[00:00:00] Speaker 01:
Okay, now I'm good.

[00:00:09] Speaker 01:
Our next case is Yeta Research and Devonan Company versus Mylan Pharmaceuticals.

[00:00:35] Speaker 01:
So as I mentioned before, we'd like to hear from the parties on the SAS opinion, along the parameters that I spoke about in a general sense, also in how we should treat that opinion, but also how it applies specifically to this case.

[00:00:48] Speaker 03:
I'd be happy to do so, Your Honor, and I appreciate your raising it and giving us the opportunity.

[00:00:54] Speaker 01:
And this is Mr. Jay.

[00:00:57] Speaker 01:
No time right now.

[00:00:58] Speaker 01:
Don't take up a lot of time.

[00:01:00] Speaker 03:
I don't think it will take me very long, Your Honor.

[00:01:05] Speaker 03:
So I'll cover just a couple of points.

[00:01:08] Speaker 03:
And I think it really would be a question for Mr. Anstead because he represents the petitioner.

[00:01:14] Speaker 03:
But in this case, I think that the three salient points are, number one, in this case, the board invalidated all the claims.

[00:01:22] Speaker 03:
And the petitioner did not take a cross appeal.

[00:01:26] Speaker 03:
So the petitioner could not ask this court to set aside anything that the board had done without taking a cross appeal.

[00:01:33] Speaker 03:
SAS would not be a basis for affirming on an alternative ground because it would be taking up something that the board literally never did.

[00:01:42] Speaker 03:
Just to get the facts out on the table, in this case, the board invalidated all of the claims challenged the petition.

[00:01:48] Speaker 03:
It did not institute on two grounds that were raised in the petition, but it did address all of the claims.

[00:01:53] Speaker 03:
So if you look at pages one and four of the Supreme Court.

[00:01:55] Speaker 01:
And those two grounds were with respect to one prior reference?

[00:02:00] Speaker 03:
One was anticipation, one was obviousness.

[00:02:03] Speaker ?:
OK.

[00:02:03] Speaker 03:
But on a different combination.

[00:02:06] Speaker 03:
If you look at the question presented in the Supreme Court, if you look at page one of the slip opinion, and I believe at page four of the slip opinion, you'll see that the court is focusing primarily on section 318, which is about the requirement that a final written decision address every claim challenged by the petitioner.

[00:02:25] Speaker 03:
And that was done here.

[00:02:27] Speaker 03:
We understand that the Patent Office has now adopted a procedure whereby it will not do partial institution anymore, but we don't take that to be compelled by the Supreme Court's decision.

[00:02:37] Speaker 01:
It's certainly not compelled by anything in Section 318, and that would have nothing to do with... Is the institution, the partial institution you're talking about, does that...

[00:02:47] Speaker 01:
apply only to the claims or to the grounds above?

[00:02:52] Speaker 03:
My understanding, and again, this is just based on guidance that's just come out in recent days, and I don't pretend to have a thorough understanding of the board's reasoning for doing this.

[00:03:03] Speaker 03:
But my understanding is that the board is now going to institute not only on all claims, but on all grounds.

[00:03:09] Speaker 00:
But I thought the Supreme Court was reasonably clear that both grounds and claims were encompassed within the scope of their decision.

[00:03:17] Speaker 00:
So is that not so?

[00:03:19] Speaker 03:
I don't have a firm position on that, Judge Grayson.

[00:03:21] Speaker 00:
Well, but doesn't the Supreme Court have a firm position on that?

[00:03:25] Speaker 00:
I have the impression they did.

[00:03:26] Speaker 03:
So here are the things that I think the court would look at.

[00:03:29] Speaker 03:
So I think you would look at the statements on page one, where the court describes the question before as all of the claims or only some.

[00:03:37] Speaker 03:
I think you would look at page four, which says that the plain text of section 318 A supplies a ready answer.

[00:03:43] Speaker 03:
So those are the places that I, and of course the question presented,

[00:03:46] Speaker 03:
on which the court granted cert.

[00:03:48] Speaker 03:
Those are the things that I think would counsel in favor of looking at claim by claim.

[00:03:52] Speaker 03:
There certainly is language in the opinion that suggests that the court was also looking at the petition and whether the petition controls the subsequent conduct of the IPR.

[00:04:03] Speaker 03:
But because none of this, I think, has anything to do with how this court should dispose of this IPR appeal,

[00:04:09] Speaker 03:
You know, candidly, we don't have a position on behalf of our client in this case.

[00:04:13] Speaker 00:
So in a nutshell, your position is that SES has no effect on this case?

[00:04:18] Speaker 00:
That's correct.

[00:04:20] Speaker 03:
All right.

[00:04:20] Speaker 03:
No cross appeal, no possibility to affirm on alternative ground because of the additional work that it would require.

[00:04:27] Speaker 03:
Anticipation, of course, is a factual finding.

[00:04:29] Speaker 03:
So the court can't do the anticipation work itself and affirm on the alternative ground on a factual finding that the board never made.

[00:04:36] Speaker 03:
So I think that no cross appeal and no ability to affirm on alternative ground, that's enough to say that this is not the case in which to address the impact of SAS.

[00:04:43] Speaker 03:
I mean, if Mr. Anstead, of course, represents the petitioner, and if he wants to try and raise something, at this point, I'd be happy to reply to it.

[00:04:50] Speaker 03:
But I think that's my take.

[00:04:51] Speaker 01:
Mr. Anstead, can we hear from you, please?

[00:04:56] Speaker 04:
Thank you, Aaron.

[00:04:57] Speaker 04:
I think we do have a fundamental agreement that this is not the case in which to address SAS, because the board here instituted on every challenged claim in all three paths.

[00:05:08] Speaker 00:
But not all grounds.

[00:05:09] Speaker 00:
But not all grounds.

[00:05:10] Speaker 00:
Do you agree that?

[00:05:12] Speaker 00:
The court, do you believe that the court was reasonably clear in suggesting that it was grounds as well as claims?

[00:05:19] Speaker 04:
I think the key words there, Judge Bryson, are reasonably clear.

[00:05:22] Speaker 04:
Was the court reasonably clear?

[00:05:24] Speaker 04:
And I certainly, when I read SAS, I see how the court's reasoning could be read that way.

[00:05:29] Speaker 04:
They say, for instance, at page five of the slip opinion,

[00:05:34] Speaker 04:
In an inter-parties review, the petitioner is master of its complaint and normally entitled to judgment on all the claims it raises, not just the decision-maker, not those that the decision-maker just might wish to address.

