[00:00:00] Speaker 00:
Before we begin our regular proceedings today, we have two motions.

[00:00:04] Speaker 00:
I'll turn it over to Judge Chen for a motion.

[00:00:07] Speaker 03:
Yes, thank you, Chief.

[00:00:11] Speaker 03:
This morning I'd like to move the admission of Timothy Q. Lee, who's a member of the Bar and is in good standing with the highest court of New York.

[00:00:19] Speaker 03:
I have knowledge of his credentials and am satisfied that he possesses the necessary qualifications.

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I know these things because Mr. Lee has been

[00:00:28] Speaker 03:
one of my clerks for the past 18 months, and most clerks come through for one year.

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Tim has managed to stay with me for a whole year and a half, and that can be, I understand, a withering, relentless experience, but Tim has really held up well.

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He's been an excellent clerk for me, very thoughtful, great writer, commonly has been

[00:00:57] Speaker 03:
doing bench memos of 50 pages or more, and yet I always ask for more.

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But he also has other great qualities.

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I just know him as an honorable, kind person with a lot of dignity and poise, and I think he's going to be a great member of our bar.

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So I respectfully move for Mr. Lee's admission to our bar.

[00:01:19] Speaker 00:
Well, we have the pleasure around our court because we're all on two floors of getting to know each other's cliques as well.

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So it's with pleasure that I grant the motion.

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And now I will, if you will allow me, I will entertain a motion.

[00:01:36] Speaker 00:
Oh, well, did we grant my motion?

[00:01:38] Speaker 00:
Yes.

[00:01:39] Speaker 00:
I'm sorry.

[00:01:42] Speaker 00:
Well, we're taking hostages here today.

[00:01:44] Speaker 03:
Oh, gosh, back in Congress.

[00:01:49] Speaker 00:
OK.

[00:01:49] Speaker 00:
I move the admission of Vincent Young-Ling, who is a member of the Bar and is a good standing in the highest court of New York and Massachusetts.

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I have knowledge of his credentials, and I'm satisfied that he possesses the necessary qualifications.

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And I think Judge Chen and Judge Hughes will appreciate that ours is kind of an odd job because

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In normal work settings, you hire someone, they work out great for a year, and what that means is that you keep them forever.

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And in our situation, in our circumstance, we have the pleasure and the honor of working so closely with our clerks for a year, and then they go on to do other things.

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So it's kind of a weird position we're in.

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It's a very bittersweet circumstance we find ourselves in because

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We do hold onto them forever in a different way, which is they become a member of the clerk family and also the court family.

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Vinny has been with our chambers for a year.

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He came to me well-trained by first Judge Sue Robinson and then Judge Kent Jordan.

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And in an odd moment this morning, I just told Vinny that my phone rang and I hadn't talked to Kent Jordan in almost a year.

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And he was calling on another matter, but we both concluded it was telepathy.

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that he was calling on this morning.

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So on behalf of myself and Kent, Judge Jordan wishes you congratulations.

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Then he's been a pleasure in the chambers.

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He's a thoughtful and measured professional young man.

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He's been unique as a member in certain respects because his mature judgment causes him constantly to think several steps ahead of where we are at the moment in terms of the consequences of what we do.

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I'll have to admit that sometimes drives me crazy.

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But it's been a pleasure and a challenge to have him do that in chambers.

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He's clearly destined to do consequential things in his personal and professional life.

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And in his personal life, that includes moving his wife across country to join a firm in LA and hopefully to finally be getting at least one dog.

[00:04:05] Speaker 00:
So it's been a great pleasure, and I move the admission of this talented young man.

[00:04:13] Speaker 00:
Motion is granted.

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

[00:04:16] Speaker 00:
Will you both stand, please?

[00:04:23] Speaker 04:
You saw and you swore that you would court yourself as an attorney and counselor of this court, a bribe and a court of law, and that you will support the Constitution of the United States of America.

[00:04:33] Speaker 04:
I do.

[00:04:35] Speaker 04:
I do.

[00:04:36] Speaker 00:
Congratulations.

[00:04:41] Speaker 00:
Okay.

[00:04:41] Speaker 00:
First case for argument this morning is 16-1962, Atsuka Pharmaceutical versus Ida's Pharmaceutical.

[00:04:49] Speaker 00:
Mr. Browning, whenever you're ready.

[00:04:57] Speaker 04:
Good morning.

[00:04:57] Speaker 04:
Paul Browning for Plankett Health, Atsuka.

[00:05:00] Speaker 04:
The district court below construed the claim terms from the perspective of a lay person, not one of ordinary skilled law.

[00:05:07] Speaker 04:
And having construed the claim terms in this fashion, the district court disregarded those portions of the specification that he believed did not comport with his lay reading of the claims.

[00:05:17] Speaker 00:
Well, you say disregarded.

[00:05:18] Speaker 00:
That's kind of a harsh word, it seems.

[00:05:20] Speaker 00:
He considered all the sites in the specification that you were arguing went the other way or should cause them to go the other way.

[00:05:28] Speaker 00:
And he dealt with them, right?

[00:05:30] Speaker 04:
Well, I certainly mean no disrespect for Judge Simandal, but with all due respect, I don't believe he took into account those other portions of the specification.

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He certainly did not show how they aligned in any way with his construction of the claims.

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Now, this court in Phillips said the specification is the single best guide to the meaning of the claim terms.

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The Judge Bullough did not use the specification as the single best guide.

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Well, you say that those provisions that you cite, and I think we're aware of them in my mind, at least two come to mind, and you say they didn't align with his construction.

[00:06:05] Speaker 00:
But what he said is, in those same paragraphs or the same sections of the specification, clearly talked about the composition using the words in the claim, and you talked about using one single dosage.

