SMITHKLINE BEECHAM CORP. v. APOTEX CORP.
Oral Argument — 01/05/2004 · Case 03-1285 · 55:14
0:00
Judge Rader
Our first case this morning is Smith-Klein-Beekham v. Apotex. Mr. Faribault.
0:08
Appellee Attorney (Mr. Faribault)
Thank you, Your Honor. Good morning.
0:10
There are a couple of errors of law we'd like to ask the court to correct.
0:15
One is on claim construction. One is on remedy.
0:20
As far as claim construction is concerned, there are only four words in the claim.
0:26
It's clear, unambiguous.
0:28
If you look at the certification letter from Apotex that started this case,
0:35
which is on page 8832 of the appendix,
0:40
Apotex didn't have any difficulty understanding what the claim meant.
0:44
They did not say in that letter that the claim was indebted.
0:47
Judge Rader
Mr. Faribault, isn't this case a prescription for perpetual patent?
0:52
You can come up with an ever-purer crystalline form
0:56
and then write...
0:58
recognize that it'll degenerate into trace elements of an infringing form.
1:04
And so, after this patent, we'll have an even purer crystalline form
1:09
and an even purer crystalline form with practically the same...
1:14
well, it does have identical, the same utility,
1:17
and yet it'll always degenerate into trace elements of the prior one.
1:23
Perpetual patent, very much against our vision of the patent,
1:28
which is a system with limited terms.
1:30
Appellee Attorney (Mr. Faribault)
Well, I would think that would be, Your Honor, but that's not this case.
1:35
Judge Rader
How can it not be this case?
1:37
It's precisely this case.
1:38
You've got Paxil being used for Paxil.
1:41
And what they've done is got a different crystalline form
1:46
that degenerates into the former.
1:48
And you're saying, well, we've got infringement.
1:51
Appellee Attorney (Mr. Faribault)
Your Honor, Paxil came on the market in 1993.
1:54
It's only been on the market 10 years.
1:56
The patent issued in...
1:58
1988. The patent will expire in 2006. After that, anyone can make crystalline peroxidant
2:07
hydrochloride hemihydrate. The problem that Apotex has is they chose to make a form that
2:13
they knew was unstable. If you look at Dr. Sherman's letter, which I think is a smoking
2:19
gun in this case, he acknowledges at A8300... You try very hard to convince me that it's
2:27
Judge Rader
Apotex's fault, but doesn't the record show and the district judge find that this seeding
2:34
process presents an inevitable case of infringement? There's almost no way to avoid it?
2:41
Appellee Attorney (Mr. Faribault)
There are two ways to avoid it. One is to avoid seeds. The other is to avoid water,
2:46
and Apotex didn't try to do either one. In fact, they purposely brought the seeds into
2:51
their facility by grinding up Paxil tablets, and they also used...
2:57
They used a humid environment with up to 60% humidity and used a water-based coating
3:02
for their product.
3:03
Judge Gajarsa
But under the law, though, Mr. Faribault, don't they have the right to test the Apotex
3:08
in order to file and hand their application?
3:11
Appellee Attorney (Mr. Faribault)
Yes, they do have a right to test, but, Your Honor, they don't have a right to commercialize
3:16
when they know they're going to infringe. But the key fact in this case...
3:20
Judge Gajarsa
But you're saying that they brought it into the lab themselves. They brought the Apotex
3:25
into the lab, right?
3:27
Appellee Attorney (Mr. Faribault)
They brought Paxil in and they also made Hemihydrate and they tested Hemihydrate to see what its
3:36
properties were.
3:37
Judge Gajarsa
So Hemihydrate though, is that a stable product?
3:42
It is a stable product.
3:43
The Hemihydrate is not a stable product.
3:46
Appellee Attorney (Mr. Faribault)
The Anhydrate is the one that's unstable, Your Honor, and the Anhydrate was known to
3:51
convert to Hemihydrate.
3:53
SB published that in 1987 in the Buxton and Lynch article.
3:59
Dr. Sherman read that.
4:00
He knew it.
4:01
He read the patent.
4:02
The patent itself says that the product, the Anhydrate form is unstable.
4:10
If you look at A8300, that's Dr. Sherman's letter, he says precisely that.
4:19
He says and admits that people in the old days were very stable.
4:23
The art knew in 1996, quote, that peroxidine hydrochloride anhydrate converts to peroxidine
4:31
hydrochloride Hemihydrate when exposed to moisture and compressed into tablets.
4:37
He said that four times in that document over the course of three or four pages, at A8300.
4:42
Why did he say it?
4:44
Because his own head of technology at BCI, Dr. Murthy, wrote him a letter, which is Appendix
4:54
8829, which says there are several polymorphs of this product, some of them are unstable.
4:59
And the one they chose to make, he said, they were found to be unstable under humid conditions.
5:05
They knew it converted.
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And yet they went ahead anyway.
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Now why did they do that?
5:12
Yeah, they wanted to be first generic in the market.
5:14
I understand that.
5:15
They wanted to make a lot of them.
5:16
Judge Gajarsa
What does it take to convert it, though?
5:18
Appellee Attorney (Mr. Faribault)
Sir?
5:18
Judge Gajarsa
What does it take to convert it?
5:20
Appellee Attorney (Mr. Faribault)
It takes water and seeds of the more stable.
5:23
It takes water and seeds of the more stable.
5:23
It takes water and seeds of the more stable.
5:23
It takes water and seeds of the more stable.
5:24
Amicus Attorney
It takes water and seeds of the more stable.
5:24
It takes water and seeds of the more stable.
5:24
Judge Gajarsa
So the seeding, how was the seeding done?
5:26
The seeding was done...
5:28
Appellee Attorney (Mr. Faribault)
Seeding is what their expert, Dr. Threlfall, admitted to be adventitious seeding.
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That means the seeds are present in the atmosphere.
5:38
Dr. Threlfall was asked about that at Appendix 5130, and Judge Posner on page 5581, when
5:51
Mr. Parr over here...
5:53
When Mr. Parr over here came back and was questioning the witness about whether there
5:56
would be adventitious seeding and whether it would cause conversion.
5:59
The judge said, your expert already admitted that.
6:03
Why are you asking this question?
6:05
Judge Gajarsa
But is that a natural conversion?
6:07
It's automatic, isn't it?
6:09
Appellee Attorney (Mr. Faribault)
What does it take to convert it?
6:12
It has rate controls, Your Honor.
6:14
It has...
6:15
The...
6:15
The hemihydrate has water, one molecule of water inside the crystal form.
6:20
If there's water present, then...
6:22
That crystal form will tend to form, provided there are templates or seeds on which that
6:28
crystal form can form.
6:30
There are other more stable forms.
