[00:00:00] Speaker 02:
This appeal is about holding Lilly accountable for its statements made to the FDA while seeking regulatory approval from Glenda, statements that are at odds with those now made to the PTO and to this court to save its patent, and statements that the PTAB intentionally ignored, which is legal error.

[00:00:20] Speaker 02:
Lilly's admissions to the FDA are not all that the PTAB improperly ignored in its decision.

[00:00:26] Speaker 02:
It also ignored many of the teachings of the EPOL5 reference, which is also a legal error.

[00:00:33] Speaker 02:
Turning to the FDA communications, prior to the patents filing date, Lilly communicated in a series of letters to the FDA that are not prior art, not because of their date, but because they were not disseminated and published.

[00:00:53] Speaker 01:
Am I correct that the appellants are asking us to address their 101 arguments presented for the first time on appeal?

[00:01:01] Speaker 02:
Yes, you are, Your Honor.

[00:01:03] Speaker 01:
I must be, because you couldn't have them below.

[00:01:08] Speaker 01:
It's an interesting argument.

[00:01:11] Speaker 01:
Putting aside for a moment the inter-partis versus ex-partis distinction that you request us to find determinative

[00:01:22] Speaker 01:
Are you arguing that no matter the context, even if a statute expressly prohibits the party below from raising 101, which of course the statute does, an appellant should always be able to assert 101 on appeal as effectively jurisdictional or equivalent to jurisdictional or what?

[00:01:51] Speaker 02:
For the most part, yes, Your Honor.

[00:01:53] Speaker 02:
We believe that when the 101 decision is a question of law, that it is appropriate for this court to determine, as a threshold matter, whether or not it was raised below.

[00:02:03] Speaker 03:
As you mentioned, the committee is- But even questions of law have to be preserved below.

[00:02:08] Speaker 03:
And if it's not only not preserved, but prohibited from being raised below, how can we, in the context of administrative review, rely on a ground

[00:02:18] Speaker 03:
not raised to or relied on by the administrative agency.

[00:02:22] Speaker 02:
Well, the APA says that this court shall decide all questions of law.

[00:02:27] Speaker 01:
How can you square it with Berkheimer?

[00:02:29] Speaker 02:
Berkheimer states that there may be underlying questions of law in the 101 decision, but it explicitly states that not all 101 decisions... That's true.

[00:02:41] Speaker 01:
Doesn't it have to be addressed below?

[00:02:43] Speaker 01:
If the other side says there are factual questions, do we throw up our hands and say, oh, my goodness?

[00:02:51] Speaker 03:
Even if it's a pure legal issue, doesn't Chenery require that we only affirm or decide APA cases based upon the grounds relied on by the agency below?

[00:03:05] Speaker 03:
How could we resolve this case on 101 and be consistent with Chenery?

[00:03:10] Speaker 02:
Chenery was cited in Komitski when Komitski decided that even though 101 was not raised before the PTO below, that it could still be raised as a threshold issue before this court.

[00:03:22] Speaker 02:
It's similar to the Ayayama case in which this court looked at indefiniteness for the first time, even though that could happen.

[00:03:29] Speaker 03:
At least in Komitski, 101 potentially could have been relied on by the agency in resolving that case.

[00:03:36] Speaker 03:
and could have been a potential legal ground for the rejection of the claims.

[00:03:41] Speaker 03:
There are some exceptions to Chenery for things like that.

[00:03:44] Speaker 03:
But when it is not at all possible for it to be a potential legal ground for the agency to rely on, how is it consistent with Chenery for us to look at it?

[00:03:55] Speaker 02:
Well, Comiskey explains that Chenery does not

[00:03:59] Speaker 02:
The Chenery position does not apply when it would be wasteful to send a decision back down to... Well, in fact, we can't send this back down for them to do 101.

[00:04:09] Speaker 04:
We can.

[00:04:09] Speaker 04:
In Comiskey, they did, right?

[00:04:11] Speaker 04:
On the method claims, or on the apparatus claims, they actually remanded to the PTO and said, now you address 101 in the first instance.

[00:04:17] Speaker 04:
We can't even do that here, can we?

[00:04:19] Speaker 02:
I don't believe so.

[00:04:22] Speaker 02:
The statute says that the petitioner cannot raise 101.

