[00:00:00] Speaker 00:
Call up Case 19-2400, IBSA versus Teza.

[00:00:07] Speaker 00:
Mr. Johnson, whenever you're ready.

[00:00:11] Speaker 04:
Thank you, Your Honor, and may it please the Court, Brian Johnson from Fenwick and West on behalf of the IBSA Appellants.

[00:00:18] Speaker 04:
Your Honor, this appeal concerns a single-claim term, the word half-liquid.

[00:00:23] Speaker 04:
Now, the District Court found itself unable to construe that term and held it to be indefinite.

[00:00:29] Speaker 04:
But the court deprived itself of two critical guides to the terms meaning, both of them within the intrinsic evidence.

[00:00:37] Speaker 04:
First, there's the inventor's Italian priori application.

[00:00:41] Speaker 04:
And every single place where the 390 patent uses the term half liquid, the Italian application uses the term semi-liquido, which can also be translated as semi-liquid, which is a well-known and commonly understood term.

[00:00:58] Speaker 04:
And to be clear, yours is a perfect one-to-one match.

[00:01:01] Speaker 04:
The Italian application uses semi-liquido the same number of times in the same places within the specification to describe the same chemicals and compositions described as half liquids in the 390 patent.

[00:01:14] Speaker 04:
So if one were trying to understand what the inventors meant by half liquid, their corresponding use of a well-known term, semi-liquid, in their original application is a natural place to look and a highly helpful source.

[00:01:28] Speaker 04:
yet the district court declined to consider it.

[00:01:31] Speaker 04:
Instead, it gave the document no weight whatsoever, and the court's reasons for doing so simply don't hold up.

[00:01:39] Speaker 04:
First, the district court professed to be quite sure that documents written in a foreign language are irrelevant to claim construction.

[00:01:47] Speaker 04:
Now, the district court cited no precedent for that finding, and that's because there is none.

[00:01:52] Speaker 04:
Your Honor, there's no precedent whatsoever for discounting evidence because it's written in a foreign language.

[00:01:58] Speaker 04:
not in claim construction, not in indefiniteness, not in any other patent infringement or validity analysis.

[00:02:05] Speaker 04:
And in fact, this court and many others around the country regularly consider foreign language documents in construing claims.

[00:02:14] Speaker 04:
Here, considering the inventor's original application written in their native tongue, undeniably helps illuminate the inventor's understanding of their invention.

[00:02:24] Speaker 04:
And this court has emphasized time and again that that's an important aim of claim construction.

[00:02:29] Speaker 04:
But that's one that the district court missed altogether.

[00:02:33] Speaker 04:
Now the district court's second reason for discounting the Italian application was that the district court focused on some differences in word choice and phrasing between Ibsen's translation of the Italian application and the 390 patent.

[00:02:47] Speaker 04:
And according to the district court, those differences conclusively established that the inventors deliberately used a different word in the United States, that is half liquid,

[00:02:58] Speaker 04:
to convey a different meaning than semi-liquid.

[00:03:01] Speaker 04:
But, Your Honors, that interpretation is not correct, and frankly, it's not reasonable.

[00:03:06] Speaker 04:
The differences between the translation of the Italian application and the 390 patent that the Court mentioned, the Court highlighted the field of invention and prior art sections of the patent, they're extremely minor.

[00:03:19] Speaker 04:
We're talking about one translator's word choice or phrasing as compared to another.

[00:03:23] Speaker 04:
These are not substantive differences.

[00:03:25] Speaker 04:
And I'd invite you to compare the language used in the specification in our translation versus the 390 patent.

[00:03:32] Speaker 04:
You'll see what I mean.

[00:03:33] Speaker 04:
You'll see that the inventor's use of semi-liquido directly parallels their usage of half liquid in the 390 patent.

[00:03:41] Speaker 04:
But, Your Honors, there's no indication that the district court actually considered this important context.

[00:03:47] Speaker 04:
Had it, it could not have concluded that the inventors intended to convey some different but undisclosed meaning

[00:03:54] Speaker 04:
by using the term half-liquid.

