[00:00:05] Speaker 01:
Just in case you guys didn't know.

[00:00:21] Speaker 03:
Thank you.

[00:00:21] Speaker 03:
All right.

[00:00:25] Speaker 03:
We have four cases for argument before the court this morning.

[00:00:29] Speaker 03:
The first case before the court.

[00:00:36] Speaker 03:
After we play musical chairs, the first case before the court is send you pharmaceutical versus, is it Acorn or Acorn?

[00:00:47] Speaker 03:
Acorn.

[00:00:48] Speaker 03:
Acorn.

[00:00:49] Speaker 03:
Case number 171511, it is an appeal from a decision of the Patent Trial and Appeal Board.

[00:01:00] Speaker 03:
Mr. Medlitsky.

[00:01:04] Speaker 03:
Medlitsky?

[00:01:04] Speaker 03:
Medlitsky.

[00:01:05] Speaker 03:
Medlitsky.

[00:01:06] Speaker 03:
OK.

[00:01:07] Speaker 03:
You want five minutes for rebuttal?

[00:01:09] Speaker 03:
Yes.

[00:01:09] Speaker 03:
All right.

[00:01:09] Speaker 03:
You may begin.

[00:01:10] Speaker 00:
Thank you, Your Honor, and may it please the Court.

[00:01:20] Speaker 00:
The invention here is a novel diflupredinate emulsion, which improved upon the diflupredinate suspension disclosed in the Kimura 848 patent by dramatically increasing the drug's bioavailability within the eye.

[00:01:34] Speaker 00:
and was the first and remains the only steroidal emulsion I dropped ever approved by the FDA and sold.

[00:01:40] Speaker 00:
The board found that the patent here was obvious because a person of ordinary skill in the art would have identified problems with steroidal suspensions, for example, low bioavailability, and supposedly would have been motivated by DING to solve the problems.

[00:01:54] Speaker 01:
Is it your argument that the creation of the emulsion, the use of the emulsion, was beyond the skill of a person of ordinary skill in the art?

[00:02:03] Speaker 01:
This is back in, at the time of the invention, 1997.

[00:02:06] Speaker 00:
No, our argument isn't that the creation of the emotion itself was beyond the skill of a person of ordinary skill in the art, but our argument, for example, is that there would have been no motivation to do so.

[00:02:16] Speaker 03:
But there were other ocular emotions on the market at the time, right?

[00:02:24] Speaker 00:
There were not any other ocular emotions on the market at the time, and there still are no

[00:02:29] Speaker 00:
ocular steroidal emulsions on the market at the time, except for Durazol, which embodies the claimed invention.

[00:02:38] Speaker 03:
But there were emulsions that were not steroidal, right?

[00:02:42] Speaker 00:
I'm not sure there were emulsions that were not steroidal on the market at the time.

[00:02:47] Speaker 00:
But for example, there is Allergan, who is Ding's assignee, in 2002 put out a drug called Restasis, which is Ding's cyclosporine emulsion.

[00:02:59] Speaker 00:
Allergan markets a different eyedrop, a steroidal eyedrop, as a suspension.

[00:03:06] Speaker 00:
So the first argument I wanted to discuss with the court today is the fact that- The issue here isn't necessarily the medication.

[00:03:12] Speaker 01:
Isn't it more the vehicle that's used to deliver the medication?

[00:03:16] Speaker 01:
That's what we're talking about right now.

[00:03:19] Speaker 01:
And there were emulsions that were used to deliver medication to an eye at the time.

[00:03:26] Speaker 00:
There was prior art that described emulsions, for example, DING.

[00:03:31] Speaker 00:
Yes, sure.

[00:03:32] Speaker 00:
But there are questions about whether a person of ordinary skill in the art would have been motivated to combine the Kimura suspension with DING, which is the question in this case, when DING actually taught that as to the target tissue of diphyl predinate, the castor oil emulsion that DING described was inferior

[00:03:55] Speaker 00:
to other formulations, including a solution.

[00:03:59] Speaker 00:
Ding actually discussed suspensions or steroids.

[00:04:02] Speaker 00:
But he tested the emulsion against several other formulations, including a solution that the reference elsewhere describes is what Ding was trying to improve upon and found that the emulsion was inferior.

[00:04:14] Speaker 03:
And our expert makes- You're not really making a teaching away argument, though, are you?

[00:04:17] Speaker 00:
We're not making a teaching away argument.

[00:04:19] Speaker 00:
We're taking Ding for all it teaches.

[00:04:20] Speaker 00:
But what Ding teaches is that the emulsion is inferior.

[00:04:25] Speaker 00:
to most other formulations tested as to the target tissue of the active here.

[00:04:31] Speaker 00:
And our expert explained.

