[00:00:41] Speaker 03:
Okay, the next case before the court is case number 182361, Persian Pharmaceuticals versus Albigen Malta Operations Limited.

[00:00:51] Speaker 03:
It is an appeal from the District of Delaware.

[00:00:56] Speaker 04:
Yes, Your Honor, and I've reserved three minutes for rebuttal.

[00:01:00] Speaker 04:
This court should reverse because undisputed facts show that the district court's conclusions that the claims were obvious and lacked written description were legally wrong.

[00:01:10] Speaker 03:
As to obviousness, the district court... Those cover all the claims, right?

[00:01:14] Speaker 03:
Yes, Your Honor.

[00:01:14] Speaker 03:
So you have to win on both points.

[00:01:16] Speaker 04:
Yes, Your Honor.

[00:01:17] Speaker 03:
Okay.

[00:01:18] Speaker 04:
The district court made a factual finding that there was no guidance in our

[00:01:22] Speaker 04:
on the proper dose for hepatically impaired patients.

[00:01:26] Speaker 04:
And second, the district court made a finding that the art was unpredictable, which is the touchstone of non-obviousness.

[00:01:33] Speaker 04:
Those findings alone should have resulted in a conclusion that the claims were not obvious.

[00:01:38] Speaker 04:
And as to written description, there's no dispute that the inventors possessed the claimed invention.

[00:01:43] Speaker 04:
Example eight in the patent is the claimed invention.

[00:01:46] Speaker 03:
Couldn't we conceivably conclude that one of the

[00:01:49] Speaker 03:
one of the findings in the alternative holding was just wrong and that therefore the finding as it relates to obvious was correct or vice versa?

[00:01:59] Speaker 04:
Well here's the problem Your Honor, it's a question of perspective.

[00:02:02] Speaker 04:
So the 103 analysis is done without having any knowledge of the patent.

[00:02:08] Speaker 04:
The 102 analysis is done knowing the patent.

[00:02:10] Speaker 04:
The district court said that the prior art was unpredictable.

[00:02:14] Speaker 04:
He didn't make any carve out for any prior art that made it predictable.

[00:02:18] Speaker 04:
He said all the prior art was unpredictable in the 112 analysis.

[00:02:22] Speaker 04:
And in fact, based on those undisputed findings, this court should reverse the obviousness.

[00:02:28] Speaker 04:
And with regard to

[00:02:30] Speaker 04:
written description, not only was there an example in the patent that shows that the inventors possessed it, but there was other information that will allow formulators to make other examples.

[00:02:39] Speaker 04:
And what happened here, contrary to Alcon v. Barr, the district court added additional requirements that are legally irrelevant.

[00:02:47] Speaker 04:
Before I go into the substance, I just want to make sure we're all clear as to what the claims are.

[00:02:52] Speaker 04:
Here, they address the appropriate dose for an opioid, hydrocodone, to give to patients who have hepatic impairment.

[00:03:02] Speaker 04:
And the danger with diminishing these types of drugs to hepatically impaired patients

[00:03:07] Speaker 04:
is that if they're given too much drug and that could happen because their livers don't metabolize all the drug, they could get either respiratory side effect or overdosing and potentially even die from the drug.

[00:03:19] Speaker 04:
And prior to the invention, every commercial extended release opioid product

[00:03:25] Speaker 04:
that had been tested in patients with hepatic impairment or moderate hepatic impairment had a dose reduction in it.

[00:03:31] Speaker 04:
So at the time of the filing, the state of the art was that you reduced the dose for extended release products for hepatically impaired patients.

[00:03:39] Speaker 04:
And to the surprise of the inventors, their invention did not require that dose adjustment for hepatic impairments, which is important because it allowed the doctors to give the proper dose to alleviate the pain and not have to worry about potential overdose.

[00:03:54] Speaker 04:
Here, the district court's conclusions as to obvious cannot be reconciled with his findings or other admissions by Alvagen's expert.

[00:04:02] Speaker 04:
So for example, on motivation, the court merely said, a post would have been motivated to look to Jane and the Vicotin slash lower tab labels for guidance.

[00:04:11] Speaker 04:
as to the proper dose of the DeVane formulation in hepatic impairment patients.

