[00:00:00] Speaker 01:
Our next case is Dr. Falk Farmer versus Generico Flatline in My Land, 2017-23-12, Ms.

[00:00:11] Speaker 01:
Burke.

[00:00:11] Speaker 01:
Thank you, Your Honor.

[00:00:19] Speaker 00:
May I please support?

[00:00:20] Speaker 00:
I would like to address three of the errors that the Board made in this case.

[00:00:26] Speaker 00:
One pertains to the construction of the remission phrase.

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The second pertains to the board's finding of obviousness with respect to the without food limitation.

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And the second pertains to the board's considerations of or analysis of the secondary considerations of non-obviousness as it pertains to the long felt need issue.

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First, I want to start with the board's construction of the remission phrase.

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Namely, remission is defined as a DAI score of 0 or 1.

[00:00:59] Speaker 01:
Let me ask you about the obviousness issue first, though, if you don't mind.

[00:01:04] Speaker 01:
Sure.

[00:01:06] Speaker 01:
Don't the press release and the endo nurse reference pretty much show the invention and that it's successful?

[00:01:16] Speaker 00:
The press release and the endo nurse show the method of maintaining remission

[00:01:21] Speaker 00:
with the once daily administration of the misalignment formulation.

[00:01:26] Speaker 00:
But what the press release and engineers do not show is A, how remission is defined, and B, the without food limitation.

[00:01:38] Speaker 01:
Well, you've got another reference which discloses without food.

[00:01:42] Speaker 01:
This is an obviousness rejection, not anticipation, right?

[00:01:46] Speaker 00:
That is correct, Your Honor.

[00:01:48] Speaker 00:
What the Board did and what the petitioner argued was the Board took the methods of the press release and end-owners, combined them with Marikowski and Bruner, two of which are, one of which was a comparative clinical study,

[00:02:08] Speaker 00:
and the other of which was a gastrointestinal transit time study with gamma centigraphy.

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And then recognized that they had to bridge the gap between those two, those references, because neither of them actually were sufficient to show a reasonable expectation of success for achieving the claimed method of maintaining remission without food.

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And the reason for that is,

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because of the significant evidence of unpredictability which Falk submitted and the board summarily dismissed by finding that the claims did not require a food effect.

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That is true, to be sure.

[00:02:56] Speaker 00:
We don't dispute that.

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But what we do dispute is the fact that because of the considerable

[00:03:03] Speaker 00:
unpredictability in the art about the impact of food on colonic bioavailability, that therefore, to establish a reasonable expectation of success, one has to have something more than the press release and end-of-interest in combination with Marikowski and Brunner.

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And both the petitioner and the board recognized that.

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And what did they turn to?

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And before I go to that, just

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For the record, the evidence of unpredictability is set forth in detail in our blue brief at pages 41 to 42 and in our gray brief at page 15.

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So what did they do?

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They went to Davis to fill the gap, Davis 1985, which is an academic paper.

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And the problem with where they aired there is they misunderstood the teachings of Davis.

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The board relied on two separate paragraphs from Davis 1985, and that's found in Appendix 40.

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Both of those paragraphs are talking about a, gastric emptying within a fasted state, and transit time.

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And let's be clear, what Davis was looking at was delivery systems intended to release the active ingredient in the small intestines.

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where systemic bioavailability is important.

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With mesalamine formulations, which are intended to target the colon and act locally on the inflamed mucosa of the colon, what's important is colonic bioavailability.

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So that's different.

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But going back to what Davis taught, Davis taught that delivery systems in a fasted state had lower systemic bioavailability.

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And that's because they could,

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They empty the stomach fast, and they pass through the small intestine fast, and they could sometimes reach the colon in three hours.

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Therefore, they weren't getting enough to be absorbed systemically, which is where you would want those drugs to be absorbed.

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And then the board took a leap of faith from that and said, OK, we're the opposite of that.

[00:05:20] Speaker 00:
We want to reach the colon.

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So if we want higher colonic bioavailability,

[00:05:27] Speaker 00:
then we want to do it in a fasted state.

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And then they use that to leap to the fact that Davis taught you without food.

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The problem with that entire analysis is that transit time and gastric emptying are simply irrelevant to the formulations that are disclosed in the press release in Maracusti and Brunner.

