extensive evidence

[00:17:26] Speaker 03:
that Regeneron was providing.

[00:17:29] Speaker 03:
And it found, page 8065, or page 66, the evidence does not show that a flibroceph was known or understood to be a buffer in a pharmaceutical composition during the relevant time frame.

[00:17:40] Speaker 03:
So it would not be fair, in our case, where the issue is raised, to construe buffer expressly to include a flibroceph as an example, because nobody at the time would have understood that.

[00:17:50] Speaker 03:
It's also found that the POSA at the relevant time would not consider a therapeutic fusion protein like a flibocept to be a buffer in the context that these things might happen.

[00:17:58] Speaker 03:
You're not going to put the word a flibocept into the construction if nobody at the time would have considered a flibocept to be a buffer.

[00:18:06] Speaker 03:
What becomes dispositive here is that there's a big difference between taking something from a construction and saying, well, that construction's broad enough.

[00:18:17] Speaker 03:
It includes the sun, the moon, the stars.

[00:18:20] Speaker 03:
That construction's broad enough that you could have overlapping things.

[00:18:22] Speaker 03:
There might be ingredients that qualify for one in a second.

[00:18:25] Speaker 03:
And having something in the patent itself, something in the patent itself that tills skilled artisans, gee, yes, I know.

[00:18:31] Speaker 03:
I'm listing four structures separately.

[00:18:35] Speaker 03:
And I know that ordinarily means four separate structures.

[00:18:37] Speaker 03:
But in this case, that's not what I mean.

[00:18:40] Speaker 03:
I mean something different, something that puts them on notice that that's going on.

[00:18:43] Speaker 03:
And in every single case in which this court has found that Becton presumption overcome, there's been something in the patent

[00:18:50] Speaker 03:
something in the claims, something in the specification that makes clear to the skilled artist that although we have separate listings of elements, those separate listings don't require a separate... I think that you're asking for a higher standard right now than what Beckton and our cases require.

[00:19:08] Speaker 01:
And I'm not sure why, because I don't think you need it, but I do feel like you're asking us to extend beyond what those cases require.

[00:19:15] Speaker 03:
I think the answer is

[00:19:17] Speaker 01:
I think your answer should be, no, no, I'm not doing that.

[00:19:21] Speaker 03:
I think that is the correct answer, and that's where the courts come.

[00:19:23] Speaker 03:
Because this is a matter of giving people notice that when you read out four separate structures, unless there's something that overcomes the presumption, the ordinary meaning.

[00:19:31] Speaker 01:
Let me give you an example.

[00:19:32] Speaker 01:
Suppose in this case, the Amgen product used 300 whatever units they are of the flipper set, instead of the 40.

[00:19:42] Speaker 01:
And that a skilled artisan would know if you

[00:19:46] Speaker 01:
By an order of magnitude, increase the amount of the flipper step, it's going to function both as a buffer and as the active ingredient that's necessary.

[00:19:53] Speaker 01:
Well, then you would just have a flipper step.

[00:19:56] Speaker 01:
It would be exceeding the raw amount that is laid out in the examples in the specification.

[00:20:02] Speaker 01:
But a portion of it could be fulfilling the buffer role, and a portion of it could be fulfilling the active ingredient role.

[00:20:08] Speaker 01:
In a situation like that, why does the spec have to say anything at all?

[00:20:12] Speaker 01:
I wouldn't want to tell a district court it couldn't conclude under those circumstances.

[00:20:15] Speaker 03:
Thankfully, as you point out, we don't have anything like that.

[00:20:18] Speaker 01:
I know.

[00:20:18] Speaker 01:
But the rule of law you just asked for would preclude the example I just gave.

[00:20:22] Speaker 01:
And that's why I want this court to be very careful as we're thinking about this.

[00:20:25] Speaker 03:
I think the court does not have to go as far as I go.

[00:20:27] Speaker 03:
But there just has to be something.

[00:20:31] Speaker 03:
You've got to be able to look at the claim.

[00:20:33] Speaker 03:
You've got to be able to look at the specification.

[00:20:34] Speaker 03:
And the artisan who's going to come up

[00:20:36] Speaker 03:
a better, simpler formula, one that's actually more stable, one that has three ingredients and has to four, has to have something that puts them on notice that even though it recites four separate structures, four structures separately, that doesn't mean four separate structures.

[00:20:51] Speaker 03:
There's something that's got to put them notice that three will do.

[00:20:54] Speaker 03:
There's absolutely nothing of that sort here.

[00:20:56] Speaker 03:
In fact, it's the exact opposite.

[00:20:57] Speaker 03:
anybody who's a formulation scientist and looks and says, oh, we're going to stabilize a flibrocept because we're going to have the flibrocept and we have three additional ingredients.

[00:21:05] Speaker 03:
They list them out.