[00:03:57] Speaker 04:
Your Honor, in the end, there's no evidence whatsoever in the record showing that the inventors intended those terms to have some different meaning or scope.

[00:04:05] Speaker 04:
And that's totally consistent with this court's precedence, explaining that two different words can, in fact, mean the same thing.

[00:04:13] Speaker 04:
In other words, they can be synonyms.

[00:04:15] Speaker 00:
And that's even when they're both used in the... Let me ask you, was Dr. Sheall, I don't know how to pronounce the name, C-H-Y-A-L-L, how do you pronounce that?

[00:04:25] Speaker 04:
That's Dr. Shile, Your Honor.

[00:04:26] Speaker 00:
Shile, okay.

[00:04:27] Speaker 00:
He was your expert.

[00:04:29] Speaker 00:
And I think the district court relied on this, but he was unable to articulate the meets and bounds of the term, was he not?

[00:04:41] Speaker 04:
No, Your Honor.

[00:04:42] Speaker 04:
In fact, Dr. Shile gave clear explanations of the boundaries of the term, past liquid.

[00:04:48] Speaker 04:
Certainly clear enough for a person of ordinary skill to understand what past liquids are and what they're not.

[00:04:53] Speaker 04:
He explains there's liquids.

[00:04:56] Speaker 00:
Why don't you cite me to the appendix while you're talking about it?

[00:04:59] Speaker 00:
Sure, Your Honor.

[00:05:04] Speaker 04:
Just give me one moment to identify that.

[00:05:09] Speaker 04:
Now, Dr. Scheil described liquids as free-flowing.

[00:05:14] Speaker 04:
They're things that do not have a thick consistency, and that's in the appendix at 718, page 66, lines 5 through 7.

[00:05:22] Speaker 04:
He also described liquids as solvents, such as methanol, ethanol, acetone, ethyl acetate.

[00:05:28] Speaker 04:
He said these were things that you buy in jugs and you could pour out readily.

[00:05:32] Speaker 04:
They flow like water.

[00:05:33] Speaker 04:
That's in the appendix at 722.

[00:05:34] Speaker 04:
That's page 84 of his transcript lines, 11 through 18.

[00:05:40] Speaker 04:
And then he described that semi-liquids and half-liquids, they have thick consistencies between the liquid and a solid.

[00:05:47] Speaker 04:
They respond to gravity, and they will flow.

[00:05:50] Speaker 04:
And that's in the appendix at page 707,

[00:05:52] Speaker 04:
page 23 of his transcript, line 22, through page 25, line 19, and he offered examples, clear examples of these substances, syrups, toothpaste, peanut butter.

[00:06:05] Speaker 04:
Those are in the appendix at pages 710, 725, and 721.

[00:06:11] Speaker 04:
Now he also explained how, I'm sorry, was there a question?

[00:06:17] Speaker 03:
Yeah, this is Judge Raina.

[00:06:19] Speaker 03:
But he was also asked during the deposition,

[00:06:22] Speaker 03:
He said, if I wanted to make a soft elastic capsule that contains thyroid hormones, gelatin, and glycerol, and I wanted the interphase not to be a half liquid, how would I test to know whether I achieve that goal?

[00:06:34] Speaker 03:
And he responded that he wasn't sure.

[00:06:37] Speaker 03:
It seems that throughout even that deposition that he refused to clarify how one would determine whether a substance was half liquid or a solid.

[00:06:45] Speaker 03:
So your own expert wasn't able to explain

[00:06:49] Speaker 03:
the parameters of half liquid.

[00:06:53] Speaker 04:
Well, it's interesting, Your Honor, because Dr. Schile was asked, what are the range of consistencies that are associated with a half liquid versus something else?

[00:07:03] Speaker 04:
What are the numerical values?

[00:07:05] Speaker 04:
And what he said was, that's not necessary to determine whether something is a half liquid versus a solid.

[00:07:12] Speaker 04:
He said, persons of under skill understand without some quantification or some kind of a test method

[00:07:19] Speaker 04:
when they're working with a half liquid versus a solid.