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So he dealt with that, and he

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And so why is he wrong in that?

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He said those sections, those alternative uses that are cited in the spec, don't undermine the conclusion that the words in the spec refer to the first portion of the specification and not the second.

[00:06:35] Speaker 04:
Well, there are multiple problems with that.

[00:06:37] Speaker 04:
But the problem is that those portions of the specification are talking about composition, the broad term composition.

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It makes clear that composition has alternative forms.

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It can be in one dosage form or it can be in two.

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And the specification is very clear in language.

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And it uses the term dosage form, which the discord below erroneously equated with composition, differently and distinctly.

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If you look through the specification, it only uses dosage form in very few places.

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Every single time it does, it says that there are alternative approaches.

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One is a single dosage form.

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Another is multiple dosage form.

[00:07:10] Speaker 03:
Well, let's take a step back.

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I mean, this is a pretty long patent.

[00:07:17] Speaker 03:
In so many different places throughout the patent, we're talking about the combination of the two ingredients in a single pharmaceutically acceptable carrier, right?

[00:07:28] Speaker 03:
A single carrier.

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So, I mean, it's like a jackhammer to my forehead.

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So the point is, is that it's very consistent with what I think everyone's common sense background understanding of what a composition would be, which is essentially a

[00:07:45] Speaker 03:
chemical or physical union into a single thing of multiple elements or ingredients.

[00:07:52] Speaker 03:
Like, for example, if I had two cups here on the bench and one was a cup of lemonade and the other was a cup of iced tea, I don't think the Supreme Court would be very surprised if I told them that that was a composition of an Arnold Palmer, because we're talking about two separate cups of iced tea and lemonade respectively.

[00:08:14] Speaker 04:
Perhaps, Your Honor, but we're not talking about iced tea, we're talking about pharmaceutical compositions.

[00:08:19] Speaker 03:
Right, but as far as I know, there's nothing in the record that suggests that a common background understanding of the word composition in chemistry is so broad that it encompasses two separate dosage forms.

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So now the next step is, okay, is there something in your spec that is clear or clear enough

[00:08:42] Speaker 03:
that displaces that common background understanding of the word composition.

[00:08:47] Speaker 04:
Right, Your Honor.

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But with all due respect, I believe that's not the correct approach, in that we don't look to common sense lay interpretations of composition.

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We look to how one of skill and the art in the context of this patent specification would understand that term.

[00:08:59] Speaker 02:
But to be clear, you're not arguing that outside the context of this patent, a skilled artisan would understand a composition or the composition

[00:09:11] Speaker 02:
to, as a matter of course, be one or more dosages.

[00:09:18] Speaker 02:
You're looking to the specification of the patent.

[00:09:21] Speaker 02:
Not quite, Your Honor.

[00:09:22] Speaker 02:
I mean, we are looking, of course, to the specification of the patent.

[00:09:24] Speaker 02:
Did you provide any expert testimony or anything that would suggest a skilled artisan would understand in this pharmaceutical industry a composition or the composition to be

[00:09:36] Speaker 02:
two or more dosages combined.

[00:09:38] Speaker 04:
Yeah, and to be clear, it's pharmaceutical composition is the term, and the testimony undisputed by both sides' experts were that combination therapy is the norm.

[00:09:48] Speaker 02:
I'm sorry, that's not answering my question.

[00:09:50] Speaker 02:
I'm trying to be very specific because I understand your argument is based on the specification and also particularly that in this field, combination therapy is used, but I don't see any evidence that

[00:10:05] Speaker 02:
In isolation, a skilled artisan in the pharmaceutical industry would understand a composition or the composition to be anything other than a singular dose.

[00:10:16] Speaker 04:
Again, Your Honor, we have to consider the claim term.

[00:10:19] Speaker 03:
Could you just answer his question, please?

[00:10:21] Speaker 03:
Is there anything in the record?

[00:10:23] Speaker 04:
I'm sorry.

[00:10:24] Speaker 04:
I'll answer it backwards then.

[00:10:26] Speaker 04:
Your Honor, Dr. Carell, who's our expert, did offer his opinion that one of ordinary skill in the art would understand pharmaceutical composition as a broad term.

[00:10:34] Speaker 04:
that it doesn't specify the dosage form.

[00:10:37] Speaker 04:
And then in the context of the claim to the specification.

[00:10:40] Speaker 04:
Where did he say that?

[00:10:41] Speaker 04:
In his declaration, which is in the appendix.

[00:10:44] Speaker 03:
But did he actually say it's a broad term that can actually encompass two separate dosage forms, can represent a composition?

[00:10:55] Speaker 03:
No, that's OK.

[00:10:56] Speaker 04:
He said that it just means there's more than one part, and it's very broad.

[00:11:00] Speaker 04:
He said it's very broad language, I'm quoting from his deposition.

[00:11:02] Speaker 03:
That's great.

[00:11:03] Speaker 03:
Where is that?

[00:11:07] Speaker 04:
cheat sheet you're on.

[00:11:11] Speaker 04:
If you look at Appendix 6352, he says that's the nature of a composition.

[00:11:29] Speaker 04:
Composition means more than one part, and he compares it to musical composition.

[00:11:34] Speaker 04:
There's more than one part, although you call it a whole thing,

[00:11:36] Speaker 04:
It's a definition of something that has subparts.

[00:11:39] Speaker 04:
So he's saying it's very broad language.

[00:11:40] Speaker 04:
And again, this is, we're talking about a pharmaceutical composition and the claim is directed to a combination of two active ingredients.

[00:11:48] Speaker 04:
The judge, district court judge found the undisputed reality is that when one in the skilling art is practicing that type of technology, it's always in two different dosage forms.