[00:04:32] Speaker 03:
Was it inferior as to the target tissue or inferior when used in combination with the cyclosporine?

[00:04:41] Speaker 00:
Well, all of the formulations were used in combination with the cyclosporine.

[00:04:44] Speaker 00:
They were all tested as to four different tissues.

[00:04:46] Speaker 03:
Right.

[00:04:46] Speaker 03:
So one was inferior to the other in that combination, right?

[00:04:52] Speaker 00:
Right.

[00:04:52] Speaker 00:
So there was, for example, a casseroil.

[00:04:54] Speaker 00:
with cyclosporine, a casserole emulsion, which is the emulsion here with cyclosporine, a solution, an aqueous solution with cyclosporine and so forth, as to four different tissues.

[00:05:03] Speaker 00:
The board agreed with us that the lacrimal gland experiment had no relevance to motivation to combine, but found that the experiment as to the conjunctiva was relevant because the conjunctiva was a diphylprednisate target tissue.

[00:05:17] Speaker 00:
And in that experiment,

[00:05:18] Speaker 00:
You can look at page 11 of the board's opinion.

[00:05:21] Speaker 00:
It's the top left bar chart.

[00:05:22] Speaker 00:
And it shows that the emulsion is the fourth out of five best formulation.

[00:05:26] Speaker 00:
And it's substantially worse than the solution that DING is actually trying to improve upon.

[00:05:31] Speaker 00:
The Castro emulsion is second from the left.

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And the solution is third from the left.

[00:05:37] Speaker 04:
And what inference do you think is mandated from that, if you take into account

[00:05:46] Speaker 04:
the findings about reduced irritability and eliminating the need to vigorously shake instability, if that's a fair term, I don't know.

[00:05:57] Speaker 00:
I don't think that there's any inference that's necessary, right?

[00:06:01] Speaker 00:
But the question, the legal error that we're discussing here as to the motivation to combine analysis is the board's simple assertion that there would have been a motivation without any explanation

[00:06:14] Speaker 00:
or a reliance on expert testimony for why there would have been.

[00:06:17] Speaker 04:
Our expert explained that a person of ordinary skill in the art... I'm sorry, doesn't DING expressly talk about the reduced irritability benefits at least and maybe the stability benefit too?

[00:06:29] Speaker 00:
Compared to other prior emulsions.

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DING doesn't discuss suspensions at all.

[00:06:35] Speaker 03:
Well, what do we do about the fact that the board expressly found that DING broadly states that emulsions are appropriate

[00:06:43] Speaker 03:
for delivery to these tissues?

[00:06:46] Speaker 00:
Well, that's a separate error.

[00:06:47] Speaker 00:
That, that, the board, in particular, the board said that in response to our unexpected results argument.

[00:06:55] Speaker 00:
We explained that the diphylloprednisate emulsion exhibited four times bioavailability, twice the bioavailability at half the volume to Kimura's diphylloprednisate suspension.

[00:07:06] Speaker 00:
And our expert explained that that would have been unexpected.

[00:07:09] Speaker 00:
The board said, no, it wouldn't have been because person of ordinary skill in the art

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at the time would have generally expected emulsions to exhibit enhanced bioavailability to suspensions, no matter the active.

[00:07:21] Speaker 00:
And the reference that they relied on was the Sevive reference, which ran an experiment on indomethacin, which is a non-steroidal anti-inflammatory drug found enhanced by availability of emulsions to suspensions.

[00:07:33] Speaker 00:
Our expert explained, look, a person of ordinary skill in the art wouldn't expect an indomethacin experiment to apply to any other

[00:07:42] Speaker 00:
drug, particularly a steroid, because, for example, the structure of the actives are very different, and that can affect bioavailability.

[00:07:48] Speaker 00:
And the board rejected that argument based on two references, Casim and Ellis, which don't mention suspensions.

[00:07:54] Speaker 00:
They only look at emulsions versus solutions.

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And so that by itself is arbitrary and capricious for two reasons.

[00:08:01] Speaker 00:
First of all, it's a non sequitur.

[00:08:03] Speaker 00:
The board itself recognized that the question is whether emulsions generally exhibit enhanced bioavailability over suspensions.

[00:08:10] Speaker 00:
So emulsion

[00:08:11] Speaker 00:
over solution references is just a logical error.

[00:08:14] Speaker 00:
And the second problem, if you're going to for some reason look at emulsions versus solutions, surely you can't ignore DING, which teaches that as to the target tissue of diphupredinate, emulsions are, at least this castor oil emulsion in particular, is inferior to a cyclodextrin solution.

[00:08:33] Speaker 00:
So you can't ignore the primary reference in the case when you're trying to prove an already illogical point.

[00:08:39] Speaker 00:
that the fact that emulsions are better than solutions somehow demonstrates that emulsions as a general matter are better than suspensions, right?