[00:07:22] Speaker 04:
And that's in the appendix at page 737.

[00:07:25] Speaker 04:
It's page 144 of its transcript lines, four through 11.

[00:07:29] Speaker 03:
So this is a limitation that you'll know it when you see it?

[00:07:36] Speaker 04:
It's a limitation that persons of ordinary skill understand, Your Honor, because

[00:07:41] Speaker 04:
First, there are clear examples in the patent of what half-liquids are.

[00:07:45] Speaker 04:
The patent lists out chemicals that persons of ordinary skill could use as liquids or half-liquids to make these capsules.

[00:07:52] Speaker 04:
And Dr. Shile explained during his deposition that a lot of these are substances that have a thick consistency in between solid and liquid.

[00:08:01] Speaker 00:
But that's hardly specific.

[00:08:04] Speaker 00:
I mean, just because it includes something and it doesn't include others is hardly dispositive of

[00:08:11] Speaker 00:
determining what the meets and bounds are of the term used, right?

[00:08:18] Speaker 04:
Well, Your Honor, terms are construed according to their plain and ordinary meanings of persons of ordinary skill in the art.

[00:08:24] Speaker 04:
And the point is that persons of ordinary skill have no difficulty distinguishing between half liquids and solids.

[00:08:31] Speaker 04:
So the claims in question, they cover capsules filled with liquids or half liquids.

[00:08:36] Speaker 04:
So what's outside the claims are solids.

[00:08:39] Speaker 04:
And the patent gives very, very clear guidance on what solids are, the pharmaceutical solids that can be filled within these capsules.

[00:08:47] Speaker 04:
And these are hard, dry materials like pellets and granules and powders.

[00:08:55] Speaker 04:
There's no question that a person of ordinary skill in the art can distinguish between those things and the liquids and half liquids that are covered by the claims.

[00:09:03] Speaker 04:
That's Dr. Shiles' testimony, and that's perfectly consistent with

[00:09:07] Speaker 04:
the intrinsic evidence.

[00:09:08] Speaker 04:
That's what the intrinsic evidence shows, and that's what a person of ordinary skill understands.

[00:09:16] Speaker 04:
And your honor, that brings me to the second issue that the district court failed to consider, or rather the second error in evaluating the intrinsic evidence that the district court made, and that was not actually considering the specification.

[00:09:32] Speaker 04:
The court said, I'll look to the specification for guidance

[00:09:36] Speaker 04:
on the meaning of half liquid.

[00:09:38] Speaker 04:
But, Your Honors, the district court's discussion of the specification is just four sentences long.

[00:09:45] Speaker 04:
The court never mentioned the most relevant information, the examples of half liquids given within the 390 patents specification.

[00:09:54] Speaker 04:
And that's a list.

[00:09:56] Speaker 04:
In column eight, lines 43 through 45, these are the types of chemicals that can be used to create liquids and half liquid fillings.

[00:10:04] Speaker 04:
Your Honor, the patent says,

[00:10:06] Speaker 04:
that persons of ordinary skill in the art can use these chemicals or others that are, quote, commonly used at the pharmaceutical field to create SEC, soft elastic capsules, with liquid or half liquid content.

[00:10:20] Speaker 04:
So the inventors are referencing commonly used half liquids, and that's incompatible with the suggestion that this might be some obscure or unknown category.

[00:10:31] Speaker 04:
of chemicals.

[00:10:32] Speaker 04:
And the patent also includes experimental examples.

[00:10:35] Speaker 04:
That's columns 10 through 14.

[00:10:38] Speaker 04:
And these are capsules and capsule fillings that comprise liquids or half liquids.

[00:10:43] Speaker 04:
Now, Ibsa explained that persons of ordinary skill know that many of these substances are thick viscous materials with a consistency that's not solid, but also not purely liquid.

[00:10:54] Speaker 04:
And Dr. Shile testified to that very same thing.

[00:10:58] Speaker 04:
And that guidance is embodied in the second part of IBSA's proposed construction of half liquid that provides that a half liquid has a thick consistency between solid and liquid.

