[00:00:00] Speaker 03:
The United States Court of Appeals for the Federal Circuit is now open and in session.

[00:00:06] Speaker 03:
God save the United States and this honorable court.

[00:00:12] Speaker 05:
Good morning.

[00:00:14] Speaker 05:
We have two cases scheduled for argument this morning, both between the same parties.

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One is the first is case number 20-1673.

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It's an appeal from the Patent Trial and Appeal Board.

[00:00:30] Speaker 05:
Mr. Kelly, are you prepared to argue?

[00:00:33] Speaker 03:
Yes, Judge O'Malley, I am.

[00:00:35] Speaker 05:
You may proceed.

[00:00:39] Speaker 03:
May it please the Court, good morning, Your Honors.

[00:00:41] Speaker 03:
The Board committed two fundamental errors in this case.

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First, it erred when it concluded that evidence of unexpected comparable efficacy between 480 milligrams and 720 milligrams of BMF to treat MS demonstrated non-obviousness in the face of Mylan's evidence.

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The board also aired when it failed to grapple with a critical issue relevant to all the grounds before it, whether a skilled artisan would have learned information about DMF dosing from Schimmert 2004, a study teaching an MS treatment method using fumiderm, a composition including DMF as its main constituent.

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Now starting with the first issue, the obviousness issue.

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Biogen has not contested our reading of the law.

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They do not dispute.

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that in order to overcome a prima facie showing of obviousness, their secondary considerations and particularly unexpected results have to demonstrate a superior result, a result that's different in kind when compared to the closest prior art.

[00:01:41] Speaker 05:
Did you actually make that argument to the board?

[00:01:45] Speaker 03:
Your Honor, we did not, nor did they.

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Both parties, Biogen and Mylan, marched down the same path.

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What Biogen said to the board, and they said it like bookends around their discussion of secondary consideration, is that their quote unquote evidence of secondary consideration demonstrates the non-obviousness of their invention.

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They did not specifically say that the unexpected results alone demonstrates non-obviousness, nor did they say that with respect to commercial success, long-held unmet need, or praised by others.

[00:02:16] Speaker 05:
But they never really said that

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You only, if you have all of them, I mean, they basically said that they all demonstrated non-obviousness.

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So how can you say they have to show all of them in order for them to establish non-obviousness?

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Your Honor, they talked about their strong evidence of secondary considerations collectively.

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They did not talk about their individual secondary considerations like they had done in a previous IPR brought by the coalition.

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They just didn't say that.

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And so they approached it the way they did, which is to say, there's four pieces of secondary considerations.

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There's four pieces of evidence.

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They're going to put it up on the scales.

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And then once it's up there, the scales are going to tilt.

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And so we responded in kind.

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We said that they hadn't proven each of the four.

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It was an evidentiary challenge.

[00:03:08] Speaker 05:
But in saying you hadn't proven each of the four, one of the four is unexpected results.

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So I guess I don't understand how you can say,

[00:03:17] Speaker 05:
that you didn't have an obligation to raise this difference in degree and difference in kind in front of the board without having forfeited it?

[00:03:26] Speaker 03:
Well, Your Honor, first of all, this court has been clear that when the board passes on an issue, it is not forfeited.

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And that's what happened in this case.

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The board actually decided this.

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And so we're entitled to appeal it.

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And we're not asking this court to consider evidence that's outside of the record, as was asked in red line detection, which Biogen cites in its brief.

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nor are we asking this court consider something that wasn't passed on below, which is what happened in Singleton, the other case they cite in their brief.

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We're just asking the court to review the actual decision the board made.

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And it's true that if we had failed to rebut each one of their four secondary considerations and the board weighed them all collectively, we would have a hard time standing here arguing that the four collectively cannot overcome our obviousness case, even if proven.

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That would have been waived.

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But the board didn't walk down the path either party laid out.

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The board stepped off the path.

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And we think it did for pretty clear reasons, which is that our showing on all of the other secondary considerations was very, very strong.

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On unexpected results.

[00:04:37] Speaker 00:
What's the legal authority that you cite to support the position that you're making right now?

[00:04:45] Speaker 03:
Your Honor,

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that when something is actually raised by the board that we can appeal it.

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I think that would be lifestyle enterprises.

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We have that in our brief.