[00:08:48] Speaker 00:
So that's as to the board's unexpected results analysis.

[00:08:51] Speaker 00:
That's just an independent arbitrary and capricious error that supports affirmance.

[00:08:57] Speaker 00:
But before I run out of time, I wanted to

[00:08:59] Speaker 04:
uh... get uh... uh...

[00:09:16] Speaker 04:
Not unexpected compared to what was in the prior.

[00:09:21] Speaker 00:
Yeah, I wouldn't disagree with that.

[00:09:24] Speaker 04:
What evidence is there that the benefit here, the results here, were unexpected compared to what somebody would reasonably expect, like a doubling of effect from Aviv?

[00:09:38] Speaker 00:
So our expert testified, opined, that the result was unexpected.

[00:09:44] Speaker 00:
And the board accepted that expert testimony could be sufficient, but the board found that other evidence contradicted the fact that this would have been an expected result.

[00:09:56] Speaker 00:
And the evidence is what I just described.

[00:09:58] Speaker 00:
It's the Aviv reference with an NSAID that our expert explained wouldn't have

[00:10:05] Speaker 00:
told you anything about a steroidal emulsion versus suspension result.

[00:10:11] Speaker 00:
And then these other references about emulsions versus solutions that are, first of all, arbitrary, and second of all, don't even mention DING, right?

[00:10:18] Speaker 00:
So the other error that I wanted to discuss is the fact that the board completely ignored real world objective evidence of non-obviousness that we put before it.

[00:10:32] Speaker 00:
Um, and that it never even acknowledged, let alone considered first, we demonstrated that there are, uh, today, I believe six steroidal eye drops on the market.

[00:10:45] Speaker 00:
Three of them are suspensions.

[00:10:47] Speaker 00:
One is a gel, one is an ointment, and one is Durazol, which is...

[00:10:53] Speaker 00:
No, to the precise contrary, Your Honor, we're arguing... We're trying to look at whether person, owner, skill, and art would have combined at the time of the invention, not... You absolutely do.

[00:11:04] Speaker 00:
And the Supreme Court and this Court have explained over and over again that the way to guard against hindsight bias in that analysis is to consider objective, real-world evidence in the market of non-obviousness.

[00:11:17] Speaker 00:
And this is objective, real-world evidence in the market of non-obviousness.

[00:11:20] Speaker 00:
As I said before,

[00:11:21] Speaker 00:
First of all, nobody has migrated steroids to emulsions.

[00:11:25] Speaker 00:
If their theory of obviousness is that steroids exhibit particular problems, and it would have been obvious that the way to fix those problems is just to migrate the active from a suspension to an emulsion.

[00:11:36] Speaker 00:
Nobody has done that.

[00:11:37] Speaker 03:
And in particular, allergens are not limited just to eye drops, right?

[00:11:43] Speaker 00:
That's true.

[00:11:44] Speaker 00:
They're not limited to eye drops, but this is evidence that provides a real-world test of their hypothesis of non-obviousness, right?

[00:11:54] Speaker 03:
So the other piece of evidence is that allergan itself, which is... But the motivation to combine doesn't necessarily have to be exactly what your motivation might have been.

[00:12:05] Speaker 03:
So they might have had the motivation to combine this for purposes of using it as a nasal drop or for the ears.

[00:12:12] Speaker 00:
Oh, I mean, the board didn't say anything like that.

[00:12:15] Speaker 00:
The board thought that the motivation to combine was based on the conjunctiva experiment in DING.

[00:12:23] Speaker 00:
But right now I'm not even talking, motivation to combine, we're talking about a hypothetical motivation based on the prior art of the time.

[00:12:29] Speaker 00:
I'm talking about basically like a secondary consideration, real world objective evidence that tests their hypothesis, their own theory of obviousness here.

[00:12:38] Speaker 00:
So for example, if it were true that

[00:12:40] Speaker 00:
Emulsions, excuse me, suspensions exhibit particular problems, and that it would have been obvious to look at DING and say, OK, I know how to solve those problems.

[00:12:49] Speaker 00:
I'm just going to make a castor oil emulsion.

[00:12:51] Speaker 00:
Why hasn't anybody done it in particular?

[00:12:53] Speaker 00:
Why hasn't Allergan, DING's assignee, that actually markets DING's own castor oil emulsion with cycle sporing, still market a steroidal suspension?

[00:13:04] Speaker 00:
Now, I'm not saying that, I mean, if we were before the board, I would say that this is conclusive evidence of non-obviousness.

[00:13:10] Speaker 00:
I'm not saying before this court that it's conclusive evidence of non-obviousness.

[00:13:13] Speaker 00:
I'm saying the board can't just ignore it.

[00:13:16] Speaker 00:
That's an error of patent law.

