[00:00:02] Speaker 00:
The first case for argument this morning is 18-1-2-2-1.

[00:00:05] Speaker 00:
Mel Proppen, pharmaceuticals versus activists.

[00:00:10] Speaker 00:
Mr. Ball, whenever you're ready.

[00:00:18] Speaker 04:
If it may please the court, there are three patents that are at issue in this appeal.

[00:00:23] Speaker 04:
I'd like to focus today on one of those patents, and that is the 195 dissolution profile patent.

[00:00:29] Speaker 04:
And the sole issue on appeal with respect to the 195 is whether the district court erred in finding adequate written description for claim 11, a claim which was added by amendment years after the application was filed.

[00:00:42] Speaker 00:
Can I ask you a question about, maybe I'm confusing this with something else, but my recollection is that the district court, this is kind of a legal question, the district court seemed to base his conclusions on the fact that disclosing one of the range was sufficient for written description.

[00:01:04] Speaker 00:
And I assume you take issue with that.

[00:01:08] Speaker 00:
So, you know, this case law is a little thin on the written description area.

[00:01:13] Speaker 00:
We just haven't had that many cases.

[00:01:15] Speaker 00:
But do you, isn't that what the district court concluded or based his conclusion on?

[00:01:20] Speaker 04:
That was one of the things the district court based the conclusion on, which, if I understand the question, the district court was referring to the dissolution data in example 3, table 10,

[00:01:31] Speaker 04:
which the testimony from plaintiff's expert was that dissolution profile fell within the scope of the claim, even though there was this open issue about whether or not that was obtained using the proper USP apparatus 2 dissolution method as claimed as opposed to the unclaimed USP apparatus 1.

[00:01:51] Speaker 04:
But leaving that second issue aside, we certainly take issue with the fact that the entire range

[00:01:58] Speaker 04:
of dissolution values could be supported by this single dissolution profile.

[00:02:03] Speaker 04:
And in fact, I don't believe.

[00:02:05] Speaker 01:
But look, Mr. Ball, the dissolution profile is a result.

[00:02:11] Speaker 01:
This is a method of treating obesity which consists of steps.

[00:02:16] Speaker 01:
It's the steps of orally administering two compounds in specific amounts

[00:02:25] Speaker 01:
in sustained release form administered twice daily.

[00:02:30] Speaker 01:
Each of those is steps.

[00:02:32] Speaker 01:
You have to describe those steps to describe the invention.

[00:02:37] Speaker 01:
The dissolution profile is a result.

[00:02:42] Speaker 01:
That's not a step.

[00:02:44] Speaker 01:
So why is that relevant to satisfying the written description requirement when the steps have adequately been described?

[00:02:55] Speaker 04:
I understand the question.

[00:02:56] Speaker 04:
So the dissolution profile here is an in vitro dissolution profile.

[00:03:01] Speaker 04:
It's not the inherent result of simply taking the tablet and saying it dissolves in the patient in a certain amount of time.

[00:03:08] Speaker 01:
But there are no other steps in the claim that would create one dissolution profile versus another.

[00:03:17] Speaker 01:
The steps in the claim are all recited in the patent and therefore

[00:03:24] Speaker 01:
the written description requirement is met.

[00:03:27] Speaker 04:
The particular dissolution profile is absolutely a limitation of this claim and it's not an inherent feature.

[00:03:33] Speaker 04:
There were existing tablets that were... Is that a step in the method for you?

[00:03:40] Speaker 01:
Is the dissolution profile a step in the method claim?

[00:03:44] Speaker 04:
The dissolution profile is defining what must be a property of the tablets that are given.

[00:03:50] Speaker 04:
Those tablets have to be characterized by meeting this certain dissolution profile.

[00:03:55] Speaker 04:
In other words, according to this USP standard apparatus to paddle method, when those tablets are placed into the vessel, the in vitro vessel, and measured, they must deliver this rate.

[00:04:07] Speaker 04:
And the testimony.