[00:04:17] Speaker 04:
However, in another section of the decision, the district court directly contradicted that.

[00:04:21] Speaker 04:
He said that nothing in the ARP provided guidance as to which ER formulations could be administered to hepatically impaired patients.

[00:04:29] Speaker 03:
But is it your point that the district court should have ignored the teachings in Jane?

[00:04:34] Speaker 04:
I don't believe he ignored the teachings in Jane, but I'm saying, are you saying he should have?

[00:04:38] Speaker 04:
Well, I'm not saying that he should have ignored the teachings of change.

[00:04:41] Speaker 04:
What I'm saying is that he said specifically that Jane provided no guidance as to what the proper dose would have been.

[00:04:48] Speaker 04:
And in fact, on that point, if you look at the motivation finding, the ultimate finding, it only says that the art would have, quote, provided guidance.

[00:04:58] Speaker 04:
He doesn't say what guidance.

[00:05:00] Speaker 04:
And if you look at other parts of the decision,

[00:05:03] Speaker 03:
The district court said... He walks through it, right?

[00:05:06] Speaker 03:
He says Devane discloses a formulation that's identical to the one described in the patents, right?

[00:05:11] Speaker 04:
That's right, but at the time of the filing, no one knew what the proper dose of that formulation would have been for hepatically impaired patients.

[00:05:18] Speaker 04:
There was nothing in the art that pointed to that.

[00:05:20] Speaker 02:
And that's where Jane steps in, where he finds that Jane reports out that there's similar results for people who are hepatically impaired and normal subjects.

[00:05:33] Speaker 02:
And I realize that's a hydrocodone plus a C to medicine combination.

[00:05:38] Speaker 02:
But then there's another finding.

[00:05:40] Speaker 02:
the court below makes, which is that acetaminophen and hydrocodone metabolize differently and don't really impact each other's

[00:05:52] Speaker 02:
AUC or PK properties?

[00:05:55] Speaker 04:
That particular data is irrelevant because it wasn't in hepatically impaired patients.

[00:06:00] Speaker 04:
That's a line of theme throughout the decision.

[00:06:03] Speaker 03:
But doesn't Jane say that there's no dose adjustment that's necessary for it?

[00:06:06] Speaker 04:
No, Jane, it doesn't actually say that.

[00:06:08] Speaker 03:
Well, the district court made a finding of fact that it did.

[00:06:11] Speaker 04:
Well, what the court said is that he presumed, he only presumed that the levels, because what Jane does is gives information about the acetaminophen.

[00:06:21] Speaker 04:
It said it was between I think 35 to 40 or so above what would be expected.

[00:06:26] Speaker 04:
And the court said presumably that that would be the same for hydrocodone without having any data whatsoever.

[00:06:33] Speaker 04:
And a presumption is not clear and convincing evidence.

[00:06:36] Speaker 04:
In addition, to go back to your point, Judge Chen, the data you were referring to was in Devane.

[00:06:42] Speaker 04:
And Devane has no information on how you would use any of those formulations for hepatically impaired patients.

[00:06:49] Speaker 02:
And there's no information... No, the hepatic impairment study is in Jane, right?

[00:06:54] Speaker 04:
Yes, there is a reference to one.

[00:06:56] Speaker 02:
It reports out that the outcomes are similar between a hepatically impaired and normal subjects, right?

[00:07:05] Speaker 04:
It does report that out.

[00:07:06] Speaker 02:
What that means is... And then the court below relied on that to conclude that

[00:07:11] Speaker 02:
Therefore, if you had a hydrocodone-only administration, you would have that same kind of similar outcome, whether you happen to be mildly or moderately impaired or you're a normal patient.

[00:07:25] Speaker 04:
So what the district court said is that he presumed that the percentages for acetaminophen would be the same for hydrocodone.

[00:07:33] Speaker 04:
And in fact, he also relied on the FDA guidance.

[00:07:36] Speaker 04:
And under the FDA guidance, the amount of acetaminophen that was over what they expected would have been subject to a potential dose adjustment.

[00:07:44] Speaker 04:
So you wouldn't be able to know whether there was a dose adjustment based on those values or not.