[00:21:06] Speaker 03:
They're not going to read that as being a flibrocept plus two ingredients.

[00:21:09] Speaker 03:
This is about stabilizing a flibrocept with those three additional structures, not a flibrocept somehow stabilizing itself.

[00:21:16] Speaker 03:
That wasn't known.

[00:21:17] Speaker 03:
No one knew you could do that.

[00:21:18] Speaker 04:
But that takes me back, though, to the Formicon record.

[00:21:21] Speaker 04:
And I recognize you're not bound by it.

[00:21:24] Speaker 04:
I don't think anyone is arguing it is.

[00:21:25] Speaker 04:
But there, the district court, looking at this very same patent and the same expert, Dr. Trout, writes, the court notes that the aflibrosep protein is also disclosed in the patent.

[00:21:36] Speaker 04:
And Dr. Trout explains that a person of ordinary skill in the art would have understood proteins like aflibrosep to be buffers.

[00:21:44] Speaker 03:
Right.

[00:21:44] Speaker 03:
And by the time the district court got

[00:21:46] Speaker 03:
a fuller view of the facts, and it came to ours.

[00:21:50] Speaker 03:
It made fact findings that just can't be reconciled with that dictum, because it was dictum.

[00:21:54] Speaker 03:
They had four structures there.

[00:21:57] Speaker 04:
So he was just wrong there, is your position.

[00:21:59] Speaker 03:
I think he just was not correct.

[00:22:01] Speaker 03:
But you don't even have to go there, because he just didn't have Beckton in front of him, because the issue wasn't presented.

[00:22:06] Speaker 03:
When the judge got back in front of him, realized, oh, it lists out four structures separately, that means separate structures.

[00:22:14] Speaker 03:
But when he got to the intrinsic record and said, what would a skilled artisan have known, he specifically found, and this is nowhere identified as clear error on page 65, that a posa at the relevant time would not, not have considered.

[00:22:27] Speaker 00:
You mean a person of ordinary skill speaking English?

[00:22:30] Speaker 03:
Yes, I'm sorry, a skilled artisan, I should say.

[00:22:32] Speaker 03:
He wrote posa, but a skilled artisan at the relevant time

[00:22:35] Speaker 03:
would not consider a therapeutic protein, like a Flavorcept, to be a buffer in the context of that 8, 5, 6 patent.

[00:22:42] Speaker 03:
And that's important because these are formulations for ophthalmic, pharmaceutical formulations.

[00:22:48] Speaker 03:
This is something you put in your eyes.

[00:22:49] Speaker 03:
So the notion that, for example, horse blood could have buffering properties in a biological system or tuna muscle.

[00:22:56] Speaker 03:
That's not going to tell you that a Flavorcept can be bufferless because you can make it in a way, which Amgen invented, that ensures that it

[00:23:06] Speaker 03:
doesn't need a separate buffer.

[00:23:07] Speaker 01:
Can I ask you to turn to your bond issue for a second?

[00:23:10] Speaker 03:
Yes.

[00:23:14] Speaker 03:
Go.

[00:23:15] Speaker 03:
So the short answer is that when we briefed the bond issue before this court, Regeneron said, flat out, that you didn't need to require a bond.

[00:23:25] Speaker 03:
Because this court can, quote, remand to assess Amgen's actual harm caused by the injunction.

[00:23:32] Speaker 01:
I know.

[00:23:33] Speaker 01:
Here's what I'm worried about.

[00:23:35] Speaker 01:
Tullock, Supreme Court.

[00:23:36] Speaker 01:
You familiar with it?

[00:23:38] Speaker 01:
Because you guys didn't brief any of this, unfortunately.

[00:23:40] Speaker 01:
And you probably didn't brief it because you're going to tell me they basically has already admitted that they can get a bond.

[00:23:45] Speaker 01:
I get that you're going to say that.

[00:23:47] Speaker 01:
But the Supreme Court and Tullock, followed by the Second, Third, and Fifth, and Sixth Circuits, have all said the bond creates

[00:23:53] Speaker 01:
a contract between the parties and the court, and that creates the basis for the damages that would flow there from.

[00:24:01] Speaker 01:
There was no bond here.

[00:24:03] Speaker 01:
I was not on the panel that didn't give you a bond of judges.

[00:24:06] Speaker 01:
There was no bond here.

[00:24:08] Speaker 01:
Where does the cause of action come from that entitles you to damages given that a bond wasn't put into place?

[00:24:17] Speaker 01:
And the Supreme Court in Tullock said the bond is the contract.

[00:24:22] Speaker 03:
So the bond requirement can be waived.

[00:24:24] Speaker 03:
It's not a requirement, it's you can waive it.

[00:24:27] Speaker 03:
There's a case called Continuum versus Inceps, 873F2nd, 801.