[00:05:45] Speaker 04:
And if the petitioner is the master of its complaint, then you could certainly see how one might read this to suggest that it relates not only to the claims, but to grounds upon patentability.

[00:05:55] Speaker 02:
Is it your position that even if that is the correct reading,

[00:05:58] Speaker 02:
there's nothing else that needs to be done in this case under SAS?

[00:06:02] Speaker 04:
I think in this case that is true, Your Honor, because there was a full institution on all claims.

[00:06:09] Speaker 04:
The Supreme Court's decision clearly addresses claims.

[00:06:12] Speaker 02:
So just to make sure, if we think that perhaps the PTO should have instituted on all grounds, if we were to think that, is it your position that

[00:06:20] Speaker 02:
In this case, that's not necessary because you're not asking the PTO to do that.

[00:06:25] Speaker 02:
You're not raising that issue before this court.

[00:06:27] Speaker 04:
We are not raising that issue before this court.

[00:06:29] Speaker 04:
That's absolutely right, Judge Stoll.

[00:06:32] Speaker 04:
I think if for some reason there was a remand here to the PTAB, and we don't think there is any reason for a remand to the PTAB, but if there was, it would be up to the PTAB to decide whether those grounds should then come into the proceedings because, as Mr. Jay said, they have issued some guidance.

[00:06:48] Speaker 04:
that they are taking a, I think what they've characterized as a conservative approach.

[00:06:51] Speaker 04:
And from here on forward, they're going to institute on all claims and all grounds.

[00:06:56] Speaker 04:
But I think the PTAB's also said they don't think the Supreme Court's decision compels that.

[00:07:00] Speaker 04:
But because there's enough uncertainty about that, that's going to be their procedure.

[00:07:04] Speaker 04:
But again, I don't think it directly impacts this case.

[00:07:07] Speaker 01:
If that's the case, should we expect the parties should have preserved a right to appeal?

[00:07:13] Speaker 04:
I think because with respect to claims, with respect to claims, Your Honor, partial institution on claims, I mean, there certainly could be an argument that you should have maintained a conditional cross-appeal.

[00:07:24] Speaker 04:
But of course, that wasn't an issue in this case because the PTAB instituted on all claims across all three patents.

[00:07:30] Speaker 04:
So there was nothing for us to preserve that's dictated by SAS.

[00:07:36] Speaker 04:
OK.

[00:07:36] Speaker 01:
All right.

[00:07:37] Speaker 01:
We thank the party for the comments.

[00:07:39] Speaker 01:
This helps us in our sorting out SAS as well.

[00:07:43] Speaker 01:
So let's get to the case, Mr. Jay.

[00:07:46] Speaker 01:
And you're reserving four minutes of your time for rebuttal.

[00:07:49] Speaker 03:
That's correct.

[00:07:51] Speaker 03:
May I please the court?

[00:07:53] Speaker 03:
William Jay for YETA.

[00:07:55] Speaker 03:
There's obviously some substantive overlap with the prior appeal.

[00:07:58] Speaker 03:
But one, I think, important difference, and this has been brought up by some of the questioning already, is that this court is reviewing the PTAB in this case.

[00:08:06] Speaker 03:
And it can only review the PTAB, the agency decision, on the grounds given by the agency.

[00:08:10] Speaker 03:
I think a couple of Judge Bryson's questions bring out things on which the agency, for example, specifically declined to credit the other side's position.

[00:08:19] Speaker 03:
And it's just not permissible to try and backfill the holes in the agency's reasoning.

[00:08:25] Speaker 03:
In this case, we think the holes are really quite substantial.

[00:08:28] Speaker 03:
And I want to focus on three key deficiencies.

[00:08:30] Speaker 03:
And one has to do with the reasonable expectation of success with respect to three times a week.

[00:08:35] Speaker 03:
And the other two have to do with the board treating the uncertain operation of the drug

[00:08:40] Speaker 03:
as a reason to find obviousness as opposed to not obviousness.

[00:08:45] Speaker 03:
And third, the board's refusal to acknowledge the minimum effective dose principle.

[00:08:49] Speaker 03:
But I really want to begin with the reasonable expectation of success on three injections a week.

[00:08:54] Speaker 03:
As I think has come out during my friend Mr. Aucoin's rebuttal, but I think it's worth reiterating, three injections a week is not in the prior art.

[00:09:03] Speaker 03:
Never studied, not even taught in the prior art for any GA product.

[00:09:08] Speaker 03:
In fact, there is no testing in the prior art of anything less than every other day.

[00:09:17] Speaker 03:
And there's certainly no testing of the 40-milligram dose in anything less than daily.

[00:09:22] Speaker 03:
So the idea that there is a reasonable expectation of success for three injections a week, the board rested that on two things.

[00:09:31] Speaker 03:
One, CON 2009, which is impermissible for a whole host of reasons.

[00:09:35] Speaker 03:
Now, the board, con 2009 is not prior art.

[00:09:38] Speaker 03:
That is common ground.

[00:09:39] Speaker 00:
But the board seemed to have accepted that proposition.

[00:09:42] Speaker 00:
I think there was a loose citation at some point to, well, it was stuck in the string citation.

[00:09:49] Speaker 00:
But the board said on several occasions that it was treating it as not prior art.

[00:09:53] Speaker 00:
I think we have to take that at face value, don't we?

[00:09:56] Speaker 03:
I think it understood that it was not prior art, but I think, so I agree.

[00:09:59] Speaker 03:
that far, Judge Bryson, but I also think that if you look at that string citation and if you look at the board's other usage of Con 2009, the way that the board said it would use it in its ruling on the motion to strike just isn't consistent with how the board actually used it in its decision.

[00:10:16] Speaker 03:
And let me explain why that is.

[00:10:18] Speaker 03:
So first, you're right that in the string cited page 18, the board actually describes it as prior.

[00:10:25] Speaker 03:
You can call that a straight citation, but I think you should also look at what the board emphasizes on pages 15 and 21.

[00:10:32] Speaker 03:
The board underscores the fact that Con 2009 is twice weekly.

[00:10:37] Speaker 03:
That's the only thing that it cites, I would say, in the art, but of course it's not in the art.

[00:10:43] Speaker 03:
for the proposition that you can go to something less frequent than every other day.

[00:10:47] Speaker 03:
Now my friends this morning, and my friends in their briefs, and the board eight times in its decision, uses some variant of less than daily, or less frequent than daily, or less often than daily.

[00:10:57] Speaker 03:
But of course, that's not the choice.

[00:10:59] Speaker 03:
It's not daily or less often than daily.

[00:11:01] Speaker 03:
The claims are three injections a week.