[00:13:18] Speaker 00:
This court has repeatedly held that every fact finder has to consider evidence probative of obviousness.

[00:13:24] Speaker 03:
Are there multiple reasons why someone might choose not to market a particular product?

[00:13:29] Speaker 00:
There may well be, Your Honor.

[00:13:30] Speaker 00:
That's a question for the board.

[00:13:32] Speaker 00:
Again, the board has to consider this evidence

[00:13:37] Speaker 00:
make a finding on it, both as a matter of patent laws and just as a matter of administrative law.

[00:13:41] Speaker 00:
This court can't review the board's decision when it hasn't actually responded to probative evidence.

[00:13:46] Speaker 00:
There's another piece of evidence that the board ignored, which is their own expert's patent application, which invented a combination of cyclosporine, which was DING's active, and a steroid in an eye drop.

[00:13:58] Speaker 00:
And he recited DING disgusting, talked about DING as having formulated cyclosporine in an emulsion.

[00:14:05] Speaker 00:
But then when he described his own formulations, he doesn't mention an emulsion at all.

[00:14:09] Speaker 00:
Again, that's real-world evidence of what an actual artisan would do when looking at eye drops and looking at D. And it was obviously not obvious to him that the way to formulate the drug would have been as an emulsion.

[00:14:29] Speaker 03:
All right.

[00:14:29] Speaker 03:
You're into your rebuttal time.

[00:14:30] Speaker 03:
I'll give you three minutes for rebuttal.

[00:14:32] Speaker 00:
Thank you.

[00:14:42] Speaker 03:
Can we start with this objective in vitro evidence?

[00:14:47] Speaker 03:
Because it is kind of surprising that the board doesn't even mention any of this real-world evidence.

[00:14:54] Speaker 03:
And yet, our case law is very clear that that's very relevant to the question of whether we're overdoing the use of hindsight.

[00:15:02] Speaker 02:
That's right, Your Honor.

[00:15:03] Speaker 02:
Your Honor, I am Chandra Kavira, Your Honor, for Appellee Acorn.

[00:15:07] Speaker 02:
Your Honor, the board actually does cite to this evidence on page

[00:15:11] Speaker 02:
eighth of their decision, the board considered this hindsight argument that Senju was making and found it just not persuasive because the patent was not to a method of choosing Dactylprednisate or a method of choosing emulsions.

[00:15:29] Speaker 02:
So it actually did consider the argument.

[00:15:32] Speaker 02:
It acknowledged the patent owner's position on this issue and simply decided that it was not persuasive because

[00:15:40] Speaker 02:
What Senju is not disputing here is that every claim.

[00:15:45] Speaker 03:
Well, they don't cite to any of this real world evidence.

[00:15:48] Speaker 03:
That statement by the board is totally addressed to a different argument.

[00:15:55] Speaker 02:
Your Honor, so the citation at the end of the paragraph on JA 8, ID at 10 to 16, there the board is citing to the pages of the patent owner's response where Senju made this hindsight argument

[00:16:10] Speaker 02:
and made this argument regarding the availability of current commercial formulations and Dr. Shah's application.

[00:16:21] Speaker 02:
So they did consider it.

[00:16:22] Speaker 02:
It came up in the oral argument as well.

[00:16:24] Speaker 02:
So the board had an opportunity to consider it, but simply found that the evidence was not persuasive.

[00:16:30] Speaker 02:
And their conclusion is on the top of the next page, JA9, the first sentence.

[00:16:37] Speaker 02:
And the reason the board found this to be true is it is uncontested here that every claim limitation of the 3-9 patent was already present in the prior art.

[00:16:48] Speaker 02:
So you already had DING.

[00:16:50] Speaker 02:
You already had the 848 patent disclosing and teaching the use of diphyl predinate.

[00:16:56] Speaker 02:
And you had DING that taught the use of an emulsion as a suitable vehicle to formulate poorly water-soluble drugs.

[00:17:06] Speaker 02:
And that was the issue in the prior art is the formulation of poorly water-soluble drugs, such as Dacuprednate.

[00:17:13] Speaker 02:
Dacuprednate?

[00:17:14] Speaker 03:
I'm still having a problem with these statements by the board that you think are so meaningful, because unlike a district court decision where we can assume the district court considered all the evidence, under the APA, there is an obligation to engage in reasoned decision-making.

[00:17:30] Speaker 03:
And how is the statement that we considered seven pages of argument and we reject it?

[00:17:35] Speaker 03:
recent decision-making?

[00:17:37] Speaker 02:
Your Honor, because, well, the first, the thing that I want to point out is the weight of this evidence.

[00:17:42] Speaker 02:
So it is unclear to, it is unclear what argument Senju is really making or what the weight of this evidence should be that current commercial formulations should play a role in determining the obviousness of a patent whose priority date is in 1997.