6:32
Judge Rader, if you look at A8829, Apotex at that point had another form that they said
6:41
is much more stable, but they chose not to make that.
6:44
They chose to infringe because they didn't think they were going to get caught.
6:48
More stable than anhydride or more stable than the hemihydrate?
6:50
More stable than either one of them.
6:52
It's mixed.
6:52
It's mixed.
6:53
That's what the memo says, Judge Price.
6:54
Judge Bryson
Okay.
6:56
Can I ask you...
6:57
I infer from your brief that your claim construction is one crystal is all that's required to
7:05
satisfy the claims, that claim?
7:07
Any amount.
7:08
Any amount.
7:08
Any amount.
7:08
So one crystal or more.
7:09
Appellee Attorney (Mr. Faribault)
It says it's a chemical compound.
7:11
If that chemical compound is present, then I think that's an infringement.
7:16
There are three things.
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Of course, there's claim construction, there's proving infringement, and then there's what's
7:22
the remedy going to be.
7:22
What's the remedy?
7:23
Judge Bryson
And now, let's suppose, and I think Judge Posner gets pretty close to this, he may not quite cross this bridge, but let's just suppose that the circumstance was that there is enough now, by virtue of the invention of hemihydrate form,
7:44
there is enough of the hemihydrate in the biosphere, that there is no way that anybody could, under any circumstance, make an anhydrate that would not have some hemihydrate conversion.
8:00
Your view is that would necessarily result in infringement, regardless of the amount.
8:05
Appellee Attorney (Mr. Faribault)
Well, I don't think that's true.
8:07
Judge Bryson
Well, I understand, but Judge Posner comes pretty close to saying that. I think you'll agree with me.
8:13
Let's do an R.
8:14
Right. But let's suppose that, take my case, in which we don't even have to argue about that, just scientifically incontrovertible.
8:24
There would be, I take it in your view, infringement under those circumstances.
8:29
Appellee Attorney (Mr. Faribault)
I think there would be infringement if there is hemihydrate present.
8:33
Judge Bryson
Now, what if, to take that one step further, how do you analyze the following case?
8:40
Suppose that Smith-Klein, in order to try to prohibit anybody,
8:46
from making the anhydrate form, goes over to the lab where it's being made, and basically cedes the area sufficiently that it will cause conversion.
8:58
What's the right way to analyze that case? Because then, you'll have conversion.
9:03
Appellee Attorney (Mr. Faribault)
Well, I think if you had water. Now, they could make an alka-cell supplant and avoid water.
9:09
Judge Bryson
Well, it's water vapor. I mean, I take it all you need is water vapor. There's water vapor in the atmosphere even in Antarctica.
9:16
Right.
9:16
It's low, but it's there.
9:18
Sure.
9:18
Appellee Attorney (Mr. Faribault)
Okay, there are precautions you can take if they didn't take them.
9:23
But anyway, I think the point is that there are many, many other salts that they could make.
9:29
There are other crystals.
9:30
Judge Bryson
But before you get to the other salts and so forth,
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how do you analyze the case in which someone has done something in order to provoke the conversion
9:42
and then tries to get a remedy against the asserted infringement?
9:49
Appellee Attorney (Mr. Faribault)
Sure.
9:50
Your Honor, I think there would be a case where there would be no equitable relief because conversion was caused.
9:58
Judge Bryson
How about damages?
9:59
Appellee Attorney (Mr. Faribault)
And damages, I think, in Imbrex, in Judge Rader's opinion in Imbrex,
10:04
he talks about damages being the remedy that you'd look to in a case of de minimis infringement.
10:12
Well.
10:12
But you'd have infringement.
10:15
Judge Bryson
The infringement, so are you saying that you would not have damages under the circumstances that I set out because?
10:25
Appellee Attorney (Mr. Faribault)
If you went in and intentionally caused the infringement, then there might not even be liability.
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But what would be the theory of non-liability?
10:32
I can't think of that.
10:34
Judge Bryson
That's my problem, too.
10:35
Well, I'm struggling to try to come up with that.
10:37
Appellee Attorney (Mr. Faribault)
Judge Posner certainly was trying to do that, I think.
10:40
Judge Bryson
He was, and that's, to me, the central question.
10:43
The central question in this case is, what's the place we start with at that end of the spectrum and work backwards to this case?
10:48
Appellee Attorney (Mr. Faribault)
I notice I'm on my rebuttal time, but, Your Honor, we...
10:52
Go ahead.
10:53
Okay.
10:54
The key here is whether or not SB caused the infringement.
10:59
We didn't cause them to infringe.
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They intentionally made an unstable form.
11:05
Anhydrate, it's not like, they want to say anhydrate was in the 196 patent.
11:09
The anhydrate is never mentioned in the 196 patent.
11:13
Judge Bryson
Well, Judge Posner says that SmithKline is the cause of the infringement, and that's, you disagree with that characterization, but that's his view of the matter.
11:21
Appellee Attorney (Mr. Faribault)
That was his conclusion of law because he concluded that they have a license based on their Hatch Waxman safe harbor, and therefore, because of that license, it was us that caused the infringement.
11:35
I don't think that's good reasoning.
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He says elsewhere in the opinion that they themselves went out and brought the Paxil into their plan.
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And that they made him dehydrate in their plan.
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Now, that, whatever safe harbor you have under Hatch Waxman can't carry forward to commercial production, and it's not intended to do that.
11:57
Judge Gajarsa
Mr. Furbrough, let me just ask you a hypothetical.
11:59
Let's assume that I'm a corn farmer, and I have a field of corn.
12:03
And that corn basically is growing six feet tall, and it's yellow corn.
12:08
My neighbor uses your seed, which is a blue corn seed.
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And he gets beautiful blue corn.
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But the next year, because he has raised blue corn in a field next to mine, my corn also turns blue.
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And it has the same DNA as your blue corn.
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I did nothing to buy your seed or otherwise not buy any seed from him.
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It was seeded by his blue corn coming over in my field.
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Am I infringing your patent at that point?
12:39
Appellee Attorney (Mr. Faribault)
A patent infringement is a strict liability tort, as I understand it.
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I think the answer is yes.
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I think the claim still reads blue corn.
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And you still are making or producing or selling blue corn, so you're infringing.
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I think the real question is, what remedy is the patentee going to get?
12:59
Judge Gajarsa
But if your seed naturally came into my field and seeded my field naturally, I did nothing to seed it myself.
13:06
I think you're still infringing, John.
13:09
Judge Rader
Let me ask you one other quick question.
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And we'll make sure.
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I'm sure that everybody gets plenty of time and the equal amount of time.
13:19
Appellee Attorney (Mr. Faribault)
Thank you, Ron.
13:21
Judge Rader
If I understood your colloquy with Judge Bryson, you're interpreting this claim to mean any amount.
