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This case before the court, case number 172513 is a decision out of the district court in the district of New Jersey.

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Su Pernis Pharmaceuticals, Inc.

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versus TWI Pharmaceuticals.

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Mr. Mizork?

[00:00:20] Speaker 04:
Mizork, yes.

[00:00:21] Speaker 03:
Okay.

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And you also want to try to keep five minutes for Republicans.

[00:00:25] Speaker 04:
I will try, yes.

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Nobody's been doing very well with that so far, but we'll see what we get.

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Good morning.

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May it please the court, my name is Don Mazurk.

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I represent TWA Pharmaceuticals in this matter.

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Each asserted claim of the patents in suit requires, one, an agent that enhances the solubility of oxycarbazepine, and two, a matrix that is homogeneous.

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Now, I'd like to begin with the solubility enhancing agent issue.

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Now, Superness argues that the accused agent in TWA's drug product

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is an agent that enhances the solubility of oxcarbazepine.

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I'm using accused agent as directed by the court's order.

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However, the specifications of the patents in suit explicitly state that the accused agent is not either a solubility agent or a release promoting agent.

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Now, thus, it was clear error for the district court to find the accused agent

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to be a solubility enhancing agent as used in TWIs and the product.

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The district court had an answer to that allegation that you've just made, right?

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Didn't the district court say, well, I looked at the specification and there's some and or language in there, and I'm going to read that as being it's not one thing or another, right?

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Yes, and that's the error.

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I mean, the district court said that I'm going to read and or to mean just and.

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Now the district court has a lot of discretion in these cases to find facts, but one thing the district court does not have discretion to do is to ignore the plain language of the patent specification, which says repeatedly that when we say enhanced formulations in the patent, it's at column four, you can direct yourself to column four of the patent, it says the patentee defines

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enhanced formulations to be formulations that include, I guess we can read it right at the beginning of page four, it says, based on human data, improvements were made to the formulations by incorporating solubility enhancers and or release promoting excipients, PARIN.

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Such formulation are referred to as enhanced formulations.

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So what the district court did and what SuperNAS said is they point to other parts of the specification where they say by

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the invention we claim, or we're including combinations of release promoters and solubility enhancing agents as encompassed by the invention.

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Well, yeah, that's the and part of and or.

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So the district court clearly dismissed all the, the accused agent is actually used in examples of the patent.

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Found in, I think it's examples one of the patent.

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in table one.

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The accused agent is actually used in these examples.

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These examples are described as not working, and these examples are described as not containing a, they're not enhanced, and they're not containing a release promoter slash solubility agent.

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That is on, well it's the passage we just read, and it is the description of the examples on column two

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at the bottom of the page beginning at line 60.

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Figure one shows the dissolution profiles of the three examples, CRF, CRM, and CRS.

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Those are the examples listed in table one.

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Oxycarbazepine formulations containing no solubility slash release enhancer.

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And the district court said that slash means either or.

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It means and or.

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But the district court said either or, right?

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The district court said it meant and.

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meant and.

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It didn't mean either or.

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It meant and.

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You had to have both.

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And so the district court said, what you're saying about example one isn't right.

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I'm sorry?

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Your view is that the backslash means and.

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Not my view, Your Honor.

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English language view is that we cite it in our brief.

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It's the dictionary says slash means and or.

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The case law says and or.

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The slash means and or.

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And this pen itself says

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the slash means and or.

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When you read every other example of the patent, column four, lines one to four as we read.

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I think our brief reply group, especially, or our brief goes through all the places in the patent where it says, column five, lines 57-ish to 59.

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It says, as these polymers swell, they form a homogeneous matrix structure.

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that maintains its shape during drug release and serves as a carrier for the drug, solubility enhancers, and or release promoters.

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I mean, throughout the entire specification, the slash means and or.

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And the patent and the district court just did not have discretion to say that and or means just bank.

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Is the compound capable of being an enhancer?

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I'm sorry?

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Is the compound capable of being an enhancer in the real world?

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As far as the evidence shows, no.

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The only evidence that shows that the accused agent has the capability of being a solubility agent for oxcarbazepine is the solubility data

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that they submitted in this case pursuant to the example of what's said here is a solubility agent to test in example three.