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And why is that?

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Because they have a pH-dependent coding.

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a pH-dependent coating which is intended to prevent the release of the drug in the stomach, prevent the release of the drug in the small intestine, and allow release of the drug when it reaches the terminal ilium and coal.

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So that's why transit time, gastric emptying, everything that's taught by Davis is completely irrelevant to the without food limitation.

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And quite frankly, that takes us back to, well, why is there a need for a food effect study?

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There's a need for a food effect study to be able to determine whether you have the right amount and type of enteric coating on your drug so that it doesn't release prematurely with food and that at least if you give it with food or without food, you have the same

[00:06:54] Speaker 00:
colonica by availability, if not better.

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So that's the without food limitation.

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And we believe the board erred for those reasons because it misunderstood the Davis reference.

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Turning back to the claim construction issue, remission is defined as a DAI score of 0 or 1.

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False construction was that construction should be a sum of two subscores

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with a rectal bleeding score of 0 and a mucosal appearance score of 0 or 1.

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It's a binary system.

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As opposed to the four subscores that are used for the generic description of the revised Sutherland Disease Activity Index.

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The intrinsic evidence is clearly in support of this construction.

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And this court's precedent is clear that

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Under the broadest reasonable interpretation standard, the construction cannot be divorced from the specification, and it must correspond with what and how the inventor describes his invention.

[00:08:06] Speaker 00:
While the plain language of the claim explicitly states that remission is defined as a DAI of one or zero, it does not define the phrase

[00:08:18] Speaker 00:
DAI score of 0 or 1 nor does it explain how you calculate it.

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That's why you need to resort to the specification.

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The board relied on a general description of DAI in column 17 that makes absolutely no reference to remission whatsoever and ignored the express and repeated lexicographer definition in the specification.

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Remission, the patentee here acted as his own lexicographer.

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He repeatedly and consistently defined remission based on two subscores.

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We have all of those sites in our blue brief at pages 30 to 32.

[00:09:04] Speaker 02:
Was there a definition of the DAI score itself?

[00:09:08] Speaker 00:
There is a definition of the DAI, the general DAI score in the patent.

[00:09:14] Speaker 02:
As a lexicographer?

[00:09:16] Speaker 00:
Not for remission.

[00:09:19] Speaker 00:
Not for remission.

[00:09:20] Speaker 00:
The lexicographer comes in where you say, well, what does DAI of 0 or 1 mean in the context of remission as this patentee used that term?

[00:09:31] Speaker 00:
There's a piece of art that the board relied on for its obviousness determination.

[00:09:37] Speaker 00:
It's the Cooney article.

[00:09:38] Speaker 02:
But back to remission, you would agree that that's defined in the plain language of the claim?

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I would agree that it states remission is defined as a DAI of 0 or 1.

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But that begs the question, what does DAI of 0 or 1 mean?

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How do you calculate it?

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What subscores do you use?

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And which are the 0 and which are the 1?

[00:10:05] Speaker 00:
The generalized DAI scoring system, so to speak, has four subscores.

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And so you need to know what are the subscores that you are using.

[00:10:17] Speaker 02:
So it's a question of the four subscores versus two subscores.

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And what the zero or one means.

[00:10:26] Speaker 02:
The standard that the board applies is the broadest reasonable interpretation.

[00:10:30] Speaker 02:
Understood.

[00:10:32] Speaker 02:
Why wouldn't that be the four scores then?

[00:10:34] Speaker 00:
No.

[00:10:35] Speaker 00:
I don't believe so.

[00:10:35] Speaker 00:
I don't think one could say that one is broader or narrower.

[00:10:39] Speaker 00:
I mean, one could actually argue that using the two subscores

[00:10:43] Speaker 00:
the scope of the claim may be broader because more people would maintain remission because once you add additional subscores, there's more likelihood that somebody could fall out.

[00:10:54] Speaker 00:
You understand what I'm saying?

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So I don't think you can say one is broader or one is narrow in any sense.

[00:11:01] Speaker 00:
But even leaving that aside, under broadest reasonable interpretation, you must read that in light of the specification.