13:30
And it's not limited by its ability, of course, to display its useful qualities.
13:37
It's not limited to the uses of pass.
13:42
Appellee Attorney (Mr. Faribault)
That's zenith.
13:43
That's a zenith cage.
13:44
Yeah.
13:44
Judge Rader
Yeah.
13:45
That's true.
13:47
Therefore, the pharmaceutical uses and efficacy of the compound are not the claimed features, right?
13:54
That's not what you're claiming.
13:56
Appellee Attorney (Mr. Faribault)
It is the utility of what's claimed.
13:58
Judge Rader
Yeah.
13:58
That's the utility.
13:59
But it's not what you're claiming.
14:01
Appellee Attorney (Mr. Faribault)
Well, it's—
14:02
It's not the claimed feature.
14:04
Depends on the context, John.
14:05
It's not the claimed feature.
14:06
It is in one of the other claims.
14:08
It's not in claim one.
14:09
It's not the claimed feature of this.
14:11
It's not listed in claim one.
14:13
Judge Rader
So why don't you have a public use?
14:15
Because there's—you're not—you weren't testing the claimed features in the way that you've construed the patent.
14:25
Appellee Attorney (Mr. Faribault)
No, as I understand the law, Your Honor, every compound has a utility.
14:31
You have to have a utility in order to find.
14:34
Oh, yes, certainly.
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And you're entitled to experiment with regard to the utility.
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And that's what we do.
14:39
Judge Rader
I think we say claimed features are what you are testing for.
14:43
Appellee Attorney (Mr. Faribault)
Well, but that claim—
14:46
It includes every use, and particularly the ones that are listed in the patent.
14:51
If you look at EasyDoc, EasyDoc has a lot of discussion in it about whether the feature needs to be in the claim
14:57
in order for it to be part of the invention, which can be tested to avoid a public use through experimental use.
15:05
And you've got Manville, the light case where they tested in the winter.
15:09
You've got SealFlex, the athletic track case.
15:14
And in none of those.
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Was the particular element that was being tested or utility that was being tested part of the claim?
15:25
Judge Gajarsa
Mr. Faribault, could there ever become a point in time when a synthetic molecule becomes a natural molecule,
15:32
just totally existing in nature, even though it was synthetically derived?
15:38
Appellee Attorney (Mr. Faribault)
I think it's possible, Your Honor.
15:41
I mean, I don't know.
15:43
I think of penicillin, which I guess is a natural molecule,
15:47
but we think of it as something that's made synthetically most of the time.
15:51
So that's about as close as I can come, I think.
15:55
Judge Gajarsa
So what happens in a situation where the synthetic molecule just permeates the entire atmosphere
16:01
and it can't be eliminated?
16:05
Appellee Attorney (Mr. Faribault)
Then I think you've got a very good patent, Your Honor.
16:12
But that's not the case here.
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The case here, I think they can find places and conditions,
16:18
to make anhydride.
16:21
And they didn't choose to do that.
16:23
They could have done this testing in a different lab.
16:26
They didn't have to test Paxil at their plane.
16:30
Yeah, they want to say they were entitled to,
16:32
but they knew what was going to happen.
16:34
Look at 8300.
16:36
That man knew.
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He was designing their process.
16:39
Judge Rader
Well, you're arguing willful infringement,
16:41
and your point is that there doesn't have to be willfulness at all.
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There's no intent in infringement.
16:45
That's right.
16:45
You've made that point very clearly,
16:47
so I'm not sure why you need...
16:48
Rest yourself on their fault in this instance.
16:52
Appellee Attorney (Mr. Faribault)
Well, my point is that...
16:54
It's because it's so tough when it's inevitable, isn't it?
16:57
I'm sorry.
16:58
Judge Rader
It's because it's so tough when there's inevitable infringement.
17:01
You really do get into that perpetual patent problem, don't you?
17:04
Appellee Attorney (Mr. Faribault)
Well, I don't think there's inevitable infringement, Your Honor.
17:07
And certainly there's no perpetual patenting in...
17:10
The hemihydrate is a very stable form.
17:13
In 2006, when this patent expires,
17:19
the entire world will make the hemihydrate,
17:20
and they'll have no problem making it.
17:22
Judge Rader
And, of course, my hypothetical is that
17:24
what happens when there's a tetrahydrate and a quadrahydrate
17:29
and an ever-purer crystalline form
17:31
that degenerates into the former uses,
17:38
you've got a perpetual patent.
17:40
Just string out the pure crystalline forms.
17:45
You don't have any new utilities, no new uses.
17:49
Your Honor, that's not what happened here.
17:52
I understand your point on that.
17:54
Why don't we move on to...
17:56
Thank you, Your Honor.
17:57
Thank you.
17:57
Let's move on in here.
17:59
Apotex, Ms. Mazzocchi?
18:02
Appellant Attorney (Ms. Mazzocchi)
Mazzocchi.
18:03
Judge Rader
Mazzocchi, thank you.
18:04
Appellant Attorney (Ms. Mazzocchi)
Good morning.
18:07
May it please the Court,
18:09
Judge Posner reached the right result here.
18:12
Judge Posner construed the claims,
18:14
and he recognized that claims should not be construed in a vacuum,
18:18
but rather that claims are always constrained
18:20
by the judge.
18:21
There's a disclosure that's in the specification,
18:22
in the prosecution history,
18:25
the understanding...
18:26
Judge Rader
This is such a clear case of policy-driven claim construction.
18:30
The very thing we always counsel trial judges to avoid.
18:36
He looks at the outcome, doesn't like the outcome,
18:39
and quickly starts trying to see how he can jimmy
18:43
the claim construction to come up with something
18:47
that doesn't infringe.
18:50
Where?
18:51
Anywhere.
18:51
What exactly do you mean by that?
18:52
What does it say?
18:52
Only in commercially significant amounts.
18:55
Appellant Attorney (Ms. Mazzocchi)
Oh, I think if you turn to the specification,
18:57
and that's in column 1, the named inventors pointed
19:02
to the reasons why the hemhydrate was patentable
19:04
over the prior art as having certain analytical features
19:07
derived from the structure, as being stable,
19:10
non-hygroscopic, having good handling qualities.
19:13
And there was unrebudded testimony at trial
19:15
that the nature of the substance that would be able to achieve.
19:20
Judge Rader
Do we limit stress?
19:22
Structural claims to their uses, to their functions?
19:26
Oh, I don't believe...
19:27
That's even beyond importing limitations from the specification.
19:30
Do we limit them to their specific uses?
19:34
Appellant Attorney (Ms. Mazzocchi)
No, I don't think that you are importing improper limitations into the claim at all.
19:41
Judge Rader
This is a structured claim.
19:43
No one perceives ambiguity in it.
