[00:00:00] Speaker 03:
Dean, Addison's Company versus Mylan.

[00:00:55] Speaker 03:
Ms.

[00:00:57] Speaker 03:
Bloodworth?

[00:01:04] Speaker 00:
May it please the Court, Shannon Bloodworth for the violent, for Mylan.

[00:01:09] Speaker 03:
During the Haspera argument... Could I just ask a preliminary question so I'd be sure that I don't forget it?

[00:01:15] Speaker 03:
Is Mylan's position the same as Haspera's, that even if we were to find non-infringement, that we have to go on and reach the invalidity issues?

[00:01:25] Speaker 00:
If the court construes the 727 patent to have an efficient mixing requirement and affirms the 343 finding of non-infringement of summary judgment, then Mylan does not believe the court needs to reach the additional issues that were briefed in our papers.

[00:01:45] Speaker 00:
OK.

[00:01:45] Speaker 00:
Now, Your Honor, you asked a hypothetical question during the Jaspiro argument about 31 batches.

[00:01:51] Speaker 00:
and whether or not you would have to have 31 batches to know whether or not you infringed the patents it suits.

[00:01:57] Speaker 00:
And in the answer to that question, TMC's counsel referred repeatedly to the phishing mixing process.

[00:02:04] Speaker 00:
And I think that really cuts to the heart of the issue here.

[00:02:07] Speaker 00:
If right now I brought in a batch of the Valoroon with an Asp9 level of 0.4% and set it down,

[00:02:16] Speaker 00:
There would be no way of knowing whether or not that was a original angiomax batch of 0.4% or an improved batch of angiomax with less than 0.4%.

[00:02:29] Speaker 00:
In order to determine the answer to that question, you have to ask two questions.

[00:02:35] Speaker 00:
First, how was the batch made?

[00:02:38] Speaker 00:
And two, will that process always result in asthma levels of less than 0.6%?

[00:02:45] Speaker 00:
And that is the characteristics.

[00:02:48] Speaker 00:
That's the demarcation between the prior art and the patents and suit that TMC drew.

[00:02:53] Speaker 00:
All prior art batches did not have asthma levels of less than 0.6%, when in fact we know that 87% of the 87 prior art batches did have an asthma level of 0.6% or less.

[00:03:08] Speaker 03:
I want to ask the same question that I asked of Mr. Leary.

[00:03:12] Speaker 03:
Is this batch construction really

[00:03:15] Speaker 03:
right and workable.

[00:03:17] Speaker 03:
I understand the argument that 727 has to have an efficient mixing limitation under a correct interpretation, but is the district court's batch construction really correct here because as Judge Wallach has been asking, Heidegger's cat, right?

[00:03:39] Speaker 03:
problem could be avoided by a different construction of batches so that you didn't have to look to the future to see whether there was infringement, raising these problems of indefiniteness.

[00:03:51] Speaker 03:
I know both district courts here reach the same construction.

[00:03:55] Speaker 03:
We have law which says that even if the parties agree on a construction, we don't have to follow it.

[00:04:01] Speaker 03:
That's the Lubrizol case.

[00:04:03] Speaker 03:
Maybe this is an instance in which the batches construction isn't correct.

[00:04:09] Speaker 00:
It's a challenging question, and I think we struggle with it clearly in our Markman papers.

[00:04:14] Speaker 00:
And the heart of it comes down to how do you draw this line between the prior art and improved angiomax?

[00:04:24] Speaker 03:
Whether it be in line if both patents had an efficient mixing requirement, right?

[00:04:30] Speaker 00:
If both patents had an efficient mixing requirement, then yes, that would be the line.

[00:04:34] Speaker 00:
I think that if you compare example four to example five, the only two parameters in those examples that changed were how you add the pH adjusting solution and how you mix it.

[00:04:46] Speaker 00:
And example four, you add it quickly or all at once, and you have a paddle mixer or two that is at a very slow RPMs.

[00:04:55] Speaker 00:
And in example five, you add it in a controlled manner, and you have a homogenizer, a high shear mixer, and that gives you

[00:05:02] Speaker 00:
a more efficient mixing product.

[00:05:05] Speaker 00:
And here, I don't think there's any dispute that Mylan doesn't have, you know, actually we do practice, I guess I should put it affirmatively, we practice example four.

[00:05:14] Speaker 00:
We add it all at once and we have a slow paddle mixer at 200 RPM.

[00:05:20] Speaker 00:
So if there was an efficient mixing requirement in both the 343 and the 727 patent, we would not be here today.

[00:05:28] Speaker 00:
We would, maybe I guess TMC would have appealed, but we wouldn't be here as appellants today.

[00:05:33] Speaker 00:
And I do think the pharmaceutical batches of this idea of consistency across all the old prior art and all the future batches to be made does introduce an element of uncertainty that is irreconcilable with how do you keep the parity between analyzing invalidity under the 102 on sale bar and infringement.

[00:05:55] Speaker 00:
Particularly when TMC readily acknowledges it took them 25 batches before they even recognized that they had an invention here.

[00:06:04] Speaker 00:
So is it 25 batches?

[00:06:05] Speaker 00:
The first 12 batches they sold all had less than 0.6% S9 under the old process.

[00:06:12] Speaker 00:
It's a conundrum.

[00:06:14] Speaker 00:
And certainly, I think we have a footnote in our yellow brief.

[00:06:16] Speaker 00:
Once Nautilus was issued, which was post our briefing in the district court and here originally in the initial briefing, there is a zone of uncertainty about what do you actually know as a person of ordinary skill in the art, and more importantly, as a company who wants to make this product under the prior art process.

[00:06:34] Speaker 00:
Where really are you treading upon the grounds of infringing or not?