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And as for whether or not their showing of comparable efficacy is enough to overcome a prima facie showing, that's very well spelled out in this court's law.

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In fact, the Galderma case that we cite in our brief is remarkably close to this case.

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It's a situation where the evidence was that someone of skill in the art would have thought that 1% treatment of the topical solution was the optimal treatment method for treating acne, that 3% would have increased side effects.

[00:05:33] Speaker 00:
It sounds to me like you're arguing a degree in difference, that at some point the difference in degree is insufficient.

[00:05:44] Speaker 03:
Well, so Judge Rayner, two things.

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We are arguing that, but the difference in degree is subsidiary to the superior result.

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So first of all, you have to have a superior result, which they haven't shown.

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But even if you had a superior result, that superiority would have to be a difference in kind and not degree.

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So they have two problems.

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Their first problem is that they haven't shown superiority at all.

[00:06:07] Speaker 05:
But I think you're over-reading these difference in kind and not degree.

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cases and and you actually don't spend a lot of time on on any of them in your in your brief and and i think it's because they all go back to in realler and in realler only talked about that being the case where the result is different in kind from something that one of skill in the art at the time would have clearly understood your honor

[00:06:38] Speaker 03:
is relevant to simply a difference in degree, but you also have to show some amount of superiority, which they haven't shown.

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So even if their difference of degree is enough, and even if, you know, we cannot argue about the difference in degree in a factual situation like this, because they would say, and I think this is implicit in your honor's question,

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that nothing was expected from 480 milligrams and so anything would have been a difference in kind.

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Even if they could argue that, they're still stuck on the superiority issue.

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They're still stuck with the problem that no one would have expected or let me, I'm sorry, let me say that differently.

[00:07:20] Speaker 03:
They're still stuck with the fact that they haven't shown any superiority and I think it's important to- Are you saying that a lower dosage, that there's no benefit to a lower dosage?

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I'm saying, Your Honor, that that certainly wasn't proven or argued in this case, that 480 milligrams had any benefit whatsoever.

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They have pointed to a statement made by their prosecution counsel, but that statement was not an unexpected result of 480 milligrams.

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That statement was that 480 milligrams would have been expected, and that's the word their counsel used, expected to have lower side effects.

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So an expected result is not an unexpected result.

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that can prove non-obviousness and more to the point.

[00:08:05] Speaker 05:
They're arguing what was unexpected is that it was clinically equivalent to the 720 milligram dosage in terms of its benefits, right?

[00:08:17] Speaker 03:
That it was, well what the board found is comparable efficacy.

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Right.

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Yes.

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And that is the only benefit the board found.

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There's nothing in the board's opinion

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nor should there have been because there's nothing in any of Biogen's argument that 480 milligrams was better than 720 for any reason related to side effects.

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In fact, their experts at trials said the opposite.

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Their experts said once Gildon-Yar would not have understood there to be a dose dependent side effect profile.

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They actually argued that it would have been obvious to go higher than 720, not lower.

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But again, they're stuck with only comparable efficacy and if you consider the role of unexpected results

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and really all secondary considerations and obviousness, it's clear why you need a superior result.

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Secondary considerations are a check on the initial obviousness.

[00:09:12] Speaker 00:
So what marks whether you have a superior result or not?

[00:09:17] Speaker 00:
Is that just a factual determination that's made?

[00:09:21] Speaker 00:
Is there some sliding scale of degree that must be consulted?

[00:09:29] Speaker 03:
Well, certainly it's a question of fact.

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And I do think it's fair to say there could be some sort of sliding scale.

[00:09:35] Speaker 03:
I mean, there are cases like the Rexo case that they cited where there was a 66% increase in bioavailability.

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That was a case where that amount of increase was significant because bioavailability was the key problem with the drug in the first place.

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So yes, I think it's fair to compare what the unexpected result is

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the context of the whole invention.

[00:10:00] Speaker 03:
And in that sense, I suppose there's a fighting space.

[00:10:03] Speaker 03:
But what it gives us, Your Honor, is it gives us some sort of showing that our initial prima facie obviousness case was flawed, right?

[00:10:16] Speaker 03:
If it truly was obvious to do something, and doing it achieved commercial success, solved the long-sought and unmet need,

[00:10:24] Speaker 03:
garnered industry praise or produced unexpected results.