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And you must read it in light of how the patentee

[00:11:13] Speaker 00:
used that term and described it in terms of this invention.

[00:11:18] Speaker 00:
And going back to what Cooney described, Cooney described the fact that there were 13 different disease activity indexes.

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And even under DAI, if you use various different scoring systems, you got widely variable results.

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So you needed to define remission and how you were calculating it.

[00:11:39] Speaker 00:
and what the subscores were that you wanted.

[00:11:42] Speaker 00:
And that's what Cooney teaches.

[00:11:44] Speaker 00:
So the board aired in its construction of DAI.

[00:11:48] Speaker 00:
And there was no finding of obviousness based on Falk's construction, the two subscores.

[00:12:04] Speaker 00:
And there's no substantial evidence in the record to support a finding of obviousness under Falk's.

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construction.

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So this court should reverse, or at the very minimum, remand under the proper claim of construction.

[00:12:19] Speaker 00:
And I see I'm getting into my rebuttal time, so I will rest for now.

[00:12:24] Speaker 00:
Thank you.

[00:12:24] Speaker 01:
We will save it for you, Ms.

[00:12:26] Speaker 01:
Burke.

[00:12:28] Speaker 01:
Thank you.

[00:12:28] Speaker 01:
Mr. Florence.

[00:12:34] Speaker 03:
Good morning, Your Honors.

[00:12:35] Speaker 03:
May it please the Court?

[00:12:37] Speaker 03:
I'd like to talk a little bit about what

[00:12:39] Speaker 03:
the board actually did when they looked at the DAI limitation and the board in fact did look at the intrinsic evidence and found that the construction that they came up with that remission is defined as a DAI score of zero one actually means the use of the sum of all four sub scores was in fact supported not only by the claims but by the specification itself and so let's look a little bit of what the board actually did

[00:13:08] Speaker 03:
Again, as Ms.

[00:13:09] Speaker 03:
Bort pointed out, the board did apply the broadness reasonable interpretation standard as it must for these proceedings.

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And the board started, as it should, with the language of the claims itself.

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And the board found that the phrase remission is defined as a DAI score of zero or one was in itself an express definition of remission.

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And although the board did look at the specification and find that there were instances

[00:13:38] Speaker 03:
where the construction that's put forth by the patent owners, there are instances where remission is used as a sum of only two sub scores.

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But every place that it's used in the specification as a sum of two scores, it uses the term revised DAI.

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It does not use the broader term DAI.

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And Ms.

[00:13:58] Speaker 03:
Bork stated that the section of the specification that the board relied on to define DAI as four sub scores

[00:14:07] Speaker 03:
that that section of the specification does not mention remission at all, that's entirely inaccurate.

[00:14:14] Speaker 03:
That's not true.

[00:14:15] Speaker 03:
If you look at the section where the board looked at, that was from example five, and that's located in the patent itself at column 17.

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And that example is entitled Studies on Remission from Ulcerative Colitis, and it begins

[00:14:36] Speaker 03:
that studies were conducted in 562 adult subjects in remission from ulcerative colitis.

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And then it goes on to explain that disease activity was assessed using a DAI that uses the sum of all four subscores.

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So the board did find that when the specification is referring to DAI, even in the case of remission here, that it does, when it's not using the narrow term revised DAI,

[00:15:04] Speaker 03:
It is, in fact, referring to all four subscores.

[00:15:12] Speaker 03:
And the board also, as Your Honor Judge Lori pointed out at the beginning of the argument, that doesn't the Salix press release and end owners, don't they define what the invention is?

[00:15:27] Speaker 03:
What they do say is they say they don't give the measurement, as Ms.

[00:15:32] Speaker 03:
Bork pointed out.

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They don't give the measurement.

[00:15:34] Speaker 03:
of how DAI was measured.

[00:15:35] Speaker 03:
But they do say that the patients were relapse-free for six months.

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And all of the experts in the case testified that relapse-free essentially means being in remission.

[00:15:46] Speaker 03:
And so the question that the board looked at and asked is, what does a person of ordinary skill and the art think of when they see the word relapse-free in those press releases?

[00:15:56] Speaker 01:
Of course, the press release talked about one dose per day, right, rather than four?

[00:16:02] Speaker 03:
That's correct.