[00:11:08] Speaker 04:
And that's consistent with the dictionary definitions that IBSA offered, and it's consistent with the pharmaceutical packaging textbook that IBSA offered as its forensic evidence.

[00:11:18] Speaker 04:
But Your Honor, the Court never mentioned this aspect of IBSA's construction at all.

[00:11:23] Speaker 04:
It quoted it in a pro forma copy and paste of Ibsen's construction at the outset of the court's opinion, but the court literally never addressed it.

[00:11:32] Speaker 04:
Nor did it address any of this guidance in the specification on this point.

[00:11:37] Speaker 04:
So, Your Honor, the court still your address.

[00:11:40] Speaker 00:
Let me just ask you about the standard of review, because there's a little bit of a disagreement, I think, or a discussion of that in the brief.

[00:11:47] Speaker 00:
What's your position on what the standard of review is?

[00:11:51] Speaker 04:
Your Honor, the determination of indefiniteness is reviewed de novo.

[00:11:56] Speaker 04:
And the district court's evaluation of the intrinsic evidence as it relates to claim construction and indefiniteness is also reviewed de novo.

[00:12:05] Speaker 04:
And the district court's consideration of extrinsic evidence is indeed reviewed for clear error.

[00:12:12] Speaker 04:
And I think that's clear from your honor.

[00:12:16] Speaker 04:
Now, I'd like to talk a little bit about the extrinsic evidence.

[00:12:20] Speaker 04:
One piece of extrinsic evidence that the district court did consider was the opinion of Teva's expert, Dr. Khan.

[00:12:28] Speaker 04:
But, Your Honors, this court has made clear that conclusory, unsupported assertions of experts are not useful to courts when construing claims.

[00:12:38] Speaker 04:
That's language directly from this court's en banc Phillips decision.

[00:12:43] Speaker 04:
It's hard to imagine a more conclusory, more unsupported opinion than Dr. Khan's.

[00:12:49] Speaker 04:
There's no discussion of the relevant technology, no mention of any of the intrinsic or extrinsic evidence, no discussion of any analysis that he did.

[00:12:58] Speaker 04:
That's not clear and convincing evidence of indefiniteness, Your Honors.

[00:13:02] Speaker 04:
And he had quite a bit more to say during his deposition.

[00:13:05] Speaker 04:
He offered up a whole host of new technical opinions about what half liquids and semi-liquids are.

[00:13:11] Speaker 04:
Not only were those brand new opinions unsupported by evidence, they're also untimely and prejudicial to himself.

[00:13:19] Speaker 04:
Okay.

[00:13:20] Speaker 04:
Are you hearing me?

[00:13:23] Speaker 00:
Yes, we all are.

[00:13:24] Speaker 00:
Thank you.

[00:13:25] Speaker 00:
Well, we certainly may need your time for rebuttal.

[00:13:27] Speaker 00:
Let's hear from the other side.

[00:13:29] Speaker 00:
Thank you.

[00:13:31] Speaker 00:
Mr. Rosendahl.

[00:13:34] Speaker 02:
May it please the court?

[00:13:37] Speaker 02:
The patent in suit claims a soft gel capsule with a liquid or half liquid interphase.

[00:13:43] Speaker 02:
After considering all of the intrinsic and extrinsic evidence, including the expert declarations and testimony from both sides, the district court found that the term half liquid is ambiguous and that a skilled artisan at the time of the invention would not know with reasonable certainty

[00:14:01] Speaker 02:
whether an interphase is or is not a half liquid within the meaning of the claim.

[00:14:05] Speaker 02:
And that's important because it means that the claims do not give the public adequate notice of what is still open to them.

[00:14:13] Speaker 00:
In other words, a person wishing... Let me interrupt just with two quick little points.

[00:14:20] Speaker 00:
One is on the standard of review, I have a vague record that you are arguing because extrinsic evidence was involved.

[00:14:28] Speaker 00:
The entirety of our review should be

[00:14:30] Speaker 00:
should not be de novo.

[00:14:33] Speaker 00:
Is that your position, or do you agree with your friend?