[00:04:08] Speaker 01:
What makes that happen?

[00:04:10] Speaker 01:
in terms of a particular step, other than the steps that are already recited.

[00:04:16] Speaker 04:
What makes that happen is the way the tablet is engineered.

[00:04:18] Speaker 04:
It has to be constructed with sustained released excipients in a very precise way.

[00:04:24] Speaker 04:
The testimony was that it took over a year to get just that precise dissolution profile that was claimed in this patent.

[00:04:32] Speaker 01:
It's not just... This isn't a claim to formulating a capsule or a tablet that dissolves in a certain way.

[00:04:39] Speaker 01:
This is a method of treatment of obesity.

[00:04:43] Speaker 04:
And that method of treatment of obesity was in the 626 patent, the other patent that's at issue in this case.

[00:04:49] Speaker 04:
That was prior art against this.

[00:04:51] Speaker 04:
So the treatment of obesity was not invented in the 195 patent.

[00:04:55] Speaker 04:
This came years later, and it was directed solely... Well, that might mean that the claim's invalid.

[00:04:59] Speaker 04:
Well, we certainly believe the claim's invalid.

[00:05:02] Speaker 04:
But this came years later, and the sole contribution that has been claimed in this 195 is about that dissolution profile.

[00:05:11] Speaker 02:
And that was- Regarding the at least 99% dissolution over, range over eight hours, and you take issue with that.

[00:05:22] Speaker 02:
So at least 99% means that less than 1% remain.

[00:05:27] Speaker 02:
Is less than 1% an effective amount?

[00:05:32] Speaker 04:
There was no testimony certainly on this at trial whether or not one percent is an effective amount or not.

[00:05:37] Speaker 04:
Less than one percent.

[00:05:39] Speaker 04:
Less than one percent.

[00:05:41] Speaker 04:
The reality is this patent simply says nothing at all about a range of values at eight hours.

[00:05:47] Speaker 04:
There is a single data point for the at least 99% at eight hours.

[00:05:51] Speaker 04:
That is in table 10 of example three, and it says 99% exactly.

[00:05:57] Speaker 04:
Now, six years after the patent was filed, maybe it became important for the patentee to have a range of values of above 99%, but that's just not in the application as filed, not even in passing.

[00:06:11] Speaker 02:
at 18 in the Blueberry, you say the district court, quote, recognized in its questioning ellipsis the inconsistent and random selection of the upper bounds of one and two hour ranges from these passages neither made any sense nor conformed with normal scientific practice.

[00:06:30] Speaker 02:
Those were questions.

[00:06:32] Speaker 02:
How can you claim the district court's new conclusions by asking questions?

[00:06:36] Speaker 04:
Well, so the district court, and this relates to the issue from column 13 of the patent where there's disclosures of upper endpoints, where there's four different combinations that can be used for the one and two-hour upper endpoints.

[00:06:50] Speaker 04:
And the question was asked by the district court judge to Dr. Treacy, plaintiff's expert, does it make any sense to mix and match and combine these in that way?

[00:06:58] Speaker 04:
And Dr. Atresi's explanation, I mean, I'll submit, was less than compelling.

[00:07:03] Speaker 04:
And he just simply said, well, there's pharmacokinetics involved, and it may be the case.

[00:07:08] Speaker 04:
But he certainly didn't say that there was a rhyme or reason for selecting one value over the other for the upper end.

[00:07:16] Speaker 02:
So you're citing what he said.

[00:07:17] Speaker 02:
How does the district court's question equate recognition?

[00:07:22] Speaker 02:
Quite obviously.

[00:07:23] Speaker 02:
That i.e.

[00:07:24] Speaker 02:
a holding.

[00:07:25] Speaker 04:
Quite obviously the district court did disagree with us on that because ultimately the district court found that there was support for the upper end point because the district court didn't apply the blaze marks law from Inrei Russia, Fujikawa, Viva Tonneson, and this court's precedent that requires, in order to get this- You're not answering my question though.