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If doing it actually did that, then that shows it wasn't obvious in the first place.

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But here, they haven't proven that.

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What they've proven is that a lower dose has comparable efficacy to the known 720 milligram dose.

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That is as much as they've proven.

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And that is not enough to overcome a showing that would have been obvious to optimize dosing in the face of evidence that showed 720 milligrams as a successful treatment method for MS and respectfully to the board, 360 milligrams.

[00:11:02] Speaker 03:
And that second point is related to the second point we break in this case about the Shimerick reference.

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The board had an obligation to show its work.

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It had an obligation to wrestle with the issue that the parties were disputing.

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In the second ground that we've raised here on appeal, the issue with the SHMRC reference, the board clearly didn't do that.

[00:11:22] Speaker 05:
You know, Biogen says that... Wait, didn't the board make a factual finding that the results of SHMRC could not be extrapolated to how DMF would work as a monotherapy?

[00:11:33] Speaker 03:
The board said that, Your Honor, but the board said that because of repeated statements by the board that there was more than DMF in Fumidor.

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And this is clear.

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at pages 17 and 18 of the board's decision.

[00:11:46] Speaker 05:
Right.

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And why is there not substantial evidence to support that factual finding?

[00:11:50] Speaker 03:
Because, Your Honor, that wasn't the dispute between the parties.

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We were not disputing the presence of additional constituents in Fumiderm.

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There's no debate that DMF is in Fumiderm along with other components.

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So when the board reached its finding that Fumiderm does not teach anything about a DMF monotherapy, it was essentially ignoring the debate between the parties.

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And the debate was what one skill in the art would have gleaned from fumiderm.

[00:12:16] Speaker 05:
But haven't we said repeatedly that the board, once the evidence is before it, the board is free to consider it, regardless of how the parties fashion their arguments?

[00:12:27] Speaker 03:
Sure, Your Honor.

[00:12:28] Speaker 03:
They're free to consider however they want, but they have to, under the APA, they have to lay out a roadmap to facilitate this Court's review and our appeal.

[00:12:36] Speaker 03:
You know, Biogen has

[00:12:38] Speaker 03:
has challenged us for not making a substantial evidence appeal here, but we can't because we don't know what the board did.

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We don't even know that the board understood the issue.

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We had evidence and Biogen pointed to the same evidence that skilled artisans were actively studying fumiderm.

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They were actively studying the role of DMF.

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We had evidence that DMF proved no worse than fumiderm

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We had evidence that DMF was the only constituent in humiderm that breaks down into MMF, monomethyl humerate, once it's ingested, and that is the active component.

[00:13:19] Speaker 03:
And they fought us on that evidence.

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They didn't just walk into the board and say, nope, there's additional constituents, therefore we win.

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They produced declarations.

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They explained why.

[00:13:30] Speaker 00:
So then this argument comes down to,

[00:13:35] Speaker 00:
whether Futiderm has multiple active ingredients and whether a poser would have understood the teachings of Futiderm because DMF is the most abundant active ingredient in that composition.

[00:13:53] Speaker 00:
That's what you're arguing.

[00:13:53] Speaker 00:
It's the most abundant active ingredient, correct?

[00:13:59] Speaker 03:
It's more than that, Your Honor.

[00:14:00] Speaker 03:
So that is correct, but it's much more than that.

[00:14:02] Speaker 03:
We're not arguing

[00:14:03] Speaker 03:
that a skilled artisan would simply read Shimerick and say, aha, that's the amount of DMF we should use.

[00:14:11] Speaker 03:
Our position is that Fumiderm and Shimerick 2004 discussion of Fumiderm taught something to people skilled in the art.

[00:14:19] Speaker 03:
It taught something about DMF dosing.

[00:14:21] Speaker 00:
And in fact, Shimerick only referred to the... It taught something, but it doesn't teach it now so that a public can draw conclusions.

[00:14:31] Speaker 00:
about the efficacy of DMF monotherapy.

[00:14:34] Speaker 00:
And your argument is that the reason that a poser can't draw those conclusions is because phutiderm has multiple active ingredients.

[00:14:45] Speaker 03:
No, Your Honor.

[00:14:46] Speaker 03:
I think that's the other side's argument, and it's part of it.

[00:14:49] Speaker 03:
Our argument is that someone skilled in the art would have looked deeper than simply the identification of phutiderm.

