[00:00:00] Speaker 04:
is Eli Lilly versus Tampa Pharmaceuticals, 2020, 1876, 77, and 78.

[00:00:08] Speaker 04:
Mr. Reich.

[00:00:10] Speaker 00:
Thank you, your honor.

[00:00:11] Speaker 00:
May it please the court.

[00:00:13] Speaker 00:
The board committed three legal errors, which led it to conclude there was no reasonable expectation of success in using the claimed antibodies for the very purpose that the prior art identified as a reason to pursue them, treatment of migraine.

[00:00:26] Speaker 00:
I'd like to start by addressing the Board's error in requiring Lilly to prove a reasonable expectation of success for achieving clinical results that the parties and the Board agree are not required by TEVA's claim preambles.

[00:00:40] Speaker 00:
The Board expressly held at Appendix 16 that the preamble does not require achieving a result, but just two pages later, the Board reached the contrary conclusion

[00:00:51] Speaker 00:
that the preamble required a reasonable expectation that performing the recited method would bring about the recited result, a result that's not required by the preamble.

[00:01:02] Speaker 04:
Well, the crimes recite an effective amount.

[00:01:06] Speaker 04:
Doesn't that mean it's got to be effective for something, which requires that the preamble be meaningful?

[00:01:14] Speaker 00:
No, Your Honor.

[00:01:15] Speaker 00:
I think that's wrong for at least three reasons.

[00:01:18] Speaker 00:
First of all,

[00:01:21] Speaker 00:
As this court held in Alcon and Bristol Myers and Copaxone, an effective amount term just refers to some amount of a drug.

[00:01:30] Speaker 00:
It does not describe a result or require a showing of clinical efficacy.

[00:01:35] Speaker 00:
And Teva hasn't cited any contrary authority.

[00:01:38] Speaker 00:
While Teva cites to the definition of effective amount in the specification,

[00:01:42] Speaker 00:
That definition merely requires an amount sufficient to affect the desired result, not that the result is achieved.

[00:01:50] Speaker 00:
And indeed, that definition states expressly that a desirable result may be or is achieved, may be achieved.

[00:01:58] Speaker 00:
That's an A195, 19.2 to 3.

[00:02:02] Speaker 00:
Second, Teva's position is belied by its failure to disclose even one actual clinically effective dose anywhere in the specification or claim.

[00:02:10] Speaker 00:
There's no clinical data.

[00:02:12] Speaker 00:
In Bristol Myers and Copaxone, the claims recited specific clinically effective doses supported by clinical trial data.

[00:02:21] Speaker 00:
Yet this court held that no showing of efficacy was required to invalidate them.

[00:02:26] Speaker 00:
Teva should not be entitled to a higher standard for obviousness than in those cases when Teva disclosed less and claimed less.

[00:02:36] Speaker 00:
And the third point is that Teva's argument violates claim differentiation and contradicts its specification.

[00:02:42] Speaker 04:
One doesn't need clinical results to support a method of treatment claim.

[00:02:51] Speaker 04:
A broad statement of effective doses generally suffices.

[00:02:58] Speaker 00:
I think the reason that I reference the clinical results specifically is because that's something that courts often point to in terms of construing a term like effective amounts.

[00:03:10] Speaker 00:
So here you have a definition of effective amount that just requires an amount of a drug.

[00:03:15] Speaker 00:
And then in addition to that, the specification doesn't actually include any clinical data.

[00:03:20] Speaker 00:
It just has these broad statements.

[00:03:21] Speaker 00:
And so, again, that just goes to the fact that effective amount is pointing to the purpose of the drug, not a result required by the drug.

[00:03:30] Speaker 00:
And I think that, again, that ALKAN versus Apotex case, which I was getting to with respect to claim differentiation, is helpful there.

[00:03:37] Speaker 00:
And there,

[00:03:40] Speaker 00:
So you have, you had a dependent claim which recited a specific dose, dose range, and you had an independent claim that recited an effective amount.

[00:03:52] Speaker 00:
The same setup that you have here.

[00:03:53] Speaker 00:
And in our case, just like in that case, the evidence showed that the claimed range encompassed many clinically ineffective doses.

[00:04:03] Speaker 00:
That's A3114 and A11844.

[00:04:08] Speaker 00:
And so Teva's position is that this range is just a hunting ground for future attempts to find a clinically effective amount.

