[00:00:00] Speaker 04:
Our third case this morning is number 23-2302, N. Ray Strongbridge, Dublin.

[00:00:05] Speaker 04:
Mr. Millican?

[00:00:09] Speaker 02:
Good morning, Your Honours.

[00:00:10] Speaker 02:
May it please the Court?

[00:00:13] Speaker 02:
The inventor here identified a dangerous drug-drug interaction between dicorfenamide and OAT-1 substrates.

[00:00:21] Speaker 02:
He discovered that co-administration of these categories of drugs can cause toxic levels of the OAT-1 substrate to accumulate in the body.

[00:00:29] Speaker 02:
hence the claimed method, administered dichlorofenamide while also avoiding co-administration of methotrexate or famotidine, which are two commonly used OAT-1 substrates.

[00:00:41] Speaker 01:
Can I just ask a general thing?

[00:00:42] Speaker 01:
I mean, this isn't a label issue or whatever.

[00:00:44] Speaker 01:
I mean, the FDA hasn't recognized the danger of these two.

[00:00:48] Speaker 01:
There's no, is there any labeling?

[00:00:50] Speaker 01:
Is it a missed question?

[00:00:52] Speaker 01:
Is there any labeling requirement in regard to the drug?

[00:00:55] Speaker 02:
There is, Your Honor.

[00:00:56] Speaker 02:
After this study was performed and this drug-drug interaction was discovered, the FDA required amendments to the label of the branded dichlorphenamide drug, and it now states that co-administration of dichlorphenamide and OAT-1 substrates, quote, is not recommended and should be avoided.

[00:01:16] Speaker 01:
So looking at the claim language, it's hard to see who's the player here.

[00:01:21] Speaker 01:
But you've got the method claim.

[00:01:23] Speaker 01:
You've got a physician doing the prescribing, right?

[00:01:27] Speaker 01:
Correct.

[00:01:27] Speaker 01:
So the claim says administering this, presumably that means the physician's going to, and while also avoiding concomitant, leaving aside the claim construction dispute on Biden, the same physician that's treating these people for paralysis, which is different than the other,

[00:01:45] Speaker 01:
drug, what the other drug is used for, has to advise, under the FDA requirements now, has to advise the patient that they shouldn't take them concomitantly?

[00:01:57] Speaker 02:
The FDA approved package insert states that the drug shouldn't be taken concomitantly.

[00:02:02] Speaker 02:
Presumably, the physician prescribing dichlorfenamide, if they had reason to think that their patient might be in need of methotrexate or famotidine, that they might say,

[00:02:13] Speaker 02:
hey, this drug has an interaction with this category of drugs called O1 substrates.

[00:02:19] Speaker 02:
And so you shouldn't take famotidine, for example, as pepsid.

[00:02:22] Speaker 01:
But would your claim, if it were allowed, allow you to, I mean, let's assume that before the FDA required and recognized that there was this problem, all of these physicians for six years have been prescribing thousands and thousands of this drug that's not

[00:02:43] Speaker 01:
your invention anymore, whatever, at the same dosage, and have not been telling them, you're not allowed to do this because now the FDA says that there's a problem with people using it.

[00:02:56] Speaker 01:
Are those guys going to be tapped for infringement?

[00:02:59] Speaker 02:
I apologize, Your Honor.

[00:03:02] Speaker 02:
I'm not sure that I'm following the hypothetical.

[00:03:05] Speaker 02:
In the instance where... Who's the infringer?

[00:03:10] Speaker 02:
The physician and potentially the patient might play some role in practicing this method also.

[00:03:16] Speaker 02:
For example, if the patient is the one avoiding taking Pepsid, I mean, that's an over-the-counter medication.

[00:03:23] Speaker 02:
If the patient is the actor that's saying, oh, I know I'm not supposed to take famotidine because I'm on dichlorofenamide, I'm going to take something else for my heartburn other than

[00:03:35] Speaker 02:
pepsid, that could be part of the avoiding step.

[00:03:38] Speaker 02:
I agree the physician's going to be involved because the physician is going to be the one who's prescribing the dicorfenamide.

[00:03:45] Speaker 01:
So every physician who's prescribed the, whatever it's called, and not told the patient, you can't take it with these other drugs, even though I have no idea whether you have the condition or not, is going to be charged with infringement?

[00:04:01] Speaker 02:
Well, if the physician is not

[00:04:04] Speaker 02:
saying anything about the, is not telling the patient to avoid the drugs, then the patient's probably not going to avoid the drugs unless they go and read the package insert themselves.

[00:04:17] Speaker 02:
And so in that instance, you wouldn't be avoiding the co-administration and you would not be infringing.

[00:04:24] Speaker 04:
Your claim is drafted much more broadly than that.

[00:04:27] Speaker 04:
That's the problem here.

[00:04:29] Speaker 04:
The claim is not drafted to a physician that says, if you're taking these other drugs, don't take this.

[00:04:35] Speaker 02:
The claim is drafted to require administration of dichlorphenamide and then also avoiding- Yeah, but you don't answer my question.

[00:04:44] Speaker 04:
The claim is not limited to a situation in which the physician says, don't take this if you're taking these other drugs like pepsin.

[00:04:53] Speaker 02:
I agree.

[00:04:54] Speaker 02:
That is an example of avoiding that is not coextensive for avoiding.

[00:04:58] Speaker 03:
That's the problem.