[00:07:48] Speaker 04:
And in fact, their experts said you couldn't predict

[00:07:50] Speaker 04:
whether you needed a dose adjustment or not for the hydrocodone formulation alone.

[00:07:56] Speaker 04:
And to the extent that the district court assumed that it would be the same for HI versus non-HI patients because of this data in the vein, that's basically speculation.

[00:08:05] Speaker 04:
Because every place you turn, you see entities saying, well, you need to do a hepatic impairment study in order to be able to determine whether a dose adjustment was needed or not.

[00:08:17] Speaker 04:
Their experts said that.

[00:08:18] Speaker 04:
The FDA said that.

[00:08:19] Speaker 04:
Our experts said that.

[00:08:20] Speaker 04:
Indeed, I think what happened here is that I think that the decision falls into a hindsight trap because, as I mentioned earlier, there was no information in the vein as to whether or not you needed to adjust the dose.

[00:08:35] Speaker 04:
Their expert agreed to that.

[00:08:36] Speaker 04:
There's no IHI or hepatic impairment information at all.

[00:08:40] Speaker 04:
And there's no statement in the vein.

[00:08:42] Speaker 04:
It doesn't say you don't need to adjust the dose.

[00:08:44] Speaker 04:
None of the references, none of the prior art references say there's no need to adjust the dose for our particular formulations.

[00:08:50] Speaker 04:
And so fundamentally, neither the district court nor Aligen provide a reason to select Jane as.

[00:08:55] Speaker 03:
So the district court's finding a fact, specific of finding a fact, that Jane, that a posita would understand that Jane taught that there was no need to adjust the dose.

[00:09:07] Speaker 03:
You're saying that finding a fact was clearly wrong.

[00:09:10] Speaker 04:
Well, it's also inconsistent with its other findings that there was no guidance in the art.

[00:09:14] Speaker 04:
It's also inconsistent with its finding that the art is unpredictable.

[00:09:17] Speaker 04:
And as a matter of law, in our view, the findings that there was no guidance in the art and that the art is unpredictable is inconsistent with the finding that the claims are obvious.

[00:09:28] Speaker 04:
We could go to the next layer and say, yes, I also disagree with the particular findings.

[00:09:31] Speaker 04:
But I think at a threshold matter,

[00:09:34] Speaker 00:
our argument is that yes your honor and that was a

[00:09:51] Speaker 04:
That was at A105.

[00:09:53] Speaker 04:
In addition, earlier in the opinion... Are you reading the entire quote there?

[00:09:59] Speaker 00:
I know that in the brief it wasn't the entire quote.

[00:10:02] Speaker 00:
You left an important part out.

[00:10:05] Speaker 04:
Your Honor, I wasn't just now reading the entire quote, so... And I wasn't intending to say that I was, if that was understood that way.

[00:10:14] Speaker 04:
But I also remember earlier in the opinion, the district court says that there was nothing in the art that would give anyone confidence how to dose hepatically impaired patients.

[00:10:24] Speaker 04:
So it's not just what he said in the written description section.

[00:10:27] Speaker 04:
It's also in the beginning when he was looking at the prior art as a whole, when he said, well, there's nothing in the art that would give any confidence as what the prior art for hepatically impaired patients would be.

[00:10:38] Speaker 04:
So we believe that those statements are entirely inconsistent with one another.

[00:10:43] Speaker 04:
I'd like to just touch on written description very briefly.

[00:10:49] Speaker 04:
The test for written description is whether the specification allows a person of ordinary skill – whether the test is whether the specification, excuse me, allows a poster to recognize whether the inventors had the claimed invention.

[00:11:03] Speaker 04:
There's no dispute here that Example 8 represents the claimed invention.

[00:11:06] Speaker 04:
There's also no dispute that the patent provides additional formulations.

[00:11:10] Speaker 04:
It provides dissolution data.

[00:11:13] Speaker 04:
It provides PK data.

[00:11:14] Speaker 04:
And with regard to those additional formulations and PK data, a person of already skill could use the PK data and dissolution data as target data, where they could make formulations.

