[00:00:00] Speaker 02:
The United States Court of Appeals for the Federal Circuit is now open and in session.

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God save the United States and this honorable court.

[00:00:12] Speaker 03:
Good morning.

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Our first case for argument today is 21-1070, Novartis Pharmaceuticals versus Accord Health Care.

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Mr. Steermont, please proceed.

[00:00:26] Speaker 00:
Thank you, Your Honor, and may it please the court.

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Both of the written description failures that are on appeal are directed to dose limitations of the asserted claim.

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And the reason is that the 405 patent does not disclose an invention directed to Fingolimod dosing, as the inventors were not in possession of such an invention by their own admission.

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In addition to the inventor's own admissions,

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The patent itself in the very setup to the only two places that all parties agree matter from the patent specification, which does not begin until column 10 with the description of the EAE experiments and the investigation of clinical benefit.

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Even those portions of the specification are introduced in column 10, line 25,

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as a description of the utility of the S1P receptor modulators can be illustrated in the following animal tests and investigation of clinical benefit.

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And that's precisely what this patent, the 405 patent, was directed to, directed to establishing the utility of a broad class of compounds called S1P receptor modulators

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And it was not a patent directed to disclosing an invention about any particular dosing of S1P modulators in general or Fingolimod specifically.

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What do we do about the fact that the district court found that the prophetic application was all about coming up with the lowest possible human dosage based on the lowest dosage available from the animal studies?

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Right, so with respect to that argument that goes to the argument about this 0.5 milligram claim limitation,

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The response is that the district court did not cite any evidence either from the patent itself or expert testimony that links the description of the RAT EAE experiments with the investigation of clinical benefit that follows those.

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There is no discussion in the patent at all

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about how rat dosing would apply to human, rat dosing in an EAE model would apply to human dosing for the treatment of our RMS.

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That is not in the patent and all of the experts that testified agreed that that is not in the patent.

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And in addition to there not being any explanation whatsoever about how to

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translate or use the RAT data for the purpose of designing the investigation of clinical benefit.

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There is also not any discussion in the patent admitted by the experts that shows the public that the inventors used the EAE experiments, used some proportionality analysis for humans,

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and how they arrived at any of the doses that are listed in the investigation of clinical benefit, whether it be 0.5, 1.25, or 2.5 milligrams.

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None of those doses that are disclosed in the investigation of clinical benefit are tied back or explained or linked in any way in the specification to the RAD experiment.

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The only testimony linking them is that the investigation of clinical benefit followed the RAD experiment.

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But what it doesn't do is give the public or a person of ordinary skill, most importantly, any information about how the EAE experiments, really how or whether the EAE experiments related to

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the doses in the investigation of clinical benefit, particularly... He made specific findings, paragraphs 54, 55.

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I mean, he specifically said that he further found that a skilled artisan would understand that the RAT model were good models for relapsing EAA.

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EAA was the dominant model for stuttering

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MS treatments.

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He then went on to say that they credited Novartis's experts to say that the skilled artisan would have converted the 0.3 milligram to the 0.5 and he went through the details of how that was done.

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I don't really understand your blanket statements that there's nothing there.

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I mean, he cited to a lot with respect to the 5 milligrams.

[00:05:42] Speaker 00:
Well, with respect to the testimony he cited, Your Honor, I think the point is that he cited essentially some direct testimony, but then did not address any of the admissions made by those same experts.

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For example, to use an example, in paragraph 56,

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the order cites Dr. Steinman describing the conversion, but Steinman admitted that that conversion is nowhere disclosed in the past application.

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Council, this is not an agency analysis.

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We're not supposed to analyze whether they cited every single thing that supported or didn't support the conclusion.

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Ultimately, the court has to make determinations and findings of fact, and they have to cite the support for those determinations.

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And we're supposed to assume that a trial court considers the totality of the evidence when it makes those decisions.

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So the mere fact that he doesn't cite to something doesn't mean that he didn't find it unpersuasive.

[00:06:43] Speaker 00:
Fair enough, Your Honor.

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The point isn't so much about what he cited.

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The point is that our brief sets out using the testimony of those same experts and argues that as a matter of law,

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the things that the district court uh... the the reported evidence that that uh... testimony from the experts that the district court relied upon is insufficient as a matter of law to make to make the finding that uh... that uh... that he did well you have to play his findings are clearly erroneous mean correct and i and i think i'm not only in our in our brief or make it we we both say that he uh...

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misapplied the legal standard, particularly in the other argument about absent and immediately preceding loading dose.

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But for the 0.5 milligram argument, the point is that the testimony, and I'll just use an example of how we address that in the brief.

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In paragraph 56, the order cites Dr. Steinman,

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as saying that a person of skill would have converted 0.3 to 0.042 in the rat study.

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But the evidence is that that's not in the patent.

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The evidence is that Dr. Steinman admitted that it wasn't in the patent, as did Drs.

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Lublin and Jusko.

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And the evidence is also, as it went in, that the calculations and the math that Novartis's experts

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explained, testified that they thought that this is how a person of ordinary skill would interpret it, is also contradicted by the inventors themselves, who explained, who conceded that their calculations were not only not in the patent, they were not, these calculations that they've come up with for the litigation, were not even in the internal Novartis document describing their experiments.

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And that's in evidence as well.

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where the inventors were describing a conversion without any documentary evidence, but described a conversion process that was different than the ones that the experts testified

[00:08:58] Speaker 02:
I still think you're just asking us to say that basically everything he said in paragraphs 52 through 59 that you disagree with and that, yes, reasonable minds might be able to go either way, but our standard of review has to say, are his conclusions clearly erroneous?