[00:14:38] Speaker 02:
Well, Your Honor, the legal conclusion of indefiniteness is reviewed de novo, but I think that given the factual findings here, the factual findings are reviewed for clear error because they are based in part on... So is the distinction here between the

[00:14:57] Speaker 00:
Excuse me.

[00:14:58] Speaker 00:
Is the distinction here to be drawn with regard to the intrinsic versus the extrinsic evidence?

[00:15:04] Speaker 00:
Is that correct?

[00:15:06] Speaker 02:
I don't see how there's a way to draw that distinction here, because ultimately the question is, what would a person of ordinary skill and the art understand at the relevant time?

[00:15:17] Speaker 02:
And in answering that question, the court relied on both the intrinsic evidence and the extrinsic evidence.

[00:15:23] Speaker 02:
So I don't know how you would review one part of that

[00:15:27] Speaker 02:
if you did a denover review of the intrinsic evidence, how would you then weigh it with the extrinsic evidence?

[00:15:32] Speaker 02:
So I think that the way that comes before the court, the factual finding should be reviewed for clear error.

[00:15:41] Speaker 00:
The factual finding, okay.

[00:15:43] Speaker 00:
And let me ask you, what are we to do with the statement made by the court about not considering the Italian translation stuff?

[00:15:53] Speaker 02:
Well, I think we should be

[00:15:56] Speaker 02:
careful to look at exactly what the court that he did not say what what mister johnson that he said that the judge that uh... in a footnote first of all i think we should say he didn't think he wasn't considering it he didn't say as a matter of law i'm not going to look at that if you've got that i think this would be a different case what he said in a footnote on page twelve of the joint appendix is i'm dubious that the italian language materials even a part of the intrinsic record informapose of understanding so he's saying essentially

[00:16:24] Speaker 02:
It's not clear to me that I really need to do this analysis.

[00:16:27] Speaker 02:
But he then spends all of page 12 doing the analysis.

[00:16:31] Speaker 02:
So he considers exactly the argument that was put beforehand.

[00:16:35] Speaker 02:
And I think it's worth focusing on exactly what that argument was.

[00:16:38] Speaker 02:
So you start with the term half liquid in the claims, and you're trying to figure out what that means.

[00:16:45] Speaker 02:
And the argument put forth by Ipsa is, well, if you look at the Italian priority document, you'll find that there's an Italian word

[00:16:54] Speaker 02:
semi-liquido that appears to correspond to the term half-liquid.

[00:17:01] Speaker 02:
And then they say, and we're telling you, Judge, that semi-liquido really means semi-liquid because we did a translation after this lawsuit started and 18 years after the application was filed in which our translator said that semi-liquido

[00:17:21] Speaker 02:
can be translated as semi-liquid, and therefore you ought to interpret half-liquid, which is the only term we care about, as a synonym of semi-liquid.

[00:17:32] Speaker 02:
But it's worth pointing out that absolutely nothing in the intrinsic evidence, or even in their translation, equates the word half-liquid with the word semi-liquid in English.

[00:17:45] Speaker 02:
There is no place where the inventors or anybody else said

[00:17:49] Speaker 02:
these two terms mean the same thing.

[00:17:52] Speaker 02:
They are asking the court to draw an inference about the meaning of one term based on a post-doc litigation-inspired translation of a different term from the Italian priority document.

[00:18:07] Speaker 02:
And what the district court said was, OK, I'm confronted with essentially these two competing translations of this Italian term.

[00:18:17] Speaker 02:
And it's worth pointing out that this is not a case where the Italian priority document gives an explanation for what the term means, right?

[00:18:25] Speaker 02:
It's not.

[00:18:26] Speaker 02:
It's where the Italian priority document says, semiliquido and by semiliquido we mean x, y, or z. All we're left with is the bare word, semiliquido, which was rendered once as half liquid in the application, and now, you know, 18 years later,

[00:18:42] Speaker 02:
has been translated as semi-liquid in the new translation.

[00:18:45] Speaker 02:
And the district court on page 12 of the Joint Appendix says, Plaintiff's re-translation of the Italian priority application is not, however, good evidence of what the applicant meant by semi-liquido.