[00:07:48] Speaker 02:
My question was, how does that questioning equate recognition?

[00:07:54] Speaker 02:
As you say, it came out the other way.

[00:07:56] Speaker 04:
You can't say the court conceded either.

[00:08:01] Speaker 02:
I don't like those words.

[00:08:02] Speaker 04:
The court obviously did not concede that there would have been no rhyme or reason to select those values because he so held in the opinion, our point being that there was never offered in this court's opinion any reason

[00:08:19] Speaker 04:
that a person of ordinary skill in the art, looking at this application, would have had the appropriate blaze marks to make this combination together with the multitude of other selections that needed to be made to get this dissolution profile.

[00:08:34] Speaker 04:
Court disagreed with you there, too.

[00:08:36] Speaker 04:
The court certainly disagreed with us because he found adequate written description for the claim, but we submit it was error, legal error on multiple grounds.

[00:08:45] Speaker 04:
One, by not even applying the correct legal standards, looking for blaze marks.

[00:08:50] Speaker 04:
What this application really discloses is in table

[00:08:55] Speaker 04:
five of example two, you've got some data.

[00:08:59] Speaker 04:
And the court went to the 15% HPMC data, plucked two data points from that curve, and used those to support the lower endpoint, even though that was USP1 data, not USP2, and even though the unrebutted testimony was that the USP1 and USP2 data are not comparable and produce different results.

[00:09:20] Speaker 00:
And is there a difference between the 10% and the 15%?

[00:09:24] Speaker 00:
HPMC on that table?

[00:09:27] Speaker 04:
There is a difference, and the testimony was that none of those fell within the scope of the claim, but I think both experts said that the 10% was too fast of a release to qualify as sustained release.

[00:09:40] Speaker 04:
But there was nothing articulated that would point specifically and say, as an integrated whole,

[00:09:49] Speaker 04:
this profile, this dissolution profile, where you need at least 99% at eight hours, even though there was no range in the patent at all.

[00:10:00] Speaker 04:
This was just invented out of whole cloth in the amendment.

[00:10:04] Speaker 04:
to say, I'm going to take this eight-hour data from Table 10, even though there's no range, I'm going to combine it with two data points from Table 5 and reject all the other data points, and then I'm going to take this aggregation of upper bounds from Column 13 and with no apparent... The district court accredited Dr. Treacy's testimony.

[00:10:30] Speaker 02:
regarding how a person's skull would understand the dissolution methods.

[00:10:37] Speaker 04:
The district court credited the testimony, but the testimony was not ever pointing to blaze marks saying, Dr. Treacy,

[00:10:47] Speaker 04:
I'll submit the same error that the district court did, which was simply look at the claim and work backwards, using the amended claim as a road map to go hunting for support in the specification.

[00:11:02] Speaker 04:
There is no way that a person of ordinary skill in the art, without foreknowledge of this amended claim that did not exist in the application, would have been directed

[00:11:13] Speaker 04:
to select those two data points from the 15% HPMC tablet, selectively pluck them out, reject the remainder of that profile, because it didn't fall within the scope of claim 11.

[00:11:25] Speaker 01:
So this claim was amended to avoid the prior off by adding a result, but not a step to achieve that result.

[00:11:36] Speaker 04:
This claim was amended.

[00:11:38] Speaker 04:
In the application that's filed, Your Honor, the original claims related to pharmacokinetic parameters, in vivo parameters, there wasn't a dissolution profile claim.

[00:11:51] Speaker 04:
The dissolution profile was presented for the very first time by amendment.

[00:11:57] Speaker 04:
You can read this patent, start to finish, and you'll never find these ranges.

[00:12:01] Speaker 04:
You'll never find a discussion of ranges of 39%

[00:12:06] Speaker 00:
But the question is why was the amendment to overcome a WD rejection or an obviousness rejection?

[00:12:15] Speaker 04:
There was no testimony about that, but my understanding is it just became desirable for the patentee to seek protection for a dissolution profile.