[00:11:03] Speaker 03:
And the board used Con 2009 to suggest that you could go beyond every other day, because Con 2009 was twice a week.

[00:11:11] Speaker 03:
Now, that's impermissible because what the board said it would do is to look only at the fact that CON 2009 was initiated, that the study was initiated.

[00:11:19] Speaker 03:
If that were right, the board would not have gone into great detail about the findings of CON 2009, about the conclusions, about what it taught.

[00:11:27] Speaker 03:
There's a whole paragraph about that.

[00:11:29] Speaker 00:
And in addition to that... But do you agree that the board could legitimately consider

[00:11:36] Speaker 00:
the initiation of the Khan study is indicative of what a person of ordinary skill might regard as worthy of investigation, i.e.

[00:11:46] Speaker 00:
twice?

[00:11:47] Speaker 03:
No, for two reasons.

[00:11:48] Speaker 03:
I think that in a different case, that it might be permissible to look at a publication indicating that there was a study begun.

[00:11:57] Speaker 03:
But in this case, there is no publication before the priority date indicating that anybody knew that Khan had begun this study.

[00:12:03] Speaker 03:
So that's one reason.

[00:12:05] Speaker 03:
And the second reason is the

[00:12:06] Speaker 03:
really broad reasoning that the board applied in crediting Con 2009, which is saying that the mere fact of initiating this study showed not just a motivation to combine, but a reasonable expectation of success.

[00:12:22] Speaker 03:
Now, the Con 2009 is a small study.

[00:12:24] Speaker 03:
48 people, and it would be extremely broad to say that any time that anybody begins an investigational study, even a small study like that, that they must automatically have a reasonable expectation of success, and that anyone in the art would share that expectation.

[00:12:39] Speaker 03:
So there's no indication whatsoever that anyone in the art knew what Dr. Kahn was up to with that study, or that anyone would draw that conclusion.

[00:12:48] Speaker 03:
So I think that those are all reasons why the boards

[00:12:51] Speaker 03:
decision was impermissible.

[00:12:53] Speaker 03:
There's the further reason that while if there were something in the art to show that the study had begun in a PTAB proceeding, it would of course have to be a patent or printed publication.

[00:13:05] Speaker 03:
It couldn't just be an expert testimony that people knew about this.

[00:13:08] Speaker 00:
Well, the PTAB is not limited to printed publications.

[00:13:15] Speaker 00:
with respect to evidence that is available as opposed to prior art.

[00:13:20] Speaker 00:
So you're not suggesting, are you, that they couldn't consider that kind of evidence just as evidence of the state of the art and so forth?

[00:13:28] Speaker 00:
We've held on a number of occasions that various types of evidence are admissible, including expert's testimony.

[00:13:34] Speaker 03:
We're not disputing that.

[00:13:35] Speaker 03:
What we are pointing out and what you've never held, what the court has never held, is that you could look at something that's not in the art

[00:13:42] Speaker 03:
You can look at expert testimony that doesn't go to the art to establish reasonable expectation of success.

[00:13:48] Speaker 03:
So the scope of prior art is what informs whether a skilled artisan at the priority date would have had a reasonable expectation of success.

[00:13:56] Speaker 03:
And prior art, of course, in a board proceeding is limited to patents and printed publications.

[00:14:00] Speaker 03:
No, we're not saying no experts can ever testify before the board.

[00:14:03] Speaker 03:
But we are saying, in this case, what the board really did was to use this to fill a gap in the prior ARC.

[00:14:10] Speaker 02:
That is not using a- It doesn't seem to be what they're saying, like on Appendix Page 15.

[00:14:16] Speaker 02:
They seem to be talking about, the board is talking about con and not saying that it's relying on con to show reasonable expectation of success, but rather just probative of the fact that those skilled in the ARC were motivated to investigate dosing regimens with fewer injections.

[00:14:32] Speaker 03:
Well, I would point, Your Honor, to page 21, the last sentence on page A21, in which the board specifically says, because CON 2009 commenced its study, dot, dot, dot, dot, further convincing that an ordinary artisan would have had a reasonable expectation of success.

[00:14:48] Speaker 03:
It doesn't get more black and white than that, that it was relying on this non-prior art study for reasonable expectation of success, bottom of page A21.

[00:15:00] Speaker 03:
So we've dealt with one of the two things, COM 2009, on which the board, and we could stay on page A21 because this is where the reasoning is contained.

[00:15:10] Speaker 03:
We've dealt with one of the two things that the board cited, which is legally impermissible.

[00:15:13] Speaker 03:
And the other thing that the board cites for this three injections a week point is the idea that this is a forgiving drug, and there's a range of doses out there in the prior art.

[00:15:24] Speaker 03:
three injections a week is okay because the total quantity, 120 milligrams, falls within this range of doses.

[00:15:31] Speaker 03:
Now, I think it's important to note that even the other side's expert would not defend that proposition as far as it goes because if what matters is the total weekly dose, a concept that does not appear in the prior art for this drug anywhere, if it really were the total weekly dose, then two injections a week of 70 milligrams, one injection a week of 140 milligrams,

[00:15:53] Speaker 03:
would be exactly the same for reasonable expectation of success purposes.

[00:15:57] Speaker 03:
And at page 11180, their expert declined to say that there would be reasonable expectation of success.

[00:16:05] Speaker 03:
And why not?

[00:16:06] Speaker 03:
Because of the gap.

[00:16:07] Speaker 03:
Because of the gap between injections.

[00:16:09] Speaker 03:
The 72-hour gap between injections is exactly what's missing from the prior art and what the board fails to muster any defense of, other than Con 2009, with its twice weekly.

[00:16:21] Speaker 03:
But it certainly fails to establish why a skilled artisan would believe that three injections a week with this 72-hour gap would succeed.

[00:16:33] Speaker 03:
They have this discussion about whether glaterum or acetate is a forgiving drug, but that's based on one thing and one thing only.

[00:16:39] Speaker 03:
It's based on the dosing of the daily 20 milligram product.

[00:16:43] Speaker 03:
And the dosing instructions say, if you miss a dose, you forget to take a dose of your 20 milligram product daily.

[00:16:50] Speaker 03:
Don't take a second dose.

[00:16:53] Speaker 03:
In other words, don't take 40 milligrams.

[00:16:55] Speaker 03:
Skip it and go on to the next day.

[00:16:57] Speaker 03:
Take your next regularly scheduled dose.

[00:16:59] Speaker 03:
That is far from licensed to go as far as 72 hours.

[00:17:04] Speaker 03:
And it, of course, has nothing to say about the 40 milligram quantity

[00:17:08] Speaker 03:
as a dose.