[00:04:26] Speaker 02:
It does not necessarily prohibit the board from deciding 101 on its own.

[00:04:30] Speaker 04:
Do you think that after SAS was decided by the Supreme Court, the board is now free to renegade petitions, go off petition, in fact go off statute, and decide on whatever basis it wants?

[00:04:41] Speaker 02:
The board cannot go off statute.

[00:04:43] Speaker 02:
But this court is not obligated or is not held to that statute.

[00:04:48] Speaker 02:
This court can decide any issue of law.

[00:04:51] Speaker 02:
And we submit that this would be a proper

[00:04:54] Speaker 02:
use of judicial resources to... Enablement is a question of law.

[00:04:58] Speaker 04:
You're telling me you can raise enablement on appeal from an IPR and I have to or should decide it.

[00:05:06] Speaker 04:
Even though you clearly can't raise enablement in an IPR, enablement is a question of law.

[00:05:13] Speaker 04:
You're telling me all questions, there's a million patent law questions of law.

[00:05:18] Speaker 04:
whether something's a printed publication is a question of law.

[00:05:20] Speaker 04:
But there are a lot of them, and many of them cannot be raised in IPRs.

[00:05:23] Speaker 04:
But you're telling me all of those are fair game on appeal at the Federal Circuit, despite the fact that Congress has said they expressly cannot be raised in IPRs?

[00:05:31] Speaker 02:
No.

[00:05:32] Speaker 02:
The US Supreme Court has said that patentability is a threshold issue.

[00:05:35] Speaker 02:
And so we think that when we're discussing patentability, that that is a threshold issue that- But not in the terms of a jurisdictional issue, right?

[00:05:44] Speaker 03:
It's a threshold merits issue.

[00:05:47] Speaker 02:
It is a threshold merits issue, although what the Supreme Court has said is that you don't get to 102, 103 if something is not patentable.

[00:05:56] Speaker 03:
So what?

[00:05:57] Speaker 03:
I mean, if Congress had wanted the threshold issue to be involved in IPRs, they could have done it.

[00:06:02] Speaker 03:
But they didn't.

[00:06:04] Speaker 04:
And they expressly made it available in CBMs with the same statute, right?

[00:06:07] Speaker 04:
The same statute.

[00:06:08] Speaker 04:
The AIA comes out, and CBMs is expressly available.

[00:06:10] Speaker 04:
And in IPRs, it's expressly not available.

[00:06:14] Speaker 03:
I mean, what you're asking us to do is in,

[00:06:17] Speaker 03:
you know, a sharp departure from what Chenery requires and what other courts do in administrative law cases from other agencies.

[00:06:27] Speaker 03:
There's no way that other courts come up with a brand new legal theory on appeal that the agency couldn't have relied on to resolve the case.

[00:06:37] Speaker 03:
Can you cite me one single instance of that?

[00:06:41] Speaker 02:
I cannot.

[00:06:41] Speaker 02:
We agree that this is an issue of first impression, but we believe that under Komitsky,

[00:06:46] Speaker 02:
that this court has the authority to look at 101.

[00:06:50] Speaker 03:
What do you think in Kaminsky allows us to do that?

[00:06:53] Speaker 03:
In Kaminsky, at least, the agency had the authority to decide the issue before it.

[00:06:59] Speaker 03:
You're asking us to take it a step farther and say, even if the agency didn't have the authority, we do.

[00:07:05] Speaker 03:
Can you cite a single case from any court that's ever stood for that proposition?

[00:07:11] Speaker 02:
No, Your Honor, we acknowledge this is an issue of first impression.

[00:07:13] Speaker 03:
But we also are not standing... I think if we agreed with you, we would get a 9-0 reversal from the Supreme Court in a matter of months.

[00:07:21] Speaker 02:
Understood, Your Honor.

[00:07:22] Speaker 02:
But we also are not standing on the 101 issue exclusively.

[00:07:26] Speaker 02:
We have, we believe, a very strong obviousness problem here.

[00:07:32] Speaker 01:
Am I correct that the parties don't dispute that despite their express teachings regarding folic acid

[00:07:41] Speaker 01:
pre-treatment, Grimley, Hammond 1, and Warzalla do not teach anything regarding the administration of vitamin B12.