[00:16:04] Speaker 03:
That's correct.

[00:16:05] Speaker 03:
It did, Your Honor.

[00:16:07] Speaker 03:
And in fact, the press release said that under that dose, it was successful in obtaining remission essentially for six months of treatment.

[00:16:15] Speaker 03:
But in addition to looking at the intrinsic evidence, the board also looked at the intrinsic evidence and carefully weighted both of the petitioner's expert, Dr. DeGennes, and also Dr. Softy, the patent owner's expert.

[00:16:30] Speaker 03:
And what the board noted about that

[00:16:34] Speaker 03:
was that Dr. Degenis looked at the background art, specifically the Meyerhoff reference, taught that within that reference itself, it provides a customary marker that's used in clinical practice for determining remission.

[00:16:52] Speaker 03:
And it stated that remission would be defined as it says, a patient is considered to be in remission for ulcerative colitis

[00:17:04] Speaker 03:
if an ulcerative colitis, DAI, score of less than or zero one is obtained.

[00:17:09] Speaker 03:
And it gives the sum of all those sub scores.

[00:17:12] Speaker 03:
So a person of ordinary skill in the art reading this 2007 press release and seeing the word relapse free would know that it's customary to use a DAI of all four sub scores in the art when determining remission.

[00:17:27] Speaker 03:
Now, Ms.

[00:17:28] Speaker 03:
Burke mentioned the Cooney reference, so I would like to touch on it.

[00:17:33] Speaker 03:
that Cooney Reference does provide information regarding the different indices that are available to APOSA as well.

[00:17:45] Speaker 03:
But as the board pointed out, the board found that Cooney actually teaches toward using a DAI with four subscores rather than two, because Cooney, one, teaches that the DAI is currently favored by the Food and Drug Administration for trial design and ulcerative colitis.

[00:18:03] Speaker 03:
And it's one of the most widely used of the activity indices in clinical trials.

[00:18:09] Speaker 03:
The board also found that contrary to patent owner's argument, CUNY would have led APOSA to define remission as a DAI score of 0 or 1, where the score is in fact based on all four subscores, because CUNY discloses three different remission endpoints.

[00:18:25] Speaker 03:
It disclosed 0, less than or equal to 1, or less than or equal to 2.

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And this is key.

[00:18:31] Speaker 03:
cited Dr. Safdie's own testimony that each of these endpoints disclosed in Cooney for remission are based on the full DAI score, so the sum of all four scores.

[00:18:44] Speaker 03:
And the court concluded that because a post would have had a reason to use any one of these three numerical definitions of remission in the method described in the September 2000 press release in EndoNurse, it would have been obvious.

[00:18:57] Speaker 03:
So the board didn't disregard any of the evidence

[00:19:01] Speaker 03:
put forth by Dr. Softy, and in fact found that Cooney actually teaches toward finding a DAI.

[00:19:10] Speaker 03:
One thing that I wanted to touch on just briefly was that there is evidence in the record that was before the board that would indicate that even under the patent owner's construction, that if that construction would have been adopted by the board, that it also would have been obvious.

[00:19:30] Speaker 03:
And that evidence was before the board in the petitioner's reply to the patent owner's response.

[00:19:40] Speaker 03:
And now to be sure, the board did not make a finding as to whether or not, if they applied the construction that had been put forth by the patent owners on DAI, the board did not make a finding if it would be obvious under their construction, because the board found that it would be the sum

[00:19:59] Speaker 03:
all four subscores under the DEI, and found that was obvious.

[00:20:02] Speaker 03:
But the evidence is, in fact, there.

[00:20:05] Speaker 03:
What the petitioners had argued was that the construction put forth by the patent owner was too broad, because it's really directed at what's called registration remission.

[00:20:17] Speaker 03:
And registration remission, as Dr. Softe testified, and is also disclosed in CUNY, is based on only the two same subscores that the patent owner advocates for, for their definition.

[00:20:29] Speaker 03:
the rectal bleeding score and the mucosal score.

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And it excludes the more objective sub-scores of stool frequency and physician's overall assessment.

[00:20:41] Speaker 03:
But Cooney does provide that exact same definition within it.