[00:14:56] Speaker 03:
And what the board said, and I'm quoting now at page

[00:15:00] Speaker 03:
18 of the board's decision, quote, we find SHMR 2004 does not teach or suggest anything about the effectiveness of any individual fumarate.

[00:15:09] Speaker 05:
Right, but they said it for two reasons.

[00:15:11] Speaker 05:
It wasn't just the fact that it had additional components.

[00:15:14] Speaker 05:
It also said that it described two different phases of doses, not two ranges of doses.

[00:15:24] Speaker 03:
Your Honor, that is not what the board said.

[00:15:27] Speaker 03:
I mean, the board said over and over again

[00:15:29] Speaker 03:
If you look down on page 17, sentence after sentence, the board simply repeats the mantra that there is more than DMF and fumidor.

[00:15:38] Speaker 03:
That's the board's analysis in full.

[00:15:44] Speaker 05:
Okay.

[00:15:45] Speaker 05:
We'll save your time, Mr. Kelly.

[00:15:47] Speaker 05:
Thank you.

[00:15:48] Speaker 03:
Thank you, Your Honor.

[00:15:53] Speaker 05:
Mr. Lee?

[00:15:55] Speaker 02:
Thanks, Your Honor.

[00:15:57] Speaker 02:
Can you address that last point first?

[00:16:01] Speaker 02:
I sure can, Your Honor.

[00:16:02] Speaker 02:
I was going to start with Shemrek, because I think what Mr. Kelly has suggested to you is not an accurate summary of the support for the findings that the board cited in support of the proposition that was that Mr. Kelly is now challenging.

[00:16:21] Speaker 02:
What the board did at Appendix 18 was expressly acknowledge Mylan's argument

[00:16:27] Speaker 02:
that DMF is the most active ingredient, but then found that there were three other active ingredients that cumulatively totaled 44% of the composition, and found that multiple experts testified, and I'll quote the finding, the presence of multiple active agents in Pumiderm precludes extrapolation of SHMRC's 2004 results in any dose of DMF monotherapy.

[00:16:55] Speaker 02:
That is the key.

[00:16:56] Speaker 02:
It's DMF monotherapy that's claimed in the patent.

[00:16:59] Speaker 02:
And what the board was focused on is, does SHMREC describe or suggest a DMF monotherapy in any particular dose?

[00:17:08] Speaker 02:
And at A17, it expressly finds that it does not and articulates its findings.

[00:17:15] Speaker 05:
Do you agree with Mr. Kelly that you never actually made any of these arguments?

[00:17:20] Speaker 02:
No, Your Honor.

[00:17:21] Speaker 02:
These arguments are actually the express findings that the board made as a result of the evidence that we offer to them.

[00:17:27] Speaker 02:
And in fact, when they made those, Your Honor, the board cited our expert, Dr. Duddy, who provided the detailed breakdown at our request about the percentages.

[00:17:39] Speaker 02:
They also cited his testimony about an independent study of fumiderm, in that case for the treatment of psoriasis,

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where the authors cautioned that you can't make conclusions about any particular component when you have a mixture.

[00:17:54] Speaker 02:
The board also cited another of our experts, your honor, again, offered by us that says that Dr. Nguyen, who testified that the person of ordinary skill in the art could make no determinations about the relative contributions of any of the four active components.

[00:18:13] Speaker 02:
And the board even, your honor, cited my land expert, Dr. Benet, at appendix 18 to 19, where he said that any two drugs can have a synergistic effect and you need to figure out what it is.

[00:18:27] Speaker 02:
So I think that, at least as I understand the challenge on this fourth issue, and I thought there were four issues that were being raised, but I think it's now been collapsed into two.

[00:18:38] Speaker 02:
But on this Chimrick issue, the precise finding that

[00:18:43] Speaker 02:
My land is suggesting was not made, was in fact made.

[00:18:48] Speaker 02:
The challenge, as I understand it, is an Administrative Procedure Act challenge that the board didn't articulate the reasons for the finding.

[00:18:57] Speaker 02:
But if you look at the finding itself and the portions of the record that are cited, you will find that there is number one, ample support, certainly substantial evidence to support the finding.

[00:19:13] Speaker 02:
The specific citations are to, among other things, experts that we offered to the board and who offered expressed opinions on the consequences of having a composition of four different compounds rather than monotherapy of one, and the reasons they couldn't draw any conclusions from that.