[00:12:23] Speaker 01:
That's because controlling obesity with naltrexone and bupropion was in the prior art.

[00:12:28] Speaker 04:
That was in the prior art.

[00:12:30] Speaker 04:
So what they were trying to do was carve out a very narrow niche around their approved drug product, Contrave, to very narrowly try to capture the dissolution profile for the Contrave drug product, which did not even exist when this application was filed.

[00:12:48] Speaker 04:
So the reason this was put in was to try to get, for the very first time, a claim to a dissolution profile.

[00:12:58] Speaker 00:
Can I move you just a quick, I know you weren't calling forward the obviousness rejection and claim one of 111 patent, but let me ask you about that.

[00:13:08] Speaker 00:
Is your argument on obviousness and what the prior art teaches necessarily predicated on our thinking that it's sufficient to disclose decreasing sugar and carbohydrate, what's the word for it, cravings?

[00:13:25] Speaker 00:
Is that, in your view, equivalent to trying to achieve weight loss?

[00:13:30] Speaker 00:
And is that necessary?

[00:13:31] Speaker 00:
Or is your view that the prior art also disclosed not just the diminishing cravings, but also the weight loss that accompanied that?

[00:13:40] Speaker 04:
For the 111, I would say all of that is irrelevant because it's a composition of matter patent, and it's all but anticipated by claim 19 of the O'Malley patent, even though we argued it as obviousness.

[00:13:51] Speaker 04:
The intended result for treating obesity is not a limitation of the 111.

[00:13:58] Speaker 04:
So that one stands apart a little bit.

[00:14:01] Speaker 02:
Is decreased increased the same as decreased?

[00:14:05] Speaker 04:
Well, and that goes to the 626.

[00:14:07] Speaker 04:
So the essential answer is we would say yes.

[00:14:10] Speaker 04:
And the question there was O'Malley used the same combination, sustained release, naltrexone and bupropion for preventing weight gain.

[00:14:22] Speaker 02:
It's for decreasing weight gain when you stop smoking.

[00:14:26] Speaker 04:
Yes, for inhibiting the weight gain, and that was because of appetite control.

[00:14:31] Speaker 04:
That was because it causes you to eat less, have less hunger cravings, and the position was that necessarily in an obese population is going to lead to the same appetite control and reduced cravings.

[00:14:44] Speaker 04:
I see that I'm well into my rebuttal time, so I'll rest unless there's further questions.

[00:15:06] Speaker 00:
Good morning.

[00:15:07] Speaker 02:
Good morning.

[00:15:07] Speaker 02:
May I please the court?

[00:15:08] Speaker 02:
The claims were amended to remove the reference to standard dissolution test and replace it with the specific reference to the paddle method.

[00:15:18] Speaker 02:
What does that mean to us?

[00:15:20] Speaker 03:
Well, I think what it means for purposes of infringement, you need to use that specific paddle method.

[00:15:24] Speaker 03:
But if you look in terms of the 112 issues, the patent is clear that USP-1 and USP-2 are equivalent to one another.

[00:15:34] Speaker 03:
Our experts testified that they're equivalent.

[00:15:37] Speaker 03:
And Dr. Mayerson effectively

[00:15:40] Speaker 03:
said that they were equated to one another.

[00:15:42] Speaker 03:
And in addition, another important fact is that when in that amendment, when asked for support for the dissolution ranges, the inventors pointed to Table 5, which actually uses USP-1.

[00:15:54] Speaker 03:
So when you read the prosecution history as a whole, one skill not would understand that for purposes of 112, the differences in the paddle are not substantial.

[00:16:07] Speaker 01:
Regarding validity, these references pretty much show naloxone and bupropion for weight loss.

[00:16:20] Speaker 03:
So, Your Honor, if I understand your question correctly, we're turning to the obviousness issues, and I think... Well, Your Honor, I think the most important thing about the obviousness is that we need to look at the ARDA as a whole.