[00:07:51] Speaker 02:
The particular references that you just mentioned do not teach anything regarding vitamin B12.

[00:07:56] Speaker 02:
The EPO5 reference on the other hand, which has not been before this court before, does teach administering B12 in addition to folic acid to achieve a synergistic effect in lowering homocysteine.

[00:08:11] Speaker 02:
for cardiovascular disease.

[00:08:14] Speaker 02:
Actually, the EPO-05 says that it's for lowering home assisting from any known cause.

[00:08:18] Speaker 04:
Okay, but there is evidence in this record, and this seems to me is a question of fact, that B12 pretreatment could increase tumor growth and therefore was counterindicated for cancer treatment.

[00:08:31] Speaker 04:
So this is a question of fact.

[00:08:34] Speaker 04:
Maybe you're right about what EPO says.

[00:08:36] Speaker 04:
It seems tangential at best, but there's direct evidence

[00:08:40] Speaker 04:
that tumors will grow bigger with B-12.

[00:08:43] Speaker 04:
Do you want me to reverse the PTO's fact-finding, given that state of the record?

[00:08:48] Speaker 02:
The PTO actually did not find that there was evidence of tumor growth.

[00:08:53] Speaker 02:
The PTO, when it mentioned tumor growth, was merely regurgitating Lilly's position, saying that Lilly argued that there is evidence for tumor growth.

[00:09:00] Speaker 02:
But contrary to what Lilly states in its briefs, if you look at where they actually cited that, the PTO never made a factual finding.

[00:09:07] Speaker 02:
that there is evidence that adding B12 could give tumor growth.

[00:09:12] Speaker 02:
In fact, Lilly has admitted to the FDA in correspondence trying to get a drug that's going to be administered to patients out into the public.

[00:09:21] Speaker 02:
What Lilly told the FDA was that for vitamin B12, this is direct quote, literature searches found no evidence for stimulation of tumor growth by this vitamin.

[00:09:30] Speaker 02:
That is in the record, and that is a pre-Priority Day admission by Lilly to the FDA.

[00:09:36] Speaker 01:
You want us to rely on your expert testimony like Dr. Blyer to support a finding that it was known that cancer patients being treated are more likely to have B12 deficiencies, and therefore a person would be motivated to include it.

[00:09:55] Speaker 01:
But in the IRP237 proceeding, the PTAP found that Dr. Blyer's

[00:10:05] Speaker 01:
testimony was unclear and internally inconsistent, correct?

[00:10:11] Speaker 02:
Yes, Your Honor.

[00:10:12] Speaker 01:
So how can we disrupt that credibility finding at this level?

[00:10:18] Speaker 02:
We're not asking this Court to disrupt any credibility findings.

[00:10:21] Speaker 02:
We're asking this Court to address the errors of law that the PTAB made in the case, that they actually applied the incorrect legal standards in coming to their factual findings.

[00:10:32] Speaker 02:
For instance, Lilly

[00:10:33] Speaker 02:
The PTAB refused to look at Lilly's admissions at all, that they refused to read the prior art references in light of Lilly's communications to the FDA.

[00:10:43] Speaker 04:
The communications to the FDA were made after the critical date with the benefit of the inventor's discoveries in this case.

[00:10:50] Speaker 04:
So while the PTAB may have said so inartfully by suggesting simply they're not prior art, I don't see how they were nonetheless right in disregarding those statements because

[00:10:59] Speaker 04:
The statements about what was known are being made by the company that figured out the solution to this problem that came up with this invention.

[00:11:10] Speaker 04:
That company is making statements to the FDA about what it knows right then and there, which include the knowledge that these inventors developed by virtue of their invention.

[00:11:19] Speaker 04:
So I guess for me, while the PTO may not have in the most artful way explained why those statements are not

[00:11:27] Speaker 04:
going to carry any water in this case, it's nonetheless entirely correct given the state of the art and the timing of the statements.

[00:11:35] Speaker 02:
The statement that I just read, for instance, is that literature searches found no evidence for stimulation of tumor growth by this vitamin.

[00:11:43] Speaker 02:
That is not a statement that is reflecting in any way any invention that Lilly had made.

[00:11:49] Speaker 02:
That is simply a statement of the knowledge

[00:11:51] Speaker 02:
that APOSA would have at the time.