[00:17:57] Speaker 02:
The weight of that evidence is tiny, to say the least.

[00:18:03] Speaker 02:
In terms of this argument that they make regarding Dr. Shah's work at Bashin Lam and his patent application, as Dr. Shah testified on the record, his work at Bashin Lam and any formulation that he worked on at Bashin Lam was not his decision.

[00:18:22] Speaker 02:
It was a business decision.

[00:18:24] Speaker 02:
And Dr. Shah was bound by confidentiality agreements to Bashin Lam and couldn't

[00:18:31] Speaker 02:
explain exactly why Bashin al-Assad had not picked an emulsion.

[00:18:36] Speaker 03:
But what he did say... When you say... I mean, it's not really relevant.

[00:18:40] Speaker 03:
Why isn't it relevant that no one else has picked an emulsion after all these years, and yet you turn around and say, but it would have been really obvious to do that?

[00:18:50] Speaker 02:
Because, Your Honor, as Dr. Shah testified, there are several reasons why somebody would not have picked an emulsion.

[00:18:56] Speaker 02:
One of them, he said, was the use of a blocking patent.

[00:18:59] Speaker 02:
And if one looks at the fact that ding,

[00:19:01] Speaker 02:
was issued in 1995, claimed, as an example, cyclosporine in an emulsion.

[00:19:09] Speaker 02:
And if you consider the fact that Bosch and Lomb was working on a formulation that combined cyclosporine with the soft steroid, there are reasons why, just as Dr. Shah said, somebody might not have made an emulsion.

[00:19:22] Speaker 02:
Senju has not pointed to any statement in this entire time where anybody has said,

[00:19:29] Speaker 02:
we did not use emulsions because emulsions were bad, or that we did not think emulsions an appropriate vehicle.

[00:19:35] Speaker 03:
What about his point that even DING puts emulsions at the end of the category of useful options?

[00:19:47] Speaker 02:
Your Honor, that statement is completely unsupported by the record.

[00:19:52] Speaker 02:
The invention of DING is an emulsion

[00:19:56] Speaker 02:
Four, suitable for delivery to ocular tissues.

[00:20:00] Speaker 02:
That is all that DING is disclosing, and it's an emulsion.

[00:20:04] Speaker 02:
It runs these comparisons between emulsions and the cyclodextrin solution, but its entire invention is this emulsion used to formulate poorly water-soluble drugs.

[00:20:16] Speaker 02:
The claims of DING are to a emulsion suitable for delivery to ocular tissues.

[00:20:22] Speaker 02:
At least five points in DING, DING expressly says,

[00:20:26] Speaker 02:
that it is suitable for delivery of medications to ocular tissues.

[00:20:30] Speaker 02:
And I can point those out.

[00:20:31] Speaker 02:
It's at joint appendix 675, joint appendix 681 to 682, 687, and joint appendix 694.

[00:20:42] Speaker 02:
At 694, this is page 18 of DING, DING concludes, the emulsions were also effective in delivery of the active ingredient to the tissues of interest.

[00:20:55] Speaker 02:
Lacrimal gland, cornea, and conjunctiva.

[00:20:57] Speaker 03:
Right.

[00:20:58] Speaker 03:
And the 848 is not directed to the lacrimal gland, right?

[00:21:03] Speaker 02:
Your Honor, the 848 is directed to exactly what DING is directed to, which is eye tissues in general.

[00:21:10] Speaker 02:
The 848 discloses a diphluopredinate suspension and discloses expressly that diphluopredinate was used to treat inflammation and allergy disorders of the eye.

[00:21:22] Speaker 02:
And this can be found in the abstract as well as in these are expressed disclosures.

[00:21:27] Speaker 03:
Well, there are different parts of the eye.

[00:21:28] Speaker 03:
I mean, if you go through this record, there's a lot of discussion about the different eye tissues that need to be treated and which ones get more irritated by certain formulations.

[00:21:40] Speaker 03:
I mean, I don't think you can just say it goes in the eye, so therefore it's the end of the inquiry.

[00:21:45] Speaker 02:
Your Honor, so this rereading of this interpretation of the 848 patent is Senju's and Senju's alone.

[00:21:52] Speaker 02:
Because if you look at what the 848 patent is expressly teaching you, it is essentially teaching the fact that diflupedinate is an ophthalmic suspension that shows superior anti-inflammatory and anti-allergic reaction by local administration for disorders of the eye.

[00:22:11] Speaker 02:
And as exemplary for diseases, it lists a bunch of diseases.

[00:22:17] Speaker 02:
So there is nothing in

[00:22:20] Speaker 02:
The 848 patent.

[00:22:20] Speaker 03:
Was the lacrimal gland ever mentioned in the 848 patent?