[00:16:33] Speaker 03:
And what is unrefuted and not denied by activists is that there were numerous failures in the obesity art at the time of the filing.

[00:16:41] Speaker 03:
In fact, there were only three approved products for obesity as of 2003.

[00:16:46] Speaker 03:
One was FENFEN, which I think everyone knows was withdrawn by then.

[00:16:49] Speaker 03:
The other two products, one was withdrawn shortly thereafter, and the third one had significant side effects.

[00:16:56] Speaker 03:
And the reason that this is important is that that's why the district court said that the defendants were using hindsight, because in this art, when there's all these failures, you need to use hindsight to pick that combination.

[00:17:07] Speaker 03:
When you look at the references themselves,

[00:17:10] Speaker 03:
When you look at them closely, this is what you'll find.

[00:17:12] Speaker 03:
You've got the Jane reference, which talks about bupropion having a modest at best weight loss effect.

[00:17:19] Speaker 03:
In fact, if you look at the data on bupropion, the average weight of the... Excuse me.

[00:17:24] Speaker 01:
How about Dante?

[00:17:25] Speaker 03:
Right.

[00:17:26] Speaker 03:
So Dante, you're under... So O'Malley, Dante, and Bernstein are sort of in the same bucket.

[00:17:31] Speaker 03:
None of them were directed to treating obesity.

[00:17:34] Speaker 03:
So O'Malley was to nicotine withdrawal.

[00:17:37] Speaker 01:
But this is a composition.

[00:17:39] Speaker 03:
The key issue there, Your Honor, is that the actual disease state that the patient has is very important because the neurochemistry of each one of those patients is different.

[00:17:50] Speaker 03:
A person who has smoking cessation issues may not have the same thing going on either in their neural system or otherwise than a person who is obese.

[00:17:58] Speaker 03:
And in fact, a person who has smoking cessation could be skinny as a rail and not have any obesity issues.

[00:18:03] Speaker 03:
The same thing for Bernstein, which goes to the carbohydrate craving.

[00:18:06] Speaker 03:
Judge Prost, you raised that before.

[00:18:08] Speaker 03:
The testimony on the record that was credited by the district court from Dr. Seeley is that they're not the same.

[00:18:13] Speaker 03:
The carbohydrate craving doesn't necessarily mean weight loss.

[00:18:17] Speaker 00:
So I think when you look at the record, if you look at it as O'Malley, Dante, and- Well, but Dante, doesn't Dante provide specific examples and talk about weight loss, saying refers to one obese man

[00:18:29] Speaker 00:
and no longer craved sweets and reported losing about 10 pounds a week.

[00:18:36] Speaker 00:
Then a woman, I think, cravings, it diminished her cravings, and she lost 30 pounds in three weeks.

[00:18:45] Speaker 00:
So there's a reference there that correlates the sort of diminishment of cravings to a weight loss, right?

[00:18:51] Speaker 03:
Well, I would disagree, Your Honor.

[00:18:52] Speaker 00:
First of all, you disagree with what I said the reference teaches?

[00:18:56] Speaker 03:
They don't correlate.

[00:18:57] Speaker 03:
Well, they talk about weight loss.

[00:18:59] Speaker 03:
But the only testimony on examples two and three was from our expert.

[00:19:04] Speaker 03:
Defendants experts didn't rely on example two and three at all.

[00:19:07] Speaker 03:
And what our experts said is that those patients were very complicated.

[00:19:10] Speaker 03:
And if you look at what went on with those patients, what it effectively says is that the carbohydrate craving came on as a result of the other drugs they were taking.

[00:19:19] Speaker 03:
So they were taking some other antidepressant.

[00:19:20] Speaker 01:
But you have several references here.

[00:19:23] Speaker 01:
And why does testimony control here when we can simply read the references?

[00:19:29] Speaker 03:
Because as our expert explained, these patients are very, the disease states that they have are very different and very specific.

[00:19:36] Speaker 03:
So I don't think that as a lay person, you can look at these references and say, well, I know exactly what's going on.