[00:19:39] Speaker 02:
And the last thing I would say in this, Your Honor, is this.

[00:19:42] Speaker 02:
I think it's not a coincidence that this is being offered to you as an administrative procedure challenge.

[00:19:50] Speaker 02:
In some sense, that's a way to avoid considering it in the traditional sense that simply is there a substantial evidence, which there surely would be.

[00:20:01] Speaker 02:
The effort to characterize it as an APA challenge is an effort to take what is really a substantial evidence question and turn it into a legal question, but there

[00:20:13] Speaker 02:
is no legal question.

[00:20:14] Speaker 02:
There was the articulation of the finding.

[00:20:17] Speaker 02:
There was the articulation of the reason for the finding.

[00:20:20] Speaker 02:
There was the specification by the board of the testimony upon which it relied.

[00:20:25] Speaker 02:
And to answer your question, again, Your Honor, at the risk of being slightly redundant, it was... Was there an articulation of commercial success?

[00:20:36] Speaker 02:
Your honor, there was, the board did not make an articulation of commercial success.

[00:20:41] Speaker 02:
So if I come back to- I'm sorry, the board did not?

[00:20:45] Speaker 02:
No, your honor, in its opinion, the board relied on- Isn't that an APA issue then?

[00:20:54] Speaker 02:
It's not, your honor.

[00:20:55] Speaker 02:
So this would be what I would call the third issue that they cited in their briefs and a different issue from Shemrek.

[00:21:01] Speaker 02:
But you're right, Judge Raina, this is their second or first, depending on how your county

[00:21:07] Speaker 02:
APA issue.

[00:21:08] Speaker 02:
And the issue that they've characterized as an APA issue is the suggestion that when turning to secondary considerations, and under psychobenzaprin, you don't turn to them, you actually incorporate them into the overall obviousness determination.

[00:21:28] Speaker 02:
When you turn to them, the claimed APA violation here is that you are somehow obligated to consider

[00:21:36] Speaker 02:
all of the secondary considerations that had been offered by the patentee.

[00:21:43] Speaker 02:
And that is incorrect both as a matter of law and a matter of fact.

[00:21:49] Speaker 02:
It's incorrect as a matter of law because, as the panel knows, if the absence of secondary considerations is not an indication that a claimed invention is obvious, the presence of secondary considerations

[00:22:06] Speaker 02:
is an indication that it's not obvious.

[00:22:09] Speaker 00:
Should the board at minimum say there's an absence of this secondary consideration and then move on?

[00:22:17] Speaker 00:
Can it just not address at all arguments that were actually raised?

[00:22:25] Speaker 02:
Your Honor, it can, and it can for this reason.

[00:22:28] Speaker 02:
If we're correct in our understanding of the law, which is that

[00:22:33] Speaker 02:
Any one secondary consideration, when considered under GRAM and psychobenzeprene, any one consideration can provide important information about whether an invention is novice or not.

[00:22:50] Speaker 02:
There is no obligation to move to the other three, and that happens frequently.

[00:22:55] Speaker 02:
and all of the district courts, the International Trade Commission, the different fora that provide appeals to the court.

[00:23:06] Speaker 02:
The courts consider one of a group of asserted secondary considerations.

[00:23:14] Speaker 02:
Particularly in this case where it found one to be sufficiently superior and overwhelming to move back to the first issue,

[00:23:22] Speaker 01:
Mr. Lee, can I just interrupt you?

[00:23:25] Speaker 01:
I think you're moving back to unexpected results anyway.

[00:23:28] Speaker 01:
This is Judge Hughes.

[00:23:31] Speaker 01:
Your friend, Mr. Kelly, argues that for unexpected results, you need a superior result, not just a comparable result or a comparably better result.

[00:23:41] Speaker 01:
Do you agree with that as a matter of law?

[00:23:44] Speaker 02:
I think, Your Honor, what we agree to is that the

[00:23:49] Speaker 02:
Articulation of the requirement by this court is you need unexpected results.

[00:23:57] Speaker 02:
Unexpected results can be characterized in many ways and has been in many opinions.

[00:24:04] Speaker 02:
In this particular case, what the board found was that the unexpected results of the 480 milligram per day dose was unexpected.