[00:09:23] Speaker 00:
understood your honor and that but but clearly erroneous and that's where we fight the the supreme court's uh... gypsum case clearly erroneous does not mean that it means that you it means that uh... will that uh... that we have to establish that uh... that that you are firmly convinced there was an error and it and it in just and so with this evidence that he fights uh... in particular which which is all relies on the experts admittedly is not in the patent

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And our argument in the brief is that you cannot use the expert, as a matter of law, you cannot use the expert testimony that the district court used to fill the utter failures of disclosure.

[00:10:10] Speaker 02:
You can use the expert testimony to explain what one of skill in the art would have known at the time.

[00:10:21] Speaker 00:
Yes, agreed.

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But where there is a complete absence, I mean, the patent doesn't even state.

[00:10:36] Speaker 03:
Council, why don't you answer that question quickly, but then I do want you to move on to your negative limitation issue, please.

[00:10:43] Speaker 00:
Yes, Your Honor.

[00:10:45] Speaker 00:
So the issue on the 0.5 milligram is

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that there is no disclosure in the specification.

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While the court can take testimony from a person of ordinary skill of how they would interpret the patent, they have to be interpreting something that is in the patent.

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There has to be some hook for them to say, here's what the skilled person would have understood

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as to why the inventors are in possession of 0.5 milligrams for human dosing.

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And that is where the testimony the district court relied on is our argument is insufficient as a matter of law for that purpose in light of the record as a whole, including their admissions.

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And I will move on to absent and immediate proceeding loading dose.

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For this argument,

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In the first instance, the district court did not cite or apply any of this court's precedent in applying Ariadne to negative claim limitations, and we are not arguing there is a heightened standard for negative claim limitation.

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The point is that the Federal Circuit has developed at least a narrow body of law with respect to negative claim limitations in this context because it wrestles with the notion

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of how do you describe a negative and those cases apply AREAD to do that.

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So it is not applying a heightened standard, it is taking AREAD and saying in a situation where the issue is an exclusionary claim limitation, a negative claim limitation,

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Those cases explain that there has to be something in the specification that supports the exclusion.

[00:12:35] Speaker 01:
Right.

[00:12:37] Speaker 01:
Go ahead.

[00:12:38] Speaker 01:
This is Judge Lynn.

[00:12:42] Speaker 01:
The question in my mind is that since these are all really fact-based determinations, why is not the standard in Ariadne met in this case?

[00:12:57] Speaker 00:
The standard in Ariad is not met in this case because there was no disclosure in the specification that the inventors possessed an invention which was to practice a method in the absence of an immediately preceding loading dose.

[00:13:16] Speaker 00:
The patent office said that just practicing a method of 0.5 directed to RRMS is not patentable.

[00:13:24] Speaker 00:
It was rejected based on Novartis' earlier research into transplants using the same drug.

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It was rejected as obvious.

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In order to get the claims issued at all, Novartis first tried to argue that they didn't need to amend the claims, and they tried to get around the obviousness rejection, and when it was maintained, they amended the claims, and what the Patent Office issued a claim on was an invention that cannot be infringed, essentially,

[00:13:52] Speaker 00:
uh... but if there is an immediately preceding loading dose and so that is what the pat that is what the claimed invention is and there is a no disclosure in the specification at all that shows that the inventors possess uh... an invention to omit to forbid the taking of it immediately proceed well i don't know if that doesn't satisfy him but the patent does talk about a daily dose it doesn't talk about anything

[00:14:21] Speaker 01:
in addition to the daily dose.

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And there are findings relating to this issue.

[00:14:34] Speaker 00:
Agreed there are findings related to the issue.

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And it relies on initially and daily.

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And daily is not required.

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I mean, it's required by the claim.

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But the daily that is cited in the specification is purported support.

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is is one of several dosing regimens including that every other day every third day and weekly

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And if daily excluded a loading dose, there wouldn't have needed to be a claim element because the claim amendment, because the claim says that it's daily administrative.

[00:15:08] Speaker 02:
So Judge Jordan did go through a variety of facts that he said supported the absence of a loading dose.

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He found that loading doses were well known in the art and it was well known that loading doses are higher than the dose ultimately given.

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He said that the application made clear that 0.5 was to be an initial dose, thereby indicating that no loading dose should proceed it.

[00:15:33] Speaker 02:
He found that it was clear from the application that the point of the study and prophetic application was to disclose the lowest human dose that could be efficacious.

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And finally, he said that the application did discuss alternative dosing regimens but never contemplated any higher dose than that chosen.

[00:15:49] Speaker 02:
And, you know, the point is we've got a really high level of skill in this art.

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Everybody knows what a loading dose is, especially those with that high level of skill.

[00:16:01] Speaker 02:
If there was a loading dose contemplated, it would have been disclosed.

[00:16:07] Speaker 02:
And so, you know, it's hard to prove a negative.

[00:16:10] Speaker 02:
I get that.

[00:16:11] Speaker 02:
But I don't think we have ever said that there's any one formula for how you establish the negative.

[00:16:20] Speaker 00:
Correct.

[00:16:22] Speaker 00:
Agreed, Your Honor.

[00:16:23] Speaker 00:
There's not one formula, but our argument is that all of the formulas that have been articulated by this Court for satisfying a negative claim limitation are not satisfied here.