[00:22:25] Speaker 02:
The lacrimal gland is not, Your Honor.

[00:22:27] Speaker 02:
But the lacrimal gland suffers from inflammation, same as it is a disorder of the eye, and so would be covered as a use for diacetylprednisate in the suspension.

[00:22:42] Speaker 02:
The 848 discloses a suspension.

[00:22:48] Speaker 02:
And so the target tissue is, again, said more to what diphluopredinate does.

[00:22:53] Speaker 02:
And diphluopredinate is an anti-inflammatory and anti-allergic which treats any disorder of the eye.

[00:22:59] Speaker 02:
This entire conversation, this argument that Senju has made regarding this target tissue is simply not, is a red herring because both the 848 patent as well as DING both teach formulations that are suitable for delivery to the eye.

[00:23:17] Speaker 02:
The 319 patent, the patent at issue, is a purely composition patent.

[00:23:22] Speaker 02:
It has four, it claims a composition with di-suprenate, water, castor oil, and polysorbate 80.

[00:23:30] Speaker 02:
So it does not target, it does not have a target tissue or a minimum therapeutic value.

[00:23:36] Speaker 02:
So these arguments that Senju has made regarding this target tissue, these are all of its own making.

[00:23:40] Speaker 02:
The express disclosures of DING,

[00:23:43] Speaker 02:
The express disclosures of the 848 patent and the arguments made by Dr. Shah make very clear that both of these pieces of prior art covered formulations that were suitable for delivery to the eye.

[00:24:01] Speaker 01:
So just to be clear, your claim is that the 319 patent is our formulation claims.

[00:24:07] Speaker 02:
Yes.

[00:24:08] Speaker 01:
And that there's nothing in the formulation claims that are directed to or claim a specific target.

[00:24:13] Speaker 01:
in the eye.

[00:24:14] Speaker 02:
That's right, Your Honor.

[00:24:15] Speaker 02:
The claims to a 319 platin R, they claim this emulsion in the form of an eye drop, a nose drop, and a ear drop.

[00:24:24] Speaker 02:
And so a skilled artisan may assume, take that to mean that it could be for delivery to the eye, generally, the nose, or the ear.

[00:24:31] Speaker 02:
But again, there's no target tissue requirement, and there is simply no minimum therapeutic value that it has to reach.

[00:24:39] Speaker 02:
So these arguments are simply just

[00:24:41] Speaker 02:
Senju's attempt to steer the conversation away from what the board found, which was that there would have been a reasonable motivation to combine and a reasonable expectation of success, to combine what was clearly disclosed in the 848 patent ending.

[00:25:06] Speaker 02:
The other point that I would like to make is that in terms of this

[00:25:11] Speaker 02:
real-world evidence that Senju keeps pointing to.

[00:25:14] Speaker 02:
All of this real-world evidence, they argue, should be a post I should have considered in its motivation to combine analysis, yet it's all post-filing evidence.

[00:25:27] Speaker 03:
The patent that Senju spent so much time talking about, Dr. Shah's patent... Well, objective indicit is often post-filing evidence.

[00:25:35] Speaker 03:
That's the whole point.

[00:25:36] Speaker 03:
is that you've got real-world evidence of what's going on.

[00:25:40] Speaker 03:
And your whole point is to say, are we overdoing our assumptions with respect to motivation to combine?

[00:25:47] Speaker 03:
Are we putting too much hindsight bias into that?

[00:25:51] Speaker 03:
And so you look at the broad scope.

[00:25:53] Speaker 03:
I mean, obviously, and I shouldn't use the word obviously, but when you're talking about, for instance, the success on the market,

[00:26:05] Speaker 03:
That's post-filing evidence.

[00:26:07] Speaker 03:
So you can't say post-filing evidence is not relevant to motivation to combine.

[00:26:11] Speaker 03:
That's exactly what it's relevant to.

[00:26:13] Speaker 02:
That's right, Your Honor, but this is not.

[00:26:14] Speaker 02:
So Senju is sort of hedging on words.

[00:26:17] Speaker 02:
It calls it real-world evidence, but it hasn't actually articulated an objective indicia that it is applying this real-world evidence to.

[00:26:25] Speaker 02:
This real-world evidence that it is talking about, it actually is in its reason to motivation to combine and reasonable expectation of success.

[00:26:33] Speaker 02:
So it is actually once you do a plug.

[00:26:36] Speaker 04:
I was just looking at, I think I was looking at the right document, the patent building response.

[00:26:40] Speaker 04:
This is the stuff cited 10 to 16.

[00:26:43] Speaker 04:
The heading that that's under is person of ordinary skill on the arc.

[00:26:46] Speaker 04:
It's not even motivation to combine, let alone any of the secondary considerations.