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And this concept is repeated not only in the specification, it's also repeated in the prosecution history,

[00:12:03] Speaker 04:
that Utsuka repeatedly pointed to example 9.

[00:12:06] Speaker 04:
There's no dispute that was two different dosage forms as being representative of the scope of the claims.

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Utsuka also submitted the Hirose Declaration.

[00:12:14] Speaker 04:
Again, two different dosages were tested.

[00:12:17] Speaker 04:
And Dr. Rossi said this is representative of showing the unexpected results of the claimed invention.

[00:12:22] Speaker 03:
I guess what was a little murky for me with the prosecution history was that the Hirose Declaration and all didn't really tightly associate

[00:12:33] Speaker 03:
his observations with the actual claim term composition.

[00:12:38] Speaker 03:
I understand that maybe one could argue that he was implicitly somehow injecting some meaning into the word composition by talking about these different dosage forms and things like that and how you need a certain effective level of each ingredient.

[00:12:57] Speaker 03:
But in the end, he doesn't actually

[00:13:00] Speaker 03:
come through and say, this is what we mean by the word composition.

[00:13:03] Speaker 03:
And in fact, we know the examiner didn't believe that because the examiner got on record and said, he understood or she understood the word composition to imply that everything is in a single carrier, single vehicle.

[00:13:18] Speaker 04:
Well, you're right.

[00:13:19] Speaker 04:
I disagree in that, first of all, Dr. Hirose said, I'm quoting from his declaration, that it was in order to show the unexpectedly superior effects of the present invention.

[00:13:29] Speaker 04:
So yes, he didn't use the word composition, but he was pointing to the claimed invention before the office of the time.

[00:13:35] Speaker 04:
Moreover, despite I think what the patent examiner said, I think is a little ambiguous.

[00:13:40] Speaker 02:
However, it's important.

[00:13:42] Speaker 02:
I don't understand how that proves your point, because the claimed invention could still have unexpected results if it's combined in one dosage.

[00:13:52] Speaker 04:
Correct.

[00:13:53] Speaker 04:
But here, he is submitting specific data where it's in two different dosage forms.

[00:13:58] Speaker 04:
And he doesn't say, well, this isn't the invention, but maybe it'll help show the unexpected results.

[00:14:03] Speaker 04:
He says this is showing unexpected results of the present invention.

[00:14:07] Speaker 04:
I think that's very clear language.

[00:14:08] Speaker 04:
And what's important is the Patent Office, no matter what it may have said at one snippet of the prosecution history, allowed the claims.

[00:14:15] Speaker 04:
And in the patent examiner's reason for allowance, one piece of evidence she points to is the Hirose Declaration.

[00:14:20] Speaker 04:
And again, this point is repeated.

[00:14:21] Speaker 04:
It's not just the Hirose Declaration.

[00:14:22] Speaker 04:
It's example nine, which the applicant points to as showing

[00:14:27] Speaker 04:
unexpected results of the invention.

[00:14:29] Speaker 04:
And again, example nine, there's no dispute, it's two different liquid formulations of the two different components.

[00:14:34] Speaker 04:
And they're administered to the mouse.

[00:14:36] Speaker 04:
Can I take you back to the specification?

[00:14:38] Speaker 02:
Because I mean, I think this case is hard.

[00:14:41] Speaker 02:
And there are definitely different portions that support each side.

[00:14:45] Speaker 02:
But every time you cite things that support, I think, in your view, your side, it uses different words than composition to describe

[00:14:55] Speaker 02:
multiple dosage forms.

[00:14:56] Speaker 02:
It either uses preparations or things like that as an alternative.

[00:15:02] Speaker 02:
It doesn't use in the same sentence, although it does in the same paragraph, I agree.

[00:15:09] Speaker 02:
How do we read that?

[00:15:10] Speaker 02:
It seems to me that we could read it either way.

[00:15:11] Speaker 02:
Here's the composition form.

[00:15:14] Speaker 02:
The composition form is one tablet.

[00:15:16] Speaker 02:
but you can do it in two preparations or in two dosage forms, and that's somehow different from the composition.

[00:15:23] Speaker 04:
Right, I think you raise a very important point, is the patent uses the terms composition and preparation differently, because they're different terms, right?

[00:15:31] Speaker 02:
But doesn't that, I understand you want that to cut into your favor, but I suspect your friend is going to say it cuts against you, because if you admit composition to cover

[00:15:41] Speaker 02:
those different terms, you would have included it as a description of a composition rather than as an alternative.

[00:15:49] Speaker 04:
Well, Your Honor, if you're referring to the portion in column three, it says there are two alternatives for the claim or inventive composition.

[00:15:59] Speaker 04:
It says one, they can be in a single preparation, or two, they can be in two preparations.

[00:16:03] Speaker 04:
The whole paragraph is talking about the

[00:16:05] Speaker 04:
compositions.

[00:16:05] Speaker 04:
It begins with talking about the compositions.

[00:16:07] Speaker 04:
It may be this way.

[00:16:09] Speaker 04:
And then it ends with saying how the compositions can then be administered to treat a mood disorder.

[00:16:14] Speaker 04:
So the whole paragraph is talking about compositions.

[00:16:16] Speaker 04:
It's not disclosing alternatives to the claimed composition.

[00:16:20] Speaker 04:
And I think that the district court just simply misread that.

[00:16:27] Speaker 02:
But I think, obviously, column three is your best piece of evidence.

[00:16:33] Speaker 02:
You get to column 14.

[00:16:36] Speaker 02:
lines roughly 10 through 20, and it looks a little bit different.

[00:16:45] Speaker 02:
In one embodiment, they can be in one pharmaceutical composition.