[00:16:35] Speaker 00:
The facts do not support any of the Santeros, Infi, or Nike recitations of what satisfies written description for a negative claim limitation.

[00:16:45] Speaker 00:
And I know that I'm over time, and so I'm happy to address that.

[00:16:48] Speaker 03:
Thank you, Mr. Stiermont.

[00:16:49] Speaker 03:
Let's hear from Ms.

[00:16:50] Speaker 03:
Love.

[00:16:51] Speaker 00:
Thank you, Your Honor.

[00:16:53] Speaker 04:
Thank you, Your Honor.

[00:16:54] Speaker 04:
May it please the court, Jane Love for Novartis.

[00:16:57] Speaker 04:
HEC has failed to carry its heavy burden to show clear error.

[00:17:01] Speaker 04:
Three different fact-finders have analyzed written description, the PTAB and an IPR, Judge Stark and a preliminary injunction proceeding, and Judge Jordan at trial.

[00:17:08] Speaker 03:
Counsel, do you agree that silence

[00:17:12] Speaker 03:
in the specification is not enough under our case law to support a negative limitation?

[00:17:18] Speaker 03:
That if the patent spec was completely silent, that our law makes it clear that that's not enough?

[00:17:24] Speaker 04:
No, Your Honor.

[00:17:25] Speaker 04:
Silence is in the ears of the beholder.

[00:17:30] Speaker 04:
Silence under area needs to be interpreted from the point of view of the person of skill.

[00:17:35] Speaker 04:
And here, the court made factual findings that the person of skill reads the human example to convey the message

[00:17:41] Speaker 04:
that the daily dosage of 0.5 milligrams is given initially, excluding the possibility of a loading dose given the undisputed definition that a loading dose is a higher than daily dose given at the beginning of treatment.

[00:17:56] Speaker 03:
Even... Just to be clear, you... Because I'm kind of surprised at your answer.

[00:18:00] Speaker 03:
I thought that you would immediately say, yes, of course, if the spec was completely silent about something, but then you would go on to say, but this spec isn't silent.

[00:18:08] Speaker 03:
But instead, you said silence

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can be okay, that we can find a negative claim limitation even when the spec is completely silent as to it?

[00:18:20] Speaker 04:
Your Honor, I guess the definition of silence is what's in question to the person of skill in the art.

[00:18:26] Speaker 04:
If the words are not on the page, so if we're talking about silence being no literal recitation of the words that you can read in the claim, if that's the definition of silence,

[00:18:38] Speaker 04:
then there still can be written description because the person of skill takes meaning

[00:18:44] Speaker 04:
from the whole specification in ways that a layperson will not.

[00:18:50] Speaker 04:
So just the binary question of yes or no, whether the words are on the page isn't the test.

[00:18:57] Speaker 03:
So if you're the person of skill in the art, the fact finding is that a person of skill in the art would understand when the specification uses the word daily, like in column 15, that that excludes a loading dose.

[00:19:11] Speaker 04:
In that context, yes, Your Honor.

[00:19:12] Speaker 04:
The person of skill is looking at the dosing regimen in this particular art.

[00:19:18] Speaker 03:
So the use of the word daily excludes the loading dose, and that's how a skilled artisan would understand the inventor to have possessed this invention?

[00:19:27] Speaker 04:
The possession comes from the combination of the EAE example, which shows surprising results at very low doses of completely inhibiting relapses.

[00:19:37] Speaker 03:
I'm focused on the loading dose.

[00:19:39] Speaker 03:
Focus on the loading dose.

[00:19:41] Speaker 03:
So the entire support for the loading dose comes from the word daily, correct?

[00:19:47] Speaker 04:
It's in the context of the whole patent, and in this case, the daily dosage in the example is given initially, which in combination, the findings below show that testimony looks at the proximity of the word initially

[00:20:06] Speaker 04:
and with the understanding that a loading dose is a higher than daily dose given at the beginning of treatment, exclude the loading dose.

[00:20:13] Speaker 03:
Okay, so the word, I'm sorry, one more question, please, if you don't mind.

[00:20:17] Speaker 03:
The word daily is what supports the no loading dose limitation.

[00:20:22] Speaker 03:
I understand your argument.

[00:20:24] Speaker 03:
Now, here's a question for you, though.

[00:20:25] Speaker 03:
Claim one contained the word daily.

[00:20:28] Speaker 03:
It already had the word daily in it.

[00:20:32] Speaker 03:
you added absent and immediately preceding loading dose regime.

[00:20:37] Speaker 03:
So if the word daily already implied no loading dose, and I use that language because that's Judge Jordan's actual fact finding that the word daily plainly implies no loading dose.

[00:20:49] Speaker 03:
That is his paragraph 64 or 63 fact finding.

[00:20:53] Speaker 03:
So if the word daily said that, why did you have to then superfluously add absent a loading dose to the claim?

[00:21:02] Speaker 04:
Yes, sir.

[00:21:03] Speaker 04:
During the examination, the examiner was reading the claims with the broadest reasonable interpretation and cited the covariate reference that my friend on the other side had mentioned.

[00:21:13] Speaker 04:
That's prior art about designing loading dose regimens for transplant patients using different rates and ratios.

[00:21:21] Speaker 04:
The amendment was added to clarify that the claim does not overlap that co-barric prior art record.

[00:21:26] Speaker 03:
Really?

[00:21:27] Speaker 03:
Because I read the prosecution history and it doesn't look like the amendment was added to clarify.

[00:21:31] Speaker 03:
Is there something in the prosecution history you can point me to that would suggest this is a clarifying amendment as opposed to an amendment to overcome obviousness?