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But I was wondering, even if your argument was good that the patent shows that this product, this thing is not an enhancer for their patent, it's capable of enhancing in your product.

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Well, all I can talk about is the evidence in this case, Your Honor.

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The evidence in this case is that

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There is a passage in the patent that says low molecular weight versions of this accused agent can be solubility enhancing agents.

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But if you look at the actual test, when the panties tested the low molecular weight agents in Table 3 in Column 10,

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The only thing that they tested that made the solubility of oxcarbazepine worse was this particular accused agent.

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It didn't make it a little worse.

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It made it a lot worse.

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So you have the actual testing in Table 3 that says that lower molecular versions of this accused agent, which were what was preferred as a solubility enhancing agent, made the situation much worse.

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The district court ignored all of this.

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I just wanted to ask you a question.

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I understand your emphasis on the language and the specification.

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But just to make sure I understand your argument, are you saying, if I agree with your interpretation of the specification, are you saying that that trumps all other evidence?

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Because I know that the district court considered other evidence, including the test results of experts, including your own expert, in making the determination that she made

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And so would the specification then trump that evidence, or how are you just saying that there's clear error because of failure to consider the statement and specification?

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Well, I'd say there's clear error because of the basic error.

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Secondly, I'd say that it's pretty strong evidence and very difficult to overcome if the PAND itself says that the accused agent is not a solubility enhancer.

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Now, whether there's some set of facts in which somebody could get away with it, I don't know.

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But here... But the district court laid out

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huge amount of evidence.

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I mean, this was not just one point that the district court made.

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The district court relied on substantial evidence in the record, and as Judge Stoll said, even evidence from your own ex.

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Well, Your Honor, I just disagree on that for several reasons.

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One, the district court did have a lengthy discussion of evidence.

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But if you look through the evidence, most of the evidence was just picking and choosing statements about

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um, the excipient as in general, not in the specific context of whether it actually had a beneficial effect on the solubility of oxcarbazepine.

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Secondly, the issue, the district court was supposed to, there was an agreement about what the claim term solubility enhancer meant, which was that the effect on solubility was greater than de minimis.

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Now the district court said, well, wait a minute, you know, even though she recognized that that was how we got through a claim construction debate earlier in the case,

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She then said, well, I don't see anything in the patent that says that any particular amount of improvement is required for something to be a solubility-enhancing agent.

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And here, it was this negligible difference.

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And we introduced it.

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But she made a lot of findings that make it clear that she was rejecting that de minimis argument.

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Well, she couldn't reject the de minimis argument because, I mean,

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She said, her findings, I mean, her findings were specific.

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She said, it's more, right?

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She said it's more, and I don't find anything in the patent or specification that says it has to be anything just more.

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And while she has a lot of findings, Your Honor, this is where we're kind of infected by the old activist case that I know Judge Stahl and Judge Clevenger, you were on the panel that heard the prior case involving these same patents and guarding activists.

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And the evidence on this issue was so dramatically different than it was in the activist case.

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In the activist case, when they tested the accused agent.

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Well, but I mean, it's pretty extreme for you to say we have to send this back to another judge because she can't possibly see through the fact that it's different evidence.

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I mean, she said repeatedly that she knows that her determination has to be based on this record.

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She said it was being based on this record.

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And she made a lot of specific findings only citing to this record.

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So for you to come here and say, oh, this judge obviously was blinded by the fact that she was in a different case that had similar circumstances, I don't think that's a fair characterization of what this judge did.

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Well, Your Honor, I mean, all I have to prove is that there was an error in the finding.

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I mean, I don't really have to prove the motivation.

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I do believe that despite the district court saying so many times that she was not considering evidence from the prior case, she did.

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She referenced.

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evidence from the activist case regarding whether or not the ex-teller product was tested and compared in some of the testing from their experts, and she referenced it.

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So if she was so careful about not thinking about the prior thing, then she would have.

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And then secondly, we asked her about the proper way to use the activist decision.

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And we challenged that the district court misused the prior decision, didn't understand

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this court's precedent about what weight to give to a prior decision.