[00:16:51] Speaker 02:
On the other hand, they can be individually in a pharmaceutical preparation, respectively,

[00:17:01] Speaker 02:
And each one of these preparations, not compositions, may be administered at the same time.

[00:17:06] Speaker 04:
Right.

[00:17:06] Speaker 04:
Your honor, when the composition is administered, both components at once, you're administering the composition.

[00:17:13] Speaker 04:
If I am administering the composition in different dosage forms, you might explain that, well, it's in different preparations that I'm administering the composition.

[00:17:21] Speaker 04:
So this portion of the specification is really getting at the breadth of the administration forms.

[00:17:27] Speaker 04:
And one administration form assures is the composition is a combined dosage form.

[00:17:32] Speaker 04:
And it describes that as a composition, which is entirely accurate.

[00:17:36] Speaker 04:
Maybe it could have been written differently, but I think it's an entirely accurate presentation of the language.

[00:17:41] Speaker 03:
When I was talking about administration forms, could that really be like taking, administering something orally, administering something intravenously, suppository?

[00:17:55] Speaker 03:
And so therefore, that's the

[00:17:57] Speaker 03:
different types of administration forms that that particular portion of the specification is referring to and not necessarily referring to breaking up the composition into two compositions and calling two compositions a single composition?

[00:18:11] Speaker 04:
Well, again, the patent specification doesn't use the composition the way you are, Your Honor, with all due respect.

[00:18:16] Speaker 04:
And the language is that it can be of any type, so it's delivered to the body in vivo

[00:18:22] Speaker 04:
at the same time.

[00:18:24] Speaker 03:
Right, I guess that's what I'm trying to figure out, following up, is what does it mean to be any type and why isn't that phrase referencing the different types of ways you can administer the drug, i.e.

[00:18:40] Speaker 03:
administer it orally, administer it intravenously.

[00:18:44] Speaker 03:
So that is what any type is referencing, not how you can

[00:18:52] Speaker 03:
you know, reorganize all the elements of the composition into, like, one thing or two separate things.

[00:19:00] Speaker 04:
Well, again, with respect, I disagree, and that's exactly what the Roasted Declaration does, is it takes the two components of the composition.

[00:19:07] Speaker 03:
I'm just trying to understand the meaning of the phrase, any type, in column 14, and why is my proposed interpretation of any type necessarily wrong, and why is, I guess,

[00:19:20] Speaker 03:
your interpretation of any type necessarily right.

[00:19:24] Speaker 04:
Well, it's very broad language, Your Honor.

[00:19:25] Speaker 04:
It doesn't say anywhere that the two components of the composition have to be in a single dosage form.

[00:19:29] Speaker 04:
That language isn't there.

[00:19:31] Speaker 04:
If the only time that language appears, it's always conjoined with the alternative.

[00:19:36] Speaker 04:
Every single time.

[00:19:38] Speaker 03:
Yeah, but then single dosage form is always also conjoined with the word composition.

[00:19:43] Speaker 03:
And I don't quite see multiple dosage forms that phrasing

[00:19:48] Speaker 03:
necessarily conjoined with the word composition?

[00:19:51] Speaker 04:
Well, actually, that occurs at least in column three of the patent.

[00:19:54] Speaker 04:
It says the whole paragraph is talking about pharmaceutical compositions of the invention.

[00:19:58] Speaker 04:
It begins by talking about them.

[00:20:00] Speaker 04:
It says they may be in one dosage form.

[00:20:02] Speaker 04:
Alternatively, they may be inseparate.

[00:20:04] Speaker 04:
And then it says these compositions can be used to treat a mood disorder.

[00:20:07] Speaker 04:
That whole paragraph is talking about the pharmaceutical compositions of the invention.

[00:20:11] Speaker 04:
That's the broad language that's throughout here.

[00:20:13] Speaker 04:
And this appears throughout the specification.

[00:20:16] Speaker 04:
There's also the description of the different

[00:20:18] Speaker 04:
dosage combinations that can be used.

[00:20:21] Speaker 04:
And if you limit this to a single dosage form, you can't practice big swaths of the specification because the two different drugs are given on different dosage schedules.

[00:20:31] Speaker 04:
And therefore composition was used very broadly here by the patentees and they're very clear about it.

[00:20:35] Speaker 04:
They said it repeatedly throughout the specification.

[00:20:38] Speaker 04:
They said it in the prosecution history.

[00:20:40] Speaker 04:
And again, it was the undisputed reality as found by the district court judge that this is how one of skill in the art would understand

[00:20:47] Speaker 04:
this type of technology.

[00:20:49] Speaker 04:
I'd also like to point out, I'm not the only person who's interpreting the specification this way.

[00:20:53] Speaker 04:
Their own expert interpreted the exact same way we did and testified that way at the Markman hearing.

[00:20:58] Speaker 04:
I have a citation for that if you'd like.

[00:21:00] Speaker 04:
Everybody agreed that those portions of the specification were talking about a composition that can be administered in two different dosage forms.

[00:21:07] Speaker 04:
The only question was whether that portion of the specification should be looked at interpreting the claims.

[00:21:12] Speaker 04:
The district court said no.

[00:21:14] Speaker 04:
I want to go with my lay reading of the claims, and I'm going to not accept portions that don't comport with that.

[00:21:20] Speaker 04:
That was legal error under this court's questions.

[00:21:23] Speaker 04:
Under this court's questions, the district court should have started with a specification and read the language in that context, and also in the context of one of ordinary skill in the art.

[00:21:32] Speaker 04:
And again, it was undisputed that those of skill in the art who understand combination therapy know that the two drugs are administered separately, so that they can be titrated separately, which is very important.

[00:21:43] Speaker 02:
If you really meant combination theory, why didn't you use that in your claim language?