[00:05:00] Speaker 03:
Well, respectfully, Your Honor, I don't- I thought you were arguing that the administration

[00:05:06] Speaker 03:
requires a doctor's involvement.

[00:05:09] Speaker 02:
It does, because this is a prescription drug.

[00:05:11] Speaker 03:
If it involves the doctor's involvement, the doctor's going to prescribe in the first place.

[00:05:17] Speaker 03:
And if the doctor knows that you're not supposed to be taking something else, the doctor's going to tell you not to take it.

[00:05:22] Speaker 02:
Presumably, yes, Your Honor.

[00:05:23] Speaker 03:
So that's a claim construction issue.

[00:05:25] Speaker 03:
And that would be an example of avoiding... But what happens if we disagree and we say the claim doesn't involve the doctor's involvement, it just involves whether or not somebody did or did not take

[00:05:37] Speaker 02:
If you disagree with our claim construction and agree with the board that all the claim requires is merely that you administer Dichlorphenamide to a patient who happens not to be taking methotrexate or famotidine, we still win because

[00:05:51] Speaker 02:
Sansone, the Prado art reference that is alleged to anticipate here, does not disclose anything about OAT-1 substrates generally.

[00:06:00] Speaker 03:
Well, not most of the theory of OAT-1 and OAT-2.

[00:06:03] Speaker 03:
Correct.

[00:06:04] Speaker 03:
From the examiner's point of view, saying, well, if you're being told to take this, then you're not going to be taking anything else.

[00:06:12] Speaker 02:
That's the rationale.

[00:06:22] Speaker 02:
Because?

[00:06:31] Speaker 02:
avoiding administration of methotrexidophimodadine.

[00:06:34] Speaker 02:
That limitation has to be the inevitable consequence of what... Okay, but the board didn't view this as an inherency thing.

[00:06:40] Speaker 04:
They didn't use the word inherency, right?

[00:06:43] Speaker 02:
Yes, they did, Your Honor.

[00:06:44] Speaker 02:
This was explicitly an inherency rejection, Your Honor.

[00:06:48] Speaker 04:
Where does the board say it's an inherency rejection?

[00:07:01] Speaker 02:
If you look at Appendix 5, this is the 405 decision.

[00:07:06] Speaker 02:
Towards the top of the page, the board is summarizing the examiners.

[00:07:14] Speaker 02:
This is Appendix 5, page 5 of the appendix.

[00:07:18] Speaker 02:
This is the decision in the 405 case.

[00:07:21] Speaker 02:
The board is describing the examiners

[00:07:24] Speaker 02:
reasoning and says, the examiner stated that Sansone does not explicitly teach the claim limitation, it recites the limitation, but found that Sansone does not disclose administration of famotidine to patients, and thus the examiner determined that the claim limitation is met.

[00:07:40] Speaker 02:
In other words, the examiner found that Sansone inherently teaches that the famotidine was not concomitantly administered with dichlorfenamide by staying silent.

[00:07:53] Speaker 03:
I mean, isn't the question here of how long of ordinary skill in New York would have read Sanson?

[00:07:59] Speaker 03:
And my understanding of the board of the examiner's rationale was that personal ordinary skill would look at this and see that the D drug is being prescribed, nothing else, that there's no connection, no reason why the others would have been prescribed or used.

[00:08:16] Speaker 03:
And so we're going to presume one of ordinary skill in the arc that in every case in Sansone, the only thing that happened was the prescription of the D drug, the main drug.

[00:08:25] Speaker 03:
And that's the rationale based on the

[00:08:28] Speaker 03:
examiner's view of one of ordinary skill in the art and the board.

[00:08:32] Speaker 03:
And they just finished.

[00:08:34] Speaker 02:
I apologize.

[00:08:34] Speaker 03:
They get to that stage, they say, well, we now have a premise for one of ordinary skill reading the sentence on reference to understand that the only thing that was happening in that study was the taking of the drug.

[00:08:47] Speaker 03:
I can't pronounce it with a D. And that the other was never taken, meaning anticipation.

[00:08:54] Speaker 03:
And they're treating it as though it's inherent because of that, for one reason, as opposed to saying it's just proof of.

[00:09:01] Speaker 03:
And then the burden under that, the prima facie case, as it comes into existence, and the burden shifts to your side to rebut it.

[00:09:08] Speaker 03:
And you're told that the only way you can rebut it is to disprove it by showing that the other drug was always different.

[00:09:14] Speaker 03:
Right?

[00:09:15] Speaker 03:
That's my understanding of the rationale.

[00:09:17] Speaker 02:
I agree that that was the board's rationale.

[00:09:19] Speaker 03:
The question for us is whether that's a sufficient

[00:09:22] Speaker 03:
whether that was a sufficient reading of how one of ordinary skill in the art would have looked at this peculiar case with this one study of 60 or 70 or 80 patients.

[00:09:33] Speaker 02:
It is not sufficient, Your Honor, and I want to make two points, one legal and one factual.

[00:09:38] Speaker 03:
Is it a substantial evidence question here, then, on the?

[00:09:42] Speaker 02:
No, the board misapplied the law.

[00:09:44] Speaker 02:
The board misunderstood the standard for inherent anticipation.

[00:09:49] Speaker 02:
The board's reasoning was essentially that, look, it's likely that at least one of the sansone patients was not taking methotrexate or famotidine while being administered this Dicorfenamide.