[00:11:25] Speaker 02:
And to the extent the argument is is what you have any sense of how many formulations would fit within these

[00:11:33] Speaker 02:
target claims for dosage amounts and

[00:11:38] Speaker 02:
and PK values?

[00:11:39] Speaker 04:
Well, there's an important limiting factor to the number that would fit within it, and that is that the ratio of the extended release portion to the immediate release portion has to be 80 to 20.

[00:11:50] Speaker 04:
And so you have to have that limitation by itself will narrow the universe of potential formulations that could be used.

[00:11:55] Speaker 04:
The fact that it's hydrocodone only narrows the universe.

[00:11:58] Speaker 04:
The fact that it's an extended release narrows the universe.

[00:12:01] Speaker 02:
But do you have any broader sense

[00:12:03] Speaker 04:
no one provided a specific number.

[00:12:05] Speaker 04:
I mean, in fact, the testimony from Alvigyn's expert was conclusory.

[00:12:10] Speaker 04:
He just said a myriad.

[00:12:11] Speaker 04:
He didn't put a number.

[00:12:12] Speaker 04:
He's not a formulator, so he wasn't really capable of giving that information.

[00:12:16] Speaker 04:
Our expert said that, well, based on all the information here, 1-skill ER could easily make additional formulations that fit within the no dose adjustment claim.

[00:12:26] Speaker 04:
I just wanted to

[00:12:27] Speaker 03:
But wasn't that the point of the district court's findings?

[00:12:30] Speaker 03:
The district court was concerned that your claims were so broad that there was nothing that really explained how you would cover the breadth of those claims.

[00:12:41] Speaker 04:
That was the expressed district court issue.

[00:12:43] Speaker 04:
But the problem is that the district court didn't consider structural limitations that were provided in the specification and testified by the experts that would limit the breadth of the claims.

[00:12:55] Speaker 04:
So the district court said,

[00:12:57] Speaker 04:
that unclaimed structural features, like the 80 to 20 ratio, doesn't count.

[00:13:03] Speaker 04:
And in fact, in the Alcon v. Barr case, this court ruled that unclaimed characteristics can be used.

[00:13:11] Speaker 04:
And likewise, in the Abbey case, this court rejected an argument that unclaimed characteristics can't be used.

[00:13:19] Speaker 04:
The district court also made a few other legal errors by adding certain types of requirements that are legally impermissible.

[00:13:27] Speaker 04:
All of them are addressed in our brief, but I want to address two more aside from the unclaimed characteristics.

[00:13:32] Speaker 03:
One- Way into your bottle.

[00:13:33] Speaker 03:
Do you want to keep any of it?

[00:13:34] Speaker 04:
I'm going to take the next 20 seconds and do these and then I'll go to two.

[00:13:38] Speaker 04:
One is that he imposed a requirement that you understand how the invention worked.

[00:13:42] Speaker 04:
That's legally irrelevant.

[00:13:44] Speaker 04:
He imposed a requirement that you had to test every single formulation.

[00:13:47] Speaker 04:
That, too, is legally irrelevant.

[00:14:04] Speaker 01:
Thank you.

[00:14:04] Speaker 01:
May it please the court.

[00:14:06] Speaker 01:
I'd like to start where Mr. Conde talked about the court statement and judge your comment about Judge Bryson's comments about nothing in the state of the art.

[00:14:15] Speaker 01:
That's got to be looked at in context.

[00:14:16] Speaker 01:
In the context there, Judge Bryson was distinguishing the Amgen case.

[00:14:20] Speaker 01:
And he was setting forth why this case is distinguishable from the Amgen case.

[00:14:25] Speaker 01:
And he was also doing it in the context of the specification here.

[00:14:28] Speaker 01:
The specification here talks about the fact that it's Persians position.

[00:14:32] Speaker 01:
It's consistently been their position.

[00:14:34] Speaker 01:
That there are some subset of hydrocodone formulations that do require dose adjustment and some that don't.

[00:14:40] Speaker 01:
So when Judge Bryson was making those statements about the state of the art there, he was talking about the Amgen case and specifically

[00:14:48] Speaker 01:
He was distinguishing the Amgen case from the case at bar.