[00:21:47] Speaker 04:
Well, combination is used in the claim.

[00:21:51] Speaker 04:
And there are methods where the combination is administered.

[00:21:54] Speaker 04:
So yeah, combination theory, those words per se aren't used, but similar words are used.

[00:21:59] Speaker 04:
And certainly, that's how one of Spill in the Art would read it.

[00:22:01] Speaker 04:
There's no dispute on that as well.

[00:22:04] Speaker 03:
You said that the district court didn't

[00:22:07] Speaker 03:
reference columns 3 or columns 14, he block quoted them right in here and then explained why in his view they weren't persuasive.

[00:22:18] Speaker 03:
So I guess I'm a little bit bothered when you say he didn't consider it or refused to consider it.

[00:22:24] Speaker 03:
He did consider it and you didn't evaluate it.

[00:22:26] Speaker 03:
He just ended up coming out the other way than you would want.

[00:22:31] Speaker 03:
So I don't know why you're saying that he ignored it or refused to consider it.

[00:22:37] Speaker 04:
He did not show how his claim construction could be reconciled with a full scope of the specification.

[00:22:44] Speaker 04:
That's what he didn't do.

[00:22:45] Speaker 04:
Yes, he did cite to those portions of the specification.

[00:22:47] Speaker 03:
He quoted them.

[00:22:48] Speaker 03:
He evaluated them.

[00:22:50] Speaker 04:
Right, but again.

[00:22:51] Speaker 03:
Okay, so he didn't ignore them and he didn't refuse to consider them.

[00:22:56] Speaker 04:
correct, but he did not correct Ron.

[00:22:58] Speaker 04:
Maybe my language is not quite precise.

[00:23:01] Speaker 04:
But he did not take them into account in the final construction.

[00:23:04] Speaker 04:
And again, he said that he was not going to accept portions of the specification that didn't comport with his reading of the claims, which was based on the singular structure of composition and the structure of the claims.

[00:23:15] Speaker 03:
I don't know why you keep saying that.

[00:23:17] Speaker 03:
He's looking at all the intrinsic evidence, including block quoting the ones that, in your view, favor you.

[00:23:25] Speaker 04:
Correct, Your Honor.

[00:23:26] Speaker 04:
Again, I don't mean to suggest that he didn't view the evidence.

[00:23:29] Speaker 04:
He certainly viewed the evidence.

[00:23:30] Speaker 04:
My point is he should have used the specification as a guide.

[00:23:34] Speaker 04:
He shouldn't have come to a conclusion about what the claim construction meant and then go back to the specification and pick and choose which portions he'd like to rely on.

[00:23:43] Speaker 04:
That is, with all due respect to this perjudice, is not correct.

[00:23:47] Speaker 04:
I think we've exceeded our time.

[00:23:49] Speaker 04:
Yes.

[00:23:51] Speaker 00:
We'll restore three minutes if you'd like.

[00:23:52] Speaker 04:
Thank you, Your Honor.

[00:24:02] Speaker 01:
I think that you've seized on the infirmity with Atsuka's position here.

[00:24:14] Speaker 01:
Essentially, it is using a number of statements in the prosecution history, as well as the rest of the intrinsic evidence in the specification, indeed the claims, where it's comparing apples and oranges.

[00:24:26] Speaker 01:
I think that the reference to the term a-pharmaceutical composition

[00:24:30] Speaker 01:
has been used as a matter of expediency to truncate the entire limitation within that claim, which not only talks about a pharmaceutical composition, but one that is comprised of two ingredients referred to in certain portions.

[00:24:43] Speaker 00:
I understand that.

[00:24:44] Speaker 00:
But in the two provisions of the specification that we've been talking about today, your friend, I think he argues, and it has some at least facial appeal, when you're talking about you've got one paragraph and you're talking about this present invention.

[00:24:58] Speaker 00:
and then you use the introductory words alternatively or on the other hand.

[00:25:03] Speaker 00:
So why shouldn't the words that follow alternatively or on the other hand also be used to inform what the present invention consists of?

[00:25:14] Speaker 01:
Well, I think that those paragraphs that

[00:25:16] Speaker 01:
Otsuka is referring to do give the dichotomy that is in the disclosure between a single dosage form and a dosage form with more than one component.

[00:25:26] Speaker 01:
But if we go into the specifics of what's stated within those three portions, because I think we're all focused on the same exact statements within the specification, if you read through them, you will see that it's not simply talking about a pharmaceutical composition by way of dosage form.

[00:25:41] Speaker 01:
It actually uses the terminology when it refers to a single dosage form of the two components in combination with each other.

[00:25:49] Speaker 01:
Well, can you just, you know, instead of talking generality, go straight to column three.

[00:25:53] Speaker 01:
Okay.

[00:25:54] Speaker 01:
So with column three, it states the novel compositions of the present invention comprising at least one carborosteroid derivative with activity as a dopamine serotonin system stabilizer and at least one serotonin reuptake inhibitor in a pharmaceutically accepted carrier may be combined in one dosage form.

[00:26:11] Speaker 01:
With that particular statement, the district court looked at the use of the term in a pharmaceutically accepted carrier and in a single dosage form to mean the same thing for that purpose.

[00:26:23] Speaker 01:
Then it continues to say, alternatively, the at least and the same components, and maybe in separate dosage forms in each in a pharmaceutically accepted carrier.

[00:26:33] Speaker 01:
That's column three.

[00:26:35] Speaker 01:
There are two other references in example six and example eight.

[00:26:38] Speaker 03:
But then there's the next sentence.

[00:26:39] Speaker 03:
Could you read the next sentence?

[00:26:41] Speaker 03:
I'm afraid I don't have that.

[00:26:43] Speaker 03:
Oh, that's an important sentence.