[00:10:03] Speaker 04:
Is your view that that is supported by substantial evidence or not?

[00:10:07] Speaker 02:
I believe there is no evidence in the record one way or another about whether the patients in Sansone were or were not receiving these other drugs.

[00:10:16] Speaker 04:
We do know, and this is a factual... My question is, is that determination that it is likely that one or more of the patients in the study is not taking, let's say, Pepsid, that that's not supported by substantial evidence?

[00:10:30] Speaker 02:
It's hard to say that it is because there is no evidence one way or another about it.

[00:10:36] Speaker 02:
We know that Sansone excluded the patients from taking certain drugs.

[00:10:42] Speaker 04:
taking Pepsid, but certainly far fewer than the majority of the people.

[00:10:50] Speaker 04:
And the study here shows that only one person out of the 37 was suffering from heartburn, reflux.

[00:11:00] Speaker 04:
There seems to be pretty good evidence in which you could infer that one or more of these people was not taking Pepsid.

[00:11:11] Speaker 02:
So we can accept for the sake of argument that it is likely that at least one patient in Sansone was not taking methotrexate or famotidine.

[00:11:19] Speaker 02:
That does not impact our argument at all because our point is the question that you ask when you're looking at inherent anticipation is not was it likely or even extremely likely that this limitation was in the prior art.

[00:11:34] Speaker 02:
You're asking is the missing element the

[00:11:38] Speaker 02:
inevitable result of what's expressly in the reference.

[00:11:42] Speaker 02:
And I'll give you a case law analogy, if your honors don't mind.

[00:11:46] Speaker 02:
In the MEHL biophile case, which is cited in the briefing, the claim there required removing hair with a laser.

[00:11:55] Speaker 02:
And one of the claim limitations was aligning the laser vertically over a hair follicle opening.

[00:12:01] Speaker 02:
The prior reference was a manual for a laser that was used to remove tattoos.

[00:12:07] Speaker 02:
And this court found no inherent anticipation because they said this manual for the tattoo removal laser doesn't talk about hair follicles, and it doesn't disclose a lining the laser over a hair follicle open.

[00:12:20] Speaker 02:
It does teach aiming the laser at skin that has tattoo pigment on it.

[00:12:25] Speaker 02:
But quote, the record discloses no necessary relationship between the location of a tattoo and the location of hair follicles.

[00:12:34] Speaker 02:
Similarly here, there is no necessary relationship

[00:12:37] Speaker 02:
between the patients in Sans-Sony, the fact that they were taking dicorfenamide, and the requirement that they be also avoiding taking these two other drugs.

[00:12:48] Speaker 04:
You may be correct that the board's use of the term inherently is misnomer, but if the board's finding, factual finding, that it is likely

[00:13:01] Speaker 04:
that one or more of these people was not taking Pepsidium.

[00:13:04] Speaker 04:
Why isn't that in itself sufficient to show anticipation under the broad claim construction that the board adopted?

[00:13:13] Speaker 02:
Because anticipation requires that all the limitations have to be disclosed expressly or inherently in a single reference.

[00:13:21] Speaker 02:
There is no disclosure in Sansonium.

[00:13:23] Speaker 02:
The government concedes this.

[00:13:25] Speaker 02:
There is no disclosure of anything about methotrexate, anything about famotidine, or anything about Oat-1 substrates.

[00:13:32] Speaker 02:
And the reason there's no disclosure is no one knew about this drug-drug interaction.

[00:13:37] Speaker 02:
until after the Sansone study was performed.

[00:13:40] Speaker 02:
No one knew that there was a reason to avoid co-administration of these drugs.

[00:13:44] Speaker 01:
Can I just do an infringement question?

[00:13:45] Speaker 01:
Certainly.

[00:13:46] Speaker 01:
If you were to get this patent, and let's say a million people take this drug, and 990,000 of them don't take the other drugs because they don't have the condition, are they infringing that?

[00:14:00] Speaker 01:
Do they constitute avoiding taking the drug?

[00:14:03] Speaker 01:
Do patients who don't take the other drugs

[00:14:07] Speaker 01:
Infringing?

[00:14:10] Speaker 02:
Under the board's construction, yes.

[00:14:12] Speaker 02:
Under our construction, avoiding requires some sort of affirmative activity.

[00:14:17] Speaker 01:
If you don't lead the others... Okay, but let's assume we accept the board's construction independently.

[00:14:23] Speaker 01:
So if we're talking about the board's construction of this claim, does that mean that 990,000 of these people who never heard of this other drug, because they don't have any conditions relating to this other drug, are nonetheless infringing this claim?

[00:14:38] Speaker 02:
Under the, under the board's construction, they would be avoiding, if they're not taking the other drug, they would be avoiding the other drug.

[00:14:46] Speaker 01:
Now, as I'm sure your honor knows... The answer to my question is yes.

[00:14:51] Speaker 02:
If they are being administered dichlorofenamide at the frequency and dosage recited in the claim and are not taking the other drug, under the board's construction, yes, they would be practicing the claim.

[00:15:02] Speaker 02:
Now, there would be inducement questions, because this would be a drug label case.

[00:15:06] Speaker 01:
OK, under your construction, why not?

[00:15:10] Speaker 02:
Because avoidance requires some sort of course of conduct or affirmative activity to not encounter the thing that one is trying to avoid.