[00:20:47] Speaker 03:
And Dr. Softy testified in his declaration when he was advocating for that position that that's exactly why he uses it in his own practice.

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In his own practice, he uses registration remission

[00:20:59] Speaker 03:
to determine remission because it gets rid of the subjective sub-scores, it gets rid of stool frequency, because that can be subjective because it's the patient's point of view, and global overall assessment can vary from physician to physician.

[00:21:15] Speaker 03:
So he doesn't use those.

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So there is evidence in the record that that was commonly in use.

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Dr. Softy himself uses it.

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But Cooney does say that registration remission itself is most favored by the FDA.

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for Phase III clinical trials.

[00:21:30] Speaker 03:
What is the 2007 press release?

[00:21:32] Speaker 03:
It says it's the results of a Phase III clinical trial.

[00:21:37] Speaker 03:
And so even though the board didn't go there, they could have, but our position is essentially that the claim does require the sum of all four DAI scores because it's plain on its face.

[00:21:50] Speaker 03:
The definition within the claim does not include

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The statement revised DAI.

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It just broadly says DAI.

[00:21:58] Speaker 03:
And under the broadest reasonable interpretation, that's where the board went.

[00:22:02] Speaker 03:
And that's where you properly need to go by the teachings of the intrinsic evidence and also the extrinsic evidence as well.

[00:22:11] Speaker 03:
So what I would like to do now, if there are no questions related to DAI, is I would like to address the food effect issue that's also raised by Ms.

[00:22:20] Speaker 03:
Bork and the patent owner.

[00:22:27] Speaker 03:
Now, Ms.

[00:22:27] Speaker 03:
Borks had stated that the board really had to bridge the gap between Marikowski and Brunner, but summarily dismissed evidence in the art regarding predictability with food.

[00:22:42] Speaker 03:
That's not quite accurate.

[00:22:44] Speaker 03:
And the teachings of Davis, 1985, it teaches something a little bit broader.

[00:22:50] Speaker 03:
So Ms.

[00:22:51] Speaker 03:
Bork only stressed the fact that Davis, 1985, teaches that the pellet formulations

[00:22:57] Speaker 03:
are delayed in the stomach.

[00:23:04] Speaker 03:
Well, the transit times talked about in Davis 1985 relate to systemic bioavailability, but as the board correctly pointed out, Davis 1985 in itself states, there's a whole section on position drug release, and it states that sometimes you don't want the drug to be released in the upper GI tract.

[00:23:26] Speaker 03:
you want it to be available to be administered locally.

[00:23:29] Speaker 03:
And it uses ulcerative colitis and mesalamine as an example.

[00:23:37] Speaker 01:
What about Marikowski?

[00:23:39] Speaker 03:
Sure.

[00:23:39] Speaker 03:
Marikowski, your honor, relates to a study between a granulated mesalamine formulation and a TAVA formulation.

[00:23:48] Speaker 03:
And the overall daily dose was 1.5 grams, the same dose from the

[00:23:56] Speaker 03:
2007 press release.

[00:23:58] Speaker 03:
Now that dose, however, was given three times a day.

[00:24:01] Speaker 03:
It wasn't given as a once daily dose, but the overall daily dose was the same.

[00:24:06] Speaker 03:
And in Marikowski, the drug was administered three times a day without food.

[00:24:12] Speaker 03:
It was given an hour before meals each time.

[00:24:15] Speaker 03:
And what Marikowski teaches, and what the board found, is that Marikowski teaches that

[00:24:25] Speaker 03:
The treatment was in fact shown to be effective for inducing remission.

[00:24:28] Speaker 03:
So it was an eight week study.

[00:24:30] Speaker 03:
It wasn't six months like the study in the 2007 press release, but it was eight weeks and it showed that the granulated mesalamine formulation was equally effective at inducing remission as the tablet formulation was.

[00:24:44] Speaker 03:
And so the board concluded from that that one, there doesn't need to be a food effect study.

[00:24:52] Speaker 03:
The board started with the premise that

[00:24:53] Speaker 03:
The claims don't require a food effect study, that the reasonable expectation of success has to relate to the claims.

[00:25:00] Speaker 03:
But even if they did, Marikowski shows that for eight weeks, a 1.5 gram daily dose is effective for a granulated miscellany formulation of actually inducing remission.