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And she made specific findings that she wasn't giving undue weight to the prior decision.

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But then, while she said, well, what she described as the appropriate weight does not comport with what this court says is the appropriate weight to give to a prior decision.

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In the Mendenhall case, Gillette case, which I know Judge Clevenger had been a participant to, it's a red flag.

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That's the amount of weight.

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You can't give weight to the findings, the factual findings in the case.

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Can you tell me what page you're relying on for where she referred to something in the other case?

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Certainly it's... Is that the same page that you gave in your briefing?

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Yes.

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Something beyond that?

[00:12:33] Speaker 04:
No.

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That was the one, that was the example where she, and we reference it in our brief, yes.

[00:12:39] Speaker 03:
Okay, so it's just that one example.

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On the de minimis page, just going back to that for a minute.

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Yes.

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A57, this is her decision.

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And she says, TWI argues that such minor increases in solubility are insignificant and insufficient.

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The court disagrees.

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And then she talks about Dr. Chayel's statistical analysis.

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And she says that he said that's statistically significant.

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And why, even though she didn't use the

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magic words, de minimis.

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Why doesn't this discussion on page 57 show that she actually considered de minimis?

[00:13:18] Speaker 04:
Well, two things, because the court said specifically that she didn't see anything in the patent that required any amount of improvement.

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So she's made a direct finding that's opposite to what I think you're arguing about, whether de minimis needed to be found.

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And secondly, on page 57... I'm just saying we're discussing the concept of it.

[00:13:38] Speaker 04:
Well, and we kind of, we looked at this.

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She explicitly disagreed with your position that it wasn't statistically significant, right?

[00:13:45] Speaker 04:
No, she says, you know, we're responding to this.

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Statistically significant, as we point out in our brief, statistical significance is irrelevant.

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Statistical significance, as our reply brief goes into, does not matter.

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You have to find practical significance.

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Statistical significance has nothing to do with whether there's any

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practical significance of a difference in the change.

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So the original is that this isn't discussing the de minimis requirement because it's not talking about practical significance.

[00:14:18] Speaker 04:
Well, correct.

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It's like de minimis means practically different.

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And what we did discuss, this section of the opinion, because Supernus tries to cobble together some kinds of other findings to say that the court actually did do it.

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And we explain in our brief how

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of statistical significance is not what the claim term was defined to mean and it wasn't disagree with you on that.

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Just hypothetically.

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Sorry?

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Say we disagreed with you on that, hypothetically.

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Do you agree that the discussion here on page A57 is getting across the idea of whether something is de minimis or not or significant or not?

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I don't think so because it doesn't address any practical effect.

[00:15:01] Speaker 01:
doesn't it doesn't you're out of time I'm going to give you two minutes for rebuttal okay thank you honor of course we still stand on our refunding homogenous matrix issues good morning and may it please the court like to start off by correcting a misstatement council repeatedly made the statement that the specification throughout states that

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The accused agent is not a solubility enhancer.

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It never says that.

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There is only one place in the entire patent that uses the words without solubility enhancer.

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That's at column three, lines 14 to 19, APPX 155.

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And that passage refers to formulations that do not include the accused agent and have no relevance here.

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Again, that site is column three, lines 14 to 19.

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That is the only statement in this specification of any of the asserted patents that uses the words without siability enhancer.

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It's describing figure five.

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It's describing formulations that do not include the accused agent.

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Now, just to clarify this concept with table three and the end or argument,

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I would direct the court's attention to column three of the 898 patent.

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Again, we're staying with APPX 155.

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This is at column three, lines 54 to 61.

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And I really do think it's worth reading.

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Quote, it is the object of this invention to provide controlled release oxcarbazepine formulations suitable for once-a-day administration.

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So let's stop there.

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The focus of this patent is to I apologize.

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Yes.

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I'm in column.

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No problem.

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I'm column three.

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A P P X one fifty five if you're using that.

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Okay.

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And I'm at lines fifty four to sixty one.

[00:17:08] Speaker 02:
Okay.

[00:17:08] Speaker 01:
Okay.

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So it is it is the it is the object of this invention to provide controlled release oxcarbazepine formulation suitable for once a day administration stopping there.