[00:18:58] Speaker 02:
A comparison of Plaintiff's translation of the Italian application's field of invention and prior art sections against those portions of the 390 patent specification

[00:19:07] Speaker 02:
quickly reveals that the applicant and the translator regularly interpret words and phrases differently.

[00:19:13] Speaker 02:
The inconsistency between the two translations is likely because translation requires the translator to use judgment.

[00:19:20] Speaker 02:
So he says, I'm confronted with these two competing translations and I credit

[00:19:25] Speaker 02:
not the late-comer litigation-inspired translation that's being offered to me, I credit the one given by the inventors to the patent office at the relevant time.

[00:19:38] Speaker 02:
And I find that that's the best evidence of what they intended the word to be rendered as in English.

[00:19:45] Speaker 02:
And based on that, I don't give any weight to either your late

[00:19:52] Speaker 02:
translation or the naked word in Italian, semiliquido, which, you know, I have to interpret using two competing translations.

[00:20:01] Speaker 02:
And the translation that they have offered, of course, is extrinsic evidence and not intrinsic evidence.

[00:20:07] Speaker 02:
I think that Mr. Johnson in his argument sort of assumed that the word semiliquid in English appears in the Italian priority document, but that's just not the case.

[00:20:16] Speaker 02:
The only evidence we have of semiliquid is in the form of translations, which are both extrinsic evidence

[00:20:22] Speaker 02:
and not intrinsic evidence.

[00:20:25] Speaker 02:
I think it's also relevant.

[00:20:26] Speaker 02:
And by the way, Mr. Johnson said that he invited the court to compare the two translations and see that there were no significant differences.

[00:20:35] Speaker 02:
But if we apply the form of argument that he has espoused, that Ipsa has espoused, to other words in those sections, we come up with a problem.

[00:20:47] Speaker 02:
So for example, the court said that

[00:20:53] Speaker 02:
If you look at the prior art section and compare it to the patent specification, you find that the translator interpreted the words differently from the application.

[00:21:03] Speaker 02:
And one example of that is in the title of the section itself, because in the translation supplied by IPSA, the section is entitled Prior Art.

[00:21:13] Speaker 02:
But in the application and in the patent, the section is entitled State of the Art.

[00:21:20] Speaker 02:
And so if we take the argument that's being put forward by IBSA, we would say, well, state of the art appears in the US application.

[00:21:29] Speaker 02:
There's some Italian word that corresponds to that in the Italian priority document.

[00:21:36] Speaker 02:
That's been translated, 19 years later, as prior art.

[00:21:40] Speaker 02:
And therefore, we must assume that state of the art is synonymous with prior art.

[00:21:46] Speaker 02:
And that's just not a very convincing argument, because the terms don't really mean the same thing.

[00:21:51] Speaker 02:
And we don't know if that's a disagreement in the translation of the Italian original, or if it represents a decision by the applicant to use different words in the application than they used in the Italian document.

[00:22:08] Speaker 02:
But either way,

[00:22:12] Speaker 02:
It's just not a sound reason to change the meaning of state of the art and treat it as if the words were prior art, which is essentially what it is asking the court to do.

[00:22:21] Speaker 02:
It is also relevant that when the look... Can I just interrupt before your time runs out?

[00:22:28] Speaker 00:
I just wanted to ask you about the argument from the other side that Dr. Khan's opinions come largely from his deposition testimony.

[00:22:37] Speaker 00:
and therefore not in compliance with FRCP 26.

[00:22:44] Speaker 02:
Well, Your Honor, there are two problems with that argument from the other side.

[00:22:48] Speaker 02:
It's true that some of the opinions that he gave were elicited at his deposition.

[00:22:54] Speaker 02:
They were elicited by IBSA asking him questions at his deposition.

[00:22:59] Speaker 02:
They were not elicited by us.

[00:23:00] Speaker 02:
And it's certainly not the case that you can ask an expert questions at their deposition, get answers that you find unhelpful, and then simply ignore the answers that you don't like.

[00:23:12] Speaker 02:
So they're the ones who brought that information into the record, not us.