[00:24:17] Speaker 02:
It's important.

[00:24:18] Speaker 02:
Two things are critically important, Judge.

[00:24:20] Speaker 01:
Can I just stop you there so I understand your answer?

[00:24:24] Speaker 01:
That sounds like you're at least implicitly saying the 480 doesn't have to be better than the 720.

[00:24:32] Speaker 01:
It doesn't have to be superior to it.

[00:24:33] Speaker 01:
It just has to be unexpected for some reason.

[00:24:36] Speaker 02:
Is that right?

[00:24:37] Speaker 02:
Yeah, that's exactly right.

[00:24:39] Speaker 02:
And Your Honor, this is particularly important when you consider the fact that the arguments that my land made

[00:24:46] Speaker 02:
that led to the board's finding on this question of unexpected results are arguments that MyLand has abandoned now.

[00:24:54] Speaker 02:
They are not making any of the arguments they made before.

[00:24:57] Speaker 02:
What the board did in rejecting those arguments is find the following.

[00:25:02] Speaker 02:
It compared the post-filing phase three results of the 480 milligram per day dose to the prior art, and that was the phase two.

[00:25:13] Speaker 02:
The board found that in phase two,

[00:25:15] Speaker 02:
that closest dose to the 480 was the 360 milligram per day dose, which was found to be not effective compared to placebo for treating MS, although the 720 milligram per day dose was.

[00:25:30] Speaker 02:
The board found, in rejecting their arguments, that a skilled artisan would have expected the efficacy of 480 milligrams per day to be closer to 360 milligrams per day.

[00:25:42] Speaker 02:
And then the board found, and this is the portion that goes to the issue that Mr. Kelly started with, it found that the 480 milligram per day dose demonstrated significantly and unexpectedly superior results.

[00:25:57] Speaker 02:
It was better than the closest dose in the prior art, the ineffective 360 milligram per day dose.

[00:26:04] Speaker 02:
But in addition, it was effective across all phase three endpoints.

[00:26:11] Speaker 02:
which were a broader set of endpoints, clinical and radiological than phase two, and the performance of the 480 milligram per day dose matched the significantly higher 720 milligram per day dose.

[00:26:28] Speaker 02:
That is what the board found to be unexpected, that a relatively small increase from an ineffective dose would produce such a strong result matching the performance of the much higher dose.

[00:26:41] Speaker 02:
Those findings are really not challenged, in part because Mylan has abandoned the arguments made below.

[00:26:49] Speaker 02:
Instead, they say two things to you that the questions from Judge O'Malley and Judge Rainier touched on during Mr. Kelly's argument.

[00:26:57] Speaker 02:
The first is this question of the similarity between the 480 milligram per day dose and the 720 milligram per day dose in phase three.

[00:27:08] Speaker 02:
And candidly, I'm not quite sure I understand the argument because phase three was not the prior art.

[00:27:14] Speaker 02:
We all agree upon that.

[00:27:16] Speaker 02:
Phase two was.

[00:27:17] Speaker 02:
The fact that the 480-milligram-per-day dose had the same effectiveness in phase three as the 720-milligram-per-day dose actually proves our point.

[00:27:33] Speaker 02:
It proves our point that it was unexpected

[00:27:36] Speaker 02:
that the 480 would have that level of efficacy.

[00:27:41] Speaker 05:
What is your response to Mr. Kelly's argument that you had to show not only that the 400, that it was unexpected that it would have that efficacy, but you had to prove that there was some benefit from the lower dose?

[00:27:56] Speaker 02:
Right.

[00:27:57] Speaker 02:
Your Honor, I have to say two things.

[00:27:59] Speaker 02:
The first is that the specific arguments that were made below did not include that argument.

[00:28:06] Speaker 02:
And those are arguments that have been forfeited.

[00:28:10] Speaker 02:
Mr. Kelly was candid and honest when he said, no, they didn't assert this argument below.

[00:28:17] Speaker 02:
The fact that unexpected results were considered below doesn't mean you can bring any unexpected results argument to this panel today.

[00:28:25] Speaker 02:
Otherwise, if I had an obviousness contention that I lost at the PCAB or in the district court or at the ITC,

[00:28:35] Speaker 02:
I could come to you with a different combination or a different articulation, the same combination, and that cannot be the result.