[00:04:14] Speaker 00:
But that can't be squared with the principle of claim differentiation, which requires that independent claims be at least as broad as the dependent claims.

[00:04:23] Speaker 00:
So in view of the lack of expressed definitions, principles of claim differentiation, and the dearth of clinical data, effective amounts should not require a clinical result or elevate the standard for reasonable expectation of success.

[00:04:36] Speaker 04:
You want on the invalidation of the composition claims that you didn't hear on the method claim.

[00:04:45] Speaker 04:
They obviously differ, and we both know all the differences.

[00:04:50] Speaker 04:
But in principle, would you say the arguments are basically the same?

[00:04:57] Speaker 04:
There's Tan and Wimowonza.

[00:05:05] Speaker 04:
And are you taking the view that basically the issues are the same?

[00:05:16] Speaker 00:
Yeah, I think generally speaking, the records in the composition and method cases are substantially similar.

[00:05:21] Speaker 00:
And I think that the different results arise from two errors in the method cases.

[00:05:27] Speaker 00:
And the first is essentially applying a reasonable expectation of success in the method cases that required additional data.

[00:05:35] Speaker 00:
For example, that someone had to follow TAN's explicit dosing directions before Keva did.

[00:05:43] Speaker 00:
And that's just legally incorrect.

[00:05:45] Speaker 00:
And I think the second is the fact findings relating to alleged uncertainty about the blood-brain barrier.

[00:05:52] Speaker 00:
And that arose by failure in its analysis

[00:05:55] Speaker 00:
to consider the most recent and relevant prior art, which is the Peterson 2005 paper.

[00:06:01] Speaker 00:
So Peterson 2005 was a human clinical paper that the board simply didn't address at all in its findings, in its analysis, with respect to reasonable expectation of success.

[00:06:14] Speaker 04:
And it shows that the council... In the composition claims, the reasonable expectation is a success

[00:06:24] Speaker 04:
relates to humanizing it, and there was no biological result in the claim.

[00:06:33] Speaker 04:
Humanizing the antibody really has expectation of success.

[00:06:38] Speaker 04:
Here, the reasonable expectation of success relates to treatment of an ailment.

[00:06:44] Speaker 04:
That's a higher standard, isn't it?

[00:06:49] Speaker 00:
I think that it is a somewhat different standard, but I think the problem is that the claim doesn't actually require treatment.

[00:06:57] Speaker 00:
It just requires an approach for treating.

[00:06:59] Speaker 00:
The preamble doesn't require treatment.

[00:07:02] Speaker 00:
I think Teva and the board and Lilly all agree with that.

[00:07:06] Speaker 00:
And the effective amount term also doesn't actually require treatment.

[00:07:09] Speaker 00:
The claims are directed to an approach for treating.

[00:07:13] Speaker 00:
And so again, I think that

[00:07:15] Speaker 00:
Under the proper legal standard, there should be a one-to-one correlation between what the claims objectively require and the reasonable expectation analysis.

[00:07:25] Speaker 04:
I don't see the word approach in the claim.

[00:07:28] Speaker 04:
I see reducing incidents or treating a symptom.

[00:07:36] Speaker 00:
Excuse me, Your Honor.

[00:07:36] Speaker 00:
I apologize for cutting in.

[00:07:38] Speaker 00:
Go ahead.

[00:07:39] Speaker 00:
Go ahead.

[00:07:40] Speaker 00:
So the specification defines the word treating as an approach for treating.

[00:07:45] Speaker 00:
So again, it doesn't actually require a result.

[00:07:47] Speaker 00:
It's just a purpose.

[00:07:49] Speaker 00:
And Teva agrees with that.

[00:07:50] Speaker 00:
In Teva's briefing, they have agreed that it's merely an intent to treat, as required by the preamble, not actually treating.

[00:07:59] Speaker 04:
If the word approach had been in the claim, it would have been rejected as indefinite.

[00:08:04] Speaker 04:
What the claim says is reducing incidents of treating.

[00:08:09] Speaker 00:
I mean, Teva's specification is unambiguous, that the claim is directed to an approach for treating.

[00:08:16] Speaker 00:
That's at A19417, lines 37 to 38.

[00:08:21] Speaker 00:
So the claim is directed to an approach for treating.