19:47
They all know exactly what it is, and four words,
19:51
but everybody knows what the four words mean?
19:53
Appellant Attorney (Ms. Mazzocchi)
Well, I believe that Smith-Kline has different...
19:57
Judge Rader
And so where do you come up with commercial significance
20:01
tacked on to the end of those four words?
20:03
And I don't see commercial anywhere in the specification.
20:07
I don't see significance in the specification.
20:09
I see references to substantial here and there and things like that,
20:15
that weasel words put into every patent.
20:19
Appellant Attorney (Ms. Mazzocchi)
Your Honor, I believe if you look at...
20:21
At column one of the specification...
20:23
Judge Rader
All right, you've got it right in front of me.
20:25
Appellant Attorney (Ms. Mazzocchi)
Approximately line 49, it starts,
20:31
however, for commercial use, it is also important
20:33
that the solid product have good handling qualities.
20:36
Then they go on to differentiate their product from the prior art,
20:40
which is described as being amorphous peroxetine hydrochloride,
20:43
which is a hygroscopic solid of poor handling qualities.
20:47
They now say, continuing on,
20:49
it has been discovered that peroxetine hydrochloride can be produced in...
20:52
in crystalline form in a manner reproducible on a commercial scale.
20:57
And they then go on to say,
20:59
here's what allows you to be able to make this material on the commercial scale.
21:03
You have a material that has certain analytical characteristics.
21:08
It is stable, non-hygroscopic, and has good handling qualities.
21:14
And as Judge Posner noted in his opinion,
21:16
the reason why these features such as non-hygroscopicity
21:22
come about...
21:22
is in fact tied to the very nature of the hemihydrate molecule itself.
21:28
I believe Judge Posner referred to the molecule as not being thirsty anymore.
21:33
That because it has the water arranged in its crystalline structure,
21:37
it no longer acts in a hygroscopic manner,
21:41
which is in contrast to the amorphous material
21:44
as well as the crystalline anhydrite material
21:47
that was also in the prior art and made by Farasan.
21:51
So as a consequence of that,
21:54
Judge Posner heard testimony that was not disputed by Smith-Klein
21:57
that the only way in which you were going to be able to achieve a substance
22:01
which was, for example, non-hygroscopic,
22:04
is if you had hemihydrate that was present in levels at the high double digits.
22:09
And it was that concept of the high double digits
22:12
that Judge Posner deemed to be commercially relevant
22:16
when he construed the claims.
22:20
So as a consequence of that,
22:21
we believe that Judge Posner's claim construction is supported by the specification.
22:26
It's also supported by the British priority documents
22:29
that Smith-Klein used as the basis for filing the 723 patent.
22:35
They're British priority documents,
22:36
which are found in the prosecution history
22:38
in which this court has said in the Glaxo-V-Renvaxi case
22:41
may be used for claim construction purposes.
22:44
In the British priority documents,
22:46
Smith-Klein identified four possible substances,
22:50
one which was hemihydrate,
22:52
one which was anhydrite,
22:53
one which was a mixture,
22:55
where hemihydrate was the predominant component,
22:59
and one where anhydrite was the predominant component.
23:02
And they provided analytical tests
23:04
that differentiated between the anhydrite and hemihydrate.
23:07
And they also said that what differentiated the hemihydrate from the anhydrite
23:12
was its stability, non-hygroscopicity,
23:15
and good handling qualities.
23:17
Now when Smith-Klein proceeded to the United States
23:20
with their U.S. patent application,
23:22
they abandoned the description
23:25
of the anhydrite.
23:27
They abandoned the description
23:29
of the anhydrite as a major component.
23:32
And they don't even say specifically
23:34
in their U.S. application
23:36
that they contemplate their invention
23:38
to be hemihydrate with the anhydrite as a component.
23:44
They only proceeded with claims to the hemihydrate.
23:48
So against that background,
23:49
Judge Posner also had a basis for believing
23:52
and for construing the claim
23:54
to require,
23:56
hemihydrate in the high double digits.
23:58
Furthermore, Judge Posner also had the testimony
24:01
of Mr. Curzans, the inventor,
24:05
who differentiated the material
24:07
that he claimed to have invented
24:08
based on its stability,
24:11
non-hygroscopicity,
24:12
and good handling qualities.
24:15
So in view of all of that testimony
24:17
and all of the intrinsic evidence,
24:21
Judge Posner was fully justified
24:23
in arriving at the conclusion
24:25
that one is not within the scope of an anhydrite.
24:27
And that is the scope of what's claimed by Claim 1,
24:30
absent the presence of hemihydrate
24:32
in the high double digits.
24:33
Judge Rader
If you don't prevail on that claim construction argument,
24:37
do we have to construe shaldamine-May?
24:40
Appellant Attorney (Ms. Mazzocchi)
No, Your Honor, you do not.
24:43
And the reason why is because we have since received
24:46
final FDA approval, and we are now on the market.
24:50
As a result, the only remedies that would be available
24:52
to SmithKline are those found in 35 USC Section 271,
24:57
E, 4, B, and C.
25:00
And even SmithKline, in its opening brief,
25:03
conceded that the remedies that are provided for
25:05
in those two sections are, in fact,
25:07
discretionary for the District Court,
25:11
because they do use the word shall.
25:13
I'm sorry, they use the word may.
25:18
I'll read it for you.
25:19
Well, we're fine.
25:22
Judge Gajarsa
Okay.
25:25
Ms. Mazzocchi, just one question regarding the
25:28
conversion of anhydrite to hemihydrate.
25:30
Is that done naturally?
25:32
Does that happen by itself in the lab,
25:34
or do you have to do something to convert it over?
25:37
What has to be done?
25:38
Appellant Attorney (Ms. Mazzocchi)
Well, we don't believe that our product does, in fact,
25:41
convert to hemihydrate.
25:43
There was evidence presented at the trial court level
25:47
that indicates that, in fact, hemihydrate may be converting
25:50
to the anhydrite, but with respect to SmithKline's
25:55
position before the trial court, they did take the position,
25:58
that one does not really have to do anything
26:02
to the anhydrite material in order for it to convert.
26:05
It is, effectively, a passive conversion.
26:08
And I think that that troubled Judge Posner considerably,
26:11
because it raises two problems.
26:13
The first question is, can passive conversion
26:16
to infringing material ever be considered to be an act
26:19
of making or using an infringing substance?
26:24
The second problem that that presents is exactly
26:26
what you pointed out, Judge Rader,
26:28
is that you are now creating a situation where a patentee can
26:33
argue that their species to a hemihydrate
26:38
can dominate the entire genus of paroxetine.
26:43
Paroxetine and all of its salts was disclosed in Farah Sand's
26:47
196 patent.
26:48
That patent expired in 1992.