[00:25:15] Speaker 03:
And under the conditions where it's given without food.

[00:25:19] Speaker 03:
So yes, Marikowski does not show whether or not

[00:25:24] Speaker 03:
administering that same formulation with food versus without food would have been more or less efficacious.

[00:25:31] Speaker 03:
But the claims don't require that.

[00:25:33] Speaker 01:
The claims... Well, the claims say without food.

[00:25:37] Speaker 03:
Well, that's right.

[00:25:38] Speaker 03:
But the claims just say it has to be administered without food, but Marikowski already did that.

[00:25:43] Speaker 03:
Marikowski already administered it without food.

[00:25:46] Speaker 03:
Now the Bruner reference, which was also relied on as an alternative from the board, that reference too

[00:25:55] Speaker 03:
has some pertinent information that's helpful.

[00:25:58] Speaker 03:
Now, that reference, they did not test for efficacy.

[00:26:01] Speaker 03:
But what that reference was, it took a granulated misalamin formulation, and again, a tablet formulation.

[00:26:06] Speaker 03:
And through syndographic studies, it measured, it followed the exact time and region of disintegration in the release of the active ingredient in the body.

[00:26:17] Speaker 03:
And it showed that the

[00:26:24] Speaker 03:
Granulated misalamine in the tablets essentially both reached the targeted area, the colon, and released at approximately the same time frame.

[00:26:33] Speaker 03:
So even though it's not looking at efficacy, it is showing that a granulated misalamine formulation can make it to the targeted area just as quickly and be available for release as the tablet formulation.

[00:26:45] Speaker 03:
And Marikowski, importantly, was performed after an overnight fast.

[00:26:49] Speaker 03:
So it too was given without food.

[00:26:51] Speaker 03:
At one point I would like to just circle back to very quickly is Davis 1985.

[00:26:57] Speaker 03:
Davis 1985, as I was stating, talks about positional release of the drug in the case of ulcerative colitis and misalamine.

[00:27:06] Speaker 03:
But it also teaches that small particles, small pellets, like this formulation, a granulated formulation, that in the presence of food, they remain in your stomach.

[00:27:17] Speaker 03:
They don't pass on their own.

[00:27:19] Speaker 03:
And the presence of food increases

[00:27:21] Speaker 03:
the pH to as high as six, which would cause the enteric coding in the Salix 2007 press release, the granulama salamine there, it would cause it to prematurely dose-dump.

[00:27:33] Speaker 03:
And Davis 1985 warned, if you want positional release, you don't want dose-dumping.

[00:27:39] Speaker 03:
So that teaching is there.

[00:27:41] Speaker 01:
Thank you, counsel.

[00:27:43] Speaker 01:
We'll hear from the panel from Ms.

[00:27:45] Speaker 01:
Porth.

[00:27:46] Speaker 00:
Just a little comment.

[00:27:54] Speaker 00:
To follow up on the Davis reference, there are multiple sections of that reference.

[00:28:04] Speaker 00:
The section I was talking about is the one that's talking about the physiology of the gastrointestinal tract and transit time and gastric emptying, which is what the board relied on.

[00:28:14] Speaker 00:
As I said, the board misunderstood that teaching.

[00:28:18] Speaker 00:
The position release of the drug

[00:28:20] Speaker 00:
is later on in the article and actually supports us, because what Davis says there is for five ASA formulations that you want to target the colon for, you actually use a pH-independent coding to delay the release to get to the colon.

[00:28:42] Speaker 00:
So that actually supports our position, I would say.

[00:28:45] Speaker 00:
And I would also note that,

[00:28:49] Speaker 00:
the aspect of the pH-dependent coating to optimize that, to make certain that you don't have this premature release, which my colleague referred to in the stomach with the rise of the pH from the food.

[00:29:02] Speaker 00:
That's why you do a food effect study.

[00:29:04] Speaker 00:
Make sure that the coating is thick enough and that you have the right type of polymer on there that will release at the right pH.

[00:29:11] Speaker 02:
Why would you need a food effect study if you have a reference like Davis that apparently teaches that very same principle?

[00:29:19] Speaker 02:
that food can elevate the pH in the stomach.