[00:08:25] Speaker 00:
That is what the claim is directed to.

[00:08:28] Speaker 00:
And so that's how they've defined the term.

[00:08:30] Speaker 00:
That's how they've set this up.

[00:08:32] Speaker 00:
And they would agree that the preamble does not require actual treatment.

[00:08:37] Speaker 00:
And so again, under the proper legal standard, there should be a one-to-one correlation between what the claims objectively require and the reasonable expectation analysis.

[00:08:49] Speaker 00:
TEPAs preambles require administering antibodies for the purpose of treating, not actually treating.

[00:08:56] Speaker 00:
So the only relevant question is what the record shows regarding this purpose.

[00:09:00] Speaker 00:
And as the board found, one of ordinary skill would have combined the prior art to perform the sole method step

[00:09:07] Speaker 00:
administering antibody for that same purpose.

[00:09:10] Speaker 00:
That's an A102 to 103.

[00:09:12] Speaker 04:
Who would want to claim an approach, even if it were definite?

[00:09:20] Speaker 04:
One claims treatment, and that's what the language says.

[00:09:25] Speaker 00:
Well, I guess from the flip side, if you look at it from an infringement perspective,

[00:09:33] Speaker 00:
it would be a lower burden if the claim was directed to an approach for treating as compared to actual treatment.

[00:09:39] Speaker 00:
So there are sort of advantages if you don't actually have to prove that the claim covers actual treatment.

[00:09:45] Speaker 02:
It doesn't say approach for treatment.

[00:09:48] Speaker 02:
It says approach for obtaining beneficial or desired clinical results.

[00:09:52] Speaker 02:
And then they define what those clinical results are.

[00:09:56] Speaker 02:
And they're very specific.

[00:09:58] Speaker 02:
So they're not just saying generally thinking about treating.

[00:10:01] Speaker 02:
They're saying getting rid of these

[00:10:03] Speaker 02:
clinical problems?

[00:10:06] Speaker 00:
I think it is an approach for getting rid of those clinical problems, Your Honor.

[00:10:09] Speaker 00:
I mean, that is the way that it's defined in the specification, and Teva, Lilly, and the board all agree that the claim only requires the purpose for administering, not actually administering.

[00:10:21] Speaker 00:
So I'd like to turn now, I alluded to this earlier, but I'd like to turn to sort of what we think is a separate legal error, and that was relying on OSI pharmaceuticals

[00:10:32] Speaker 00:
to demand that the prior art disclose data to satisfy reasonable expectation of success.

[00:10:39] Speaker 00:
And so Teva asked the question, and this is independent of claim construction.

[00:10:43] Speaker 00:
So even if we assume that one needs to show reasonable expectation of success for achieving a clinical result, the board required data.

[00:10:50] Speaker 00:
Now Teva disputes this, and they indicated, well, that's not actually what the board did.

[00:10:55] Speaker 00:
But if you look at appendix pages 147 to 148, again and again, the board says,

[00:11:02] Speaker 00:
There's no data.

[00:11:03] Speaker 00:
Olsen provides no data.

[00:11:04] Speaker 00:
TAN provides no data.

[00:11:06] Speaker 00:
COVEL provides no data.

[00:11:07] Speaker 00:
Olsen, TAN, and Queens do not provide any data on whether administering a full-length anti-CGRP antibody would provide a beneficial or desired result.

[00:11:16] Speaker 00:
Or, with respect to TAN, there's no evidence in the record that anyone followed TAN's suggested approach prior to filing of the patents.

[00:11:24] Speaker 00:
That's at appendix 148.

[00:11:25] Speaker 00:
That's its demand for data.

[00:11:27] Speaker 00:
Now, OSI required data due to highly unusual circumstances.

[00:11:31] Speaker 00:
The cancer field had more than 1,600 failures in clinical trials with an overall 99.5% failure rate.

[00:11:39] Speaker 00:
Even the most promising drugs in OSI's field invariably ended up on the scrap heap.

[00:11:44] Speaker 00:
Here, the record has no similarities.

[00:11:47] Speaker 00:
TEVA identified no clinical failures of anti-CGRP drugs to the board.

[00:11:52] Speaker 00:
The migraine field instead included several FDA approved drugs

[00:11:56] Speaker 00:
the tryptans, Olson's Biven compound that has been successful in a phase two trial, and even worked with... Olson was very different.