[00:23:15] Speaker 02:
and now they're stuck with it.

[00:23:16] Speaker 02:
The second problem is that they didn't ask the district court to do anything about that issue.

[00:23:23] Speaker 02:
They didn't object to the testimony.

[00:23:25] Speaker 02:
They didn't ask for supplemental briefing.

[00:23:28] Speaker 02:
They didn't suggest that the court ought not to consider those opinions.

[00:23:32] Speaker 02:
In fact, the depositions were taken after the claim construction briefing was largely completed, and so there was a supplemental round of letters submitted

[00:23:45] Speaker 02:
specifically on the contents of the depositions and the opinions offered at the depositions for the district court to consider, and at no time did IBSA suggest that there was any impropriety in relying on those materials.

[00:24:00] Speaker 02:
So for the court to suggest that the court somehow erred in relying on that, it's really too late for them to do it.

[00:24:07] Speaker 02:
To the extent there's anything to waive, they have waived the waiver by failing to raise that issue until their reply brief on appeal.

[00:24:15] Speaker 00:
Is it your view that reliance on Dr. Kong's testimony is necessary for an affirmance in this case?

[00:24:24] Speaker 02:
no your honor i i think that i think that uh... it is significant that we have a battle of the expert here and the the the district court did credit uh... dr conflict and i think i'm just one of the most distinguished formulators in the country and and truth not credit uh... doctor uh... child opinion but i don't think it's necessary to rely on dr conflict and in order to affirm because dr child with unable to have

[00:24:52] Speaker 02:
as the passage that Judge Raina pointed to illustrates, Mr. Charles was unable to explain how you would tell what is a half-liquid or a semi-liquid and what is not within the meaning of the claims.

[00:25:10] Speaker 02:
We asked him, he said in his declaration, well, half-liquid and semi-liquid are synonyms, and semi-fluid is also a synonym, and then in his declaration,

[00:25:18] Speaker 02:
he was unable to explain the relationship between those words.

[00:25:21] Speaker 02:
Well, sometimes a semi-fluid is a half-liquid, sometimes a semi-liquid is a semi-fluid, but not always, and he was unable to sort of set up the clear relation of those, and he was unable to explain how it is

[00:25:40] Speaker 02:
that one can tell when one has a semi-liquid as opposed to or a half-liquid as opposed to something that is not a half-liquid spill.

[00:25:51] Speaker 02:
And so I think that even without relying on Dr. Kahn, it would be possible for the court to affirm, although this isn't an instance where there were

[00:26:04] Speaker 02:
competing understandings of the term semi-liquid, Dr. Khan said that it's not a term that makes sense in the context of a finished dosage form, it's a term that makes sense only in the context of a pharmaceutical that's being processed and therefore a person of ordinary skill would not understand the term as being relevant in the context of the patent.

[00:26:27] Speaker 02:
And so you had two different opinions about what the

[00:26:30] Speaker 02:
what even the term semi-liquid means, it's also noteworthy that even the dictionaries that Dr. Shile pointed to, and they were the only basis for his opinion because he didn't have any scientific literature using the term half-liquid.

[00:26:46] Speaker 02:
He wasn't able to point to anything other than these dictionaries, which were all definitions of the term semi-liquid and not half-liquid.

[00:26:55] Speaker 02:
Those sort of general purpose dictionaries don't all say

[00:26:59] Speaker 02:
that it means a viscous liquid.

[00:27:02] Speaker 02:
For example, Webster's Collegiate Dictionary says that it means having the qualities of both a liquid and a solid, and the example that's given is semi-liquid manure, which first of all calls to mind something more like a flurry that has chunks in it than a viscous liquid, and second of all is a reminder of how far these dictionaries are from the pharmaceutical context that ought to be the focus of the

[00:27:29] Speaker 02:
of the claims.

[00:27:31] Speaker 00:
So I do want... I apologize.

[00:27:35] Speaker 00:
How much time is remaining?

[00:27:37] Speaker 00:
I'm not... I've lost... We didn't hear the bell yet, did we?