[00:19:42] Speaker 03:
We had medical doctors, both sides had medical doctors take the stand, opportunity to provide testimony and direct and cross.

[00:19:49] Speaker 03:
The fact of the matter is the district court credited our expert and did not credit

[00:19:54] Speaker 03:
active as experts, even including testimony regarding examples two and three of Dante.

[00:20:01] Speaker 02:
What about that fax?

[00:20:04] Speaker 03:
Yeah, the Gaddy fax yesterday.

[00:20:05] Speaker 02:
Yes.

[00:20:06] Speaker 03:
So the district court got it right.

[00:20:09] Speaker 02:
The Gaddy fax was in... What the district court in effect said was, well, you don't have anything to back that up.

[00:20:15] Speaker 03:
Right, you don't have corroboration.

[00:20:16] Speaker 03:
And the case law is pretty straightforward on corroboration.

[00:20:19] Speaker 03:
The Finnegan case says you need some corroboration.

[00:20:22] Speaker 03:
It's not good enough just to put it in a document without independent corroboration.

[00:20:26] Speaker 02:
But it seems to me that even the testimony was sort of waffle.

[00:20:32] Speaker 03:
well it was roughly i think the other thing to keep in mind was getting getting things the same really remember what i did exactly he did not say i remember treating these patients and this would happen and in fact if you look at the table the result of so there's six patients in that table

[00:20:48] Speaker 03:
The first four are naltrexone and phylloxetine.

[00:20:52] Speaker 03:
The last two are naltrexone and bupropion.

[00:20:55] Speaker 03:
And for both, they said one had no effect, and the other, the effects were questionable.

[00:21:00] Speaker 03:
So even if you were to assume everything came in, that is not enough to say that the combination would be a success.

[00:21:06] Speaker 00:
Can I take it back to where you started on your own description?

[00:21:09] Speaker 00:
I think your first point was that they were substantially equivalent, the two-task disclosure.

[00:21:17] Speaker 00:
Do you have a case in written description where we said disclosure showing possession if something of something substantially equivalent satisfies the written description?

[00:21:29] Speaker 00:
Because that's just another leap.

[00:21:32] Speaker 00:
And I know the tests may be confusing at times, but is there a case that says that?

[00:21:37] Speaker 03:
The Lockwood case, that's right, thank you.

[00:21:40] Speaker 03:
The Lockwood case says that, that information that was substantially equivalent could be used to show the support for the written description.

[00:21:48] Speaker 01:
The Lockwood case held that you don't show written description by showing something that is obvious.

[00:21:56] Speaker 03:
That's correct.

[00:21:56] Speaker 03:
It did say that.

[00:21:57] Speaker 03:
And I know, Your Honor, you wrote the Lockwood decision, and I've looked at that.

[00:22:00] Speaker 03:
But it also has this other secondary issue about whether something is equivalent or not would be allowed to do it.

[00:22:06] Speaker 00:
But I agree that- So if you've got a disclosure of a particular test, an absolutely particular test, then you can satisfy written description by saying, well, this is another test.

[00:22:17] Speaker 00:
but it's substantially equivalent.

[00:22:19] Speaker 00:
I don't know what that means.

[00:22:20] Speaker 00:
Maybe function way results?

[00:22:22] Speaker 03:
Well, I don't think that they're challenging that the USP-2 paddle was not described by the patent.

[00:22:28] Speaker 03:
They're not saying that the claim is invalid because of the USP.

[00:22:31] Speaker 03:
They're saying that the data that was obtained was not using that particular test.

[00:22:36] Speaker 03:
But the patent makes clear that it could be USP-1 or an equivalent.

[00:22:39] Speaker 03:
So the patent itself opens up the possibility of having an equivalent test satisfy the written description.

[00:22:45] Speaker 00:
Well, but the claim requires a particular test, right?

[00:22:51] Speaker 00:
I mean, we're driven by the claim, even if the specification has other tests in it.