[00:15:20] Speaker 04:
So why did you write that into the claim?

[00:15:23] Speaker 04:
I mean, there are other examples in this record of claims which are so limited.

[00:15:28] Speaker 04:
Why didn't you write it that way?

[00:15:30] Speaker 02:
Because in our view, Your Honor, the word avoid is pretty clear on its face.

[00:15:35] Speaker 02:
It does not mean just not encounter by happenstance.

[00:15:39] Speaker 02:
It means you have to take some step.

[00:15:40] Speaker 04:
You could have amended the claims once you got the rejection from the examiner, right?

[00:15:46] Speaker 02:
We could have, but we don't think that it should.

[00:15:48] Speaker 03:
Why didn't you?

[00:15:49] Speaker 03:
Aren't I correct that in one of these two patents at one stage, the affirmative act was in a claim?

[00:15:58] Speaker 02:
There was, in one of the cases, in the 405 case, which is the one that has to do with famotidine, the claims were amended at one point to add that the patient in question is, quote, in need of treatment with famotidine.

[00:16:14] Speaker 03:
In the 405.

[00:16:15] Speaker 03:
But I thought in the 660 at some point, there was actually a claim that covered the doctor's administration.

[00:16:23] Speaker 02:
uh... when you say that covered the doctor's administration involved by someone in making the administration i'd believe that the the the main part of the claims has always just recited administering dichlorfenamide and then the only

[00:16:41] Speaker 02:
But if I'm misremembering, I apologize.

[00:16:44] Speaker 02:
But there was the amendment in the Fomota Dean case requiring that the patient be in need.

[00:16:49] Speaker 04:
Come back to my question.

[00:16:50] Speaker 04:
Why didn't you amend to make it clear that there had to be some sort of intent or explicit requirement in here instead of leaving a claim which is susceptible to the board's construction and creates a situation where anybody

[00:17:07] Speaker 04:
who administers the drug compound is a potential infringer.

[00:17:13] Speaker 02:
Well, to answer your question directly, we didn't amend the claim because we didn't think we needed to.

[00:17:19] Speaker 02:
We think the word avoid is plain.

[00:17:21] Speaker 02:
If Your Honors agree with our claim construction, we're going to be bound by it.

[00:17:26] Speaker 02:
This is part of the prosecution history.

[00:17:28] Speaker 02:
We're not going to be able to go back and broaden the claim.

[00:17:32] Speaker 04:
Doctors probably don't read our cases.

[00:17:35] Speaker 02:
I'm sorry.

[00:17:35] Speaker 04:
Doctors probably don't read our cases.

[00:17:38] Speaker 01:
That's the problem.

[00:17:39] Speaker 01:
But even under your construction, if you're saying the FDA now requires what?

[00:17:45] Speaker 01:
What is the requirement that a physician who's going to prescribe this drug also tell patients not to take the two together?

[00:17:53] Speaker 02:
Well, the FDA doesn't impose those sorts of requirements on physicians.

[00:17:58] Speaker 02:
But what the FDA did do is put in the drug label

[00:18:01] Speaker 02:
that administration of Dicorfenamide with Oat-1 substrates, quote, is not recommended and should be avoided.

[00:18:09] Speaker 02:
That language is now in the package insert.

[00:18:11] Speaker 02:
What a physician does with that information is up to the physician.

[00:18:15] Speaker 01:
So if it's in the insert, is everything, if you got this claim, every administration of this drug is going to be infringing?

[00:18:23] Speaker 01:
Because somewhere in the insert, someone is told to avoid using it.

[00:18:35] Speaker 02:
Well, Your Honor, I imagine there would be arguments down the road about whether, as I'm sure Your Honor knows, usually the defendant here is a drug company, there would be arguments down the road about whether a drug company, including this package insert with their diporphinamide product, was inducing infringement by physicians and or patients.

[00:19:00] Speaker 02:
That hasn't been adjudicated yet because

[00:19:03] Speaker 02:
patent hasn't issued, but that would be the subject of litigation potentially in the future.

[00:19:11] Speaker 04:
Okay, we're out of time.

[00:19:13] Speaker 04:
We'll give you two minutes.

[00:19:14] Speaker 04:
Thank you, Your Honor.

[00:19:16] Speaker 04:
Ms.

[00:19:16] Speaker 04:
Caprahan.

[00:19:25] Speaker 00:
Good morning, Your Honors, and may it please the Court.

[00:19:27] Speaker 00:
I have only two brief points to bring this morning.

[00:19:30] Speaker 00:
First, the board correctly construed the term to avoid concomitant administration to mean that the patient is not being administered fomatidine or methotrexate while they're receiving treatment for periodic paralysis.

[00:19:45] Speaker 00:
And that construction is supported by the intrinsic record here, the language of the claims, as well as how this invention is described in the specification.

[00:19:53] Speaker 01:
OK, point two I assume is?

[00:19:56] Speaker 00:
Point two is that substantial evidence supports the examiners and the board's determination here that a skilled artisan reading the Sans-Sony clinical trial would understand that these other drugs were not being co-administered because that clinical trial is directed to treating patients who have periodic paralysis.

[00:20:19] Speaker 01:
But it also

[00:20:23] Speaker 01:
you shouldn't do it with other stuff, take this with other drugs.

[00:20:28] Speaker 01:
Is there a reason to believe those other drugs are taken by an overlapping subset of patients that have paralysis?