[00:14:52] Speaker 03:
But if the state of the art is unpredictable, that cuts dramatically against an obviousness determination, does it not?

[00:15:00] Speaker 01:
Correct, it could cut against an obvious misdetermination, but if you read the entirety of the opinion, the district court clearly wasn't saying that.

[00:15:08] Speaker 01:
The district court clearly walked through the art, considered all the art, considered the experts' arguments, their testimony about the arguments, considered what Jane says.

[00:15:19] Speaker 02:
try to divide and make the distinction between why the court below said the art is unpredictable as to written description, but didn't find the art to be unpredictable for purposes of motivation to combine?

[00:15:34] Speaker 02:
I mean, was he talking about apples and oranges there?

[00:15:37] Speaker 02:
Or was he just talking about, well, the state of this field is unpredictable, period, and therefore there's a conflict with the motivation to combine analysis?

[00:15:46] Speaker 01:
Yeah, so specifically what I believe, and it's always difficult getting to somebody else's mind when they're writing it, I believe he was focused on distinguishing the Amgen case.

[00:15:56] Speaker 01:
And in the Amgen case, it was very different because it talked about whether there was a correlation, and there was no correlation between what was or there was a correlation.

[00:16:08] Speaker 03:
Well, whether it's distinguishing the Amgen case or not, I think Judge Chen's question is still a valid one.

[00:16:14] Speaker 03:
Whatever the purpose of his analysis was, isn't it still important?

[00:16:21] Speaker 03:
I mean, is there something to do with written description that makes the state of the art different than for purposes of obviousness?

[00:16:30] Speaker 01:
So a couple points.

[00:16:32] Speaker 01:
Written description and obviousness, obviously, are different standards.

[00:16:35] Speaker 01:
And with obviousness, it was incumbent to demonstrate on alveogen, which we did in the district court, found that a single formulation would have been expected and predictable to produce the claim pharmacokinetics or the non-adjustment, which flows from the claim pharmacokinetics.

[00:16:53] Speaker 02:
You're talking about the specific prior art formulation described in DeVay.

[00:16:57] Speaker 01:
Correct.

[00:16:58] Speaker 01:
And for written description, the standard's broader.

[00:17:01] Speaker 01:
It's not the case that if you have a reasonable expectation of success that you will necessarily demonstrate that you have possessed the invention.

[00:17:11] Speaker 01:
And in fact, the Ariad case exactly directly addressed that and said that a description that merely renders the invention obvious does not satisfy the written description requirement.

[00:17:24] Speaker 01:
So you have to look at it in the two different lenses.

[00:17:27] Speaker 01:
The other lens we need to look at is the specification here, according to the district court, and we fully support this, misconstrued what the prior art said.

[00:17:37] Speaker 01:
So when the district court is evaluating the specification, the district court is looking at what the patent holder is contending the state of the art says.

[00:17:45] Speaker 01:
The specification states that there was some unknown ability of hydrocodone of their specific claim

[00:17:56] Speaker 01:
or what they intended to claim, hydrocodone formulation that would produce the non-adjustment or the PK characteristics.

[00:18:05] Speaker 01:
When Judge Bryson is addressing the obviousness, he's not limited by what the specification states.

[00:18:12] Speaker 01:
In fact, there's a Boston scientific decision by this Court, 647 F3D 1353,

[00:18:19] Speaker 01:
in which the court specifically addressed a situation where the specification was contrary to the prior art.

[00:18:26] Speaker 01:
And when that's the case, the patent holder can't rely on the prior art to fill in the gaps that they didn't have in their specification.

[00:18:36] Speaker 01:
I wanted to address a couple other points that were raised.

[00:18:40] Speaker 01:
Certainly, it was clear in Pershing's presentation that the heart of this case are a number of factual determinations made by the court.

[00:18:47] Speaker 01:
In fact, counsel started by saying that this case should be reversed because of those factual determinations.

[00:18:54] Speaker 01:
The problem with that is there is a very high bar

[00:18:57] Speaker 01:
when there are factual determinations underlying a district court case.

[00:19:01] Speaker 01:
And this court can only overturn them if they're clearly erroneous.