[00:22:57] Speaker 00:
We've got this test here, right?

[00:22:59] Speaker 00:
Infringement is going to be determined by this test.

[00:23:02] Speaker 03:
Yes, Your Honor.

[00:23:02] Speaker 00:
Right?

[00:23:03] Speaker 00:
So does Lockwood say a substantially equivalent

[00:23:09] Speaker 00:
Test or whatever.

[00:23:10] Speaker 00:
I don't remember.

[00:23:11] Speaker 03:
Well, I think I think what the point is is the question goes back to well are the the so let me back up just a little bit on this because we When I would start from the beginning and let me ask showing for you too.

[00:23:22] Speaker 02:
Is there evidence that the two tests?

[00:23:27] Speaker 02:
Dissolution test produce the same results as

[00:23:30] Speaker 03:
Well, in fact, the district court criticized Dr. Mayerson for not coming forward with that test.

[00:23:35] Speaker 03:
He theorized that they would give different results, but he never said that they actually did.

[00:23:39] Speaker 03:
They never showed any data.

[00:23:40] Speaker 03:
Of course, it's active as a burden of proof to show, in fact, that they provide different results.

[00:23:45] Speaker 00:
And if you look... Well, that's not necessary.

[00:23:47] Speaker 00:
I don't know.

[00:23:47] Speaker 00:
That's my question.

[00:23:49] Speaker 00:
If you disclose something in the claim that's specific,

[00:23:52] Speaker 00:
And then in the spec, you use something else, and you've got testimonies saying they're substantially equivalent.

[00:23:58] Speaker 00:
I'm not clear who's got the burden to show what there, right?

[00:24:02] Speaker 03:
Right, but I think at the end of the day...

[00:24:05] Speaker 03:
We don't... Neither side submitted any testing data on that point, Your Honor.

[00:24:12] Speaker 03:
So the point is, if you look at the claim, the claim is to a dissolution range.

[00:24:18] Speaker 03:
And as the judge pointed out, if you run a dissolution test, you get one point.

[00:24:23] Speaker 03:
But of course, we all know that dissolution tests could vary from test to test.

[00:24:26] Speaker 03:
So the inventors have the right to claim the full scope of what they reasonably believe to be their invention.

[00:24:33] Speaker 03:
And what they said in that amendment is that we believe that the claimed invention would have particular dissolution profile.

[00:24:40] Speaker 03:
And they based that profile based on data in the patent.

[00:24:44] Speaker 03:
And that's all they were required to do.

[00:24:46] Speaker 03:
They were required to have data in the patent or something in the patent for those particular numbers.

[00:24:51] Speaker 00:
Well, except that was my question to your friend, so maybe you can segue to that, which is the district court seemed to me to depend on the fact that, well, they didn't, the tests that described in the specification did not have to include the entire range as long as they disclosed one point on that range.

[00:25:10] Speaker 00:
And that's all table five or table ten at the best do, right?

[00:25:15] Speaker 00:
They don't disclose the entire range.

[00:25:17] Speaker 03:
Right, they don't enclose the entire range for the very reason I just gave, which is that they only provide one point.

[00:25:22] Speaker 03:
So you need to have more than one point for a range.

[00:25:24] Speaker 03:
So what the district court said, it was reasonable for the inventors to take the 15% dissolution data from Table 5, which was the first time that there was actually sustained release.

[00:25:34] Speaker 03:
The testimony from both experts was that the 5 and the 10 were immediate release.

[00:25:38] Speaker 03:
So that became the lower range.

[00:25:40] Speaker 03:
And they went to the specification where it says the higher range could be, I think it was 70%.

[00:25:45] Speaker 03:
And because the data only gives you one point, in order to come up with a range, you have to go somewhere else to develop it, whether it be from a discussion and a specification or other dissolution data.

[00:25:55] Speaker 03:
And that's all that the applicants did, and the district court understood that and ruled in our favor.

[00:26:02] Speaker 02:
Talk about your less than one percentage.