[00:21:41] Speaker 04:
Dr. Steinman reviewed the file history and testified at A3652.

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that he read the file history as the phrase being added to clarify the claim so that it wouldn't overlap with Covarick.

[00:21:59] Speaker 02:
Counsel, isn't it more accurate to say that that silence is a factor that can be considered if one of skill in the art would necessarily expect something to be there but that it's not

[00:22:14] Speaker 02:
In other words, Judge Jordan didn't say that mere silence was enough.

[00:22:19] Speaker 02:
He found that the other things that I pointed to were important to the conclusion that one of skill in the art would understand that a loading dose was excluded.

[00:22:30] Speaker 04:
Yes, Your Honor, absolutely.

[00:22:32] Speaker 04:
I think the area test requires the whole patent to be taken into consideration against backdrop of the prior art and the knowledge of the person of skill in a... Well, that was certainly a helpful and friendly question and an answer that really said nothing.

[00:22:47] Speaker 03:
How about you point to me the other parts of the patent that you say actually supported instead of just saying, look at the whole patent.

[00:22:54] Speaker 03:
You pointed me to the word initially and the word daily.

[00:22:57] Speaker 03:
Is there something else in this patent that supports you apart from...

[00:23:00] Speaker 03:
you know, just generalities?

[00:23:04] Speaker 04:
The fact that the patent is about RRMS, it's a chronic condition, lifelong condition, where a person of skill would understand that a loading dose, which had been used in the prior art for transplant patients that had an acute condition, those patients would have needed a much higher kind of jump start loading dose at the beginning to help their body not reject the organ.

[00:23:27] Speaker 04:
RMS is a different story where it's a chronic condition and a person of skill in the art would know that and the patent is all about multiple sclerosis.

[00:23:35] Speaker 04:
Also, a person of skill would know that Singolimaj, which is the focus of this patent... So just to be clear, none of this is in the patent.

[00:23:44] Speaker 03:
You're just saying a person of skill would know these things.

[00:23:46] Speaker 03:
But none of it... My question to you was, is there anything else in the patent other than the word initially and the word daily?

[00:23:50] Speaker 03:
And you've pointed me instead to other stuff, but nothing else in the patent.

[00:23:55] Speaker 03:
I just want to be really clear.

[00:23:56] Speaker 03:
There's nothing else in the patent, correct?

[00:23:59] Speaker 04:
Well, the RRMS field is

[00:24:02] Speaker 04:
is in the patent in, you know, everywhere in the abstract and the examples.

[00:24:07] Speaker 04:
And there was a finding, like a paragraph 52, in the decision in terms of reading the patent as a whole, the person of skill is understanding that this is about RRMS based on the disclosure in the patent.

[00:24:21] Speaker 03:
So a person of skill would understand it's about RRMS and that means

[00:24:27] Speaker 03:
Is there something in the patent that suggests what that means if this is about RRMS?

[00:24:34] Speaker 04:
Well, the patent itself is focused on the treatment for relapsing remitting multiple sclerosis.

[00:24:41] Speaker 03:
Is that, just so I know, is that preamble acclaim limitation efficacy?

[00:24:47] Speaker 03:
Do you have to, because you're telling me a person would know that, that would imply that this is a claim limitation.

[00:24:53] Speaker 03:
Is actually successfully treating RRMS, which is the preamble acclaim limitation?

[00:25:01] Speaker 04:
It is a claim limitation, Your Honor, that was construed acclaim construction, but the construction is to have a treatment purpose, not efficacy at text urging, actually.

[00:25:11] Speaker 03:
So if I gave my child a placebo drug and said that the purpose of this drug is to cure your headache, that's good enough, right, because it's the purpose but it doesn't actually have to do anything?

[00:25:24] Speaker 04:
Administering a placebo knowingly would not necessarily be a treatment purpose because the placebo itself

[00:25:35] Speaker 03:
So we have to decide whether or not these claims are infringed based on whether or not somebody intended to be helpful, whether they were or not.

[00:25:45] Speaker 04:
There's a claim construction decision where Chief Judge Stark at the time did identify that

[00:25:50] Speaker 04:
The purpose in administering the drug was the factor.

[00:25:57] Speaker 03:
So the claim construction, just to be clear, in order for us to find in your favor, we have to accept the claim construction that if you intend to be helpful, if you intend to be treating RMS, whether you do or not is irrelevant.

[00:26:11] Speaker 03:
It's just your intention.

[00:26:15] Speaker 04:
Well, the written description of the preamble wasn't on appeal.

[00:26:19] Speaker 03:
So you're the one pointing to it and suggesting that a skilled artisan would utilize that in coming to the support for it.

[00:26:27] Speaker 03:
So I was assuming that it was part of this analysis.

[00:26:31] Speaker 03:
Is that not right?

[00:26:33] Speaker 04:
Well, Your Honor, the analysis looks at the fact that the whole context of the patent, the patent taken as a whole, is focused on a chronic condition, in this case, a form of multiple sclerosis, because patients need to take this drug

[00:26:48] Speaker 04:
for the rest of their lives, and there is no need to kick start the amount in the body.

[00:26:55] Speaker 04:
A person of skill would understand that no loading dose would be associated with treating a multiple sclerosis disease.

[00:27:02] Speaker 02:
With respect to the fact that the preamble is limiting, both district court judges reached that conclusion, correct?

[00:27:12] Speaker 04:
Yes, Your Honor.