[00:11:53] Speaker 02:
And that is not, the PTO cannot legally... No, it's not a statement.

[00:11:56] Speaker 04:
It's a statement of what a literature search uncovered for them.

[00:12:00] Speaker 04:
They performed a literature search and it didn't uncover something.

[00:12:03] Speaker 04:
It's not actually a statement of what APOSA would understand.

[00:12:07] Speaker 04:
But if we want to find a statement of what APOSA would understand, please turn to page 9031 of your appendix.

[00:12:15] Speaker 04:
This is the expert declaration, where... 9031.

[00:12:25] Speaker 04:
Well, this is where the expert says that although the prior art, and in particular, the Nikekiziza, I'm sorry, I'm sure I'm saying that wrong, abstracts indicates that there's a correlation between homocysteine levels and the development of various toxicities in patients who received hemantrexid.

[00:12:42] Speaker 04:
The prior art specifically recognized that a cancer patient on an anti-foliate should not receive folate to lower homocysteine levels as that would be expected to interfere with the anti-tumor effect of the anti-foliate.

[00:12:55] Speaker 04:
So you have expert testimony on this record that cites particular references on page 9031 and 9032 that was in front of the PTO, which makes the argument, or at least the factual assertion, that you should not combine these two things when dealing with anti-tumor as opposed to cardiovascular for home assisting levels because it would interfere with the anti-tumor effect that you were seeking through the chemotherapy drugs that you were using.

[00:13:24] Speaker 04:
That is a substantial evidence question of fact.

[00:13:28] Speaker 04:
I can't see it any other way.

[00:13:30] Speaker 04:
So I'm having trouble understanding how that morphs into a question of law.

[00:13:34] Speaker 02:
The PTO actually rejected that factual finding that Your Honor just mentioned.

[00:13:39] Speaker 02:
The PTO, the PTAB found that it actually was obvious, despite Lilly's expert testimony, to pre-treat with folic acid prior to giving patients pimatricid.

[00:13:50] Speaker 02:
So Lily did argue that, but the PTO rejected that as a factual finding.

[00:13:56] Speaker 02:
And I see that I'm into my rebuttal time.

[00:13:58] Speaker 02:
I'm sorry.

[00:13:59] Speaker 04:
Let me be clear.

[00:13:59] Speaker 04:
I didn't read the first part of the sentence, which says they would not pretreat a cancer patient receiving permetrix with folic acid NB12.

[00:14:08] Speaker 04:
So I'm sorry.

[00:14:08] Speaker 04:
I didn't read completely the expert's paragraph, and you don't have it in front of you.

[00:14:12] Speaker 04:
So I understand why you responded the way you did.

[00:14:15] Speaker 04:
If it was limited to the folic acid, I understand your result.

[00:14:19] Speaker 04:
It was my fault for not reading you the whole thing, or possibly your fault for not bringing the appendix.

[00:14:23] Speaker 02:
I agree that there is evidence in the record that Lilly presented, but we do submit that the PTAB erred in that it did not make its factual findings with the full record in front of it because it omitted portions of documents that it shouldn't.

[00:14:40] Speaker 02:
But I'd like to save the rest of my time for a battle.

[00:14:42] Speaker 02:
Okay, of course.

[00:14:43] Speaker 04:
And we'll restore two minutes because I asked you a lot of questions.

[00:14:48] Speaker 04:
Mr. Kerland.

[00:14:51] Speaker 04:
No, Mr. Perlman.

[00:14:52] Speaker 04:
Perlman?

[00:14:54] Speaker 00:
Yes, Your Honor.

[00:14:54] Speaker 04:
Please proceed.

[00:14:57] Speaker 00:
Good morning, Your Honor.

[00:14:57] Speaker 00:
May it please the Court.

[00:14:58] Speaker 00:
Adam Perlman of Williams & Connolly on behalf of Eli Lilly.

[00:15:01] Speaker 00:
Let me start with a factual citation.

[00:15:05] Speaker 00:
The PTAB did find that administration of B12 would be thought to create a risk to the efficacy of the chemotherapy because in the only situation where B12 will have an effect in this circumstance,

[00:15:18] Speaker 00:
it will release an unpredictable amount of folate.

[00:15:21] Speaker 00:
That's at page 73.