[00:12:04] Speaker 02:
I mean, the board specifically found that Olson is completely different, didn't it?

[00:12:09] Speaker 00:
I mean, Olson involved a small molecule receptor antagonist, but the evidence shows that receptor antagonists and antibodies were understood as alternatives, so that although there were

[00:12:23] Speaker 00:
differences between the two, it's nevertheless a highly relevant teaching.

[00:12:29] Speaker 00:
And moreover, there were also evidence with aptamers, which were described in the art as analogs to antibodies, so these were larger molecules, they were understood not to cross the blood-brain barrier, and they were being tested, and they targeted CGRP, and they were being tested in animal models for treatment of migraine.

[00:12:52] Speaker 00:
And so the board misapplies the reasonable expectation standard from OSI in our case.

[00:12:58] Speaker 00:
I know I'm into my rebuttal time, so unless there are any further questions.

[00:13:01] Speaker 03:
Very quickly, you say that aptamers were found and not to, they were understood not to cross the bone-brain barrier?

[00:13:07] Speaker 03:
Yeah, that's correct, Gerardo.

[00:13:09] Speaker 00:
And what is your reference to that?

[00:13:13] Speaker 00:
It's the Healy reference and this appendix

[00:13:21] Speaker 00:
10814.

[00:13:22] Speaker 00:
OK.

[00:13:23] Speaker 00:
Thank you.

[00:13:25] Speaker 04:
Now, shall we spend of your time?

[00:13:36] Speaker 00:
Yeah, I'd like to reserve the remainder of my time, Your Honor.

[00:13:41] Speaker 04:
Mr. Jay.

[00:13:44] Speaker 01:
Thank you, Your Honor.

[00:13:46] Speaker 01:
These patents do in fact claim the use of these antibodies that antagonize the ligand to treat headache and other fast motor symptoms.

[00:13:54] Speaker 01:
That is what the claim language reaches, and that's why that's what really was required to prove obvious.

[00:14:00] Speaker 01:
I'd like to go straight to the preamble point, if I may.

[00:14:05] Speaker 01:
In this case, you have the preamble and the independent claims woven tightly together.

[00:14:12] Speaker 01:
The claims, in both the independent claims and the dependent claims,

[00:14:16] Speaker 01:
repeatedly referring back to the preamble to provide Anna Stevens' basis and the cases on which Lilly relies don't have any such discussion of Anna Stevens' basis.

[00:14:29] Speaker 01:
So I think that the strongest or the clearest example of that is the reference in Dependent Claim 3, and I'm referring here to the 045

[00:14:38] Speaker 01:
to said vasomotor symptoms.

[00:14:40] Speaker 01:
The only way that you can give content to that vasomotor symptom is to refer back to the preamble where it is referred to, the vasomotor symptom in an individual.

[00:14:49] Speaker 01:
The same thing in dependent claim nine, the same thing in the other patents with respect to headache.

[00:14:55] Speaker 02:
What's your response to your friend on the other side saying that, well, you don't really claim treatment of headache.

[00:15:04] Speaker 02:
You actually just claim an approach to treatment, which I'm not even sure I

[00:15:08] Speaker 02:
I don't completely understand.

[00:15:10] Speaker 02:
And he said, you concede that it's not an actual treatment that's required.

[00:15:15] Speaker 01:
We don't concede that, Your Honor.

[00:15:17] Speaker 01:
When you read together the meanings of either treatment or reducing incidence and effective amount, you see that what the definitions are doing is ensuring that administering an effective amount to a person with a headache or a vast motor symptom

[00:15:37] Speaker 01:
If they don't respond, but the purpose of administering it is to achieve the beneficial or desired clinical result, then it practices the patent, even if some individuals may not respond to it.

[00:15:50] Speaker 01:
So if you look at a couple of things, one is at the end of the definition of reducing incidence, which of course is the other substantive term in the preamble here, that column 17 at the very bottom

[00:16:03] Speaker 01:
So a method of reducing incidence of headache in an individual reflects administering the antibody based on a reasonable expectation that such administration may likely cause such a reduction in incidence in that particular individual.