[00:19:05] Speaker 01:
Certainly, Persian has not demonstrated that those factual findings are clearly erroneous.

[00:19:12] Speaker 03:
discussion because, you know, we have said repeatedly that we're skeptical of use of inherency in an obviousness inquiry and we will look at it very carefully to make sure that it is fair to apply it in those circumstances as opposed to anticipation where it's more appropriate.

[00:19:32] Speaker 01:
Yes, absolutely, Your Honor.

[00:19:34] Speaker 03:
And you think that the court's inherency analysis satisfies those requirements?

[00:19:39] Speaker 01:
Yes.

[00:19:40] Speaker 01:
So this court made clear in the Par VTWI case that inherency can be used in obviousness cases.

[00:19:46] Speaker 01:
And that case dealt with the use of a drug to treat a condition.

[00:19:51] Speaker 01:
Right.

[00:19:51] Speaker 03:
But in Par Pharma and others, we made clear that use of inherency in those types of cases is very limited.

[00:19:58] Speaker 01:
Yes.

[00:19:59] Speaker 01:
And here, the district court made multiple findings to show that the claim pharmacokinetics or non-adjustment is inherent in the data formulation.

[00:20:10] Speaker 01:
As you know here, all the patent holders did here was take a prior formulation from the vein, the HCER formulation, run a test required by FDA, a hepatic impairment test, and then claim this broad functional genus result.

[00:20:26] Speaker 01:
There's no real dispute that it's the DeVane formulation that leads to the claim pharmacokinetics.

[00:20:33] Speaker 01:
So really there was no dispute below, there is no dispute here, that the DeVane formulation inherently has these claim properties.

[00:20:42] Speaker 01:
So this fits squarely within the court's discussion of when you should use inherently and obvious

[00:20:48] Speaker 01:
in this case is because it is certainly the natural result of administering Devane that you will lead to these claimed pharmacokinetic parameters.

[00:21:00] Speaker 02:
What about the predictability of administering Devane's formulation to hepatically-impaired in patients with an expectation that you wouldn't need to adjust the dose when the prior art suggested to the contrary?

[00:21:16] Speaker 01:
So there are two issues in there.

[00:21:19] Speaker 01:
The administration, just two H.I.

[00:21:21] Speaker 01:
patients, I think is undisputed that there was an expectation that you could do that.

[00:21:26] Speaker 01:
Certainly no one rebutted that you could administer.

[00:21:28] Speaker 01:
But then about your point of the no dose adjustment.

[00:21:32] Speaker 01:
While the specification would like you to believe and while Pershing would like you to believe,

[00:21:36] Speaker 01:
that the prior art taught away from that, the district court made multiple findings based on the art and based on expert testimony that that simply wasn't the case.

[00:21:45] Speaker 01:
And Jane, which is the primary reference the court relied on to that, is directly applicable to that point.

[00:21:52] Speaker 01:
So Jane performed a hepatic impairment study with a hydrocodone formulation, had hydrocodone and acetaminophen, as you talked about earlier.

[00:22:01] Speaker 01:
And Jane found that there were similar pharmacokinetics in HI patients and non-HI patients.

[00:22:07] Speaker 01:
Now, counsel would like you to believe that the court then just made presumptions after the court looked at Jane.

[00:22:13] Speaker 01:
That's simply not the case.

[00:22:14] Speaker 01:
There were multiple experts, Dr. Schmidt and Dr. Weinberger, who talked about how a person of ordinary skill in the art would interpret and read Jane.

[00:22:24] Speaker 01:
And those experts both said

[00:22:26] Speaker 01:
that a person of ordinary skill in the art would understand that when Jane is saying it is similar pharmacokinetics, Jane is saying you don't have to adjust the dose, and that's frankly the real purpose of even doing a study, a hepatic impairment study, is to find out do you need to adjust a dose.

[00:22:45] Speaker 01:
So when Jane used the shorthand of saying it was similar, that told everyone of skill in the art that you didn't need to make a dose adjustment.

[00:22:54] Speaker 03:
What's your response to your friend's argument that the court erred in looking to the FDA's directors?

[00:23:09] Speaker 01:
It's very interesting, Your Honor.