[00:26:08] Speaker 02:
more than 99%.

[00:26:09] Speaker 03:
Well, I think dissolution data, once you get to 99%, it's essentially complete.

[00:26:15] Speaker 03:
And that's what the court found.

[00:26:16] Speaker 03:
And the claim doesn't say 99 to 100.

[00:26:18] Speaker 03:
It says at least 99.

[00:26:20] Speaker 03:
And so there was data in the spec that said 99 at eight hours.

[00:26:24] Speaker 03:
And so whether 1% is effective or not, we would need to look at other data.

[00:26:28] Speaker 03:
I'm not sure dissolution data would provide that information.

[00:26:31] Speaker 03:
But what they're trying to do with the dissolution data is describe the sustained release properties of the drug that's being administered.

[00:26:38] Speaker 03:
And that was different than the prior art.

[00:26:40] Speaker 03:
So this whole bit about 99% needs to be arranged.

[00:26:44] Speaker 03:
I'm not even sure I understand all their argument.

[00:26:46] Speaker 03:
The bottom line is that 99% is essentially the same as 100.

[00:26:50] Speaker 03:
So it covers 99% or above.

[00:26:52] Speaker 03:
And that's the way the claim limitation reads.

[00:26:57] Speaker 03:
Absent any other questions, I give up the rest of my time.

[00:27:13] Speaker 04:
I would just like to address just a couple of quick points that were made there.

[00:27:17] Speaker 04:
First of all, the Lockwood case absolutely does not say that something that is substantially equivalent is the same as the invention itself.

[00:27:25] Speaker 04:
The holding of Lockwood is directly contrary to that.

[00:27:27] Speaker 04:
It says you show possession by showing the invention, including all of its claimed limitations, not possession of something that renders that obvious.

[00:27:36] Speaker 04:
So you don't show possession of an invention by showing something similar to the invention.

[00:27:41] Speaker 04:
And that's the gist of plaintiff's argument.

[00:27:43] Speaker 04:
as to why the example two data should somehow support this claim.

[00:27:47] Speaker 04:
But now, as a factual matter, the evidence is that they are not similar.

[00:27:52] Speaker 04:
The testimony that was not even considered or in the district court's opinion by the inventor in 36 witnessed Dr. Saltero testified, the inventor of this patent testified, that the results of USP1 and USP2 are not comparable to one another.

[00:28:11] Speaker 04:
You started to say it wasn't considered by the court.

[00:28:13] Speaker 04:
It's not mentioned in the opinion whatsoever, so there's no indication that the judge did consider this evidence.

[00:28:19] Speaker 04:
But it's critical, because it goes to the fundamental issue for the written description, which is disclosure of USP-1 does not indicate possession of those same values as measured by USP-2.

[00:28:32] Speaker 04:
And Dr. Saltera said there's no even accepted rule of thumb for converting between USP-1 and USP-2, and that for contrave, the drug product,

[00:28:42] Speaker 04:
it matters whether you use the USP-1 technique or the USP-2 technique, because you get different results for the very drug that we're talking about here.

[00:28:52] Speaker 04:
So that was clear error for the district court judge to either overlook or ignore this testimony.

[00:28:57] Speaker 04:
And that's all at appendix 11319 through 11321, the testimony of Dr. Saltero.

[00:29:06] Speaker 04:
Then very quickly,

[00:29:09] Speaker 04:
The council said that a single data point doesn't support a range.

[00:29:13] Speaker 04:
We agree.

[00:29:14] Speaker 04:
So how can a disclosure of 99% exactly support a range of 99 and above?

[00:29:20] Speaker 04:
It may be a small range, but it is still a range.

[00:29:23] Speaker 01:
It may be a very small range.

[00:29:25] Speaker 04:
It is still, nevertheless, a range, and one which was not in the possession and not even mentioned in the patent as originally filed.

[00:29:33] Speaker 00:
Thank you.

[00:29:34] Speaker 00:
We thank both sides on the cases submitted.