[00:29:23] Speaker 00:
Because of the unpredictability in the art with mesalamine formulations, there are various formulations of mesalamine, some tablets, some delayed tablets, some delayed and extended release, and the data is all over the place about whether to administer it with food or without food.

[00:29:41] Speaker 00:
In fact, during the prosecution, the examiner pointed to the package insert, the ALDA,

[00:29:47] Speaker 00:
which is a delayed and extended release misalamin formulation, which instructs in the label that you administer it with food.

[00:29:58] Speaker 00:
So the unpredictability in the art requires you to go to the, and Davis itself says it in his article, is that you want a food effect study to actually measure these principles, these theoretic principles that he's talking about in his paper,

[00:30:14] Speaker 00:
for systemic delivery.

[00:30:16] Speaker 02:
Is that in reference to the efficacy of the coding of the drug itself?

[00:30:22] Speaker 00:
No, no, no.

[00:30:22] Speaker 00:
His reference to needing a food effect study is in the section about the physiology of the gastrointestinal tract, which I talked about before, the transit time, the gastric emptying, where he was saying that for drugs that are targeted for the small intestine, sometimes

[00:30:39] Speaker 00:
in a fasted state, it'd go too fast through the GI tract and wouldn't release where you wanted it to.

[00:30:45] Speaker 00:
That section says nothing about drugs.

[00:30:48] Speaker 02:
So Davis teaches basically against dose dumping.

[00:30:54] Speaker 00:
Well, that's a different concept.

[00:30:56] Speaker 00:
That's a different concept.

[00:30:58] Speaker 00:
That's where the entericote, with monolithic tablets, the entericote falls off fast

[00:31:06] Speaker 00:
and the whole drug releases at one spot.

[00:31:09] Speaker 00:
And that's not what you want.

[00:31:10] Speaker 00:
With this smaller multi-particulate formulation like Aprizo, it disperses throughout the gastrointestinal tract.

[00:31:20] Speaker 00:
Let me just say something about the claim construction, the revised versus the modified.

[00:31:24] Speaker 00:
That's been a misunderstanding by the petitioners all along.

[00:31:31] Speaker 00:
And I would refer the court to our gray brief in pages 8 through 9.

[00:31:36] Speaker 00:
where there was testimony that the revised DAI or the modified DAI, they both mean the same thing.

[00:31:43] Speaker 00:
It refers to the deletion of friability from the mucosal appearance score, not to having a DAI score, a sub score, having a DAI with two sub scores.

[00:31:54] Speaker 00:
And in fact, in the generalized definition that the board went to in example five, it calls it a modified Sutherland

[00:32:05] Speaker 00:
disease activity index.

[00:32:07] Speaker 00:
That's the same as a revised Sutherland disease activity index, which is throughout the specification what is used to define remission.

[00:32:16] Speaker 00:
I don't feel like I need to go through every single site in the specification where remission was defined, but I will say it's not... You don't have time for that.

[00:32:27] Speaker 00:
I don't.

[00:32:28] Speaker 00:
I would just say it's not only in the examples, it is in the detailed

[00:32:32] Speaker 00:
description of the invention, and it's repeated throughout.

[00:32:36] Speaker 01:
I would say with respect to Maripowski, let's be clear, Maripowski... Your time for a battle is concluded, but Judge Rainer has questions.

[00:32:47] Speaker 02:
Just very quickly, if we affirm in this case, then what happens to the Salix appeal from the district court?

[00:32:54] Speaker 00:
If you affirm in this case, well, we still have additional appellate options.

[00:33:01] Speaker 00:
with respect to what to do.

[00:33:04] Speaker 01:
You mean you could seek an in-bank or?

[00:33:07] Speaker 01:
Exactly.

[00:33:08] Speaker 01:
Seek cert.

[00:33:09] Speaker 00:
Our recourse does not end immediately.

[00:33:12] Speaker 01:
Other than that, it's moot.

[00:33:13] Speaker 00:
Yes.

[00:33:14] Speaker 00:
Correct, Your Honor.

[00:33:15] Speaker 01:
Thank you.

[00:33:15] Speaker 01:
We'll take this case under advisement and give you 30 seconds to change your papers for the next one.