[00:17:09] Speaker 03:
That's what Forte studied, but the board isn't driving this reasonable expectation of success from anything in Forte, because Forte, of course, is a daily study.

[00:17:18] Speaker 03:
It studies the 40-milligram quantity, but there are no clinical trials of 40-milligrams of anything less than daily.

[00:17:24] Speaker 03:
All there is is Claim 3 of Pinchasi, and that is not supported by any data at all.

[00:17:29] Speaker 03:
So reasonable expectation of success, we think, is a major failing of the board's decision.

[00:17:35] Speaker 03:
I want to talk briefly about its failure to address the minimum effective dose principle and the aspects of this drug that make it very difficult to predict the cyclopensiprine argument that the court has already spent some time on.

[00:17:47] Speaker 03:
The board could perhaps have said some of the things that were brought out in the questioning, but it simply didn't address cyclopensiprine at all.

[00:17:54] Speaker 03:
It also didn't address the minimum effective dose principle, even though the other side's expert, Dr. Peruca, agreed specifically that higher doses may be used if they lead to increased efficacy with acceptable side effects.

[00:18:09] Speaker 03:
That's at 6460.

[00:18:10] Speaker 03:
That's the other side's expert.

[00:18:12] Speaker 02:
And what's your view on whether the board has to address each and every argument that is raised?

[00:18:18] Speaker 02:
And we have cases that have said that they need to raise the primary arguments.

[00:18:22] Speaker 02:
Do you think M-ray cyclobenzepine was your primary argument?

[00:18:28] Speaker 02:
Or a primary argument?

[00:18:30] Speaker 03:
I think it's fair to call it a primary argument because regardless of how many times that case is cited, there's I think a nine-page range in our papers in which we address this principle and its application to this drug, why this drug was not well understood, its mechanism of action was unknown, and why you couldn't simply extrapolate, well, if 20 daily is OK, then 40 every other day must be OK.

[00:18:52] Speaker 03:
much less 43 times a week, that this is not the kind of drug from which you could do that kind of back of the envelope extrapolating.

[00:19:00] Speaker 03:
What you would need are studies.

[00:19:02] Speaker 03:
That certainly is an argument that we made to the board.

[00:19:05] Speaker 03:
We don't think that the board has adequately addressed it.

[00:19:07] Speaker 03:
The same thing with the minimum effective dose.

[00:19:09] Speaker 03:
Another thing that this court's case is whole is that the board has to give some reason for disagreeing with something that is common ground between the parties.

[00:19:17] Speaker 03:
And in this case, the quote that I've just given you from Dr. Carucca agrees that the minimum effective dose is what a skilled artisan would prefer, absent evidence in the art, that there's increased efficacy.

[00:19:31] Speaker 03:
And it's exactly what Forte taught, that there is no increased efficacy with the 40-milligram dose.

[00:19:36] Speaker 03:
I see that I'm into my rebuttal time.

[00:19:38] Speaker 03:
I'll support his further questions at this time.

[00:19:41] Speaker 00:
Well, just briefly, there was increased efficacy to the extent that, as we discussed with Mr. O'Quinn,

[00:19:48] Speaker 00:
there was more rapid onset, at least for the daily, at 40.

[00:19:52] Speaker 03:
I'm very glad you brought that up, Judge Bryson, because that and the monkey studies, the two questions that you asked during the first argument, are two excellent examples of things that the board absolutely did not credit, right?

[00:20:03] Speaker 03:
Footnote 12.

[00:20:04] Speaker 00:
I understand they decided not to rely on the monkeys, but what is it that they, where did they say that they weren't relying on the early onset?

[00:20:15] Speaker 03:
All they say about 40, they don't even mention it.

[00:20:18] Speaker 00:
I didn't think so.

[00:20:19] Speaker 00:
But they don't disclaim reliance on it.

[00:20:22] Speaker 03:
OK.

[00:20:22] Speaker 03:
But the reason that they give in discussing forte is only this, that forte does not teach away, does not discredit or discourage the use of the 40-milligram dose.

[00:20:34] Speaker 03:
There's nothing in the board's opinion making any findings suggesting that the forte has any advantage.

[00:20:39] Speaker 03:
Thank you.

[00:20:46] Speaker 04:
May it please the court, David Anstead,

[00:20:48] Speaker 04:
Perkins Cooey, I represent Milan, and will be arguing on behalf of all petitioners below.

[00:20:52] Speaker 04:
And before I lay out my plan for the argument, I want to address this question that you just asked Judge Bryson, because I think my friend misspoke when he said that the board did not, in any of their opinions, refer to what you have referred to, which is the finding that the 40-milligram dose does have an advantage, which is an earlier onset of action.

[00:21:11] Speaker 04:
And if you look at appendix page 12, that's the board's decision in the 250 IPR.

[00:21:18] Speaker 04:
And there's a comparable page in the board's decisions in each of the other ones.

[00:21:22] Speaker 04:
You'll see there's a block quote from Pinchazi in which the board says, indeed, Pinchazi concludes.

[00:21:30] Speaker 04:
And then it first talks about the increased efficacy observed with 40 milligrams GA in reducing MRI-measured activity and relapse rate in RMS patients.

[00:21:41] Speaker 04:
But then it goes on in the second paragraph in that block quote to say,

[00:21:46] Speaker 04:
Also observed was the accelerated rate at which the 40-milligram day dose became effective as compared to the 20-milligram day dose.

[00:21:53] Speaker 04:
This was unexpected.

[00:21:54] Speaker 04:
Specifically, the 40-milligram day dose showed efficacy as measured by MRI by the third month, whereas the 20-milligram day dose did not show efficacy until the sixth month.

[00:22:06] Speaker 04:
And so the court did make that finding.

[00:22:08] Speaker 00:
OK.

[00:22:08] Speaker 00:
But is there anything to indicate that

[00:22:14] Speaker 00:
the more rapid onset of action would translate not just to 40 per day, but to 40 per every other day or even a less frequent administration.

[00:22:25] Speaker 04:
I don't think that there is a specific factual finding that the board made on that point aside from what... Is there any evidence to support that proposition?

[00:22:35] Speaker 04:
I think there would be some evidence, which is that the 40 milligram day dose does have this effect.

[00:22:41] Speaker 00:
It does, but

[00:22:42] Speaker 00:
But the question, and this came up in the first argument, is the question would be whether simply giving the 40 milligrams every other day is the equivalent of 20 milligrams for purposes of the early onset of action.

[00:22:56] Speaker 04:
For purposes of the early onset.