[00:15:23] Speaker 00:
And then again, at pages 161 to 162.

[00:15:26] Speaker 04:
Well, I mean, your evidence shows that B12 enhances the production of the RNA and DNA, which causes the molecules or the cells to replicate.

[00:15:34] Speaker 04:
And that's the exact opposite of what you want when you're treating cancer patients.

[00:15:37] Speaker 04:
Is that right?

[00:15:37] Speaker 00:
That is correct.

[00:15:38] Speaker 00:
Yeah, that's what I understood.

[00:15:39] Speaker 04:
OK.

[00:15:40] Speaker 00:
Anything else?

[00:15:42] Speaker 00:
On that point or overall?

[00:15:44] Speaker 05:
I will be brief.

[00:15:50] Speaker 00:
I'll hit the highlights here.

[00:15:51] Speaker 00:
On the FDA documents, I think Judge Moore hit exactly our central point.

[00:15:56] Speaker 00:
The PTAB found as a factual matter that our submissions to the FDA... But they were in our fold.

[00:16:01] Speaker 04:
They kind of said, these aren't prior art, so we're not going to consider them.

[00:16:04] Speaker 04:
And I don't think that was exactly right.

[00:16:06] Speaker 04:
I nonetheless don't think they made a mistake.

[00:16:08] Speaker 04:
But I don't think what they said was exactly right.

[00:16:10] Speaker 00:
Well, I take that critique, Your Honor.

[00:16:12] Speaker 00:
But I think if you read the context of the surrounding pages where they say it, what they say is, first, they block quote all the arguments petitioners make from the documents.

[00:16:22] Speaker 00:
So the substance of what they say was before them.

[00:16:24] Speaker 00:
And they say, they're not prior art.

[00:16:26] Speaker 00:
And we declined to read Lilly's statements as if they're prior art.

[00:16:29] Speaker 00:
But then they go on in the next paragraph, and they say,

[00:16:31] Speaker 00:
These were made by those who had knowledge of the invention.

[00:16:35] Speaker 00:
And obviousness requires having no knowledge of the invention.

[00:16:39] Speaker 00:
And they justify their reasoning.

[00:16:41] Speaker 00:
I agree that if I were to edit it, I would flip the order of those paragraphs.

[00:16:45] Speaker 00:
But I think, read in context, that is what they're saying.

[00:16:47] Speaker 00:
And I think that is correct.

[00:16:50] Speaker 00:
The second point I would make on this, and it's conspicuously absent from any of the briefing, but Lilly never told the FDA, even with knowledge of the invention, that the prior art

[00:17:01] Speaker 00:
taught to pre-treat hematrexid patients with vitamin B12.

[00:17:06] Speaker 00:
And what's interesting is the only reference in any ground that was before the PTAB or that's before you today that talks about the administration of vitamin B12 is the EP005 reference, which is not mentioned at all in any of these FDA submissions.

[00:17:21] Speaker 00:
And so in some ways, this is a bit of a tempest in a teapot.

[00:17:25] Speaker 00:
But the board was correct in its view

[00:17:28] Speaker 00:
that these documents were not probative of the issue before it.

[00:17:32] Speaker 00:
And there's no basis to overturn that.

[00:17:33] Speaker 00:
The other thing I will point out is that all of these references were before the board.

[00:17:37] Speaker 00:
Their experts' testimony about these references were before the board, our experts' testimony.

[00:17:43] Speaker 00:
And the board was well positioned to make a factual determination on the merits which it did.

[00:17:49] Speaker 00:
In terms of the substantive issue, I don't want to belabor this because I think Judge Moore hit on the key point.

[00:17:59] Speaker 00:
The relevance of homocysteine to this case is that Neuquiza found that patients who had a certain pretreatment level of homocysteine.

[00:18:08] Speaker 04:
Neuquiza, that's not the way it sounded in my head at all.

[00:18:10] Speaker 00:
Neuquiza.

[00:18:11] Speaker 04:
Thank you for saying it.

[00:18:12] Speaker 04:
Not a problem.

[00:18:12] Speaker 00:
No, I'll try the... Neuquiza and Pematrexid.

[00:18:15] Speaker 04:
Pematrexid.

[00:18:16] Speaker 00:
Yeah, it's been a... That one I should have gotten, but... Well, they're both challenging.