[00:26:47] Speaker 00:
It says, these compositions are administered to a patient with a mood disorder, blah, blah, blah, an amount and dosage regimen effective to treat the mood disorder.

[00:26:56] Speaker 03:
So why isn't that a sum up sentence referring to the two alternatives of said composition?

[00:27:05] Speaker 01:
I'm not here arguing that the specification fails to disclose

[00:27:11] Speaker 01:
two alternatives, but it's not enough.

[00:27:14] Speaker 03:
No, but the question is really why isn't this reference to these compositions a signal to all of us of what the patent drafter meant by the word compositions in light of the indication here that this sentence, these composition sentences is a sum up sentence of what has come before in the paragraph.

[00:27:36] Speaker 03:
So why isn't it an understanding of the word composition?

[00:27:40] Speaker 01:
because the alternatives as they are defined provide a single dosage form where that composition consists of the two ingredients in combination with one another, as opposed to one in which they are separate.

[00:27:55] Speaker 01:
The claim language refers only to the first, which is a composition with the two components in combination with each other.

[00:28:02] Speaker 03:
But I guess your argument wants me to read this sentence that begins with these compositions.

[00:28:09] Speaker 03:
is referring only to one of the two alternatives in the prior two sentences.

[00:28:14] Speaker 03:
And you want me to ignore the other sentence that precedes these compositions.

[00:28:21] Speaker 03:
And I need to know why.

[00:28:22] Speaker 01:
And I don't believe that they're exclusive.

[00:28:25] Speaker 01:
I do think that the compositions, as that paragraph refers to it, talks very broadly about having one embodiment with a single dosage form and a second embodiment with multiple dosage forms.

[00:28:38] Speaker 02:
Wait.

[00:28:39] Speaker 02:
that we should be keying on the word combination rather than composition, because the first sentence describes them in combination.

[00:28:47] Speaker 02:
The second sentence doesn't.

[00:28:50] Speaker 02:
So you can have a composition that contains both forms but is not in combination.

[00:28:56] Speaker 02:
And all the relevant claims use the word combination.

[00:29:00] Speaker 02:
Yes.

[00:29:01] Speaker 01:
And that is uniform throughout.

[00:29:02] Speaker 02:
Is that what the district court found, though?

[00:29:04] Speaker 02:
It is, because the district court was at the same.

[00:29:06] Speaker 02:
I heard the district court found that composition was

[00:29:09] Speaker 02:
using the word A or DA before it was singular and didn't so much key on combination.

[00:29:15] Speaker 01:
No, you're correct, Judge Hughes, that the district court did go through the syntax issue as well, but the district court did go through each of these descriptions about the alternative embodiments and reach the conclusion I'm describing, which is essentially the claim language says composition, pharmaceutical composition, having those two components in combination with each other.

[00:29:36] Speaker 01:
That's the full

[00:29:37] Speaker 02:
But so that argument seems a little odd to me.

[00:29:40] Speaker 02:
I mean, I get your argument that a or the composition seems to have a singular meaning.

[00:29:46] Speaker 02:
But if you're giving that up and saying composition based upon this language in column three can have multiple dosage forms, it's just not the kind of composition used in the claims.

[00:30:00] Speaker 02:
Now you're asking us to read the word combination in a way that seems out of the ordinary.

[00:30:07] Speaker 02:
And why wouldn't it be a combination, even if it's in two different dosage forms?

[00:30:13] Speaker 01:
Because that's not the way the patent describes it.

[00:30:15] Speaker 01:
Again, every instance in the specification where the use of the term a pharmaceutical composition or a dosage form that has those two ingredients in combination with one another refers only to a single dosage

[00:30:30] Speaker 01:
That is the way the claims recited as well.

[00:30:32] Speaker 01:
In each instance of the specification where there is a reference to multiple dosage forms, the combination or the use of the word combined is never used in that same way.

[00:30:44] Speaker 01:
And the district court so found that those three statements in the specification are the ones that most naturally align with the claim language.

[00:30:53] Speaker 03:
Can I just follow up?

[00:30:54] Speaker 03:
I think I understand your theory about in combination with and composition and when you use

[00:31:01] Speaker 03:
all those terms together, we're talking exclusively and only about a single dosage form.

[00:31:06] Speaker 03:
But just to make sure I understand your answer to Judge Hughes, is it your view that the word composition as it's used over and over again through this patent is actually an umbrella term that by itself the word composition encompasses both single dosage forms and separate dosage forms, but when the word composition is used

[00:31:30] Speaker 03:
together in the patent with the phrase in combination with, then we are channeled and necessarily must understand all those terms together as being just for the single dosage form.

[00:31:43] Speaker 03:
So really the key of that very long question was, do you think the word composition in this patent encompasses multiple dosage forms?

[00:31:53] Speaker 01:
I think that's a hypothetical, Judge Chen.

[00:31:55] Speaker 01:
To answer your question directly, the way you've articulated it is the theory

[00:31:59] Speaker 01:
behind the district court's claim construction, as well as the defendants.

[00:32:03] Speaker 01:
What I will say to you is that you can't divorce pharmaceutical composition from the remaining part of that claim language, which ties that pharmaceutical composition to having two components in combination with each other.

[00:32:16] Speaker 01:
So to say, are we advocating that composition is a broader term, it's hard to do that, because that's not what the claims say.

[00:32:23] Speaker 01:
But if you are to analyze that and say,

[00:32:26] Speaker 01:
It had the claims only referred to a pharmaceutical composition without anything else.

[00:32:31] Speaker 01:
I think the possibility is true that there may be multiple dosage forms that could be included within that definition.

[00:32:37] Speaker 01:
It's just not recited that way.