[00:27:13] Speaker 02:
And that's not an issue on appeal before us, correct?

[00:27:17] Speaker 04:
Yes, Your Honor, that's correct.

[00:27:20] Speaker 04:
And finally, a person of skill would also understand, bring to the reading of this patent the existence of a serious side effect called bradycardia.

[00:27:32] Speaker 04:
It's not in the patent per se, literally, but a person of skill looking at this patent covering Fingolimod was a known drug.

[00:27:41] Speaker 04:
There's prior art about the drug that shows

[00:27:46] Speaker 04:
the first dose has an associated serious effect called bradycardia slowing of the heart.

[00:27:52] Speaker 04:
And the physician person of skill would understand that you would want to avoid that.

[00:27:59] Speaker 03:
Well, Counsel, how do you square your argument in this case with CAPOS?

[00:28:06] Speaker 04:
So, Your Honor, CAPOS 2006 is an abstract.

[00:28:12] Speaker 04:
does not include a key part of the story in the patent, which is the EAE animal model results.

[00:28:23] Speaker 03:
But just to be clear, so we understand what Kappos discloses, it expressly says RRMS, correct?

[00:28:29] Speaker 03:
Yes, Your Honor.

[00:28:30] Speaker 03:
And it expressly says once daily, once daily, which seems even narrower than your daily, once daily,

[00:28:38] Speaker 03:
And yet Judge Jordan expressly held as a fact-finding that this piece of prior art did not exclude a loading dose.

[00:28:48] Speaker 04:
It is an abstract, and the person of skill testified that it was unknown what other information would be associated with it.

[00:28:58] Speaker 03:
Wait, something was unknown?

[00:29:00] Speaker 03:
I thought you said a person of skill in the art would know with RRMS that you don't use loading doses.

[00:29:06] Speaker 04:
With CAPOS 2006, it's a design of a clinical trial, and the design features would have been possibly not fully disclosed in that abstract, because as an abstract, a person of skill would know that... Isn't your disclosure a design for a clinical trial?

[00:29:25] Speaker 03:
Isn't your entire disclosure a prophetic example involving rats?

[00:29:30] Speaker 04:
No, Your Honor.

[00:29:31] Speaker 04:
Our disclosure is a combination of the whole patent, which includes

[00:29:35] Speaker 04:
a RRMS animal model, the EAE example, plus a prophetic clinical trial that includes the doses and the recitation of treatment.

[00:29:50] Speaker 04:
which a person of skill would understand to be a complete disclosure, whereas the CAPOS 2006 abstract, a person of skill would know it's an incomplete disclosure.

[00:30:01] Speaker 03:
I have to be honest, I really don't understand what that means, it's an incomplete disclosure.

[00:30:06] Speaker 03:
Judge Jordan made a fact finding that this is directed to RRMS,

[00:30:11] Speaker 03:
he made a fact finding that it discloses once daily, and then he concluded, based on the expert testimony, that that did not exclude the possibility of a loading dose.

[00:30:21] Speaker 02:
But he did conclude, didn't he, that CAPOS was just an abstract and was not written to fully disclose, and that there are two different concepts here?

[00:30:35] Speaker 04:
That's correct, Your Honor.

[00:30:36] Speaker 04:
The patent as a whole would be expected by the person of skill to be complete, and the abstract by its nature would be known to a person of skill to be an incomplete document.

[00:30:48] Speaker 03:
Can you explain to me what the heck that means?

[00:30:50] Speaker 03:
Because I really don't understand.

[00:30:52] Speaker 03:
I understand an abstract is the summary of something, but he didn't find that a person of skill would know, because it's RRMS, and know, even though it says once daily, that that implies no loading dose.

[00:31:07] Speaker 03:
If that was what a skilled artisan would take away, then they would know the rest of the document would say that, right?

[00:31:13] Speaker 03:
But he found the opposite.

[00:31:16] Speaker 03:
How can daily have two different meanings?

[00:31:19] Speaker 03:
One meaning in CAPOS and different meaning in your patent?

[00:31:24] Speaker 04:
Your Honor, I don't believe that daily would have two different meanings, but instead that the fact that it was an unknown additional information related to the abstract

[00:31:38] Speaker 04:
left the possibility that a loading dose still could have been included in the clinical trial design in CAPLOS 2006.

[00:31:46] Speaker 03:
Right, because the word daily didn't exclude that possibility, correct?

[00:31:53] Speaker 04:
Well, in that context, that's true, but the context of the patent is different because a patent

[00:32:02] Speaker 04:
is presumed to be a complete disclosure of what the invention is.

[00:32:07] Speaker 03:
Council, my big concern is that I feel like what you're asking us for represents a dramatic extension or even a rejection of our Santaris decision.

[00:32:21] Speaker 03:
Negative limitations are hard.

[00:32:25] Speaker 03:
And really, the patentee bears the burden of making clear to the public the scope of the invention it possesses.

[00:32:32] Speaker 03:
And you did nothing in this patent.

[00:32:34] Speaker 03:
You didn't include any information.

[00:32:36] Speaker 03:
You didn't include disadvantages.

[00:32:39] Speaker 03:
You didn't include alternatives.

[00:32:41] Speaker 03:
We have a bunch of cases that have analyzed different ways, and there are many different ways in which patentees have signaled to the public

[00:32:52] Speaker 03:
that their invention will not include this negative limitation.

[00:32:55] Speaker 03:
And your patent meets none of those.

[00:32:59] Speaker 03:
And I mean, we never said those ways are the exclusive way of doing it, but your patent has no way of doing it.