26:52
So realistically, paroxetine and all
26:55
of its pharmaceutically acceptable salts
26:57
are part of the public.
26:58
Public domain.
27:00
SmithKline now comes along with this hemihydrate,
27:02
and under its single crystal theory,
27:05
is arguing that it is now effectively entitled
27:08
to stop any pharmaceutical company from making
27:11
any paroxetine material, because you will never
27:14
be able to prove that there's no seeds there.
27:17
There will always be an exposure to water.
27:21
So under their theory, you will always
27:26
have some single crystal of infringing material in there.
27:29
.
27:29
And you don't even have to actively put the right waft
27:32
in on the air.
27:32
Judge Gajarsa
Because of the natural conversion?
27:34
Appellant Attorney (Ms. Mazzocchi)
Because in SmithKline's view of the world,
27:37
you have to do nothing to bring about conversion aside
27:41
from expose your product to seeds,
27:44
and that can come just by nature of its exposure to the air.
27:49
Judge Bryson
Setting aside what each of the two parties views
27:52
is the right way, and you, of course,
27:54
take very different views as to what
27:55
you think the evidence showed, how do you read Judge Posner's
27:59
finding on that issue?
28:00
A lot of his opinion is somewhat discursive,
28:03
and it's a little unclear to me exactly how far he
28:08
goes in the direction of saying that this is a natural, i.e.,
28:13
inevitable process.
28:15
Appellant Attorney (Ms. Mazzocchi)
I can understand your confusion, because on the one hand,
28:18
he seems to imply that this is like the law of gravity.
28:21
Yes.
28:22
Yet in a different location in his opinion,
28:26
he recognizes that the mechanisms of polymorphism,
28:29
polymorphism are not well known, are not well understood.
28:32
And SmithKline's own expert, Dr. Bernstein,
28:35
testified at trial that each polymorphic system is
28:39
different.
28:39
Judge Bryson
What is your take on where he comes down?
28:42
I mean, we are dealing with a tried case with findings
28:45
of fact and conclusions of law.
28:47
So that's the platform from which we are starting.
28:50
And so we have to understand, regardless of the fact
28:55
that the parties may take different views, what exactly
28:58
it is that the district court viewed as the, you know,
29:00
as the right way to look at this scientific process.
29:03
Appellant Attorney (Ms. Mazzocchi)
Right.
29:03
I believe that Judge Posner found the seeding theory
29:08
to be intellectually fascinating.
29:11
And I think that he was faced with some testimony
29:17
from SmithKline's experts as to the concept of seeding.
29:22
The problem is, is that he took that and then assumed,
29:27
for purposes of finding infringement
29:29
under the single crystal theory, he assumed
29:32
that he could take the theory and an inference
29:35
with no underlying actual proof that hemihydrate would,
29:41
in fact, be present.
29:42
And that can only work under the assumption
29:46
that the hemihydrate is everywhere
29:48
and that conversion will inevitably occur.
29:54
Judge Gajarsa
Is that one of his findings of fact?
29:56
If you go through the entire 71 pages, one of the findings,
29:59
the facts that he does come out with is a conversion
30:03
of hemihydrate to hemihydrate is by natural process, essentially.
30:09
It can be done without any further action.
30:12
Appellant Attorney (Ms. Mazzocchi)
He does identify that as being possible.
30:17
I think he did place some restrictions in terms
30:20
of the amount of water and timing and temperature
30:23
and that sort of thing.
30:25
Judge Gajarsa
But very limited.
30:27
Appellant Attorney (Ms. Mazzocchi)
That's correct.
30:28
But the types of situations that he's talking about, you know,
30:30
there's a lot of information that Mr. Faribault mentioned,
30:32
the Voxen and Lynch paper, that paper which serves as the crux
30:37
of all of Smith-Klein's theories
30:39
as to why anhydrite would convert to hemihydrate.
30:43
In that paper, the scientists were using extreme temperatures,
30:48
extreme pressures on the order of 10 tons or more.
30:52
And those are certainly not found in our tabulating process.
30:56
And I believe Judge Posner did recognize that fact.
30:59
If I may.
31:00
I'd like to address a few points on the 102 issue.
31:03
With respect to the.
31:05
Judge Rader
You have five minutes beyond the red light.
31:07
Appellant Attorney (Ms. Mazzocchi)
OK.
31:08
Thank you.
31:09
With respect to the 102 issue, it is undisputed
31:14
that by the critical date, the inventors had isolated
31:17
and identified the hemihydrate.
31:19
They concluded that it offered patent opportunities.
31:22
They'd made hemihydrate capsules,
31:24
sent them to doctors, given them to patients.
31:28
The inventors had no involvement.
31:30
Judge Rader
But what do you tell?
31:31
What do you test for if not for the uses,
31:34
the utility of a pharmaceutical?
31:37
Appellant Attorney (Ms. Mazzocchi)
Well, they weren't testing.
31:38
They were testing to the extent you want to call it.
31:41
Judge Rader
Testing its efficacy.
31:43
Appellant Attorney (Ms. Mazzocchi)
Well, first of all, the efficacy limitation
31:47
appears nowhere in claim one, which
31:50
is the only claim that's at issue here on appeal.
31:52
Second of all, Smith-Klein had the information already
31:56
found in the 196 patent that the paroxetine molecule itself was
32:01
an antidepressant.
32:03
The crystalline hemihydrate, once it gets into the stomach,
32:06
is going to dissolve to form a paroxetine molecule.
32:09
It's paroxetine that gets absorbed by the bloodstream.
32:13
You don't have an actual crystalline particle
32:15
making its way to the 5-HT receptor
32:18
sites in your brain tissue.
32:20
And I believe even in the 723 specification,
32:24
Smith-Klein concedes that the 196 patent taught
32:27
that paroxetine was an antidepressant.
32:30
So in view of that, the notion that Smith-Klein was conducting
32:37
FDA clinical trials to figure out whether paroxetine,
32:42
whether it's in an amorphous, liquid, anhydrate,
32:45
or hemihydrate form, could be useful as an antidepressant
32:49
is rather nonsensical.
32:51
The reason why people get FDA approval
32:54
is so that they can commercially market a product.
32:57
And it would be similar to, in terms of understanding,
33:00
efficacy.
33:02
Mr. Faribault mentioned penicillin.
33:04
If you have penicillin and you know
33:07
that it operates by killing bacteria,
33:10
and because it kills bacteria, it's a useful antibiotic,
33:13
if you come up with a molecule that's
33:15
got a structurally similar nucleus, like Cipro,
33:18
you throw it into a test tube with some bacteria
33:21
and you see that it kills them off,
33:23
you can reasonably expect that this might serve
33:26
as a useful antibiotic in humans.