[00:20:35] Speaker 00:
Well, what the examiner and the board both found is that thomatidine and methotrexate are

[00:20:43] Speaker 01:
prescribed for conditions that are unrelated to

[00:20:57] Speaker 00:
Yes, Sansone does describe other exclusion criteria for these patients, but that does not affect the fact that fematidine and methotrexate are also indicated for other indications that are not included or do not overlap with that of periodic paralysis.

[00:21:14] Speaker 01:
My question is, if the drugs that are explicitly excluded from concomitant use in Sansone

[00:21:21] Speaker 01:
if there's a greater relationship between why those other drugs are administered?

[00:21:26] Speaker 01:
Is it more likely that the patients are going to be taking those two drugs, and that's why he needed to exclude them?

[00:21:32] Speaker 00:
Perhaps.

[00:21:33] Speaker 00:
I mean, those indications may have had some relationship to periodic paralysis.

[00:21:38] Speaker 00:
And perhaps that is the reason those were specifically listed.

[00:21:41] Speaker 01:
So how do we get to, I mean, our cases, maybe there's a basis.

[00:21:46] Speaker 01:
And I know the board tried to distinguish Novartis in the cases, and you do too.

[00:21:50] Speaker 01:
But the language in the case is about it necessarily is or it explicitly inherently describing inherency.

[00:21:57] Speaker 01:
How does this rise to the level of inherency?

[00:22:00] Speaker 01:
We just got silence.

[00:22:03] Speaker 00:
So here what the board and examiner both found is that

[00:22:07] Speaker 00:
It is necessarily true that at least one patient in Sansone was not taking fematidine or methotrexate.

[00:22:15] Speaker 03:
Can I just stop you for a second?

[00:22:16] Speaker 03:
You're saying necessarily true.

[00:22:18] Speaker 03:
This is an anticipation rejection by examiner and affirmed by the board.

[00:22:23] Speaker 03:
Is this an anticipation by inherency or anticipation in fact, based on a factual assessment of Sansone, which is

[00:22:31] Speaker 00:
So the board did say that this is anticipation based on inherency, because it does not say.

[00:22:38] Speaker 00:
The examiner said that a skilled artisan would accept that there would be no teaching.

[00:22:44] Speaker 00:
So I think the examiner was a little more explicit.

[00:22:46] Speaker 03:
The examiner was saying it would always happen.

[00:22:48] Speaker 00:
The examiner was saying it would always happen.

[00:22:50] Speaker 03:
That means inherence.

[00:22:51] Speaker 00:
That means anticipation by inherence.

[00:22:54] Speaker 00:
Inherency, correct?

[00:22:55] Speaker 00:
Correct.

[00:22:57] Speaker 03:
So I'm just asking how should we be viewing this case?

[00:23:01] Speaker 00:
We should be, you should be reviewing this case as an inherency case based on anticipation because Sandstone's teachings would make it clear to one of skill in the arts that a patient was necessarily not taking these other drugs.

[00:23:15] Speaker 01:
I'm confused now because I thought the board very clearly said we're just looking for one person.

[00:23:20] Speaker 01:
That is correct.

[00:23:22] Speaker 01:
We're just looking for one person.

[00:23:27] Speaker 04:
And it's likely that there's one person, not that there's always one person.

[00:23:33] Speaker 04:
So the board did say that at least one person is not taking... It's likely, and as I understand Mr. Millican, he comes close to conceding that it is likely that there is at least one person.

[00:23:50] Speaker 04:
But I don't see that the evidence supports necessarily.

[00:23:55] Speaker 04:
That is 100% likelihood that there is one person.

[00:23:59] Speaker 04:
That's the difficulty.

[00:24:01] Speaker 03:
So it might be helpful to look at the board decision and see whether this at least one is the holding or whether that's an observation based on adopting the examiner's theory of complete inherency.

[00:24:16] Speaker 00:
So if we first look at the 405 case.

[00:24:19] Speaker 00:
We can look at, say, page APPX 10.

[00:24:22] Speaker 00:
Let's turn to that page.

[00:24:23] Speaker 03:
So we're looking at the 405?

[00:24:25] Speaker 00:
The 405, which is the Humanity Incase.

[00:24:28] Speaker 04:
What page of the appendix?

[00:24:29] Speaker 00:
APPX 10.

[00:24:34] Speaker 03:
So we're looking at the examiners.

[00:24:37] Speaker 00:
We're looking at the board's decision.

[00:24:39] Speaker 03:
The board's decision at APPX 10.

[00:24:45] Speaker 00:
And in that case, in this case, the board indicated that when we weigh the totality of the evidence, we conclude that a preponderance of this evidence supports the examiner's determination that Sanson is anticipatory to the claim.

[00:25:00] Speaker 00:
And what the board explained is that 36 subjects in the trial were administered dichlorofenamide.

[00:25:07] Speaker 00:
And it is necessary that only one of these patients did not take famatidine to be anticipatory to the claim.

[00:25:14] Speaker 00:
And I think it might be also helpful to note that in that case, in this clinical trial, only one patient had a condition of gastrointestinal distress.

[00:25:26] Speaker 00:
And so if any patient was taking fematidine, it would be that one patient.

[00:25:32] Speaker 00:
But the 35 other subjects were not taking it.

[00:25:34] Speaker 01:
But I don't understand this paragraph at all.