[00:33:04] Speaker 03:
Your patent discloses nothing that is consistent with all of those different examples we've given of how you can successfully

[00:33:12] Speaker 03:
exclude or include a negative limitation and exclude something.

[00:33:17] Speaker 03:
And I'm really worried that you're asking us for what amounts to a dramatic change in the law of negative limitations.

[00:33:25] Speaker 04:
Well, Your Honor, I think the Nike case explains that there isn't a heightened standard for negative limitations.

[00:33:32] Speaker 04:
But even if there were, there were reasons.

[00:33:35] Speaker 03:
I agree there's no heightened standard.

[00:33:36] Speaker 03:
There has to be some disclosure.

[00:33:39] Speaker 04:
Well, in this case, there is disclosure in the fact that there's an undisputed definition of a loading dose, which is a higher dose at the beginning of treatment.

[00:33:48] Speaker 04:
And this patent clearly discloses in the human example, which reflects the claims that a daily dosage is given initially.

[00:33:56] Speaker 04:
And that is a reason for excluding the possibility of a loading dose.

[00:34:02] Speaker 01:
Ms.

[00:34:03] Speaker 01:
Love, one quick question before your time is out.

[00:34:08] Speaker 01:
In finding of Act 62, Judge Jordan says, quote, the prophetic trial tells a person of skill that on day one, treatment begins with a daily dose of 0.5 milligram, not a loading dose.

[00:34:28] Speaker 01:
Where would I find that in the patent?

[00:34:33] Speaker 04:
Well, Your Honor, that comes from testimony from Dr. Steinman.

[00:34:37] Speaker 04:
who, and it's cited here, who was

[00:34:42] Speaker 04:
looking at a slide in the courtroom of that prophetic example and explaining how a person of skill would read that example.

[00:34:52] Speaker 04:
And he understood the word daily dosage to mean 0.5 milligrams given each day.

[00:35:00] Speaker 04:
And when it started initially, Dr. Simon said, well, then a person of skill understands it's day one, you're giving treatment, which is the 0.5 milligram daily dose.

[00:35:12] Speaker 01:
I see.

[00:35:13] Speaker 01:
So that's his understanding of the patent text in column 11.

[00:35:19] Speaker 04:
Well, yes, Your Honor.

[00:35:20] Speaker 04:
It's the perspective of the person of skills reading of that example, which is exactly carrying out the area test in understanding the patent disclosure.

[00:35:32] Speaker 01:
OK.

[00:35:32] Speaker 01:
But there's nothing in the patent that says treatment begins with a daily dose.

[00:35:40] Speaker 04:
The prophetic example.

[00:35:42] Speaker 04:
says treatment begins initially and treatment is the 0.5 milligram daily dose.

[00:35:49] Speaker 04:
So if that begins initially, it excludes the possibility of a loading dose.

[00:35:55] Speaker ?:
Okay.

[00:35:56] Speaker 03:
To be clear, it doesn't say treatment begins initially.

[00:36:00] Speaker 03:
Column 11 says initially, patients receive treatment for two to six months.

[00:36:06] Speaker 03:
What are you talking about?

[00:36:08] Speaker 03:
Where in the patent does it say what you just claimed it said?

[00:36:11] Speaker 03:
If it said that, this would be a different case.

[00:36:15] Speaker 04:
The interpretation by Dr. Steinman and other experts.

[00:36:20] Speaker 03:
So just to be clear, you think I can't read the words, initially patients receive treatment for two to six months.

[00:36:25] Speaker 03:
You think an expert needs to tell me to interpret that differently than it's plain meeting and I should accept that?

[00:36:32] Speaker 04:
Well, Your Honor, I think when we're in the area of

[00:36:36] Speaker 04:
dosages of drugs that are being prescribed, there are aspects to how the physician would understand the description of the prescription to be different than a non-physician.

[00:36:54] Speaker 04:
And in this case, the person of skill included a multiple sclerosis physician.

[00:36:59] Speaker 03:
So as a matter of law, I construe this language.

[00:37:04] Speaker 03:
And the patent says, initially, patients receive treatment for two to six months.

[00:37:08] Speaker 03:
And you believe I should construe that as, initially, there is no loading dose?

[00:37:16] Speaker 04:
Yes, Your Honor.

[00:37:16] Speaker 04:
That loading dose is excluded from that treatment.

[00:37:20] Speaker 03:
One last thing.

[00:37:21] Speaker 03:
MPEP 217305.

[00:37:24] Speaker 03:
How, if I hold in this case what you wish me to hold,

[00:37:29] Speaker 03:
Am I not inconsistent with that MPEP?

[00:37:32] Speaker 03:
Now, let me be clear.

[00:37:32] Speaker 03:
The MPEP is not binding law.

[00:37:35] Speaker 03:
And of course, this court can decide whatever it wants.

[00:37:38] Speaker 03:
But the definition of how a negative limitation would be satisfied that you're asking for would certainly render that MPEP completely void and inaccurate.

[00:37:50] Speaker 03:
Am I wrong?

[00:37:51] Speaker 03:
Is there something I'm missing about your definition that would still allow that MPEP to have life?

[00:37:59] Speaker 04:
Well, Your Honor, the MPEP section allows for written description to be met when a claim limitation is expressly or implicitly supported.

[00:38:14] Speaker 04:
And here, as the court found, the negative limitation is plainly implied to the person of skill, so I think it would be still in concert with that section.