33:28
Now, maybe when you get to FDA, it's
33:30
clinical trials you're going to want to test for safety and efficacy you'll want
33:35
to make sure that there's no unforeseen side effects you're going to want to
33:39
ensure that maybe it's not going to cause problems if it's consumed by
33:42
pregnant women but you will have a reasonable expectation that the material
33:47
will in fact work as an antibiotic the fact that you've even set up clinical
33:51
trials and here we had multicenter clinical trials taking place not only in
33:56
in the United States but worldwide the idea that you would be engaging in these
34:02
clinical trials if you had no reasonable expectation that paroxetine could work
34:08
as an antidepressant that's simply not the type of experimental use that this
34:14
court's precedent contemplates what we have here and I understand that Judge
34:20
Koukouris was concerned about safety and efficacy testing but under this court's
34:26
precedent
34:26
particularly in in rebrana this court has never stated that a patentee needs
34:33
to have engaged in phase 3 clinical trials before it can file a patent and as
34:39
we noted in our reply brief we believe that if that's the precedent that this
34:43
court intends to establish that would actually run contrary to the patent term
34:47
restoration Act provisions that are provided for in the Hatch Waxman
34:52
amendments because currently under Hatch Waxman
34:54
structure there is a patent term extension and an NDA applicant with a new drug is
34:59
only entitled to get a patent term extension that goes no later than 14
35:04
years after the date on which you receive final FDA approval if concepts
35:09
of safety and efficacy are going to be mandated by any claim to a pharmaceutical
35:15
product pharmaceutical companies will be able to constantly say well we were just experimenting and they will be able to avoid the possible possible
35:25
of a public use bar and potentially extend their patent term out to beyond 14 years,
35:31
possibly even as long as 20 years.
35:34
Judge Bryson
Of course, I suppose that if in this case there had been the inventors had run this test
35:43
with extraordinary confidentiality requirements and secrecy and so forth,
35:48
and there had been absolutely no information about the test going out to the public and so forth,
35:54
your same example, they would be entitled to do that, I guess, even under your analysis, right?
36:05
It depends.
36:06
They just wouldn't be publicly using it, right?
36:09
There wouldn't be a public use problem.
36:11
Appellant Attorney (Ms. Mazzocchi)
I think that there would be less of a public use problem
36:14
if the inventors here had been in control of these clinical tests.
36:20
Judge Bryson
Public use is an on-off switch.
36:23
I guess what I'm trying to ask is,
36:26
your argument about policy of the patent extension provision,
36:31
the patent term extension is, it seems to me,
36:36
not necessarily, doesn't necessarily answer the problem
36:41
since it would seem to me that one can avoid public use
36:45
and simply not go to patent until one's good and ready, right?
36:50
What would be the...
36:51
Appellant Attorney (Ms. Mazzocchi)
Well, then you have the limitation of if the invention is already reduced to practice,
36:56
right?
36:56
Then that would end any claim to experimental use.
37:00
Judge Bryson
All right.
37:01
And you think in the public use as opposed to the on-sale setting,
37:08
the reduction to practice,
37:10
the acquisition of the crystal itself starts the clock running.
37:17
Appellant Attorney (Ms. Mazzocchi)
That's correct.
37:18
Judge Bryson
What's your best case for that proposition?
37:21
Appellant Attorney (Ms. Mazzocchi)
I believe there are,
37:23
that with respect to the idea that reduction to practice ends experimental use,
37:27
Right.
37:27
Alan Engineering,
37:29
with respect to the question of,
37:34
are the inventors actually experimenting,
37:37
Lowry Brunswick stands for the proposition that if you are not experimenting
37:42
with a claimed feature of the invention,
37:45
you are not experimenting.
37:47
And here...
37:48
Judge Bryson
Of course, we've had cases like the seal flex case,
37:51
which was durability in bad weather was not one of the claimed features.
37:57
But that was regarded as being within the scope of the legitimate experimentation,
38:02
if I recall correctly.
38:03
Appellant Attorney (Ms. Mazzocchi)
But with the seal flex case,
38:05
they actually had to conduct experimentation sort of out of doors.
38:11
Here, there's no element of the claim that suggests that safety and efficacy to FDA standards
38:20
is what's being contemplated here.
38:22
And particularly not in view of the single crystal claim construction,
38:26
where all they're saying is that to prove infringement,
38:29
we just have to find the existence of a molecule that's got this structure in it.
38:35
If the standard for infringement is going to be,
38:39
we just have to prove the presence of this molecule,
38:42
then the standard for validity should also be,
38:45
all that matters is did you identify and isolate the structure of this molecule?
38:50
Judge Rader
Do you have some concluding thoughts for us?
38:55
Appellant Attorney (Ms. Mazzocchi)
Yes, Your Honor.
38:56
We believe that Judge Posner did correctly construe the claims,
39:00
and similarly that Smith-Kline here was not engaged in any experiments
39:05
with respect to the hemihydrate in the United States,
39:08
causing the patent to be held invalid.
39:09
Judge Bryson
Can I just ask one other question?
39:12
I guess procedurally the posture we're in with respect to the cross appeal
39:16
is that there was a summary judgment granted against you
39:20
and denial of your motion for summary judgment of invalidity on the 102 , correct?
39:25
Appellant Attorney (Ms. Mazzocchi)
Yes, Your Honor.
39:26
There was a granting of Smith-Kline's motion for summary judgment.
39:29
Judge Bryson
That's my understanding.
39:30
If we were to reverse here the natural, the ordinary course would simply be
39:37
to send it back for further proceedings on that issue
39:41
and overturning the summary judgment that was granted,
39:44
I take it that you would like us to do a double jump, so to speak,
39:48
is not only to overturn the summary judgment,
39:50
but to leap forward and say that there's no issue of fact here
39:55
which could possibly be triable with respect to the invalidity, public use 102 .
40:01
Appellant Attorney (Ms. Mazzocchi)
That's correct, Your Honor.
40:02
Okay.
40:03
Judge Rader
Thank you, Ms. Misaki.
40:04
And Mr. Faribault, are you going to send some Paxil to the panel
40:10
to help it treat the depression caused by this case?
40:15
Appellee Attorney (Mr. Faribault)
Would Your Honor like branded or generic?
40:20
Judge Rader
That's the subject of the case.
40:22
You may proceed.
40:23
You have six minutes, by the way.
40:25
Thank you, Your Honor.
40:28
Appellee Attorney (Mr. Faribault)
As a technical issue, these polymorphs don't just convert all the time.
40:35
Dr. Bernstein, who is the world's noted expert on this,
40:39
wrote a paper called Disappearing Polymorphs, which is in the appendix.
40:43
And over his career, he cites maybe 15 examples of this happening.
40:48
That's why Mr. Kurzes was so excited when he discovered this new polymorphic form.
40:54
He knew it was unusual.