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We're dealing with oxcarbazepine, a very difficult to dissolve, difficult to formulate drug.

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The inventors of the Pattinson suit were able to create a once a day formulation.

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That is the centerpiece of this invention.

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The paragraph continues, quote, it is an additional object of the invention to incorporate a combination of solubility enhancing excipients and or release promoting agents into the formulations.

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And this is important.

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to enhance the bioavailability of oxcarbazepine and its derivatives.

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Such compositions are referred to as enhanced formulations.

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An enhanced formulation in the context of this patent means a formulation that has enhanced bioavailability, which is just the word for saying the oxcarbazepine is available to the human body.

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It enhances the bioavailability.

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If you have an enhanced formulation, bioavailability is enhanced.

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such that you can achieve once-a-day administration.

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If you have a non-enhanced formulation, which is Table 1, which was the focus of Appellant's argument, non-enhanced in Table 1 means you do not have sufficient enhancement of bioavailability to achieve once-a-day administration.

[00:18:33] Speaker 01:
What's the evidence of that?

[00:18:34] Speaker 01:
The direct sites figures 1, 2, and 3.

[00:18:39] Speaker 03:
Well, what's your response that

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Solubility-enhancing excipients and release-promoting excipients can be one or the other in terms of accomplishing enhancement.

[00:18:53] Speaker 01:
Yes.

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So if you look at the description of the non-enhanced formulations, it uses the forward slash, an admittedly less than clear punctuation.

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But even in Appellant's own citation

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to a legal style manual, the forward slash is described as a grammatical abomination that can mean end, or, or end, or.

[00:19:25] Speaker 01:
That's in the reference the appellant cited, right?

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Here, the district court found, as a matter of fact entitled to deference based on voluminous documentary and expert and inventor testimony,

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that what was meant in the description of the non-enhanced formulations was that it did not contain that critical synergistic combination of release promoters and enhancers.

[00:19:51] Speaker 01:
And I think it's important also for me to correct a potential mischaracterization of this de minimis argument if you have no more questions on the end or issue.

[00:20:09] Speaker 01:
Appellant argues that the district court clearly erred by not addressing or making fact findings to confirm that any increase in side ability was not something more or less de minimis.

[00:20:25] Speaker 01:
The district court's opinion in this case completely contradicts that assertion.

[00:20:31] Speaker 01:
Number one, there is testing conducted by both parties' experts, Dr. Scheil,

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and Dr. Berkland, TWI's own expert.

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Dr. Berkland tested, he ran the industry standard test described in example three, table three.

[00:20:47] Speaker 01:
He ran that test almost three dozen times, every single time.

[00:20:52] Speaker 03:
But what's your response to your friend on the other side who said that really, he didn't use these words, but I think he was saying there's a difference between qualitative and quantitative impact.

[00:21:03] Speaker 03:
In other words,

[00:21:03] Speaker 03:
Just because it's statistically significant didn't mean it actually produced a practical result.

[00:21:09] Speaker 01:
That's a very good point, Your Honor.

[00:21:10] Speaker 01:
The district court found that the solubility testing in this case demonstrated a 26 to 195% increase.

[00:21:21] Speaker 01:
That is a finding of fact.

[00:21:23] Speaker 01:
Most importantly to this concept of the minimus is what you may recall from the opinion Mr. Chen's formulation document.

[00:21:33] Speaker 01:
Mr. Chen's formulation document is a document from a TWI formulator created, an appellant's formulator created before this litigation began, well before it began.

[00:21:44] Speaker 01:
This formulator took the accused agent.

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He made a whole bunch of tablets.

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He put increasing amounts of the accused agent into his tablets.

[00:22:00] Speaker 01:
When he did that, he found, quote,

[00:22:03] Speaker 01:
Higher accused agent equals faster hydration.

[00:22:07] Speaker 01:
If you look to table one, claim one, hydration promotion is the benchmark for solubility enhancement.

[00:22:16] Speaker 01:
But you don't have to rely on claim one.

[00:22:17] Speaker 01:
There is ample expert testimony that was credited by the district court to support that.

[00:22:22] Speaker 01:
So TWI formulator adds more of the accused agent, sees increased hydration, increased solubility.