[00:22:57] Speaker 00:
Why isn't that at least as plausible a proposition as that the 40 milligrams every other day

[00:23:03] Speaker 00:
has the same effect for early onset as 40 milligrams every day.

[00:23:07] Speaker 04:
I think there is a question about that.

[00:23:10] Speaker 04:
But that was a factual finding that the board made.

[00:23:13] Speaker 04:
But I think that the broader point here is that the Forte trial, which was the large clinical trial that compared the 40 milligram and 20 milligram daily dose on a head-to-head basis, found at a minimum, if nothing else, that the 40 milligram daily dose was at least as effective as the 20 milligram daily dose.

[00:23:31] Speaker 04:
And then you have the studies in the prior art that show that 20-milligram every other day dosing are equally effective as 20-milligram daily dosing.

[00:23:42] Speaker 04:
And one of the findings that the board makes at appendix 20 is that would have given you, and I think this goes to a question the US Judge told, that that would have given the person of ordinary skill in the art a reasonable expectation that 40-milligrams every other day would be efficacious in treating relapsing remitting multiple sclerosis.

[00:24:00] Speaker 04:
And that's a key issue because Pinchazi, as you have noted, is very close prior art.

[00:24:07] Speaker 04:
It discloses and claims 40 milligrams every other day dosing.

[00:24:10] Speaker 04:
That's a difference of a single dose once every two weeks.

[00:24:15] Speaker 04:
So it's very close prior art.

[00:24:16] Speaker 04:
And what the board found was, yes, there's no human clinical trial where 40 milligrams every other day was administered to patients.

[00:24:24] Speaker 04:
But what you do have is the finding from Fortid that 40 milligrams and 20 milligrams are at least equally effective.

[00:24:30] Speaker 04:
And you have multiple studies in the prior art showing that 20 milligrams every other day and 20 milligrams daily are equally, at least equally effective, but better tolerated.

[00:24:39] Speaker 04:
And that is evidence that would lead a skilled artisan to reasonably expect that Pinchazi's 40 milligram every other day dosing regimen would be efficacious.

[00:24:48] Speaker 04:
And then the question becomes,

[00:24:50] Speaker 04:
Well, what do you do next?

[00:24:52] Speaker 04:
What is the skilled artisan interested in next?

[00:24:55] Speaker 04:
And from that 40 milligram every other day dosing regimen, it's a very small step to the claimed regimen here of 40 milligrams three times a week.

[00:25:04] Speaker 00:
But it's a small step.

[00:25:05] Speaker 00:
But isn't it a small step into the dark?

[00:25:08] Speaker 04:
It's not a small step into the dark.

[00:25:09] Speaker 04:
And let me address that in two ways.

[00:25:13] Speaker 04:
One is there was motivation to go to that dosing regimen.

[00:25:19] Speaker 00:
And I don't think the convenience factor, the patients want to do Monday, Wednesday, Friday convenience and also compliance, which is a compliance.

[00:25:25] Speaker 00:
It's what I meant by convenience.

[00:25:27] Speaker 00:
Correct.

[00:25:28] Speaker 04:
But you, I think what you may be raising is the notion of this 72 hour gap.

[00:25:32] Speaker 04:
Yeah, of course.

[00:25:33] Speaker 04:
And so let's, let's put that in perspective in a, in a, in the claim dosing regimen, two thirds of the doses are separated by 48 hours.

[00:25:43] Speaker 04:
And then you have a single 72-hour gap.

[00:25:47] Speaker 04:
So those two-thirds of doses in the claimed regimen, separated by a 48-hour gap, there is abundant evidence in the prior art that that does not sacrifice efficacy.

[00:25:58] Speaker 00:
But is there anything in the prior art or in the evidence in the case that tells us anything about a 72-hour gap, except for the monkeys?

[00:26:09] Speaker 04:
I think there is, which is, first of all, you had the testimony from Dr. Green that glutarum or acetate is a forgiving drug.

[00:26:17] Speaker 04:
Remember, this is a drug that is dosed not in the clinic.

[00:26:19] Speaker 04:
Patients don't go into the clinic to take injections of glutarum or acetate.

[00:26:23] Speaker 04:
They dose it at home.

[00:26:24] Speaker 04:
They self-administer it.

[00:26:25] Speaker 04:
And he testified that with drugs like that, you have to have forgiveness because you know patients are going to miss doses.

[00:26:32] Speaker 04:
They're not going to comply with the regimen.

[00:26:34] Speaker 04:
And that was particularly true for glutarum or acetate because

[00:26:38] Speaker 04:
The regimen was daily painful injections in a lifelong disease like MS.

[00:26:43] Speaker 04:
So we know patients are not compliant, and in those situations, you have to have a forgiving drug.

[00:26:49] Speaker 04:
There was evidence that patients were instructed, prior instructions to patients, if you forget to take a dose, don't try to double up the dose, just skip it, and then resume with your regular eight

[00:27:02] Speaker 04:
scheduled dose.

[00:27:03] Speaker 00:
Were there any of those dealt with every other day or was it exclusively with respect to the daily treatment?

[00:27:09] Speaker 04:
Those were instructions with respect to the with a daily drug.

[00:27:12] Speaker 00:
So you're only skipping one day presumably?

[00:27:15] Speaker 04:
Presumably although I think there's evidence that certainly patients are not a hundred percent compliant with this even with missing just a single dose.

[00:27:22] Speaker 04:
But the other evidence Judge Bryson that I think is important again is

[00:27:26] Speaker 04:
that was a factual finding below that the board credited and is supported by substantial evidence is this known range of doses in the prior ARC.

[00:27:36] Speaker 04:
And so you had a range that went from on the low end 70 milligrams per week, that is the 20 milligram every other day dosing regimen, averages 70 milligrams per week, all the way up to 280 milligrams per week, and that would be the 40 milligram daily dose that was studied in Forte.

[00:27:56] Speaker 04:
And in between those two ranges, you had the 140 milligram weekly dose, which is the approved regimen of 20 milligrams seven times a week.

[00:28:08] Speaker 04:
And you have the claimed regimen, which is 140 milligrams every week.

[00:28:14] Speaker 04:
And Dr. Green testified that that range, that known range in the prior art,

[00:28:19] Speaker 04:
would give you abundant comfort that 120 milligrams dose over the course of the week would maintain efficacy.

[00:28:27] Speaker 04:
And of course, you would get the tolerability advantages.

[00:28:29] Speaker 04:
After all, that 120 milligram weekly dose was extremely close to the FDA approved regimen of 140 milligrams dose over the week.

[00:28:40] Speaker 04:
And that was testimony that Dr. Green's factual testimony that the board credited and is supported by substantial evidence.