[00:27:40] Speaker 04:
No.

[00:27:41] Speaker 04:
One minute, Your Honor.

[00:27:43] Speaker 02:
Okay.

[00:27:44] Speaker 02:
You've got one minute.

[00:27:45] Speaker 02:
Well, I just wanted to finish by pointing to one point of the intrinsic evidence that is important, I think, and that is that there was a point in time in which the word half-liquid

[00:27:56] Speaker 02:
and the word semi-liquid were both used in a proposed claim and then ultimately the word semi-liquid was removed and the word half-liquid was left and that indicates that for whatever reason the applicants were aware of both terms and chose to use one and not the other and that is further support for the conclusion that they're not synonyms and that the district court properly found that

[00:28:26] Speaker 02:
the meets and bounds of the term half-liquid are not discernible to people of ordinary skill in the art.

[00:28:33] Speaker 02:
For that reason, because there was no clear error in those findings, this court should affirm the district court's judgment that the patents are invalid due to indefiniteness.

[00:28:43] Speaker 00:
Thank you.

[00:28:44] Speaker 00:
Perfect timing.

[00:28:48] Speaker 00:
Now we have rebuttal time, Mr. Johnson.

[00:28:52] Speaker 04:
Thank you, Your Honor.

[00:28:53] Speaker 04:
I don't think I have too much time left, but I would love to address a couple of points that Mr. Rosendahl raised.

[00:28:59] Speaker 04:
The first is the standard of review.

[00:29:02] Speaker 04:
I believe there's the HZNP case that's cited in the party's briefing that very clearly says that in an indefiniteness posture, the court reviews the determination of indefiniteness de novo, reviews the lower court's evaluation of intrinsic evidence de novo,

[00:29:21] Speaker 04:
and reviews the lower court's evaluation of the extrinsic evidence for clear errors.

[00:29:26] Speaker 04:
That's clear from the HZNP cases and others cited in our brief, Your Honor.

[00:29:31] Speaker 04:
I also want to address Mr. Rosendahl's comment that we're relying on this post hoc litigation-inspired translation, which is something that he referenced a few times.

[00:29:43] Speaker 04:
Your Honor, Tevez never contested that translation.

[00:29:46] Speaker 04:
But there's no evidence whatsoever that the translation of semiliquido to semiliquid

[00:29:51] Speaker 04:
which is in some way inaccurate.

[00:29:53] Speaker 04:
And in fact, Your Honor, the facts of this case are that both sides experts, Dr. Khan for Teva and Dr. Scheil for IBSA, agreed that they readily understood that semi-liquido meant semi-liquid without any need for a translation.

[00:30:08] Speaker 04:
So those are the facts here.

[00:30:10] Speaker 04:
And finally, Your Honors, as to Dr. Khan, Mr. Rosendahl pointed out that the testimony we're objecting to was elicited by IBSA.

[00:30:21] Speaker 04:
Your Honor, it can't be the case that an expert can hold back a slew of opinions on technical and scientific issues that aren't hinted at anywhere in a declaration, and then offer them up for the first time during a deposition, springing them on the other side, and thereby depriving the other side of an opportunity to cross them, fairly, or offer their own expert testimony in response.

[00:30:47] Speaker 04:
That can't be the case, and that's what Rule 26

[00:30:50] Speaker 04:
warns against.

[00:30:51] Speaker 04:
And the idea that IBSA didn't object to this below, and so therefore it can't object now, below, Dr. Khan's new testimony was the subject of one or two paragraphs in a supplemental letter brief, a third round of briefing before the district court.

[00:31:09] Speaker 04:
Now it's an important centerpiece of Tevin's argument on appeal, and that's improper, Your Honors.

[00:31:14] Speaker 04:
I know that my time is up.

[00:31:16] Speaker 04:
Thank you, Your Honors, for your time.

[00:31:18] Speaker 00:
We thank both sides and the case submitted.

[00:31:21] Speaker 00:
That concludes our proceeding for this morning.

[00:31:25] Speaker 04:
The Honorable Court is adjourned until tomorrow morning at 10 a.m.