[00:22:32] Speaker 01:
More importantly,

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That same formulator takes the accused agent out of the test samples.

[00:22:38] Speaker 01:
And in his own words, the result is a dead end.

[00:22:41] Speaker 01:
That is real world, practical ramifications of having differing amounts of the accused agent and taking the accused agent out or keeping it in.

[00:22:51] Speaker 01:
Real world test.

[00:22:52] Speaker 01:
This is a rare piece of evidence in these Hatch-Waxman cases that shows that the accused infringer had used the accused ingredient

[00:23:02] Speaker 01:
and actually found before the case that this was having a demonstrable, real-world, non-dominimous effect.

[00:23:12] Speaker 01:
Non-dominimous.

[00:23:14] Speaker 01:
Also importantly here, I think we have to take a step back and realize that what we're addressing on appeal today is not a claim construction issue.

[00:23:25] Speaker 01:
Appellants had supernus's infringement contentions before the Markman proceedings in this case.

[00:23:33] Speaker 01:
They knew that we were asserting that the accused agent satisfied claim element 1C.

[00:23:38] Speaker 01:
They never argued for specification disclaimer or a negative limitation.

[00:23:45] Speaker 01:
1C means an agent that increases liability but is not the accused agent.

[00:23:50] Speaker 01:
This was never raised during markman proceedings.

[00:23:53] Speaker 01:
So what we're dealing with now is an application of a claim construction, a weighing of the evidence here,

[00:24:02] Speaker 01:
So this is a clear error standard.

[00:24:04] Speaker 01:
And I don't want to get lost, because what we're hearing essentially is a disclaimer argument.

[00:24:09] Speaker 01:
But it's being repackaged as an application of the claim construction to the facts in this case.

[00:24:17] Speaker 03:
You're going to hear- What's your response to Mr. Azurk's argument that, and I gave him a hard time about this, but the reality is district judges are human beings.

[00:24:29] Speaker 03:
You know, the district judge walks into this and she said, wait, I tried a whole case on this not that long ago.

[00:24:35] Speaker 03:
I get this science.

[00:24:37] Speaker 03:
I mean, what is your response to the fact that she did not limit herself solely to this record and instead based it on what Mr. Mazurk would say was not as good of a record for purposes of the generic in the Octavius case?

[00:24:55] Speaker 01:
Yes.

[00:24:57] Speaker 01:
The critical question was already asked of Appellant's counsel.

[00:25:02] Speaker 01:
Point me to a section in the trial opinion where a substantive ruling was based on evidence from the activist case.

[00:25:09] Speaker 01:
It does not exist.

[00:25:11] Speaker 01:
The district court and the briefing on this, I hope, has been clarified by us filling out the quotations.

[00:25:21] Speaker 01:
Because there are truncated quotations that when read in full, and we did that.

[00:25:28] Speaker 01:
We tried to correct the record in that regard.

[00:25:32] Speaker 01:
Maybe half a dozen times, she reiterated the fact that she was relying solely on evidence in this case.

[00:25:39] Speaker 01:
Now, the citation to so-called activist evidence is an introduction to Dr. Bouge, who was Supernus' chemical imaging expert.

[00:25:49] Speaker 01:
And in passing, she says,

[00:25:51] Speaker 01:
He tested TWI's product.

[00:25:54] Speaker 01:
He tested this.

[00:25:55] Speaker 01:
He tested Superinus' product.

[00:25:57] Speaker 01:
It so happens that he didn't test Superinus' product in this case because there wasn't an obviousness case.

[00:26:02] Speaker 01:
We didn't need to show nexus.

[00:26:04] Speaker 01:
He did test it in the other case.

[00:26:06] Speaker 01:
But he also used a validation protocol from the activist case.

[00:26:09] Speaker 01:
And he used the same protocol.

[00:26:11] Speaker 01:
And that was fine.

[00:26:12] Speaker 01:
There was no dispute that that was proper.

[00:26:15] Speaker 01:
At the end of the day, that was an introduction to an expert and what he did in this case.

[00:26:19] Speaker 01:
followed by paragraph after paragraph of the results of his chemical images of the TWI tablets.