[00:28:48] Speaker 04:
And let's weigh that against what they heard from Dr. Ziemson, who was Teva's expert.

[00:28:55] Speaker 04:
Dr. Ziemson testified, you know, there's some notion that we don't know how this drug works.

[00:29:00] Speaker 04:
It's black box.

[00:29:02] Speaker 04:
That wasn't exactly the story that Teva told the board below.

[00:29:05] Speaker 04:
Teva told the board that, in fact, we do know a fair amount about how this drug works and its mechanism of action.

[00:29:11] Speaker 04:
And based on that, skilled artisans would have expected that you have to dose this drug on a daily basis

[00:29:18] Speaker 04:
And their expert went so far as to say, in fact, based on what you knew about mechanism of action, you would think that the best way to get efficacy is to dose this drug twice a day.

[00:29:28] Speaker 04:
And quite frankly, that was credibility destroying for their expert.

[00:29:31] Speaker 04:
Because as the board found, there are no studies of twice a day injection.

[00:29:37] Speaker 04:
And there are abundant studies of less frequent dosing in the prior art.

[00:29:42] Speaker 04:
And their expert's position was,

[00:29:44] Speaker 04:
That wouldn't work, and skilled artisans knew it, and they knew it based on the mechanism of action.

[00:29:48] Speaker 04:
And the board didn't credit that testimony with good reason, and those findings were supported by substantial evidence.

[00:29:54] Speaker 00:
You mentioned the increased tolerability of the alternate day treatment.

[00:30:01] Speaker 00:
But that seems to me, at least potentially, does not square with the evidence in Flectors, Table 5.

[00:30:10] Speaker 00:
Have you looked at those numbers carefully?

[00:30:12] Speaker 04:
I have.

[00:30:14] Speaker 00:
I was looking at those numbers and they, frankly, look odd to me.

[00:30:20] Speaker 04:
I looked at them carefully and I can walk you through chapter and verse.

[00:30:23] Speaker 00:
Well, give me maybe the short version of the chapter and verse, preferably just the verse.

[00:30:33] Speaker 04:
So I think that the thing that you should take great comfort from is what you pointed out yourself, Judge Bryson, which was that there is no evidence.

[00:30:40] Speaker 04:
I mean, the difference that Teva points to is 11.8% termination rate

[00:30:48] Speaker 04:
in the every other day arm.

[00:30:51] Speaker 04:
And then they're doing this cross-study comparison minor, where there's an 8.9% difference.

[00:30:56] Speaker 04:
And there was no finding that that was statistically significantly different, as you pointed out.

[00:31:01] Speaker 04:
And in fact, this is getting into the big granular, but they even do the math wrong, Teva does, because one of those patients who dropped out was determined to have dropped out for reasons totally unrelated to the drug.

[00:31:13] Speaker 04:
So the actual percentage is not 11.8.

[00:31:14] Speaker 04:
It's more, it's 10%.

[00:31:17] Speaker 04:
But the point is, Judge Bryson, there is no evidence that there was a statistically significant difference based on that.

[00:31:23] Speaker 04:
But what we do have in Fletcher and what I think you should take great comfort from was his finding in text that the only statistically significant difference

[00:31:32] Speaker 04:
With the dropouts.

[00:31:34] Speaker 04:
With the dropouts, with the dropouts.

[00:31:35] Speaker 04:
In the dropouts... At the .001 level, I think, right?

[00:31:39] Speaker 04:
That is precisely right.

[00:31:40] Speaker 04:
And the dropouts were far less in the every other day dosing group, which is a clear indication that every other day dosing is tolerable, but there's more evidence in the prior art that every other day dosing is more tolerable.

[00:31:52] Speaker 04:
The KON 2009 study, not to be confused with KON 2009, KON 2009, undisputed with prior art, that was a rigorous head-to-head clinical trial

[00:32:01] Speaker 04:
radar-blinded, randomized between 20 milligrams every other day and 20 milligrams daily.

[00:32:08] Speaker 04:
And the finding in that study was that the patients in the every other day group had significantly less lipoatrophy than the patients in the daily group.

[00:32:16] Speaker 04:
And of course, lipoatrophy, as you heard this morning, is a particularly severe and disfiguring injection site reaction.

[00:32:22] Speaker 04:
And the prior art shows that when you decrease the frequency of dosing, you get increased tolerability.

[00:32:28] Speaker 04:
And KO2009 is an excellent example of that.

[00:32:31] Speaker 04:
So hopefully that wasn't too much detail on table five.

[00:32:36] Speaker 04:
In the time I've left, I do want to, there were some questions about cyclobenzeprine.

[00:32:40] Speaker 04:
And I would like to address that briefly.

[00:32:42] Speaker 04:
Judge Raina, I think you made an absolutely critical point.

[00:32:45] Speaker 04:
The infringers' obviousness theory in cyclobenzeprine was based entirely on bioequivalence.

[00:32:52] Speaker 04:
There was no bioequivalence theory of obviousness in this case.

[00:32:56] Speaker 04:
The claim language in cyclobenzeprine was a therapeutically effective plasma concentration.

[00:33:01] Speaker 04:
Plasmid concentration is PK data.

[00:33:04] Speaker 04:
So it was baked into the claims.

[00:33:06] Speaker 04:
Therapeutically effective is PD, what the drug does to the body.

[00:33:10] Speaker 04:
And what the court found in Cyclobenzprime was that the district court judge had made a mistake and assumed that there was a known PK PD relationship for an immediate release formulation of a drug.

[00:33:23] Speaker 04:
And you could just extrapolate from that to the extended release formulation.

[00:33:26] Speaker 04:
But that was a mistake.

[00:33:27] Speaker 04:
There was no known PKPD relationship in cyclobenzeprine.

[00:33:31] Speaker 04:
And therefore, the whole basis for the obviousness finding there, because that's another thing that the court points out, is that the obviousness theory was based entirely on bioequivalence.

[00:33:42] Speaker 04:
The district judge's mistake in assuming something that wasn't true about PKPD meant that the obviousness analysis was faulty.

[00:33:50] Speaker 04:
There are a huge number of differences in this case as compared to cyclobenzeprine.

[00:33:56] Speaker 04:
Again, no bio-globalist theory here.

[00:33:59] Speaker 04:
Instead, the obviousness theory was based on the extensive clinical, human clinical trials of GA at different doses and different dosing frequencies.

[00:34:06] Speaker 04:
Another important point was that the court in psycho-benzocrine found that the objective indicia of obviousness weighed heavily in favor of a finding of non-obviousness.