[00:18:20] Speaker 00:
Neuquiza found that patients who had a particular level of homocysteine prior to getting Pematrexid

[00:18:27] Speaker 00:
were predisposed to get certain pematrexid toxicities.

[00:18:31] Speaker 00:
But before they got the pematrexid, they weren't having any side effects.

[00:18:35] Speaker 00:
These are not people who have a homocysteine problem, and they need treatment for the homocysteine.

[00:18:40] Speaker 00:
It's a marker for which patients the pematrexid is going to cause toxicity for.

[00:18:46] Speaker 00:
And what's important to remember, as the board expressly found, is that homocysteine levels can be caused by multiple different things.

[00:18:53] Speaker 00:
One of them is a folic acid deficiency, and one of them

[00:18:56] Speaker 00:
is an MMA deficiency.

[00:18:58] Speaker 00:
There are multiple other things.

[00:19:00] Speaker 00:
And if all you know is that there is elevated homocysteine, you don't know.

[00:19:03] Speaker 00:
It could be any of them.

[00:19:05] Speaker 00:
But there's a more specific marker, MMA, methylmalonic acid.

[00:19:10] Speaker 00:
And when that is unique to B12 deficiency, when that marker is elevated, the patient has a B12 deficiency.

[00:19:17] Speaker 00:
And so if you know both, homocysteine levels and methylmalonic acid levels, it allows you to distinguish between

[00:19:24] Speaker 00:
the causes of the elevated homocysteine.

[00:19:27] Speaker 00:
And what the Neakeza 2 abstract reported, and the board made an express finding that our experts' reading was the correct reading on this, was that there was no correlation between patients' MMA levels and their toxicity.

[00:19:43] Speaker 00:
And so what that would have told the person of ordinary skill is that whatever was causing the elevated homocysteine, it was not a vitamin B12 deficiency.

[00:19:53] Speaker 00:
And the board found, and it's clearly supported by substantial evidence, that there would not have been any motivation to give vitamin B12 to lower homocysteine in that context.

[00:20:04] Speaker 00:
And the EP005 reference is addressed to an entirely different context.

[00:20:09] Speaker 00:
It's not about ameliorating the toxicities of a chemotherapy agent.

[00:20:14] Speaker 00:
It's not about the treatment of cancer.

[00:20:16] Speaker 00:
It doesn't say anything about what will happen to the efficacy of the cancer drug or the toxicities patients will suffer.

[00:20:22] Speaker 00:
It's addressed to a totally different problem.

[00:20:24] Speaker 00:
And the board found, as a factual matter, that the person of ordinary skill wouldn't have looked to it.

[00:20:30] Speaker 00:
And that's clearly supported by substantial evidence.

[00:20:33] Speaker 00:
The final point I will make, and I hesitate to even say it, but Your Honors are 100% correct on the 101 issue.

[00:20:41] Speaker 00:
The APA says.

[00:20:42] Speaker 00:
Thank you for agreeing.

[00:20:45] Speaker 00:
I do my best, Your Honor.

[00:20:47] Speaker 00:
The APA says a reviewing court may consider any relevant issue of law.

[00:20:51] Speaker 00:
That has to mean an issue of law relevant to the decision under review.

[00:20:55] Speaker 00:
Here, the decision under review has nothing to do with 101, could have nothing to do with 101.

[00:21:00] Speaker 00:
101 is not a relevant issue of law under the APA.

[00:21:04] Speaker 00:
And Judge Moore is 100% correct that if you were to find there was a fact question under 101, which the law clearly provides there can be, you couldn't remand it to the board because they're prohibited from hearing it.

[00:21:15] Speaker 00:
Unless your honors have any questions, I will stop at that point.

[00:21:19] Speaker 04:
Okay.

[00:21:21] Speaker 04:
Thank you.

[00:21:32] Speaker 02:
Your Honours, a few points in response.

[00:21:36] Speaker 02:
Mr. Perlman mentioned that there has to be this link, what has been referred to as a missing link, between the prior ART B12 deficiency and pemotraxid toxicity.

[00:21:48] Speaker 02:
But that was actually one of the errors of law that the PTAP committed in that it held that the appellants had to prove this quote unquote missing link in order to show motivation to combine.