[00:28:43] Speaker 02:
The second thing, Your Honor, is that the board's findings that were made, rejecting the arguments that Mylan did make but now has abandoned, demonstrate that the small increase from 360 to 480, an increase over a dose that was known to be ineffective produced

[00:29:05] Speaker 02:
a strong result, a strong clinical result, matching the performance of a much higher dose of 720 milligrams per day.

[00:29:13] Speaker 02:
That is what the board found to be an unexpected result.

[00:29:18] Speaker 02:
Judge O'Malley, as I think your question alluded to, if you look at the questions that consider the question of difference in kind and difference in degree,

[00:29:28] Speaker 02:
There's often a label that is dependent after the court has looked at the specific facts of the specific case and determined whether there has been something unexpected of significance.

[00:29:41] Speaker 02:
And to go back to Judge Hughes' question, the standard that this court has articulated is on those facts, is there something unexpected of significance?

[00:29:51] Speaker 02:
By that standard, the PTAP found that there in fact was.

[00:29:57] Speaker 02:
By any standard, the demonstrated results of the 480 milligram per day dose in phase three, matching those of the 720 milligrams per day dose in phase three, were unexpected.

[00:30:13] Speaker 02:
And the record evidence that the board relied upon demonstrated just that.

[00:30:22] Speaker 02:
That's the reason there is no,

[00:30:24] Speaker 02:
That's the reason that Milan has not pursued the arguments made below.

[00:30:29] Speaker 02:
It's the reason that there is not a substantial evidence to the board's findings rejecting those arguments.

[00:30:35] Speaker 02:
And that's the reason that there are two new arguments on unexpected results.

[00:30:40] Speaker 02:
One I would call the similarity argument, and the other I would call the difference in kind or difference in degree argument, both of which are forfeited.

[00:30:51] Speaker 02:
Let me just say one final thing to go back to, Judge.

[00:30:54] Speaker 02:
Rania's question.

[00:30:57] Speaker 02:
Judge Rania, I don't think that the board would be obligated to consider all the secondary considerations if it found a particular secondary consideration to be so compelling that it did not need to reach the others.

[00:31:12] Speaker 02:
And I think that's, in fact, what occurred here.

[00:31:15] Speaker 02:
And it occurred on a record where the evidence that was offered on the secondary consideration, which was so compelling,

[00:31:23] Speaker 02:
unexpected results was evidence that was provided separately by both parties.

[00:31:32] Speaker 02:
It was arguments made separately by both parties.

[00:31:36] Speaker 02:
And there was no contention at the PTEP by Biogen that somehow the four secondary considerations that we were offering

[00:31:47] Speaker 02:
collectively were required in order to demonstrate.

[00:31:51] Speaker 00:
But how does that allow this court, how does that give this court a basis to make an adequate review if the PTAP doesn't address all of the arguments made with respect to the objective criteria?

[00:32:06] Speaker 02:
Your Honor, it's a good question.

[00:32:08] Speaker 02:
I think Judge Gimelli, can I finish my answer to the question?

[00:32:13] Speaker 02:
Judge Rainey, here's the reason.

[00:32:15] Speaker 02:
It's the reason

[00:32:17] Speaker 02:
is embedded in the legal principle that the absence of a secondary consideration cannot prove obviousness.

[00:32:27] Speaker 02:
It is only the presence of a secondary consideration that can help demonstrate non-obviousness.

[00:32:36] Speaker 02:
If that principle is correct, and I believe it is, then what that means is if you have

[00:32:42] Speaker 02:
a compelling secondary consideration such as unexpected results.

[00:32:49] Speaker 02:
You need not reach the question of whether the other three in this case are present, because even if you assumed the worst for the patentee, even if you assumed that they were absent, it would not have any legal significance.

[00:33:03] Speaker 02:
And I think that's the reason.

[00:33:05] Speaker 05:
Thank you, Your Honor.

[00:33:06] Speaker 05:
Thank you, Mr. Lee.

[00:33:08] Speaker 05:
Mr. Kelly?

[00:33:10] Speaker 03:
Thank you, Judge O'Malley.

[00:33:11] Speaker 03:
Just a few quick points.

[00:33:13] Speaker 03:
Mr. Lee, in discussing the unexpected results findings of the board, in order to make the argument he's making now, he has to boost up what the board actually said.