[00:24:31] Speaker 03:
Admittedly, it's a Fifth Circuit case.

[00:24:34] Speaker 03:
And what they did when they told this court

[00:24:36] Speaker 03:
that you don't need a bond, the district court can do it on remand, they waived the bond.

[00:24:40] Speaker 01:
I don't suppose you've got any great Supreme Court precedent for me on this.

[00:24:44] Speaker 03:
I don't.

[00:24:44] Speaker 03:
But remember, this is simply a matter of equity in terms of ensuring that when you issue an injunction, the person who is a victim of that injunction, when it's mistaken, is not harmed.

[00:24:54] Speaker 03:
And they can waive it by saying, you know what, we'll let the district court do it.

[00:24:57] Speaker 01:
Well, according to one Fifth Circuit case.

[00:24:59] Speaker 03:
Yeah, that's what I have.

[00:25:01] Speaker 03:
But I don't want to burn too much time on that, frankly, because the central point for us

[00:25:05] Speaker 03:
what we're most concerned here.

[00:25:07] Speaker 03:
What we want to make sure is that our product, a better product, which has three ingredients, not four, remains on the market.

[00:25:13] Speaker 01:
No, I understand you don't want to waste time on it, but that's what I want to talk about.

[00:25:16] Speaker 03:
OK.

[00:25:18] Speaker 01:
So if you don't want to waste time on it and you'd like to waive that portion of your brief, feel free to do so.

[00:25:22] Speaker 03:
Well, certainly, Your Honor, if it's faster for the court and it results in a quicker result and keeps the spot on the market, we would be happy to waive that portion of our brief.

[00:25:30] Speaker 01:
So you've withdrawn the argument that you seek a remand for a calculation of damages.

[00:25:35] Speaker 03:
If it's the court's desire and you can get to a faster... No, not if it's the court's desire.

[00:25:39] Speaker 01:
Have you waived it now?

[00:25:40] Speaker 01:
Are you withdrawing it?

[00:25:42] Speaker 03:
We will not claim that there is error if the court does not address that and does not remand.

[00:25:48] Speaker 03:
I see that I'm coming to the end of my time here, but I just want to make sure that I'm very clear that

[00:25:53] Speaker 03:
We, it is emphatically our position, contrary to the representation, that the mere possibility of overlap, the fact that there is one ingredient that could do double duty, is not itself enough to overcome the Bakken presumption.

[00:26:06] Speaker 03:
And that's all they have here.

[00:26:08] Speaker 03:
In fact, the possibility of overlap wasn't even known at the time, so I don't know how you can draw an inference.

[00:26:13] Speaker 03:
But that's simply not enough, because that would render the Bakken presumption a nullity.

[00:26:17] Speaker 03:
The only time Becton matters is when you have one ingredient that can do double duty.

[00:26:22] Speaker 03:
If you don't have any ingredient that could conceivably do double duty, you don't actually need the Becton presumption.

[00:26:27] Speaker 03:
And every time this court has found the Becton presumption overcome, there's been something in the claims, something in the specification, something there that indicates that even though we've listed out separately, even though that's the ordinary normal understanding of a list,

[00:26:41] Speaker 03:
You have separately listed items.

[00:26:43] Speaker 03:
Those are separate items.

[00:26:45] Speaker 03:
We mean something different here.

[00:26:46] Speaker 03:
There's simply no notice whatsoever in this patent that would tell skilled artisans that's the case.

[00:26:50] Speaker 03:
Everything is as the opposite, including their representations to the court in Milan, including the fact that you have non-overlapping concentrations, including the fact that concentrations are different measures, including every single thing.

[00:27:03] Speaker 01:
OK, out of curiosity, you seemed very, very eager for as quick a result as you can possibly get.

[00:27:08] Speaker 01:
Just why?

[00:27:10] Speaker 01:
There's no injunction in place, right?

[00:27:12] Speaker 01:
Is your client on the market?

[00:27:14] Speaker 03:
Client is on market.

[00:27:16] Speaker 01:
So, I mean, you expressed a degree of extraordinary urgency.

[00:27:20] Speaker 03:
No, I'm not going to tell the score.

[00:27:23] Speaker 01:
I'm trying to get to the bottom of why.

[00:27:24] Speaker 01:
If there were a PI in place, I understand why you would have such an urgency.

[00:27:29] Speaker 03:
When you have a product on the market that people are relying on, the last thing you want to do is to be on the market a year and then have legal uncertainty about whether it stays there and the people relying on it continue to rely on it.

[00:27:39] Speaker 03:
Certainty helps everybody.

[00:27:41] Speaker 03:
We're interested in providing life-saving, site-saving products and making sure people can keep them.

[00:27:48] Speaker 03:
And so in this case, we believe that a quicker result is a better result.

[00:27:51] Speaker 01:
I mean, a quicker result is a better result in every case.