40:56
He knew it was something that could be very significant and important.
41:01
And that's what it's turned out to be.
41:03
That's the form that SmithKline has marketed.
41:05
And you can't go back then to the anhydrite.
41:09
Yeah, if they wanted to make Proxton, they could make Proxton malleate.
41:13
That's disclosed in the 196 patent.
41:16
That patent's expired.
41:17
And they could make it.
41:18
And they could file a 505 instead of a 505 .
41:23
And they could try to sell that different salt.
41:25
But then it wouldn't be substitutable in the marketplace.
41:30
The pharmacists couldn't just substitute theirs for ours.
41:33
That's why they wanted to use ours.
41:35
And that's why they're willing to take a chance on an unstable polymorph in order to do it.
41:42
So I don't think this permanent conversion from one form to another
41:47
is really something that the court needs to be troubled about.
41:50
Judge Gajarsa
Mr. Faribault, with respect to the findings of fact made by Judge Posner,
41:54
is it your opinion that the court needs to be troubled about it?
41:57
That there was a finding of fact that conversion from anhydrite to hemihydrate
42:01
was a natural occurrence just by taking without any further action?
42:06
No, no, sir, I don't believe it was.
42:07
Appellee Attorney (Mr. Faribault)
There was no finding of fact to that effect?
42:09
I think that what he found was that it converts in the presence of seeds and water.
42:16
And if you have an environment that has both of those things
42:19
and you add pressure and temperature, the more you have, the more you're going to get.
42:24
And he said, for example,
42:27
that in 1985, if you practiced the 196 patent,
42:31
you would not inherently get hemihydrate
42:34
because there were many areas that did not have those factors that you needed in order to produce it.
42:40
Judge Rader
Mr. Faribault, do you agree with Ms. Misaki's point
42:43
that we don't have to reach the Chalmé issue,
42:46
that if we get to that point of the analysis,
42:49
we're really not under the Hatch-Waxman Act,
42:53
we've got broader discretion for equitable remedies?
42:57
Appellee Attorney (Mr. Faribault)
No, I don't, Your Honor,
42:58
because the statute itself sets forth three remedies,
43:03
A being that the date of approval will be postponed
43:06
until the date of expiration of the patent,
43:09
then may grant an injunction, may award damages,
43:13
but the first one says shall,
43:15
and that still applies even though Apotex is now on the market.
43:19
They went on the market after Judge Posner's decision.
43:22
That's why I gave you the generic option.
43:24
Uh...
43:27
So, but the statute itself is clear
43:31
that you're entitled to all three remedies,
43:33
and the legislative history which is cited at page 51 of our original brief,
43:39
footnote 12,
43:40
says if the infringing party has begun commercial marketing of the drug,
43:46
damages and other monetary relief and injunctive relief
43:49
may be awarded for the infringement and to prevent further infringement.
43:54
In addition, the FDA would be mandated
43:59
to change the effective date of the approved and
44:01
to the expiration date of the infringed patent.
44:04
So I think we're entitled to that 271 remedy in any event,
44:11
and I think shall does mean shall.
44:13
I think this Court said that in Apotex v. Thompson
44:16
regarding the statute.
44:18
The Supreme Court certainly said it in the Alabama case,
44:21
which I think is very analogous here.
44:25
I'd like to move on briefly to the public use issue,
44:29
and I think there Apotex confuses utility
44:34
with reduction to practice.
44:38
Judge Koukouras clearly found there was no reduction to practice.
44:42
If you look at the,
44:45
and the issue was mainly regarding rat brain tests,
44:49
and if you look at anhydrite,
44:53
anhydrite had been used on rat brains.
44:56
And if you look at Cone 1 test,
45:00
this is at Appendix 13-224,
45:03
Cone ran the first double-blind test in the U.S. on anhydrite,
45:10
and it didn't work.
45:12
And Dr. Simon, our expert on this area,
45:16
said it didn't work.
45:17
And Cone himself said it didn't work.
45:20
Mark Simon's opinion is at A-1296 and 97.
45:25
So how can you have something reduced to practice that doesn't work?
45:29
And it was only through subsequent testing of efficacy
45:34
that it was established over long years.
45:37
The final data was filed in 1989.
45:40
Five years later, the product wasn't approved until 1992.
45:44
It didn't go commercial until 1993.
45:47
And we're arguing about something that happened
45:49
in 1985 within five months after they discovered the product.
45:54
It's not true that the inventors were totally absent either.
45:58
You look at A-11-938 and at C,
46:05
you find that the inventors were back working.
46:08
They were working on flow problems.
46:09
They were working on improving the process.
46:12
They don't have to be involved in clinical trials.
46:14
That's not their expertise.
46:16
This court has held repeatedly that the assignee
46:19
is entitled to control that kind of efficacy testing.
46:24
So I think Scott B. Finney is our best case.
46:28
More complex an invention.
46:30
Judge Rader
Mr. Faribault, could you answer Judge Bryson's question?
46:33
Judge Bryson
I have just one question.
46:36
Straighten me out, or perhaps you and Ms. Mazzocchi
46:41
can together straighten me out on the relationship
46:44
between the public use and reduction to practice.
46:48
Assuming we have something that we would be prepared
46:51
to call a reduction to practice at some point
46:53
before the critical date, is that it for you?
46:59
Appellee Attorney (Mr. Faribault)
Well, I don't think it is.
47:01
And our brief suggests that it's contrary to FAF
47:03
to say that it is because FAF has two prongs,
47:07
one being ready for patenting,
47:09
which would include reduction to practice,
47:11
and the other being is it experimental
47:14
or is it commercial?
47:15
Now, this court has said two or three times
47:17
in recent cases, like Zacharin, for example,
47:20
which I think was dicta,
47:22
but also in a couple of other cases
47:26
that reduction to practice ends experimental use.
47:29
That goes back to the old RCA case.
47:31
Judge Bryson
Right, and reduction to practice.
47:35
Assuming we have something that we would be prepared
47:38
to call a reduction to practice
47:39
at some point before the critical date,
47:42
is that it for you?
47:45
Appellee Attorney (Mr. Faribault)
Well, I don't think it is,
47:47
and our brief suggests that it's contrary to FAF
47:50
to say that it is because FAF has two prongs,
47:53
one being ready for patenting,
47:55
which would include reduction to practice,
47:58
and the other being is it experimental
48:00
or is it commercial?
48:02
Now, this court has said two or three times
48:04
in recent cases, like Zacharin, for example,
48:07
which I think was dicta,
48:09
but also in a couple of other cases
48:13
that reduction to practice ends experimental use.
48:16
That goes back to the old RCA case.
48:18
Judge Bryson
Right.
48:19
Appellee Attorney (Mr. Faribault)
But I don't think it is under FAF.