[00:26:51] Speaker 04:
I guess I would have maybe, I'm beginning to understand why the board discussed this only in this section of the opinion, because it's not clear what legal element.

[00:27:03] Speaker 04:
This is at A222, is that the right place?

[00:27:07] Speaker 02:
Yes, Your Honor.

[00:27:07] Speaker 02:
This is, this starts at, the section starts with the, at JA223.

[00:27:15] Speaker 02:
Petitioner uses hindsight to select DING and diphuprenate.

[00:27:19] Speaker 02:
And in the subsequent pages, Senju goes through all of these real world evidence and misleadingly uses the word objective indicia or rebuttal evidence.

[00:27:32] Speaker 02:
But really what it's arguing is that this is the evidence somebody should consider when looking at motivation to combine and reasonable expectation of success, which are all in the prima facie case.

[00:27:44] Speaker 02:
And so all of this evidence that Senju is actually relying on

[00:27:48] Speaker 02:
What is currently on the market has no relevance, really, to whether or not this patent would have been obvious.

[00:27:56] Speaker 03:
I think you're misunderstanding the whole role of objective indicia.

[00:28:04] Speaker 03:
They're not placed in one place or another.

[00:28:07] Speaker 03:
You're supposed to look at the totality of the evidence.

[00:28:09] Speaker 03:
And the whole point is you should say to yourself, am I assuming too much motivation

[00:28:17] Speaker 03:
And does this later evidence or this other evidence enlighten me as to whether or not I'm putting too much hindsight into the analysis?

[00:28:27] Speaker 03:
So you can't cut it up and say some evidence only relates to one thing, some evidence only relates to another.

[00:28:32] Speaker 03:
They're all relevant.

[00:28:34] Speaker 02:
And Your Honor, if the point with that, and I was only pointing to the argument that Senju made, but if you were to even consider this evidence, again,

[00:28:44] Speaker 02:
It has no bearing on whether or not this patent was obvious because, as Dr. Shah testified, testimony on the record, there are business decisions that go into what is currently on the market.

[00:28:55] Speaker 02:
There are blocking patents to consider.

[00:28:57] Speaker 02:
Dr. Shah testified that sometimes innovative companies may not use emulsions because emulsions are easier to reverse.

[00:29:04] Speaker 03:
Where does the board cite Dr. Shah's testimony on that point?

[00:29:08] Speaker 02:
Your Honor, this is on APX 2879.

[00:29:14] Speaker 04:
I think the question was, where did the board cite that?

[00:29:18] Speaker 04:
Where did the board cite that?

[00:29:20] Speaker 04:
Oh, I'm sorry.

[00:29:21] Speaker 02:
The board actually did not cite to Dr. Shah's testimony on this issue.

[00:29:25] Speaker 02:
But it considered, again, like I said, it considered all of this when it said that all of these hindsight arguments that Sanju was making, it did not find persuasive.

[00:29:35] Speaker 02:
Because the other thing that the board found in its decision is that emulsions had been known for several years to provide better bioavailability

[00:29:44] Speaker 02:
for poorly water-soluble drugs.

[00:29:46] Speaker 02:
Yes, my friend brought up Aviv, which showed better bioavailability using indomethacin.

[00:29:54] Speaker 02:
Indomethacin was not a steroid, but it was a poorly water-soluble drug.

[00:29:59] Speaker 02:
And that's the issue is the art had trouble formulating poorly water-soluble drugs like dactylpredinates, indomethacin, in suspensions because they don't dissolve in water.

[00:30:11] Speaker 02:
In a suspension, they remain suspended in water.

[00:30:14] Speaker 02:
you have to really shake them very hard for them to disperse in water, and they don't disperse all the way, which causes irritation to the eye.

[00:30:20] Speaker 03:
The benefit of emulsions is... Okay, you're out of time, and you're going off into a totally different argument.

[00:30:26] Speaker 03:
So we'll hear from the other side.

[00:30:30] Speaker 02:
Okay.

[00:30:30] Speaker 02:
Thank you, Your Honor.

[00:30:40] Speaker 00:
Thank you, Your Honor.

[00:30:42] Speaker 00:
So Judge Toronto, real quick on the appendix.

[00:30:45] Speaker 00:
There are pages missing in the appendix.

[00:30:47] Speaker 00:
So page nine is missing.

[00:30:49] Speaker 00:
And the title to this section is actually called Formulation Challenges.

[00:30:53] Speaker 00:
And it goes first before the priority date and then starts talking about later real-world evidence.

[00:31:03] Speaker 04:
What was the point being made to the board under this heading, Formulation Challenges?

[00:31:09] Speaker 00:
The point being made to the board as to this particular evidence is just that this is real-world evidence that tests their theory, their particular theory in this case of obviousness, which is that there were known problems with suspensions and the obvious way to fix those problems would be to migrate to an emulsion even with steroids.