[00:27:54] Speaker 03:
Yes, yes.

[00:27:55] Speaker 01:
OK, but there's not something I'm missing.

[00:27:58] Speaker 03:
There's no fire under us on this one.

[00:27:59] Speaker 03:
We're selling our products.

[00:28:01] Speaker 03:
People are benefiting from it.

[00:28:02] Speaker 03:
And we're happy with that state of affairs.

[00:28:03] Speaker 03:
We would like to keep that state of affairs and make it clear.

[00:28:06] Speaker 03:
Thank you.

[00:28:07] Speaker 03:
Thank you.

[00:28:08] Speaker 01:
OK, so we're about out of time.

[00:28:16] Speaker 02:
Just as it did in its brief, Amgen's argument today avoids the plain and ordinary meaning of buffer.

[00:28:22] Speaker 02:
They don't really dispute that the plain meaning of buffer to the person of skill in the context of this specification includes proteins like a flibrocept.

[00:28:30] Speaker 02:
Under this court's case law, that plain meaning controls absent a disavowal or a redefinition in the specification.

[00:28:37] Speaker 02:
That's what Thornor requires.

[00:28:38] Speaker 02:
Your Honor asked Amgen's counsel about the recitation and the intrinsic record in the specification.

[00:28:44] Speaker 02:
and he went through various portions of the specification none of them none of them are asserted to be a disavowal of the plain meaning of buffer that was adjudicated below to include proteins in the formicon case and that the entire record demonstrates includes proteins from dictionary definitions at a9202 and 9220 to articles called proteins as buffers to their own experts admission at a26323 where he says

[00:29:14] Speaker 02:
It was known in the literature that proteins have this buffering capacity and can buffer solutions.

[00:29:20] Speaker 02:
One solution, of course, is an ophthalmic formulation like the one in the claim.

[00:29:26] Speaker 02:
In the cases applying Beckton, one can look to Bot8, for example, one can look to SCEDCO.

[00:29:31] Speaker 02:
There need not be an example or something in the specification that shows overlap or shows double duty.

[00:29:37] Speaker 02:
There was no example at all in Bot8.

[00:29:41] Speaker 02:
where the boot inspection program and fault inspection program were one and the same.

[00:29:45] Speaker 02:
What did the court do?

[00:29:46] Speaker 02:
It looked to the ordinary meaning, it cites cases like Thorner, and it says, is there disavowal here?

[00:29:52] Speaker 02:
And if there's no disavowal, then under cases like linear technology and Google versus EcoFactor, the plain meaning applies and can't be narrowed.

[00:30:02] Speaker 02:
What Amgen is doing here is using the Bechtin implication.

[00:30:06] Speaker 02:
That's the word that's used in Bechtin, not presumption, implication.

[00:30:11] Speaker 02:
They're using the Bechtin implication to narrow the claim through a negative limitation.

[00:30:17] Speaker 02:
And implications are not enough to remove subject matter from the claims as construed, pursuant to their ordinary meaning to the person of ordinary skill.

[00:30:26] Speaker 02:
That was never disturbed by the court here.

[00:30:28] Speaker 02:
It didn't go back and revisit or change its formicon construction or conclude that the plain meaning was something different.

[00:30:35] Speaker 04:
What is your best piece of intrinsic evidence that rebuts the back-end presumption here?

[00:30:40] Speaker 02:
the ordinary use of the term buffer in the specification, and the fact that buffer, for example, is listed separately from excipients.

[00:30:48] Speaker 02:
In Columns 6 and 7, it distinguishes buffers on the one hand and excipients on the other.

[00:30:54] Speaker 02:
Excipients, as Amgen says, was understood by Per Amgen's argument to be inactive ingredients.

[00:31:00] Speaker 02:
So it's making that distinction in Columns 6 and Columns 7.

[00:31:04] Speaker 02:
And as the court found in the Formicon case,

[00:31:06] Speaker 02:
It's using buffer according to its well-understood meaning to the person of ordinary skill.

[00:31:10] Speaker 02:
That is, any substance that resists changes in pH through proton donating or accepting group, including histidine containing proteins like a flip receptor.

[00:31:19] Speaker 02:
Everyone knew that this histidine, whether in free form like Informicon's product,

[00:31:23] Speaker 02:
or as part of a protein like a fliverset, had this imidazole ring that resists pH changes.

[00:31:29] Speaker 02:
Everyone knew that already, so we didn't have to recite phosphate histidine proteins.

[00:31:33] Speaker 02:
We recited phosphate as an example, and as the district court concluded, the only time it ever addressed it, that would be understood to include proteins containing histidine like a fliverset.

[00:31:44] Speaker 02:
Subject to any more questions?

[00:31:47] Speaker 01:
I thank all counsel.

[00:31:47] Speaker 01:
Case is taken under submission.