[00:23:11] Speaker 01:
So what Pershing doesn't say is that it was legally improper for the district court to take judicial notice of the FDA guidance.

[00:23:20] Speaker 01:
And there's a very good reason for that.

[00:23:22] Speaker 01:
The law doesn't support that.

[00:23:23] Speaker 01:
The federal rules of evidence are very clear that a court is allowed to take judicial notice of a document like that.

[00:23:29] Speaker 01:
And that's what the court did.

[00:23:31] Speaker 01:
So the court took judicial notice of the FDA communication.

[00:23:34] Speaker 01:
But one thing to keep in mind on that is that was one of four separate reasons why the district court found motivation.

[00:23:43] Speaker 01:
And it wasn't even the most important.

[00:23:45] Speaker 01:
So the court made four separate findings of why a person of ordinary skill and the art would be motivated to combine.

[00:23:53] Speaker 01:
The first was that acetaminophen was known to be toxic, that hydrocodone was not.

[00:23:59] Speaker 01:
The second was that FDA relied

[00:24:02] Speaker 01:
when Persian or predecessor companies submitted an NDA to FDA, relied on a combination product, a hydrocodone-iducrofen product, in terms of evaluating whether that's a hydro product would be approved.

[00:24:17] Speaker 01:
The third was the FDA guidance, but the fourth, and this, the court deemed the most significant finding.

[00:24:23] Speaker 01:
The court said most significantly, a person of skill and the art would have appreciated that acetaminophen and hydrocodone are metabolized differently.

[00:24:32] Speaker 01:
So the court made four separate findings and the most significant was not based on the FDA guidance.

[00:24:41] Speaker 01:
Your honor, just quickly, I'd like to address some of the written description points, some of the written description points that were brought up.

[00:24:49] Speaker 01:
First, on the test itself, Council mentioned a very broad test.

[00:24:53] Speaker 01:
We have a very specific test when you have functional claims that are a genus, directed to a genus.

[00:25:00] Speaker 01:
And two things, one of two things have to be met.

[00:25:03] Speaker 01:
Either a representative number of species need to be disclosed or structural features that are common to the members of the genus need to be disclosed that would allow a person of ordinary skill in the art

[00:25:14] Speaker 01:
to determine and visualize all the members of the defense.

[00:25:18] Speaker 01:
The district court used that proper test and found out that neither were met here.

[00:25:25] Speaker 01:
Your Honor asked about how many different formulations could potentially fall under the claims here.

[00:25:31] Speaker 01:
And I think that's a key finding.

[00:25:33] Speaker 01:
And again, this is a key factual finding that could only be reversed for clear error.

[00:25:37] Speaker 01:
The court, there is testimony that a myriad number

[00:25:40] Speaker 01:
of formulations could fall under the claims.

[00:25:43] Speaker 01:
There was testimony by both Persians and Alvagen's experts that this could include liquids like suspensions, syrups, solutions, or emulsions.

[00:25:52] Speaker 01:
It could include solids like tablets, capitals, lozenges, matrix, pulsatile, osmotic formulations.

[00:25:58] Speaker 01:
And the district court heard all this testimony and came to the conclusion that there was a limitless number of formulations that potentially fall within the functional genus that's in the claims.

[00:26:09] Speaker 01:
Council mentioned some 2080 requirement.

[00:26:13] Speaker 01:
That functional limitation is not in the claims.

[00:26:16] Speaker 01:
The claims don't just don't have that in the claims.

[00:26:19] Speaker 01:
So that's really irrelevant for the written description.

[00:26:22] Speaker 01:
And maybe most importantly, the specification nowhere, and Persians expert admitted this at trial, the specification nowhere discloses a special sauce.

[00:26:32] Speaker 01:
So nowhere says that there are these special things you need to put into your formulation.

[00:26:37] Speaker 01:
And if you do, you don't have to adjust.

[00:26:39] Speaker 01:
If you don't, you're going to have to adjust.

[00:26:44] Speaker 01:
So Your Honors, if you don't have any further questions, thank you for your time.

[00:26:48] Speaker 03:
Thank you.

[00:26:52] Speaker 04:
Let me just digest the last issue first about special sauce.