[00:25:36] Speaker 01:
So it says, the board acknowledges, it is necessary that only one of these patients did not take

[00:25:43] Speaker 01:
from model, whatever, to be anticipatory to the claim, right?

[00:25:48] Speaker 01:
And then they turn to, appellant did not provide evidence.

[00:25:54] Speaker 01:
Is that a kind of shifting of the burden there?

[00:25:57] Speaker 01:
But they do describe that.

[00:25:59] Speaker 01:
They have a paradigm in their claim.

[00:26:00] Speaker 01:
They say that under the examination, the examiner says this, and then the burden of production, I assume, shifts to the appellant to come up with, to disprove that.

[00:26:13] Speaker 00:
So what the board was explaining here is that the examiner made its prima facie case.

[00:26:19] Speaker 00:
It met its prima facie burden to show that substantial evidence supported the fact that a skilled artisan reading Sansoni would accept that by not listing famatidine or methotrexate, none of the patients were taking those drugs.

[00:26:35] Speaker 00:
So that was the initial prima facie case.

[00:26:38] Speaker 04:
If you look at the prior page, A9, and the last sentence on the page,

[00:26:43] Speaker 04:
They make clear, the board makes clear, that their findings, it's more likely than not that at least one patient is not taking this.

[00:26:53] Speaker 04:
That's the standard they're applying.

[00:26:55] Speaker 00:
Sorry, where did you see more likely than not?

[00:26:56] Speaker 04:
It's the thus weather.

[00:26:58] Speaker 04:
The thus weather sentence at the bottom.

[00:27:00] Speaker 04:
That's whether the evidence makes clear that the descriptive matter is necessarily present as determined by the preponderance of the evidence more likely than not in the record.

[00:27:09] Speaker 04:
What they're saying is it's more likely than not that at least one person is not taking the other drug.

[00:27:17] Speaker 00:
I think what the board is saying there is that the more likely than not relates to whether the preponderance of the evidence shows that.

[00:27:25] Speaker 00:
They're not saying that it's more likely than not

[00:27:31] Speaker 00:
one person didn't take it.

[00:27:32] Speaker 00:
They're saying that there is enough evidence there to show that at least one person was necessarily not taking fematidine or methotrexate in addition to dichlorofenamide.

[00:27:48] Speaker 01:
I don't understand that.

[00:27:49] Speaker 01:
It's like a two-step.

[00:27:50] Speaker 01:
They've got a two-step.

[00:27:52] Speaker 01:
It's as if the examiner said,

[00:27:55] Speaker 01:
I believe conclusively that one person did not take it.

[00:27:59] Speaker 01:
Yes.

[00:28:00] Speaker 01:
And then they say, well, we're applying preponderance of the evidence to that finding.

[00:28:05] Speaker 01:
And we think it's more likely or not that that finding is correct.

[00:28:10] Speaker 01:
But what I'm missing is, did the examiner actually say that?

[00:28:14] Speaker 01:
Did he say it's necessarily, it's 100% clear that there's a person?

[00:28:19] Speaker 01:
And then they apply the preponderance of evidence?

[00:28:22] Speaker 00:
Well, the examiner, let's turn to the methotrexate example, because there is a section of the examiner's answer in the record here.

[00:28:32] Speaker 00:
And at 615, what the examiner explains, this is at the bottom half of the page.

[00:28:43] Speaker 00:
615.

[00:28:47] Speaker 00:
It's the 660, sorry, yes.

[00:28:50] Speaker 00:
615.

[00:29:00] Speaker 00:
And here what the examiner explains is that because this is a detailed experimental procedure in San Soni, it's a clinical trial, that without mentioning the co-administration of these other drugs,

[00:29:16] Speaker 00:
The Sansome teaches that one is inherently avoiding the co-administration of these other drugs.

[00:29:27] Speaker 00:
And so that is what the finding that was made by the examiner.

[00:29:31] Speaker 01:
Wait, so you're saying it says, so in the instant case, it will be universally accepted that the administration of methothexate is not necessarily present.

[00:29:43] Speaker 01:
when administering those law.

[00:29:46] Speaker 01:
And that's it?

[00:29:46] Speaker 01:
That's the finding you're talking about?

[00:29:49] Speaker 00:
Yes.

[00:29:49] Speaker 00:
And that is because this is a clinical trial directed to treating patients with periodic paralysis.

[00:29:55] Speaker 00:
And the absence of any mention of methotrexate or famatidine is indicative that these patients were necessarily not taking those drugs in combination with dichlorofenamide.

[00:30:08] Speaker 01:
So silence does it all for them?

[00:30:10] Speaker 00:
Silence does it all.

[00:30:11] Speaker 00:
Silence, I would say silence in combination that one of skill in the art would understand that these drugs are not administered for the condition that these patients are being treated for.

[00:30:22] Speaker 03:
And that shifts, that's the prima facie case?

[00:30:25] Speaker 00:
Correct.

[00:30:25] Speaker 00:
That's the prima facie case.

[00:30:26] Speaker 03:
And that's the way both of these patents were treated at the examiner level.

[00:30:31] Speaker 00:
That is correct.

[00:30:31] Speaker 03:
As a prima facie matter, and that's the board's decision, greeted that and decided it on that basis, didn't it?

[00:30:37] Speaker 00:
That is correct.