[00:16:16] Speaker 01:
So in that way, both treatment and reducing incidence,

[00:16:20] Speaker 01:
work together with the effective amount, which is defined, as my friend said, in an amount sufficient to effect beneficial or desired results.

[00:16:30] Speaker 01:
And what are those results?

[00:16:31] Speaker 01:
You refer back to the preamble to see what those results are.

[00:16:34] Speaker 01:
As appropriate, they would be to reduce or treat a vasomotor symptom or headache or a migraine as appropriate for each of the individual claims.

[00:16:44] Speaker 01:
So we think that not only is that textbook antecedent basis, you know, using

[00:16:50] Speaker 01:
definite words like the and said in the body of the claims to refer back to the prior reference in the preamble.

[00:16:59] Speaker 01:
But this really is what gives life and meaning to the claim.

[00:17:03] Speaker 01:
You know, contrast that with Lilly's construction, which says that this is a method of administering these antibodies to anyone in any amount for any purpose.

[00:17:17] Speaker 01:
The other point that I'd like to make

[00:17:20] Speaker 01:
is how the preamble language drives what BMS called a manipulative difference.

[00:17:29] Speaker 01:
In BMS there was a specific amount specified in the claims and as a result the steps were performed the exact same way regardless of the language in the preamble.

[00:17:39] Speaker 01:
That is not the case here.

[00:17:40] Speaker 01:
There is a manipulative difference because the effective amount looks back to the preamble to

[00:17:47] Speaker 01:
figure out whether this method is being practiced to treat a vasomotor symptom or a headache, for example.

[00:17:55] Speaker 01:
Ultimately, as in Janssen, this preamble is a statement of the intentional purpose for which the method must be performed.

[00:18:03] Speaker 01:
My friends on the other side have said that, well, a statement of intentional purpose is never limiting, and that is exactly the opposite of Janssen.

[00:18:11] Speaker 01:
I think for that reason, they're attempting to get out of their...

[00:18:15] Speaker 04:
Mr. Jay, ultimately, isn't this case the same as the other?

[00:18:20] Speaker 04:
We're talking about an antibody, and we're talking about treating, we're sort of carrying it further than we did.

[00:18:31] Speaker 04:
Patients carry the use of the TGIP antibody further.

[00:18:38] Speaker 04:
You've got TAN, and you've got references that talk about treating basal motor symptoms.

[00:18:46] Speaker 04:
And why wasn't the board wrong in upholding this patent when it invalidated the others?

[00:19:00] Speaker 01:
I think there are a number of differences, Your Honor.

[00:19:01] Speaker 01:
I mean, I do think that if the...

[00:19:04] Speaker 01:
It would follow that if the board was wrong in the composition claims, it would follow that these claims are patentable.

[00:19:11] Speaker 01:
But even if one accepted the composition holding, here are some of the differences.

[00:19:18] Speaker 01:
Number one has already brought out the difference in reasonable expectation of success.

[00:19:25] Speaker 01:
You would expect success in humanization more readily than you would expect success in treatment of an ailment, as I think you said.

[00:19:33] Speaker 01:
in your question to Mr. Raich.

[00:19:37] Speaker 04:
That is true, except you have mentioned, Tan mentions success for a fragment and ways to improve success for the full material.

[00:19:54] Speaker 04:
And so there's more to it than just the fact that

[00:19:59] Speaker 04:
You've got the result of the claim.

[00:20:04] Speaker 01:
So in this case, the board actually explored that the TAN optimism in a way that it did not in the other IPRs.

[00:20:15] Speaker 01:
And the same thing with the analogies from Olson and the aptamers.

[00:20:20] Speaker 01:
So let me do TAN first.

[00:20:22] Speaker 01:
So TAN relied on COVEL and the board here made detailed findings about COVEL and what it teaches, appendix 109 to 111.

[00:20:35] Speaker 01:
And that's not, that wasn't addressed in the other IPRs precisely because the board thought that it only needed to address a motivation to study or use and an expectation of success in humanizing.

[00:20:49] Speaker 01:
Whereas here everyone agrees that what,

[00:20:52] Speaker 01:
the reasonable expectation of success has to be in treatment if that's what the claims cover.

[00:20:59] Speaker 01:
And so the Cobell finding addresses that with respect to TAN.