[00:21:59] Speaker 02:
But KSR and many subsequent cases make very clear that it is improper to hold the appellants to the motivation of the inventor.

[00:22:09] Speaker 02:
There can be many motivations.

[00:22:10] Speaker 02:
And here, the board actually found one of those motivations in its factual findings and disregarded it.

[00:22:18] Speaker 02:
its factual findings for EP005 at A18, which is citing Appendix 12209, the board found that EP005 says elevated homocysteine levels are highly undesirable and the normalization of elevated levels constitutes a therapeutic goal in and of itself.

[00:22:39] Speaker 02:
Of course, there can be many motivations for lowering homocysteine, but lowering homocysteine in and of itself is a motivation.

[00:22:47] Speaker 02:
The appellants have presented other motivations that were in the art, such as improving the folic acid regimen.

[00:22:53] Speaker 04:
The PTab found that it was obvious to pretreat with folic acid in order to lower... It was obvious to pretreat with folic acid, but not necessarily folic acid and B12 in combination with epimetra, whatever that thing is, I can't say.

[00:23:08] Speaker 04:
But, you know, that's your problem.

[00:23:10] Speaker 04:
The problem isn't that there's not a motivation to combine B12 and folic acid for some purposes.

[00:23:15] Speaker 04:
And even that lowering homocysteine levels might be beneficial with cancer patients.

[00:23:21] Speaker 04:
But the problem was there was this counter indicator, which is, but, you know what?

[00:23:25] Speaker 04:
I don't think the homocysteine levels are as much of a problem as the tumors.

[00:23:28] Speaker 04:
And if there's a concern that the B12 addition is going to increase the growth in the tumors, that's what's going to kill the people, not the homocysteine levels.

[00:23:35] Speaker 04:
So don't treat with that.

[00:23:37] Speaker 04:
So I mean, usually you treat a headache with Advil.

[00:23:40] Speaker 04:
But if the person's got a stomach ulcer, you're not going to give them Advil.

[00:23:44] Speaker 04:
You know, that's the problem you have here.

[00:23:46] Speaker 04:
Motivation to combine them for lower income assisting levels, but not in patients with tumors.

[00:23:51] Speaker 02:
I agree.

[00:23:52] Speaker 02:
That's the evidence anyway.

[00:23:53] Speaker 02:
Treating patients with tumors is incredibly important, and that's why Lilly's statements to the FDA when they're trying to get a drug approved to treat these patients are critical.

[00:24:01] Speaker 02:
Lilly cannot tell the FDA that there is zero evidence that a tumor will grow.

[00:24:07] Speaker 02:
because of adding B12, and then come around when it's trying to save its patent and tell this court another thing.

[00:24:12] Speaker 02:
It just can't be the case that Lilly can't be held accountable for its admissions to the FDA that are prior to the patent's filing date.

[00:24:19] Speaker 02:
And I know Your Honor talked about them being post-invention, but there is zero evidence in the record.

[00:24:24] Speaker 02:
And the board made no finding that Lilly had possession of its invention at any point prior to the filing date.

[00:24:31] Speaker 02:
And so these pre-filing date communications are pre-priority date communications

[00:24:36] Speaker 02:
And they matter.

[00:24:36] Speaker 02:
And so what Lilly said to the FDA about what a post-it would know about whether or not there would be an expectation for tumor growth when adding B12, those statements have to matter.

[00:24:47] Speaker 02:
And if the board, by ignoring those statements, committed legal error.

[00:24:52] Speaker 02:
Did you argue below about what the critical date was in this case?

[00:24:56] Speaker 02:
We did not argue as to what the critical date was or not.

[00:24:59] Speaker 02:
It's Lilly's burden to prove that if they want to rely on something other than the priority date,

[00:25:05] Speaker 02:
then Lily has the burden to prove that they are entitled to a date other than priority day, and Lily did not make such an argument.

[00:25:12] Speaker 04:
Is your argument that this record does not reflect that those statements were made after the date of invention?

[00:25:17] Speaker 04:
Yes, Your Honor.

[00:25:18] Speaker 05:
Great.

[00:25:19] Speaker 05:
Okay.

[00:25:21] Speaker 04:
Thank you both, Council, for their arguments.

[00:25:22] Speaker 04:
The case is taken under submission.