[00:30:39] Speaker 00:
And the burden then shifted to StrongBridge to show that there would have been some sort of relationship between those patients who were being treated for periodic paralysis and those conditions that

[00:30:52] Speaker 00:
We're being treated by Fematidine and Methotrexate, but Strongbridge never showed any relationship.

[00:30:59] Speaker 03:
How do we decide whether or not the prima facie case was properly established?

[00:31:04] Speaker 03:
Is that a fact question?

[00:31:06] Speaker 00:
That is a fact question.

[00:31:07] Speaker 00:
And here, substantial evidence supports that.

[00:31:10] Speaker 00:
Due to Sandstone's silence, as well as the fact that one of skill in the art would understand that these drugs are not administered for periodic paralysis.

[00:31:18] Speaker 03:
Silence plus the lack of any relationship.

[00:31:20] Speaker 03:
Correct.

[00:31:24] Speaker 03:
And are we looking at this as how one of skill and the art would have looked at Sanson to create the prima facie case, or is this simply the prima facie case being created in the examiner's mind?

[00:31:36] Speaker 00:
This is the prima facie case based on what one of skill and the art would have understood based on Sanson's teachings.

[00:31:44] Speaker 00:
And that is what the examiner also weighed in determining that the prima facie case here was met.

[00:31:51] Speaker 04:
I'm not sure that this is correctly

[00:31:53] Speaker 04:
termed an inherency situation.

[00:31:56] Speaker 04:
Under the claim construction, it seems to me that it doesn't necessarily have to be that there was somebody in the study who was not taking the other drugs.

[00:32:07] Speaker 04:
It seems to me that it's only necessary to show that it's likely, more likely than not, that at least one person is not taking these other drugs, which does not fit easily into the inherency paradigm.

[00:32:24] Speaker 00:
I think the examiner and the board were relying on inherency because it does not explicitly say that these patients were not taking methotrexate.

[00:32:37] Speaker 04:
The point is that under the claim construction, it doesn't have to be explicit.

[00:32:41] Speaker 04:
That's the whole point of the claim construction.

[00:32:43] Speaker 04:
All it requires is that it be there, not be there.

[00:32:47] Speaker 00:
Right.

[00:32:47] Speaker 00:
And the claim construction simply says that these patients are not taking these other drugs and had Sansone

[00:32:54] Speaker 00:
explicitly said that these patients were not taking these other drugs, then perhaps that would have been an express anticipation.

[00:33:01] Speaker 00:
But because it was silent, it is inherent that these patients were not taking these other drugs.

[00:33:09] Speaker 00:
I understand that it's awkward, that the phraseology is awkward because this is a negative limitation.

[00:33:16] Speaker 00:
But that is the finding that was made by the examiner and the board, that here because one could

[00:33:22] Speaker 04:
one of Skill in the Art would read the Samsoni teaching as... Well, the problem that I'm having is if, take a cohort of 37 patients, I mean, there could be, it is possible that there could be a situation in which every one of them is taking pepsin.

[00:33:40] Speaker 04:
It's possible.

[00:33:41] Speaker 04:
Not very likely, but it's possible.

[00:33:43] Speaker 04:
But if the proof is that it has to be 100% of the time, that each and every one of those

[00:33:53] Speaker 04:
patients is not 100% of the time that one of the patients is not taking Pepsid.

[00:33:59] Speaker 04:
I'm not sure that that finding would be supported by the record here.

[00:34:06] Speaker 00:
Well, I would dispute that only because in the Sans-Sony clinical trial, only one patient out of those 36 patients

[00:34:17] Speaker 00:
was reported as having gastrointestinal distress.

[00:34:21] Speaker 00:
And so in that case, only one patient would be taking Pepsid.

[00:34:25] Speaker 00:
These other patients had reported no gastrointestinal distress.

[00:34:30] Speaker 00:
So the other patients were necessarily not taking.

[00:34:34] Speaker 04:
I think the board finding that it's likely, that last sentence on page 9, that at least one of them is not taking Pepsid is supported by substantial evidence.

[00:34:45] Speaker 04:
That's true.

[00:34:46] Speaker 04:
But I'm not sure that a board finding that in 100% of the cases, there's always one person that's not taking PEPs that is supported by substantial evidence.

[00:34:56] Speaker 04:
That's the problem on that.

[00:34:59] Speaker 00:
I think based on the evidence that was before the board and the examiner, because at least 35 of the patients did not report any gastrointestinal distress, at least then one of those patients was not taking fomatidine.

[00:35:14] Speaker 00:
And that is what the board and examiner

[00:35:16] Speaker 00:
based its decision on, that there is at least one patient in these studies that was not taking thematidine or methotrexate in combination with dichlorofenamide to treat periodic paralysis.

[00:35:29] Speaker 00:
Because there's no relationship between those drugs.

[00:35:35] Speaker 04:
OK.

[00:35:35] Speaker 04:
All right.

[00:35:36] Speaker 04:
We're out of time, I think.

[00:35:37] Speaker 00:
If there are no further questions, we ask that you reform the decision.

[00:35:40] Speaker 04:
OK.

[00:35:42] Speaker 04:
Mr. Millican?

[00:35:55] Speaker 02:
Thank you, Your Honors.

[00:35:57] Speaker 02:
Judge Dyke, I agree with you.

[00:35:59] Speaker 02:
This case does not fit well into an inherency paradigm.