[00:21:06] Speaker 01:
The second point is on the blood-brain barrier, which is not discussed in the composition of matter IPRs at all, and which the

[00:21:17] Speaker 01:
The board properly found that because of the vigorous debate, the differing viewpoints about the site of action and whether a therapy had to cross the blood brain barrier and the key finding is at page 138 of the appendix.

[00:21:33] Speaker 01:
that a skilled artisan would not have expected that a full-size antibody would be able to achieve success in treating migraine.

[00:21:42] Speaker 01:
The other side's response to that is this Peterson 2005 reference, which is not a full-size antibody study at all.

[00:21:52] Speaker 01:
It's a VIPN.

[00:21:54] Speaker 01:
But in any event, first of all, the board did address Peterson at 126 to 127.

[00:22:02] Speaker 01:
and said it was making findings in that section, but even setting that aside, what mattered is not what Peterson said.

[00:22:11] Speaker 01:
What matters is whether there were, in fact, different viewpoints that would have led a skilled artisan to conclude that the site and mechanism of action of CGRP

[00:22:20] Speaker 01:
monoclonal antibodies is unclear.

[00:22:22] Speaker 01:
And what I just said about the site and mechanism of action being unclear, the DOTIC reference that the board relied on at page 90, which is in the appendix at 22465, said exactly what I've just said in 2014.

[00:22:39] Speaker 01:
So if

[00:22:40] Speaker 01:
Even if you thought that the board's findings based on Levy and Fisher, which are both from 2005, were inadequate, it's quite clear from the post-priority date art that Peterson by no means settled the debate or was some kind of silver bullet with which no one could possibly disagree.

[00:22:56] Speaker 01:
There was a vigorous debate at and after the priority date about the blood-brain barrier, and that

[00:23:03] Speaker 01:
That finding is not necessary to the board's conclusion, but it is absolutely sufficient to sustain the board's conclusion.

[00:23:09] Speaker 01:
And that was not an issue at all in the composition of matter appeals.

[00:23:15] Speaker 03:
Do you agree with your opposing counsel that the aptamers were understood not to cross the blood-brain barrier as of 2005?

[00:23:24] Speaker 01:
So I think that

[00:23:28] Speaker 01:
I think that wasn't quite the question because the question was whether, for example, the blood-brain barrier might be compromised in a person with migraine, and so the question was not whether... Well, they need to cross the blood-brain barrier, in other words, was the question.

[00:23:50] Speaker 01:
Right.

[00:23:52] Speaker 01:
That's right.

[00:23:52] Speaker 01:
And that if they did, then would the size matter between a small molecule and an aptamer and a full-size antibody?

[00:24:00] Speaker 03:
But an aptamer is a large molecule compared to the BIBN, right?

[00:24:05] Speaker 03:
And at least in the same league with a full-size antibody?

[00:24:11] Speaker 01:
I'm not sure that it's in the same league as a full-size antibody.

[00:24:16] Speaker 01:
As I think we discussed in the first argument, the half-life of an aptamer is certainly longer than the small molecule drugs, but is significantly shorter than for an antibody.

[00:24:31] Speaker 01:
I don't have a reference about comparing them in size ready to hand, but I think that the analogy between aptamer and antibody is certainly not a perfect one.

[00:24:42] Speaker 01:
Ultimately, the question was for the board about whether the,

[00:24:47] Speaker 01:
analogy between the IPN or aptamers was one that would give an expectation of success to the skilled artisan.

[00:24:57] Speaker 01:
That's exactly the point that, as I mentioned in the first argument, the board refused to reach in the composition of matter appeal, IPRs, and when it got to it, in this case, it concluded at page 147 that the differences are too significant, the differences between, on the one hand, these other molecules studied in the prior art,

[00:25:16] Speaker 01:
and the full-length antibodies that are claimed in these, whose use is claimed in these patents.

[00:25:22] Speaker 01:
And that doesn't rest on a demand for data.

[00:25:25] Speaker 01:
It rests on a conclusion about the differences between the, you know, for example, Olson and claim 17.

[00:25:34] Speaker 01:
Olson certainly provided no data.

[00:25:35] Speaker 01:
The board made clear at footnote 75 of its decision that it understood that this court does not require data as an absolute matter.

[00:25:44] Speaker 01:
Any references to data on the pages that Mr. Raich brought up are simply pointing out the deficiencies in these references.