[00:34:16] Speaker 04:
Here, they put on evidence of secondary considerations, commercial success, unexpected results, long-fell

[00:34:23] Speaker 04:
they lost across the board in front of the PTAB on those issues and they haven't appealed them.

[00:34:28] Speaker 02:
Can you address, I want to make sure that you take time to address CON 2009 as it's discussed on page 21 of the board's opinion?

[00:34:36] Speaker 04:
Yeah, I can do that, certainly Your Honor.

[00:34:40] Speaker 04:
I think I could

[00:34:43] Speaker 04:
I could address it in each instance.

[00:34:44] Speaker 04:
It's referenced essentially three times in the board opinion.

[00:34:47] Speaker 02:
The one that seems perhaps troubling is on page 21.

[00:34:50] Speaker 04:
That's the one I'd like you to address.

[00:34:52] Speaker 04:
Exactly.

[00:34:52] Speaker 04:
So in appendix 21, the board referenced con 2009 in a single sentence at the end of a multi-page discussion of reasonable evidence of success.

[00:35:01] Speaker 04:
And it did so after finding first that there were extensive data.

[00:35:05] Speaker 04:
Again, I talked about this earlier, that 40 milligrams and 20 milligrams daily were at least equally efficacious.

[00:35:11] Speaker 04:
extensive data showing that you didn't need to dose this drug daily, and that 40 milligrams was a logical choice to use in the three times weekly regimen because of what I talked about earlier, which is this range of non-effective doses in the prior arc.

[00:35:24] Speaker 04:
So those were the three, those were three totally independent bases from Con 2009.

[00:35:30] Speaker 02:
Is it your position that because it's at the end of a long discussion in which there's many other reasons provided,

[00:35:36] Speaker 02:
that it's a harmless error, if anything, to add it in and also seek on?

[00:35:42] Speaker 04:
I have two positions.

[00:35:42] Speaker 04:
First of all, I don't think the board used it to fill a gap in the prior, to fill a void in the prior.

[00:35:47] Speaker 04:
I just absolutely dispute that they did that.

[00:35:49] Speaker 04:
But that would be the second level point, absolutely.

[00:35:51] Speaker 04:
It would be harmless because the board found many reasons.

[00:35:55] Speaker 00:
But do you regard this language as indicative of an improper use?

[00:36:02] Speaker 00:
I do not.

[00:36:03] Speaker 00:
What is the difference between an improper use and a proper use, in your view, with respect to the take that the board had on 2009 CON?

[00:36:11] Speaker 04:
Yeah, CON 2009, what the board said was, this was a publication that appeared three weeks after the priority date, but it reported on a study that had begun two years before, in 2007.

[00:36:22] Speaker 04:
Go ahead.

[00:36:25] Speaker 04:
And all the board was saying that this was further evidence, in addition to all the other evidence that had found a reasonable expectation of success,

[00:36:32] Speaker 04:
that skilled artisans would be motivated to look at less frequent dosing regimen.

[00:36:37] Speaker 04:
It never said that skilled artisans would be motivated to look at a twice a week regimen.

[00:36:40] Speaker 04:
It never said that it would.

[00:36:41] Speaker 04:
And here's an important point I don't want to lose is this case is very much like this court's decision in Genzyme.

[00:36:49] Speaker 04:
In Genzyme, there was an argument that

[00:36:52] Speaker 04:
of reference had been brought up in reply, and that the board had used it to satisfy key claim limitations.

[00:37:02] Speaker 04:
And the board said, no, it didn't do that.

[00:37:04] Speaker 04:
The patents were found obvious based on the grounds of unpatentability.

[00:37:09] Speaker 04:
And the board did not use this reply declaration to fill a void in the prior art.

[00:37:15] Speaker 04:
And that's exactly the case here.

[00:37:17] Speaker 00:
This information about the scope of the study was not, I take it, public until the study was published.

[00:37:22] Speaker 00:
Is that true?

[00:37:24] Speaker 04:
I think it would have been public in the sense that obviously Dr. Khan would have known about it, the patients would have known about it, who were participating in the series.

[00:37:30] Speaker 00:
But Dr. Khan at that point was not working for Teva anyway.

[00:37:34] Speaker 04:
No, he was not at that point.

[00:37:34] Speaker 00:
He later, I gather.

[00:37:35] Speaker 04:
He later, after Dr. Khan, had published a whole lot of prior art showing that less frequent dosing is tolerable and effective, then Teva went and hired him.

[00:37:44] Speaker 04:
That is true.

[00:37:44] Speaker 04:
And so I think, again, the due process challenge, I think Genzyme, the sports decision in Genzyme and Belden are directly on point.

[00:37:52] Speaker 04:
They had multiple opportunities to address Con 2009, some of which they took, some of which they didn't for reasons of their own.

[00:37:59] Speaker 04:
And so the notion that there's the statutory argument that my friend Mr. Jay talked about, they also have a brief due process argument.

[00:38:05] Speaker 04:
I think that process argument has no likes either.

[00:38:07] Speaker 00:
But just to hone in on the point that Mr. Jay raised,

[00:38:11] Speaker 00:
Is there any significance in your view to the fact that the fact of the study was, never mind the results, was not public at the time of the priority date?

[00:38:21] Speaker 04:
I don't think so.

[00:38:22] Speaker 04:
And I think a good example for you, Judge Bryson, is this court's decision in syntax.

[00:38:26] Speaker 04:
And that was a case in which there was a post-priority date publication.

[00:38:32] Speaker 04:
It was published five days after the priority date.

[00:38:35] Speaker 04:
And the position had been that a particular drug had not been used in pharmaceuticals, or had not been used in pharmaceuticals before the priority date.

[00:38:45] Speaker 04:
There was a post-priority date publication, as I say, five days later, that said that the use of that pharmaceutical composition was well-known in compositions.

[00:38:56] Speaker 04:
And this court said that it was incredulous

[00:39:01] Speaker 04:
First of all, let me say the patent owner said that because it came five days after the priority date, it was worthless.

[00:39:06] Speaker 04:
And this court said it was incredulous, incredulous.

[00:39:08] Speaker 04:
That's this court's word that a pharmaceutical composition could go from unknown in the prior art to well-known in the span of five days.

[00:39:15] Speaker 04:
And it said it was perfectly appropriate to rely on that post-priority date publication to that point.

[00:39:20] Speaker 00:
But you're not saying, in fact, that's just one more question.

[00:39:22] Speaker 00:
You're not saying, are you, that you can consider the inventor's course of study

[00:39:29] Speaker 00:
to show that persons of skill in the art would have been interested in studying what the inventor was studying.