48:22
Judge Bryson
And is there a different rule, you think,
48:29
with respect to on sale from public use,
48:31
with respect to that question?
48:33
Appellee Attorney (Mr. Faribault)
On sale makes it a lot easier
48:35
because, for example, in the Abbott case,
48:38
you didn't have to look for whether it was suitable
48:41
for its intended purpose because it had been sold.
48:45
Right.
48:45
So you could assume that it was useful
48:47
for its intended purpose.
48:49
So I think on sale raises a lot more strenuous issues
48:56
than public use because public use,
48:58
then you really have to look at it,
49:00
where are you doing test marketing?
49:01
Every case where this court has found public use,
49:04
I think there's been a real issue of test marketing.
49:08
And that's not what was going on here.
49:11
It's clear.
49:12
We were saying experimental use,
49:15
only we were saying this is an investigational drug.
49:20
It was eight long years before we were able to sell this product.
49:24
Judge Rader
Okay. Thank you.
49:24
Appellee Attorney (Mr. Faribault)
Thank you.
49:25
Judge Rader
Thank you, Mr. Faribault.
49:26
Thank you, Ms. Misaki.
49:28
Our next case is Dynacor Holdings versus U.S. Phillips.
49:32
One second.
49:34
Judge Bryson
She has a cross appeal.
49:35
I do think she does.
49:37
I don't think she has any time left.
49:38
Judge Rader
I think we have a cross appeal,
49:41
which the court was a little depressed.
49:47
Ms. Misaki, you have three minutes.
49:51
Appellant Attorney (Ms. Mazzocchi)
Thank you, Judge Ritter.
49:52
I'll be brief.
49:53
First, with respect to the public use issue,
49:57
Mr. Faribault mentioned the Abbott case,
50:00
and he said that there,
50:01
because it was being sold,
50:02
it must have had a purpose.
50:04
If peroxine hydrochloride,
50:06
hemihydrate was being used in worldwide clinical trials
50:08
for the treatment of depression,
50:10
it was known to have a purpose.
50:12
What really happened here is SmithKline
50:15
applied the wrong clock
50:17
in terms of when they should be applying for a patent.
50:21
They introduced this material into the United States,
50:24
into the public domain in May of 1985.
50:28
That should have been what started the clock running
50:30
in terms of the date on which they filed a patent.
50:33
They didn't use that date.
50:34
They used the date that was the clock
50:36
that was tied to their British priority applications filing date.
50:41
SmithKline never introduced any test data
50:44
from the clinical trials.
50:45
into their U.S. patent application.
50:48
If the point of the experimental use doctrine
50:51
is that patentees are supposed to figure out
50:54
whether it's valuable to file a patent,
50:56
and the public is perceived to attain a benefit by that
51:00
because they get a more perfected invention,
51:04
here, Mr. Faribault just said
51:06
that they didn't even think they had the perfected invention
51:09
until after the patent issued.
51:11
The only data that SmithKline relied on
51:15
for safety and efficacy of the hemihydrate
51:18
was data that had already been disclosed,
51:20
the rat brain data, in the Farisan 196 patent.
51:25
The public obtained no additional knowledge
51:29
about the nature of the efficacy of paroxetine
51:32
as a consequence of SmithKline's
51:34
quote, unquote, experimental use.
51:37
Similarly, Mr. Faribault also talked about how
51:47
companies should be allowed
51:49
to go on and conduct clinical trials
51:51
on behalf of inventors.
51:53
The problem with that is that
51:57
SmithKline's position that they didn't know
52:00
that the hemihydrate would work for its intended purpose
52:03
means that nobody had conceived of the idea
52:08
that the hemihydrate might, in fact,
52:11
work as an antidepressant.
52:13
Now, if none of these named inventors
52:15
had any involvement with the clinical trials,
52:19
somebody must have conceived of the idea
52:21
of hemihydrate being useful as an antidepressant,
52:25
and that person is certainly not named
52:28
on the face of the 723 patent,
52:30
which would imply that either the inventorship is wrong
52:34
or that the knowledge with respect to
52:37
paroxetine's use as an antidepressant
52:39
was sufficiently generally known
52:41
and disclosed by the 196 patent,
52:44
such that you didn't need to further provide
52:48
any conception.
52:49
Judge Bryson
Well, a lot of experimentation,
52:51
even setting aside the FDA efficacy and safety
52:54
and efficacy requirements,
52:55
a lot of experimentation is done for the purpose
52:58
of confirming what is suspected.
53:00
And it would seem to me a natural process
53:03
in a corporate setting for somebody
53:05
other than the people in the particular component
53:08
that are doing the inventing to run the test.
53:12
And it doesn't seem to me necessarily to be the case
53:16
that those people would be contributing
53:18
to anything other than their expertise
53:20
in conducting a test which is designed
53:22
to try to establish whether that which was suspected
53:25
is in fact present.
53:26
Does it make a lot of sense to say,
53:28
well, you've got to bring the inventors over
53:29
to the other side of the building
53:33
where they stand around while the tests are conducted
53:36
in order to avoid the defeat
53:40
of the experimental use exception?
53:43
Appellant Attorney (Ms. Mazzocchi)
Well, Your Honor, I believe that,
53:45
or it's Apotex's position,
53:47
that if it turns out that you have some type
53:51
of surprising efficacy results that come along
53:55
in these later experimentations,
53:57
if you want to call them that,
53:59
that would have been unexpected
54:02
compared to the teachings that were already known
54:05
for paroxetine in the prior art,
54:08
then maybe you would be justified
54:09
in filing a continuation in part application
54:12
or something along those lines.
54:13
Judge Bryson
But my concern is with what I would take to be
54:17
the great bulk of the cases,
54:19
which is that the inventors suspect
54:21
that something's going to work in the following way.
54:23
They send it over to the testing guys
54:26
and they say, run this,
54:29
maybe it's a tire or something,
54:31
run this tire around the track a few times
54:32
and see if it works.
54:33
And they're not over there,
54:35
maybe they will be out of interest,
54:37
but they're not necessarily going to be over there
54:39
running the tire around the track to see if it works.
54:41
They think it'll probably work,
54:42
but they don't know for sure.
54:43
The tests are run.
54:44
Are you suggesting that they lack
54:47
sufficient involvement in this experimentation,
54:49
therefore experimental use doesn't come into play there?
54:52
Appellant Attorney (Ms. Mazzocchi)
Yes, because you would think that the person
54:54
who sends the tire off to the track to be tested
54:57
is going to have the guys doing the testing
55:00
report something back to him.
55:02
Here the inventors didn't even get any clinical trials
55:06
reported back to them.
55:11
Judge Rader
Thank you, Ms. Mazzocchi.
55:12
Thank you, Mr. Faribault.