[00:25:52] Speaker 01:
It wasn't that these references had other teachings, but because they had no data, the board found them per se inadequate.

[00:25:59] Speaker 01:
The board found at 148, for example, that there was no evidence in the record that anyone had followed Tan's approach.

[00:26:06] Speaker 01:
That's not a request for data.

[00:26:08] Speaker 01:
It is pointing out that the record is violent on this point and that Lilly hadn't carried this part.

[00:26:18] Speaker 04:
Anything further, Mr. Jay?

[00:26:21] Speaker 01:
I don't think so, Your Honor.

[00:26:24] Speaker 01:
Unless the court has further questions, we're prepared to see that arcade.

[00:26:29] Speaker 04:
Thank you.

[00:26:30] Speaker 04:
Mr. Rich has a little rebuttal time.

[00:26:33] Speaker 00:
Thank you, Your Honor.

[00:26:35] Speaker 00:
So just very briefly on what the claims require and how it correlates to expectation of success.

[00:26:42] Speaker 00:
The preamble terms go to the treatment purpose rather than efficacy.

[00:26:48] Speaker 00:
That's a quote from Teva's red brief at page 32, that it goes to purpose rather than efficacy.

[00:26:55] Speaker 00:
And I spent some time in my opening remarks discussing the effective amount term and how that also just says that it may be functional.

[00:27:05] Speaker 00:
It doesn't require efficacy.

[00:27:08] Speaker 00:
And so when you put the preamble, which doesn't require efficacy,

[00:27:13] Speaker 00:
And an effective amount term together that doesn't require efficacy, you don't somehow get a claim that requires a clinical result or efficacy.

[00:27:22] Speaker 00:
You get a claim that is directed towards administering an antibody for the purpose recited in the preamble.

[00:27:29] Speaker 02:
Right, but the concept would be that a broad swath, I mean, if you read the specification, they're talking about the fact that a broad swath of people would receive that therapeutic effect.

[00:27:39] Speaker 02:
But we can't guarantee that every person will respond exactly the same way.

[00:27:45] Speaker 00:
Well, I mean, Your Honor, the term treatment is defined as an approach for obtaining beneficial or desired results.

[00:27:55] Speaker 00:
They could have written the claim differently.

[00:27:57] Speaker 00:
Many other patents are written differently, as you all know.

[00:28:00] Speaker 00:
They could have required treatment.

[00:28:02] Speaker 00:
they could have required that effective amount means a result, but that's not the way that the claims are written.

[00:28:08] Speaker 00:
And that perhaps makes sense because you have a data, a patent that has no clinical data in it or nothing involving administration to a human whatsoever.

[00:28:18] Speaker 00:
So again, as in other cases like ALKON and BMS and Capaxone, no clinical result should be required by the term effective amount.

[00:28:29] Speaker 00:
I also just want to emphasize the breadth of these claims.

[00:28:32] Speaker 00:
The claims are incredibly broad.

[00:28:34] Speaker 00:
They encompass doses as low as three micrograms per kilogram, which both parties' experts agree would not be clinically effective.

[00:28:42] Speaker 00:
And so the standard should be a reasonable expectation of success as to whether a person of skill in the art could make and administer the antibody for the purpose recited in the preamble.

[00:28:53] Speaker 00:
And respectfully, that is what was shown by the record.

[00:28:58] Speaker 00:
I'd like to turn then briefly to the discussion

[00:29:02] Speaker 04:
Please be brief, counsel.

[00:29:05] Speaker 04:
Your time has expired.

[00:29:07] Speaker 00:
All right.

[00:29:09] Speaker 00:
I will just say respectfully with respect to the blood brain barrier, ignoring Peterson 2005 was both a legal error because it's the most relevant study that was most recent in time.

[00:29:23] Speaker 00:
And moreover, it was a substantial evidence failure not to consider it.

[00:29:29] Speaker 00:
because it was the most relevant paper using the best available clinical results.

[00:29:34] Speaker 00:
So respectfully, Your Honors, we respectfully request that the board reverse the judgment of the board.

[00:29:43] Speaker 00:
Thank you.

[00:29:45] Speaker 04:
Thank you, Mr. H. We appreciate the arguments of both counsel and the cases submitted.

[00:29:52] Speaker 03:
The Honorable Court is adjourned until tomorrow morning at 10 a.m.