[00:38:25] Speaker 03:
Okay, so I want to ask you one last question and then we'll let you sit down and we'll let your present council have some rebuttal time.

[00:38:33] Speaker 03:
You told me that everyone would know that loading doses aren't used in MS treatment.

[00:38:43] Speaker 03:
Is that correct?

[00:38:44] Speaker 03:
Because you explained that it's sort of a long-term treatment and the word daily and all that other stuff.

[00:38:49] Speaker 03:
Is that right?

[00:38:52] Speaker 04:
Yes.

[00:38:54] Speaker 04:
true that a person of skill would believe that it's not a good idea to use a loading dose in an MS context.

[00:39:01] Speaker 03:
But then your expert testified that it happens, right?

[00:39:05] Speaker 04:
In rare instances, it can happen.

[00:39:07] Speaker 03:
So your expert testified that sometimes MS patients are treated with a loading dose first.

[00:39:14] Speaker 04:
The normal sort of baseline expectation?

[00:39:17] Speaker 03:
I think really it's a yes or no question.

[00:39:19] Speaker 03:
Did your expert testify

[00:39:22] Speaker 03:
that loading Mr. Lublin or Dr. Lublin, I'm not sure, did he testify that sometimes MS patients are treated first with a loading dose?

[00:39:34] Speaker 04:
In rare instances, Dr. Lublin did testify that that's true, yes, Your Honor.

[00:39:39] Speaker 04:
Dr. Hoffman also testified that it's not a good idea to administer a loading dose to an MS patient and there's fact finding in paragraph 66 related to Dr. Hoffman's testimony as well.

[00:39:50] Speaker 03:
Okay, thank you, Council.

[00:39:52] Speaker 03:
Let's hear from Mr. Skirmont.

[00:39:57] Speaker 03:
I'm going to restore your rebuttal time, the full five minutes, because we went way over with Ms.

[00:40:02] Speaker 03:
Love.

[00:40:02] Speaker 03:
So, Mr. Skirmont, you can have your full five minutes of rebuttal.

[00:40:07] Speaker 00:
Thank you, Your Honor.

[00:40:08] Speaker 00:
I want to go right to the heart of the issue that was just part of the last colloquy, which is Dr. Steinman's testimony about daily that the district court relied on as kind of the hook.

[00:40:22] Speaker 00:
The formulation of Dr. Steinman's testimony was actually incorrect.

[00:40:27] Speaker 00:
Dr. Steinman testified that if one were going to use a loading dose,

[00:40:33] Speaker 00:
that a person of skill, that there were two places, two gates, where a person of skill would expect that if a loading dose was going to be used, that it would be disclosed in the specification, and that's where he talked about the daily portion of the specification.

[00:40:51] Speaker 00:
But on cross-examination, and this is at appendix 23404 to 405, at transcripts, page 826, line 18,

[00:41:04] Speaker 00:
to line 27.

[00:41:06] Speaker 00:
And I asked him on cross, I said, you've analyzed this from the perspective of if there was going to be a loading dose, you would expect it here.

[00:41:16] Speaker 00:
But what we have is a negative claim limitation that a loading dose is forbidden.

[00:41:20] Speaker 00:
And I asked him, can you identify anything in the patent that discloses to a person of skill

[00:41:28] Speaker 00:
that the inventors were in possession of forbidding an immediately proceeding loading dose as an aspect of their invention.

[00:41:35] Speaker 00:
And he testified that if you're talking about the exact words, if that's what you mean by a textual hook, you have the claims and you have the specification, which I understand doesn't change.

[00:41:48] Speaker 00:
So you couldn't put a textual hook into something that doesn't change.

[00:41:52] Speaker 02:
That was his answer.

[00:41:54] Speaker 02:
Can I get back to basics again?

[00:41:55] Speaker 02:
So despite what Judge Moore said, written description is factual, not a question of law, right?

[00:42:04] Speaker 00:
Written description is a factual conclusion.

[00:42:11] Speaker 03:
Right?

[00:42:11] Speaker 03:
Written description is a question of law, but isn't considering the claim or understanding what the specification teaches a kind of part of the legal question?

[00:42:19] Speaker 02:
But the claim construction is not appealed, right?

[00:42:23] Speaker 00:
The claim construction is not appealed, but as we argued in our brief and with our citation to gypsum, the testimony can't contradict the document and the critical document here being the patent.

[00:42:41] Speaker 02:
But I just want to make sure that we understand that we're on the same page.

[00:42:44] Speaker 02:
We have to conclude that both Judge Stark

[00:42:47] Speaker 02:
who interpreted the testimony and the prophetic examples and prophetic application in one way with respect to the preliminary injunction and Judge Storton who interpreted all of that the same way that we'd have to conclude that they both committed clear error in order for you to prevail on this.

[00:43:10] Speaker 02:
And you're arguing that there's lots of testimony that goes the other way.

[00:43:13] Speaker 02:
I get that.

[00:43:15] Speaker 02:
but that's what we would have to find, right?

[00:43:18] Speaker 00:
Yes, and since judicial review of findings of trial codes does not have... Counsel, Judge Moore, you said yes to that.

[00:43:26] Speaker 03:
Did Judge Stark, I just want to make sure I understand because I don't remember all of these facts, but did Judge Stark actually hold that the word daily excluded a loading dose?

[00:43:36] Speaker 02:
He's in the preliminary injunction context.

[00:43:39] Speaker 03:
I'm sorry, I was hoping a lawyer might answer.