[00:36:03] Speaker 02:
And that's kind of the point.

[00:36:05] Speaker 02:
As Judge Bryson put it in the Pernix case that we relied on in the briefs, a modification of a method of treatment is not a necessarily present property in a far art reference that doesn't say anything about that modification.

[00:36:19] Speaker 01:
Let me ask you, what if a sense only had an appendix?

[00:36:22] Speaker 01:
And it was a long while ago, so an appendix at least

[00:36:28] Speaker 01:
And one of those patients happened to check the box, which I'm not taking any other drugs.

[00:36:33] Speaker 02:
In that case, that would be an express anticipation, I think, if that were the background.

[00:36:38] Speaker 01:
So you would want for that to be sufficient.

[00:36:42] Speaker 01:
So why isn't it sufficient under a preponderance standard that the board... Why are we supposed to say there's not substantial evidence to support the board's conclusion

[00:36:55] Speaker 01:
Given what it had about the differences of drugs and all this other stuff that they were to accept That one patient was not doing it given in the absence of your coming forward with any information Given the thing it's like, you know, you can have a claim that says that you're taking a certain drug and you shouldn't take it with Cheerios I mean, this is just you know, there's some things that just don't come out in the prior art but what why on our

[00:37:23] Speaker 01:
standard of review, can we not accept that the board said a person skilled in the art would have thought that at least one patient would have done?

[00:37:33] Speaker 02:
Because that is precisely the kind of possibilities and probabilities reasoning that is foreclosed by this court's inherency cases.

[00:37:42] Speaker 02:
The crux of the board's reasoning, and Judge Dyke, I think you share this view, is it is likely that at least one patient in the trial wasn't taking methotrexate or famotidine.

[00:37:55] Speaker 02:
We'll accept that for the sake of argument.

[00:37:57] Speaker 02:
Our point is that that is not enough for inherent anticipation.

[00:38:01] Speaker 02:
You have to show not just that it is likely that the missing limitation is in the prior art, or even very likely, you have to show that it is the inevitable consequence of what is expressly in the prior art.

[00:38:14] Speaker 02:
That showing has not been made here.

[00:38:16] Speaker 02:
The examiner and the board did not even try to make that showing.

[00:38:19] Speaker 02:
Instead, they merely relied on the references silence.

[00:38:24] Speaker 02:
And silence is not disclosure.

[00:38:26] Speaker 02:
It's not expressed disclosure.

[00:38:28] Speaker 02:
It's not inherent disclosure.

[00:38:31] Speaker 02:
I see that I'm over my time.

[00:38:33] Speaker 01:
What about silence, if it's attached?

[00:38:36] Speaker 01:
Your friend said there was some evidence in the record that they all had to indicate what other medicines they were taking, what other conditions they had.

[00:38:44] Speaker 01:
And so every one of the 38 people in the study said, we don't have this condition.

[00:38:50] Speaker 02:
So to the extent there's evidence related to that point in the record here, it supports us, not them, because Sansone has exclusion criteria that say patients taking these categories of drugs were excluded from this study.

[00:39:07] Speaker 01:
I know, but maybe that's because certain drugs, it's likely that both patients would be taken.

[00:39:13] Speaker 01:
But if a drug, it's not likely, what if the patients all said,

[00:39:18] Speaker 01:
We don't have a gastrocondition.

[00:39:21] Speaker 01:
We're not taking any medication to treat this condition.

[00:39:25] Speaker 01:
That's sufficient, right?

[00:39:27] Speaker 02:
That sounds to me like more of an obviousness argument.

[00:39:32] Speaker 02:
If the argument were, we know that famotidine is only used to treat, say, this category of gastroconditions.

[00:39:42] Speaker 02:
We know that all of the patients in this study said, we don't have any of these gastroconditions.

[00:39:48] Speaker 02:
I think you're having to make some logical inferences that would be more at home in an obviousness analysis than an anticipation one.

[00:39:55] Speaker 02:
Maybe you could get there through inherency if you found that a skilled artisan would conclude necessarily it is inevitable that these patients who didn't have these conditions would not have been taking famotidine.

[00:40:08] Speaker 02:
We might have a different case.

[00:40:09] Speaker 02:
Maybe that you could sustain an inherency rejection on that fact pattern.

[00:40:14] Speaker 02:
But that's not the fact pattern that we have here.

[00:40:16] Speaker 03:
On that claim construction issue, why don't I ask you whether or not one of these patents has been met?

[00:40:21] Speaker 03:
at some stage of the game had solved the problem of active involvement.

[00:40:25] Speaker 02:
Yes, Your Honor.

[00:40:26] Speaker 03:
I was looking at Appendix 75.

[00:40:28] Speaker 03:
I think this is talking about the 606, and it talks about a situation which also provided with a method for administering the main drug, but also informing the subject or a medical care worker that a co-administration of an OITI substrate is not recommended.

[00:40:48] Speaker 03:
Yes, so in this is in the specification and yes, there are examples of methods and also Approved provided as a method so it suggested to me that somewhere that was at least contemplating in active involvement by the physician And I couldn't tell because the whole file history wasn't presented in either one of these cases but it looked to me like at some stage would actually been a claim and

[00:41:15] Speaker 02:
understand your honor so this this is an example method that's provided in the specification this is not a method that was ever presented as a claim as in you know this is what we're trying to get a patent on okay thank you thank you counsel