[00:33:24] Speaker 03:
The board made no findings, about 360 milligrams.

[00:33:29] Speaker 03:
What he was pointing to on pages 38 to 39 of the board's decision is simply the board's recitation of their evidence.

[00:33:37] Speaker 03:
And that's not a finding by the board any more than the board's recitation of our evidence is a finding.

[00:33:42] Speaker 03:
The board's finding about unexpected results is at the bottom of page 39.

[00:33:46] Speaker 03:
And what the board said is that it was persuaded that the weight of the evidence sufficiently established the comparable efficacy between 480 milligrams and 720 milligrams.

[00:33:54] Speaker 03:
That's it.

[00:33:55] Speaker 05:
Well, if that's what the board says, then why isn't it fair for us to consider the entirety of the evidence that the board recites?

[00:34:06] Speaker 03:
Because, Your Honor, the board then as a legal matter weighs its finding against that evidence.

[00:34:12] Speaker 03:
The board's finding was about 700 or 720 and 480.

[00:34:16] Speaker 03:
The board didn't make any other findings.

[00:34:19] Speaker 03:
The board is the finder of fact.

[00:34:21] Speaker 05:
But as the finder of fact, it said that the weight of the evidence and it had just laid out all of what it considered that evidence to be.

[00:34:30] Speaker 03:
Right?

[00:34:31] Speaker 03:
Sure.

[00:34:31] Speaker 03:
yes your honor and and when the board does that it's the fact-finder and so the board says we looked at all the evidence and here's our finding it's that finding that this court can now rely on when reviewing de novo the board's weighing of the secondary consideration the only one it reached the board reached against our prima facie case that's that's what you're arguing you're arguing that there's a lack of analysis here that the board recited the evidence but didn't did uh...

[00:35:00] Speaker 00:
undertaking the analysis of it.

[00:35:02] Speaker 03:
So, Your Honor, that is our argument about the, yes, Judge Raina, about the second half of the case about Shimerick.

[00:35:09] Speaker 03:
We're not saying the board did an insufficient analysis when it did the weighing.

[00:35:13] Speaker 03:
We're saying it weighed it incorrectly, that the comparable efficacy was not enough.

[00:35:21] Speaker 03:
Yes, it should have looked at everything else that Biogen raised.

[00:35:25] Speaker 03:
If it was going to go down the path that Biogen led it down,

[00:35:27] Speaker 03:
But to the extent it did what it did, it did it wrong because 480 is merely comparable to 720.

[00:35:35] Speaker 05:
Turning to the... With respect to your point that the board should have addressed all four or all of the secondary considerations, I guess I'm not really sure I understand that.

[00:35:50] Speaker 05:
I mean, as Mr. Lee said, this happens all the time.

[00:35:52] Speaker 05:
If the board says this one secondary consideration is strong enough,

[00:35:57] Speaker 05:
that we don't need to even consider the others, that that's the end of the inquiry.

[00:36:02] Speaker 05:
If we were to say that any time secondary considerations are proffered, there must be a consideration of all of them, then I think we're changing the landscape of how courts and administrative bodies consider these issues.

[00:36:19] Speaker 03:
So your honor, just to be clear, what we're saying is not that they have to do it every single time, but that if they're only going to consider one secondary piece of evidence, if they're going to shortcut their analysis, then we can appeal that one piece of analysis and that gets reviewed de novo.

[00:36:36] Speaker 03:
And we're not suggesting that the court should send this back and say, PTAB, go consider the other three and then weigh it again.

[00:36:42] Speaker 03:
What we're asking this court to do is two things.

[00:36:45] Speaker 03:
One,

[00:36:46] Speaker 03:
to correct the board's mistake when it came to the legal analysis it did about the unexpected results, meaning that mere comparable efficacy could not overcome our case, and then remand for the board to consider the whole sum of the secondary considerations argued by Biogen.

[00:37:03] Speaker 03:
The last thing I'd like to say just in the few seconds I have left is that should this court affirm the district court's decision, it need not reach the issues raised in this appeal because

[00:37:14] Speaker 03:
The entirety of the dispute between Biogen and Mylan has been raised before the district court.

[00:37:20] Speaker 03:
There are no cliques in this case that aren't in the district court.

[00:37:25] Speaker 05:
Thank you.