[00:39:36] Speaker 04:
Absolutely not.

[00:39:37] Speaker 00:
What's the difference between that and what's going on in Khan?

[00:39:40] Speaker 04:
Well, Khan was not the inventor.

[00:39:42] Speaker 00:
I understand that, but it's one step away.

[00:39:44] Speaker 00:
But what's the difference fundamentally?

[00:39:47] Speaker 04:
What Khan 2009, Your Honor, is, respectfully, is merely additional evidence on top of other abundant evidence

[00:39:53] Speaker 04:
That counteracted.

[00:39:54] Speaker 04:
Remember, this came into the proceedings in reply because their expert had said skilled artisans were not interested in less than daily dosing because, according to their mechanism of action theory, you had to dose it daily.

[00:40:07] Speaker 04:
The board just said this is additional evidence to all the other priori studies that, in fact, skilled artisans were interested.

[00:40:16] Speaker 01:
OK.

[00:40:16] Speaker 01:
Thank you.

[00:40:17] Speaker 01:
OK.

[00:40:17] Speaker 01:
Thank you.

[00:40:18] Speaker 01:
Mr. Jay, we're going to put you back in four minutes, OK?

[00:40:23] Speaker 03:
Thank you very much, Katrina.

[00:40:24] Speaker 03:
I appreciate that.

[00:40:25] Speaker 03:
Let me begin, right, with Con 2009, as Judge Bryson asked.

[00:40:29] Speaker 03:
What was this known to the public?

[00:40:32] Speaker 03:
And the test that the board applies for printed publication that it can look at is at page A640, which from the institution decision, looking at something else.

[00:40:41] Speaker 03:
Is it sufficiently accessible to the public?

[00:40:43] Speaker 03:
This was not.

[00:40:43] Speaker 03:
We asked Dr. Green that at his deposition.

[00:40:46] Speaker 03:
Page A11177 through 78, we asked, could he identify

[00:40:52] Speaker 03:
anything in the prior art, anything in the printed record indicating that skilled artisans were aware that Dr. Khan had started this study, and he couldn't come up with anything.

[00:41:00] Speaker 03:
I think the difference between this case and syntax is right in what my friend Mr. Anstead said.

[00:41:05] Speaker 03:
Syntax said right after the priority date that a particular proposition was well known.

[00:41:11] Speaker 03:
This is very different.

[00:41:12] Speaker 03:
This is a study that comes out after the priority date and is asking, it is reading it to indicate

[00:41:20] Speaker 03:
not only that everybody knew that the study had been commenced with at any basis, but also that anybody who knew that the study had been commenced would have inferred that there was a reasonable expectation that the study would succeed, as I said in the opening argument, extremely broad and not supported by any of this course cases, certainly not by syntax.

[00:41:38] Speaker 03:
I want to talk a bit about forgiving drug.

[00:41:41] Speaker 03:
The concept of it being a forgiving drug is not in the prior art.

[00:41:45] Speaker 03:
That's just Dr. Green's characterization of the

[00:41:49] Speaker 03:
dosing regimen, all you will see in the dosing regimen is that for the 24, when you're taking it every 24 hours.

[00:41:55] Speaker 02:
Wasn't Dr. Green's testimony, that can be relied on.

[00:41:58] Speaker 02:
He was a person of ordinary skill.

[00:42:00] Speaker 02:
There was no objection to him as being an expert.

[00:42:03] Speaker 03:
We're not, but I think you have to look at the stated basis for the opinion that he's giving.

[00:42:11] Speaker 03:
He's not referring to some accepted concept of it being a forgiving drug.

[00:42:18] Speaker 03:
Expressly, his characterization of the dosing instructions for 20-milligram Copaxone.

[00:42:22] Speaker 03:
And then, of course, the board goes on to look, in addition, at the dosing instructions for the patented invention that's said in its

[00:42:29] Speaker 03:
motion to strike decision that it wasn't, although it had referred to it several times in its decision that it wasn't actually relying on it.

[00:42:37] Speaker 03:
But there's a big difference, really my point is, there's a big difference between dosing instructions that say when you're taking 20 milligrams every day, you may sometimes, if you forget, skip a dose.

[00:42:48] Speaker 03:
That's quite different from saying skip two days every single week and while also skipping a day

[00:42:56] Speaker 03:
every time you take an injection, because you're now going to 40 milligrams with a gap in between.

[00:43:01] Speaker 03:
To say that that is taught by the skip a dose occasionally instructions is just over reading the prior art.

[00:43:10] Speaker 03:
On just a word about pinkazi, Cohen.

[00:43:14] Speaker 01:
But whether you can skip one dose or several, it was clear that there was evidence that you could skip doses and not sacrifice the efficacy of the drug.

[00:43:23] Speaker 03:
I know you're on it does not say anything about not scared not sacrificing the efficacy it really is this is advice to the patient what happens if you forget you know perhaps you're referring to a different piece of the art but if what we're talking about is what Dr. Green was cited that is the dosing instructions and it does not say there are no consequences it says that if

[00:43:44] Speaker 03:
You're faced with a choice when your patient has forgotten to take an injection.

[00:43:48] Speaker 03:
You can supplement it by taking a second injection, or you can skip that dose and take your next regularly scheduled injection.

[00:43:55] Speaker 03:
And faced with those choices, the FDA-approved instruction to the patient is to go with your regularly scheduled one.

[00:44:01] Speaker 03:
But that's really quite far from saying that there is no sacrifice in efficacy in skipping one day, and that it would be even farther to say that there's no sacrifice in efficacy from skipping 72 hours every single week.

[00:44:12] Speaker 03:
I mean, that, as Judge Bryson said, and talking to my friend, Mr. Anstead, that really is the leap into the dark.

[00:44:17] Speaker 03:
And what the board didn't... I accept the correction with my apologies.

[00:44:28] Speaker 03:
Leap or step, it definitely was into the dark.

[00:44:30] Speaker 03:
And I think you can see at pages 15, 18, and 21, just how the board tried to use CON2009 to shine a little light into that darkness.

[00:44:39] Speaker 03:
Because you see, it's underscoring, it's italicizing, twice a week dosing.

[00:44:43] Speaker 03:
The only thing that the board has before it, not properly before it, but before it, that had anything to say about less than every other day, three times a week, that was in the dark.

[00:44:56] Speaker 03:
There's nothing in the prior art department.

[00:44:58] Speaker 03:
Most of the court has further questions.

[00:45:00] Speaker 03:
I like that.

[00:45:01] Speaker 01:
All right.

[00:45:02] Speaker 01:
We thank the party for the argument.