[00:32:39] Speaker 02:
But every time in the claim language when it uses composition, in your view, it also uses the word combination.

[00:32:46] Speaker 01:
It does.

[00:32:48] Speaker 01:
Every claim.

[00:32:50] Speaker 01:
And so if you trace that language back to the specification

[00:32:54] Speaker 01:
to say where in the specification do they talk about a composition with those ingredients in combination with each other.

[00:33:03] Speaker 01:
You come to this dichotomy where it says, on the one hand, you can have a single dosage form with that exact language.

[00:33:10] Speaker 01:
And on the other hand, you can have individually packaged drugs.

[00:33:13] Speaker 03:
I thought the patent also describes examples talking about

[00:33:19] Speaker 03:
combination of the different ingredients and the combination, but the administration of that combination is separate.

[00:33:28] Speaker 03:
The two ingredients are being separately administered and so therefore the whole notion of what is in combination with MEAN encompasses separate administration of the two drugs.

[00:33:42] Speaker 01:
There are two points to that.

[00:33:43] Speaker 01:
Let me address the first point to that, Judge Chen.

[00:33:46] Speaker 01:
In those particular examples, there is no direct reference to a pharmaceutical composition or even a dosage form.

[00:33:52] Speaker 01:
It simply are the administration of two separate drugs at two different times.

[00:33:58] Speaker 01:
And so it talks about a differential administration.

[00:34:01] Speaker 01:
They're not administered at the same time.

[00:34:03] Speaker 01:
But those examples aren't talking about a formulation or a dosage form or a composition.

[00:34:09] Speaker 01:
They're talking about

[00:34:10] Speaker 01:
how the results of combining two drugs together can perhaps provide data that shows unexpected results.

[00:34:17] Speaker 01:
That's used to support the patentability of this invention, but it doesn't speak to dosage forms the way that Otsuka would have you look at it.

[00:34:25] Speaker 01:
And the fact that multiple dosage forms or the co-administration or joint administration is disclosed in the specification isn't enough to actually reach the point of construing the claims appropriately.

[00:34:38] Speaker 01:
They have to have those ingredients in combination with one another.

[00:34:42] Speaker 00:
I'm a little confused by that.

[00:34:44] Speaker 00:
I guess this argument has taken me back a little.

[00:34:47] Speaker 00:
On page three, where you talk about the statement, the issues, it seems like the two issues that you described have pretty much only to do with defining the scope of pharmaceutical composition, either including a single dosage or not.

[00:35:04] Speaker 00:
It doesn't quite deal with what you proposed here

[00:35:08] Speaker 00:
which seems to me a bit of a different formulation of the issues, which is the pharmaceutical composition and then followed by the combination language.

[00:35:18] Speaker 00:
Am I missing something here?

[00:35:19] Speaker 01:
It is not my intent.

[00:35:21] Speaker 01:
And there's no departure from our position that we are here to construe the term a pharmaceutical composition.

[00:35:27] Speaker 01:
I'm just offering that there are words that follow that in every one of the claims that says and helps define what that pharmaceutical composition as that term is used in the claim.

[00:35:37] Speaker 01:
The patent itself may use the term composition, preparation.

[00:35:42] Speaker 01:
As Judge Hughes mentioned, there are lots of different words that are there.

[00:35:45] Speaker 01:
The district court actually found that none of those other statements were particularly helpful because there are multiple reasons that those statements could have been offered.

[00:35:53] Speaker 01:
So it's really the distinction between a single dosage form and a multiple dosage form that forms the crux of how the definition proceeds from that.

[00:36:02] Speaker 01:
That flows also through claim 18 and the claim language there, where it talks about ingredients that are involved.

[00:36:08] Speaker 01:
These are ingredients contained in a single composition.

[00:36:12] Speaker 01:
The prosecution history reveals that the examiner viewed this as drugs that would be put together in a single vehicle and makes very clear that her interpretation of the claims was that pharmaceutical composition related only to a single dosage form.

[00:36:30] Speaker 01:
The rebuttal that Otsuka offers for that, again, goes to issues with respect to whether the data that it

[00:36:36] Speaker 01:
supply in the Hirose Declaration showed that there was a synergistic effect.

[00:36:41] Speaker 01:
It was not about dosage forms.

[00:36:42] Speaker 01:
It was not about routes of administration.

[00:36:45] Speaker 01:
That's why it said in the declaration that it's in many respects agnostic to the route of administration because that wasn't what the data was there to show.

[00:36:53] Speaker 01:
Now with respect to the experts, because that portion was referred to by Hatsuka as well, the experts were not in concert with regard to

[00:37:04] Speaker 01:
what they were stating about a pharmaceutical composition.

[00:37:07] Speaker 01:
Again, the focus in their depositions and their declarations was on the term pharmaceutical composition stripped away from everything else within the claim that we've now put forward.

[00:37:17] Speaker 01:
And in that instance, the experts stated, well, the word composition can mean lots of different things, things that include a lot more than just one single dosage form.

[00:37:28] Speaker 01:
But again, I think that misses the mark.

[00:37:30] Speaker 01:
The mark here is what does the patent really say

[00:37:32] Speaker 01:
pharmaceutical composition comprising A and B in combination with each other.

[00:37:41] Speaker 00:
Thank you.

[00:37:54] Speaker 04:
There are a few points I'd like to make.

[00:37:57] Speaker 04:
We had a lot of discussion of combination, and it

[00:38:03] Speaker 04:
Judge Chen, clearly, better reads very carefully.

[00:38:05] Speaker 04:
We point to the examples, particularly example six begins by saying a combination of erycoprosol and at least one serotonin reuptake inhibitor, and then describes that that combination can be in separate dosage forms or single dosage forms.