[00:43:41] Speaker 00:
he i i don't judge starts orders on appeal and i don't believe he made a finding that daily exclude the loading well if you can go back and look at his his preliminary injunction order he did he said it was you would like that that that plaintiff likely to prevail on that point right now you're going to be the plaintiff was likely to prevail on that record uh... and uh... and uh... uh... but but the point is that that

[00:44:08] Speaker 00:
The court can reverse findings of facts that are clearly erroneous, and that happens when although there is evidence to support a finding, the reviewing court on the entire evidence is left with a conviction that a mistake has been made.

[00:44:23] Speaker 00:
And that's the Supreme Court case that this court has applied, and that's also the case that in explaining that standard in reviewing a trial court's judgment said,

[00:44:34] Speaker 00:
also made the point that where there is testimony that plainly cannot be squared with documentary evidence, you can find clear error.

[00:44:43] Speaker 02:
Didn't Gypsum actually say that you may give little weight to inconsistent expert testimony?

[00:44:49] Speaker 02:
So we would have to conclude that the expert testimony here was inconsistent on its face.

[00:44:55] Speaker 02:
Isn't that right?

[00:44:56] Speaker 00:
It is inconsistent with the patent.

[00:44:59] Speaker 00:
But that's not what Gypsum said.

[00:45:01] Speaker 02:
What Gypsum said is where the testimony itself is internally inconsistent, then you can give little weight to that.

[00:45:07] Speaker 02:
It doesn't say if it's inconsistent with a particular result.

[00:45:11] Speaker 02:
That's not what Gypsum says.

[00:45:13] Speaker 00:
Gypsum said where such testimonies are conflicted with contemporary documents, we can give it little weight, particularly when the crucial issues involve mixed questions of law and fact.

[00:45:23] Speaker 00:
That's the quote from Gibson.

[00:45:26] Speaker 00:
And so the point is that there is clear error here.

[00:45:33] Speaker 03:
Let me ask one last question, if you don't mind.

[00:45:34] Speaker 03:
Of course, if my colleagues have more, they're more than welcome to jump in.

[00:45:37] Speaker 03:
But my biggest concern about this case, which you heard me say clearly to opposing counsel, is that this really is a silence case.

[00:45:49] Speaker 03:
In fact, the word daily using our MM

[00:45:53] Speaker 03:
RRMS.

[00:45:56] Speaker 03:
I found myself in a stuttering pattern here.

[00:46:01] Speaker 03:
The RRMS, there is no disclosure anywhere in this specification of no loading dose.

[00:46:13] Speaker 03:
despite expert testimony that loading doses are sometimes used to treat MS, despite a prior art reference, which also uses the word daily, in fact goes further, it says once daily, and that was concluded not to exclude a loading dose, and the patent never mentions the word loading dose anywhere in it.

[00:46:31] Speaker 03:
This feels like a silence case to me.

[00:46:34] Speaker 03:
It feels like a case that lines up really clearly with what we've already treated in cases like Santaris or Nike or others,

[00:46:43] Speaker 03:
And I'm just really worried that to conclude otherwise is going to dramatically expand what patentees are capable of achieving after the fact in negative limitations.

[00:46:55] Speaker 03:
Can you address that for me, please?

[00:46:57] Speaker 00:
Yes.

[00:46:58] Speaker 00:
I think that of this court's jurisprudence on negative claim limitations, none of them could be squared with finding that the disclosure, what is disclosed here, supports

[00:47:10] Speaker 00:
the negative claim limitation directed to a loading dose.

[00:47:14] Speaker 00:
And it goes beyond Dr. Lublin's testimony, which you cited and Novartis' counsel admitted, Dr. Lublin said,

[00:47:22] Speaker 00:
that a person of skill would imagine or understands that loading doses are often used in MS patients.

[00:47:30] Speaker 00:
Dr. Jesko, Novartis' expert, testified the same thing at Appendix 23475.

[00:47:35] Speaker 03:
And opposing counsel said he used the word rarely, but he didn't, did he?

[00:47:40] Speaker 03:
In his testimony, I see where he says rarely.

[00:47:42] Speaker 03:
I see where he says, have you heard before of loading doses in trials of MS drugs?

[00:47:47] Speaker 03:
And he says it happens.

[00:47:48] Speaker 00:
That's right.

[00:47:49] Speaker 00:
And Dr. Jesko said that it went further and said that the skilled person would know that Fingolimod had already been studied in trans patients and they gave loading doses.

[00:48:01] Speaker 00:
And he also said that even though now they're going to a very small dose, I could envision the possibility of starting with a loading dose because we know, and this is an uncontested fact on which all experts agreed, because we know Fingolimod has a very long half-life

[00:48:18] Speaker 00:
very typically drugs with long half-lives, because they take so long to come to steady state to an equilibrium, they're often given with loading doses.

[00:48:28] Speaker 00:
And that was his testimony.

[00:48:29] Speaker 00:
And so there is unanimity in admissions by Novartis's experts that the skilled person reading the 405 patent would come with it, the knowledge that loading doses are often part of these kinds of methods.

[00:48:48] Speaker 00:
And so, it was in addition to Dr. Steinman not being able to identify anything in the patent that is directed to the negative claim limitation as opposed to being directed to where you would expect to find something if there was going to be a loading door.

[00:49:05] Speaker 03:
Council, I think that we are way out of time.

[00:49:07] Speaker 03:
Thank you very much.

[00:49:08] Speaker 03:
I thank both council.

[00:49:09] Speaker 03:
This case is taken under submission.

[00:49:11] Speaker 00:
Thank you, Your Honor.