[00:31:27] Speaker 00:
And the real-world evidence just demonstrates that that hasn't happened and the board needs to consider that evidence.

[00:31:32] Speaker 00:
My colleague said that there's a question about weight.

[00:31:34] Speaker 00:
Well, of course, weight is a question for the board.

[00:31:35] Speaker 01:
At the time of invention, were emulsions being used to deliver medication to the eye?

[00:31:41] Speaker 00:
I'm not sure that there was actually a marketed product.

[00:31:43] Speaker 00:
I don't think there was a marketed product, but I'm not sure.

[00:31:46] Speaker 01:
Did emulsions show instances where emulsions were used?

[00:31:48] Speaker 00:
Oh, yeah, sure.

[00:31:49] Speaker 00:
DING shows an instance where an emulsion is used to deliver cyclosporine to the eye, not a steroid, doesn't compare it to a suspension, right?

[00:31:56] Speaker 01:
The issue is when emotions began to be used.

[00:32:00] Speaker 01:
You want us to take a look at emotions only from real-world evidence as of today.

[00:32:06] Speaker 00:
Not only, Your Honor.

[00:32:08] Speaker 00:
Just also, right?

[00:32:09] Speaker 00:
Just as this Court always teaches, that you look at the

[00:32:13] Speaker 00:
Prior art, but you also have to look at real-world evidence also.

[00:32:17] Speaker 01:
What's your point?

[00:32:18] Speaker 00:
I don't understand because because it's probative of Their theory of non-obviousness their theory is that a person of ordinary skill in the art would have been motivated to combine Kimora suspension with a casserole emulsion because everybody just knew that the way to solve problems with suspensions is

[00:32:36] Speaker 00:
is to migrate them to emotions under ding.

[00:32:39] Speaker 00:
And yet nobody has actually done that.

[00:32:40] Speaker 00:
The fact that it hasn't happened a year later or two years later or three years later doesn't make it non-probative of that question is what it guards against hindsight.

[00:32:49] Speaker 04:
One way to solve the problems is to do this.

[00:32:55] Speaker 04:
It doesn't have to be the only way.

[00:32:57] Speaker 04:
And then if there are a bunch of ways, all kinds of factors go into deciding

[00:33:01] Speaker 04:
Who's going to do what?

[00:33:03] Speaker 00:
Well, so I don't think that's the theory that the board adopted.

[00:33:05] Speaker 00:
I think the board adopted the theory that it was clear that suspensions had particular problems that emulsions obviously solved.

[00:33:11] Speaker 00:
But in any event, it's still probative of the question of non-obviousness, and the board has to consider it.

[00:33:17] Speaker 03:
Did you present any testimony to rebut Dr. Shaw's testimony?

[00:33:22] Speaker 00:
Well, Dr. Shaw's testimony was which test?

[00:33:25] Speaker 00:
So Dr. Shaw testified, I think, to two relevant things in his deposition.

[00:33:31] Speaker 00:
One was that there were business reasons, right, not to choose an emulsion.

[00:33:35] Speaker 03:
Well, I mean, DING would have been a blocking patent, right, arguably?

[00:33:38] Speaker 00:
Well, I don't think so.

[00:33:39] Speaker 00:
I mean, it was limited to cyclosporine, and there's plenty of suspension patents out there, too, and yet people market suspensions.

[00:33:45] Speaker 00:
In any event, again, that's a question for the board to decide.

[00:33:47] Speaker 00:
If it's thought that the reason that this evidence wouldn't overcome a finding of obviousness is because DING was a blocking patent for some reason, it has to say so.

[00:33:57] Speaker 00:
I'm running out of time, but on motivation,

[00:34:01] Speaker 00:
to combine the question of target tissue.

[00:34:05] Speaker 00:
It's true that when you're comparing the claimed invention to the prior art, you look at the claims.

[00:34:10] Speaker 00:
But a motivation to combine, there has to be some actual motivation to combine the suspension with DING's emulsion.

[00:34:17] Speaker 00:
If DING's emulsion was taught enhanced bioavailability,

[00:34:21] Speaker 00:
to some completely like, you know, the toenail or something like that.

[00:34:25] Speaker 00:
Nobody would think that there would have been a motivation to combine even though there is no method of treatment claim in the claim patent.

[00:34:33] Speaker 00:
And the board agreed with that.

[00:34:35] Speaker 00:
That's why the board looked at the conjunctiva experiment.

[00:34:39] Speaker 00:
And as our expert explained, the conjunctiva experiment showed that the emulsion formulation was actually inferior to other formulations, including the one that Dink was trying to

[00:34:50] Speaker 00:
improve upon.

[00:34:51] Speaker 03:
You're out of time.

[00:34:51] Speaker 00:
Thank you Your Honor.