[00:26:26] Speaker 01:
In this case, in fact, the pictures are put in her opinion in color.

[00:26:31] Speaker 01:
The trial opinion is completely devoid of a single instance of Judge Bum relying on activist evidence to support a substantive ruling in this case.

[00:26:45] Speaker 01:
And that would be my response.

[00:26:46] Speaker 01:
And I think Your Honor was there already.

[00:26:49] Speaker 01:
in asking for any additional citations.

[00:26:56] Speaker 01:
Unless there are other questions, thank you for your time.

[00:27:14] Speaker 04:
Just to respond to a few of the points

[00:27:17] Speaker 04:
At the beginning of Supernus' argument here, they tried to argue that they went back to the Andor issue and tried to argue that the combination is what they tried to explain again that somehow a combination is what was meant by enhanced.

[00:27:32] Speaker 04:
And what they cited to is the section at the beginning of column three.

[00:27:36] Speaker 04:
And they said that because there were certain examples that were referenced with saying those specifically did not just have a solubility enhancer in them, that

[00:27:47] Speaker 04:
That somehow negated the statements regarding to the examples that did have the accused agent in it, that those examples were without a solubility slash release promoter.

[00:28:02] Speaker 04:
Solubility agent slash release promoter, which is just nonsense.

[00:28:05] Speaker 04:
Because the specific example that contains the accused agent is described in the patent in specific reference to the example and in the general sense of the specification.

[00:28:17] Speaker 04:
as being examples that do not have either a release promoter or a solubility enhancing agent.

[00:28:25] Speaker 04:
And people looking at the specification were entitled to rely on that.

[00:28:29] Speaker 04:
And then I think Mr. Geove made a concession that the use of the slash was a little inartful, I guess.

[00:28:44] Speaker 04:
They made the concession.

[00:28:46] Speaker 04:
And he said, well, all the witnesses testified what it meant.

[00:28:49] Speaker 04:
The inventor testified what he meant by that and everything else.

[00:28:51] Speaker 04:
Well, that's completely inappropriate.

[00:28:55] Speaker 04:
And it's completely inappropriate for the district court to rely on inventor testimony about what he meant.

[00:28:59] Speaker 04:
People, the public, looking at the specification, won't have the benefit of supernesses, witnesses, to help them and guide them through understanding the specification.

[00:29:08] Speaker 02:
And if there is an ambiguity in the specification- I don't understand the argument, but what you're really making here is a disclaimer argument.

[00:29:14] Speaker 04:
I don't, I mean, I don't think it's a dis, I mean, this is not a, well, let's go, it's not a claim construction argument, number one, because I don't know how this would crop up as a claim, you know, we, we, we said a solubility enhancer or something like that.

[00:29:26] Speaker 04:
Enhanced solubility is in more than a de minimis way, in more than a de minimis way and they agreed.

[00:29:31] Speaker 04:
As far as disclaimer argument, I don't think that it's a disclaimer argument, except whatever you call it, it is what it is.

[00:29:39] Speaker 04:
We, we made this, we made the argument, the district court considered it.

[00:29:42] Speaker 04:
They didn't say that it was a disclaimer argument or whatever at any point in time.

[00:29:46] Speaker 04:
And it's not, it's if they make a factual statement, if the patentee makes a factual statement in the patent, then we should, they should be bound by that fact at some later time.

[00:29:57] Speaker 04:
I mean, they can't go ahead and say in their patent that this is not a solubility enhancer, not a solubility enhancer, and then to come and accuse us of saying our agent, when we use it, is a solubility enhancer.

[00:30:09] Speaker 04:
And I think the point would be is that

[00:30:11] Speaker 04:
We never waived it because obviously we're talking about it, and we had a ton of evidence and done a discussion in the record about what the specification meant, which the district court just kind of dismissed because she says, I took care of this in the activist case, and I'm not going to consider it again.

[00:30:24] Speaker 04:
So that was inappropriate.

[00:30:26] Speaker 03:
OK, you're out of time.

[00:30:26] Speaker 04:
OK, thank you, Your Honor.

[00:30:27] Speaker 04:
I appreciate your indulgence.