[00:27:01] Speaker 04:
That just goes back to the fact that the vendors did not understand how the invention actually works, and so the special sauce is essentially irrelevant.

[00:27:10] Speaker 04:
Turning back to obviousness.

[00:27:14] Speaker 02:
Could you say that again?

[00:27:15] Speaker 02:
Sure.

[00:27:15] Speaker 02:
The inventors didn't understand how the invention worked?

[00:27:18] Speaker 04:
Well, the inventors didn't know why.

[00:27:19] Speaker 04:
I should have used the word why the invention worked.

[00:27:22] Speaker 04:
They didn't know why there was not a need for dose adjustments.

[00:27:25] Speaker 04:
They just knew that these formulations, that you didn't need a dose adjustment.

[00:27:28] Speaker 04:
The particulars as to why the invention didn't need a dose adjustment was not known to the inventors.

[00:27:33] Speaker 04:
But the case law is clear that the inventors don't need to know why the invention works or does not work.

[00:27:38] Speaker 02:
Well, they knew that the DeVane formulation could have these certain properties, desirable properties, and then they claimed any and every formulation that has those desired properties, right?

[00:27:51] Speaker 04:
Yes, they knew the DeVane formulation worked, but they didn't even understand what made the DeVane formulation allow you to dose the drug without adjusting the dose for hepatic impairment.

[00:28:02] Speaker 02:
So taking that as true, then how could one say that

[00:28:07] Speaker 02:
they communicated to one of skill in the yard that they had possession of every single other formulation.

[00:28:16] Speaker 04:
I don't think anyone needs to know why the invention works.

[00:28:20] Speaker 04:
What causes the invention to work?

[00:28:22] Speaker 04:
One skill in the art would look at the other information in the patent, including dissolution data, which could be used as a target to make other formulations that would fit within the claim.

[00:28:31] Speaker 04:
And ultimately, after you make the formulation, you would just run a PK study, which all the experts agreed was a standard study in this area.

[00:28:40] Speaker 04:
Just to address inherency, Judge O'Malley raised that issue.

[00:28:44] Speaker 04:
The issue here is that the vein doesn't naturally flow to having adjusting the dose for hepatically impaired patients because it's silent on the issue.

[00:28:52] Speaker 04:
And whether you could do that or not is not the point because under inherency, the fact that you could do something doesn't make it inherent.

[00:28:59] Speaker 04:
And I'm running out of time.

[00:29:01] Speaker 03:
It was the PK profiles that he was finding to be inherent, right?

[00:29:04] Speaker 03:
The ones in Devane?

[00:29:05] Speaker 04:
Right.

[00:29:06] Speaker 04:
But there was no guarantee that a person skilled in the art taking Devane would have avoided adjusting the dose.

[00:29:11] Speaker 03:
They more likely would have taken Devane and adjusted the dose and come up with different... Yeah, but he didn't rely on that for purposes of his findings.

[00:29:19] Speaker 03:
He just relied on it for purposes of saying the PK profiles.

[00:29:22] Speaker 03:
And they're exactly the same as in the patent, right?

[00:29:25] Speaker 04:
Well, there's no PK profiles in the vein for HI subjects.

[00:29:30] Speaker 04:
There are PK profiles in the patent for the HI subjects, and that's the difference.

[00:29:34] Speaker 04:
What dose would you have given an HI subject, a hepatically impaired subject, given the state of the art, and if all you had was the vein?

[00:29:42] Speaker 04:
And one skill in the art could have adjusted the dose.

[00:29:44] Speaker 04:
Just like Dr. Schmidt said, it's a hypothesis whether you could adjust the dose or not.

[00:29:49] Speaker 04:
You needed to run testing to figure that out.

[00:29:52] Speaker 04:
I see I've gone over my time now.

[00:29:55] Speaker 03:
Okay, thank you.

[00:29:55] Speaker 03:
All right, the cases will be submitted.

[00:29:57] Speaker 03:
This court is adjourned.

[00:29:58] Speaker 02:
All in the eyes.

[00:30:00] Speaker 02:
The Ottawa court is adjourned for tomorrow morning at 10 o'clock a.m.