[00:38:17] Speaker 04:
Some of the honors are familiar with that from the specification.

[00:38:20] Speaker 04:
But I'd also like to point out this also appears in the prosecution history.

[00:38:24] Speaker 04:
And I'll quote for you that there's a discussion of the tail suspension test.

[00:38:28] Speaker 04:
That's example nine.

[00:38:29] Speaker 04:
And there's no dispute that the two components of the competition are administered separately.

[00:38:33] Speaker 04:
What the patentee said about that was, quote, this is one example employing a combination of agents within the scope of the claims.

[00:38:43] Speaker 04:
That appears in appendix 4940.

[00:38:46] Speaker 04:
Couldn't be clearer that the claims encompass separate dosage forms.

[00:38:51] Speaker 04:
Moreover, the Hirose Declaration itself

[00:38:54] Speaker 04:
said it is further evidence of the enablement of the claimed invention.

[00:38:58] Speaker 04:
The Hersey Declaration also said that the combination of the present invention clearly shortened the immobility time.

[00:39:05] Speaker 04:
So he's pointing his results as the combination of the claimed invention.

[00:39:08] Speaker 04:
So again, combination doesn't take us away from the construction of pharmaceutical composition.

[00:39:14] Speaker 04:
It still is a broad term.

[00:39:17] Speaker 04:
I'd also like to point out Judge Hughes asked me earlier about

[00:39:19] Speaker 04:
evidence of how one of Schildinger would understand composition, and I pointed to Dr. Crell's testimony.

[00:39:24] Speaker 04:
I neglected to point to the Wong reference.

[00:39:27] Speaker 04:
The Wong reference was the primary reference cited during the prosecution history.

[00:39:31] Speaker 04:
That reference uses pharmaceutical composition, or I believe it says composition, the exact same way as the patentee here.

[00:39:37] Speaker 04:
and that composition encompasses two different things.

[00:39:40] Speaker 03:
Is that true?

[00:39:40] Speaker 03:
I thought the Wong claims actually specifically call out that composition will be either in a single carrier or multiple carriers.

[00:39:48] Speaker 00:
Right.

[00:39:49] Speaker 03:
So that's not quite the same as your claim, which doesn't explicitly encompass the term composition to encompass

[00:39:56] Speaker 03:
multiple carriers.

[00:39:57] Speaker 04:
Well, let me be clear.

[00:39:58] Speaker 04:
The long reference has a section of the specification that's very similar to the specification 350 patent.

[00:40:04] Speaker 04:
Moreover, it does have a claim, like you mentioned.

[00:40:06] Speaker 04:
This is dependent claim.

[00:40:07] Speaker 04:
So the long reference is using the term composition broadly the same way we did.

[00:40:12] Speaker 04:
And again, we think that's evidence of how one of ordinary sphilae are.

[00:40:14] Speaker 04:
We broadly understand composition, particularly in this context.

[00:40:18] Speaker 04:
Remember, we have to look at this context, which is combination therapy.

[00:40:22] Speaker 04:
I'd also like to point out there was another question earlier.

[00:40:26] Speaker 04:
I apologize, it may have been from you, Judge Chen, about how one would read the part of the specification at column 14 about administration forms of invention.

[00:40:34] Speaker 04:
I'd like to point out that the defendant's expert reads that the same way we do.

[00:40:38] Speaker 04:
And this appears at the appendix at page 2104 through 2105.

[00:40:44] Speaker 04:
And you can see, starting at 2104, that we're asking about this portion of column 14.

[00:40:49] Speaker 04:
And the question is, so this passage means the administration forms of the pharmaceutical composition of the present invention

[00:40:56] Speaker 04:
Can be any type where Aripiprazole and an SRI are in the body at the same time?

[00:41:00] Speaker 04:
Answer, yes.

[00:41:01] Speaker 04:
Follow-up, in this passage indicates that the Aripiprazole and the SRI may be in separate dosage forms.

[00:41:07] Speaker 04:
Answer, yes.

[00:41:08] Speaker 04:
So again, this was the undisputed reality for this court.

[00:41:12] Speaker 04:
This was Dr. Harper, defendant's own expert, reads the specification the exact same way.

[00:41:17] Speaker 03:
What's the JAS sign?

[00:41:19] Speaker 04:
It's 2105 are the portions that I read.

[00:41:22] Speaker 04:
But you would also look at 2104 to know what portion of the patent document is being talked about.

[00:41:28] Speaker 04:
It's column 14.

[00:41:30] Speaker 04:
So again, it's not just us reading the patent that way.

[00:41:32] Speaker 04:
It's the experts before the district court.

[00:41:35] Speaker 03:
That's intrinsic evidence, though, right?

[00:41:37] Speaker 03:
Isn't that a de novo question for us to understand and interpret

[00:41:45] Speaker 03:
in specification?

[00:41:47] Speaker 04:
Well, correct.

[00:41:47] Speaker 04:
I think I believe that most of your analysis is de novo.

[00:41:50] Speaker 04:
However, there were factual findings.

[00:41:52] Speaker 04:
But at this court, the district court views for clearer those factual findings were uniformly in our favor as to how one of ordinary skill in the art understands this technology.

[00:42:01] Speaker 04:
And that's, of course, supported throughout the appendix.

[00:42:05] Speaker 04:
One final question.

[00:42:06] Speaker 04:
Very short final point.

[00:42:07] Speaker 00:
No, I don't.

[00:42:08] Speaker 00:
But we've exceeded your time.

[00:42:10] Speaker 04:
OK.

[00:42:10] Speaker 04:
I'd just like to say that six of the nine examples are consistent with our construction.

[00:42:19] Speaker 04:
Thank you.

[00:42:19] Speaker 00:
We thank both sides of the case system.