[00:06:38] Speaker 00:
And that is tied, I think, directly to the pharmaceutical batch's limitation or rather construction that is taken from the patent specification.

[00:06:47] Speaker 02:
How does the district court's construction of pharmaceutical batches differ from the position you took below?

[00:06:58] Speaker 00:
Can you repeat the question?

[00:06:59] Speaker 02:
Sure.

[00:07:00] Speaker 02:
Didn't you argue

[00:07:02] Speaker 02:
for the pharmaceutical batches construction that the district court adopted?

[00:07:06] Speaker 00:
We took the specifications argument and then we thought that there was an antecedent basis that was missing and we did add an extra component that said it had to be by a said compounding process and the district court adopted that.

[00:07:18] Speaker 00:
And we believed that because it also includes various embodiments that that by a said compounding process must be efficiently mixing.

[00:07:26] Speaker 00:
And when we got into summary judgment briefing, the district court then

[00:07:30] Speaker 00:
ruled for the first time and did some derivative claim construction and found that the 727 patent was a pure product patent, which is inconsistent with the construction adopted of pharmaceutical batches, which does have a process component to it.

[00:07:44] Speaker 03:
Where is the batches language in this specification?

[00:07:48] Speaker 03:
Let's say the 727 patent.

[00:07:50] Speaker 00:
Oh, I have the 343.

[00:07:57] Speaker 00:
Round column five.

[00:08:05] Speaker 00:
Thank you.

[00:08:07] Speaker 00:
Column 5, lines 24 through 36, Your Honor.

[00:08:11] Speaker 03:
It could not be construed to mean that it's got to be a representative batch.

[00:08:34] Speaker 03:
Not that you have to look at all batches to see whether there's infringement.

[00:08:40] Speaker 03:
It's about 100% clear, right?

[00:08:42] Speaker 03:
I mean, the only thing that brings all the future batches into play is that last sentence on line 35, right?

[00:08:50] Speaker 00:
Well, it's a representative batch, but it's also that all batches have to be less than 0.6% in the final clause of the claim one of the 727 patent itself, wherein all batches are less than 0.6%.

[00:09:04] Speaker 00:
I was paraphrasing claim one.

[00:09:07] Speaker 03:
Well, it doesn't say all batches.

[00:09:11] Speaker 03:
It says the batches.

[00:09:12] Speaker 00:
The batches.

[00:09:14] Speaker 03:
But it could be talking about batches that are produced by this process.

[00:09:21] Speaker 00:
And if it is one representative batch, which is what the district court found in the Miling case is sufficient, we would

[00:09:30] Speaker 00:
We would argue, at least we do argue, that that one representative batch is representative of our entire aspenine specification of 0 to 1%.

[00:09:38] Speaker 00:
And that clearly, if you practice an efficient mixing, what the patent teaches you is that you will have a batch that goes greater than 0.6%.

[00:09:47] Speaker 00:
It might take 26 of your 87 lots or 27 or 29, but you will get there.

[00:09:54] Speaker 00:
It's a very high percentage of prior art batches that had less than 0.6% at or below

[00:09:59] Speaker 00:
0.6% S9.

[00:10:02] Speaker 00:
So is it representative?

[00:10:04] Speaker 00:
It's representative of the entirety of what myelin will make.

[00:10:07] Speaker 00:
And to determine that inquiry, you have to look at the process by which myelin makes it.

[00:10:12] Speaker 00:
And myelin clearly dumps in all the pH adjusting solution all at once and mixes very slowly at 200 RPMs with a paddle mixer.

[00:10:22] Speaker 00:
And that was not disputed.

[00:10:23] Speaker 00:
Those two facts were not disputed by TMC.

[00:10:32] Speaker 00:
So, Your Honor, those are the reasons why we do believe that there's no way to untangle the process from the patent itself, as far as that is concerned.

[00:10:45] Speaker 00:
The other point I did want to move to, if it was just also with our, and it was talked a little bit about in the hospital argument as well, is the disavowal that took place.

[00:10:54] Speaker 00:
TMC filed a petition to make special.

[00:10:57] Speaker 00:
which is an accelerated process in the patent office.

[00:11:00] Speaker 00:
They took advantage of that.

[00:11:01] Speaker 00:
They had to bring their best prior art forward and preempt it.

[00:11:04] Speaker 00:
And that petition made it quite clear their invention was the process by which the product was made.

[00:11:08] Speaker 00:
And for that reason, we also think the 727 patent has an efficient mixing component to it.

[00:11:16] Speaker 00:
Your Honors, I do not have any further questions.

[00:11:18] Speaker 00:
I'll reserve my time for rebuttal.

[00:11:19] Speaker 03:
OK.

[00:11:20] Speaker 03:
Thank you.

[00:11:20] Speaker 00:
Thank you.

[00:11:24] Speaker 03:
Mr. Fleming?

[00:11:28] Speaker 01:
Good morning, Your Honor.

[00:11:29] Speaker 01:
Porter Fleming also on behalf of the Medicines Company.

[00:11:32] Speaker 01:
If I may, I'd like to address a question you keep asking, Your Honor, about consistency.

[00:11:37] Speaker 01:
I don't think claim one of the 727 requires consistency.

[00:11:41] Speaker 01:
The language of claim one says all batches.

[00:11:44] Speaker 01:
And that's what distinguished it from the prior art.

[00:11:46] Speaker 03:
You had prior art batches, the prior art was... Well, you know what I mean?

[00:11:50] Speaker 03:
If one were to interpret the claim as including an efficient mixing requirement, that would distinguish it from the prior art.

[00:11:57] Speaker 03:
getting into this problem that you have if you have to look to determine whether there's infringement at future batches that are produced.

[00:12:06] Speaker 03:
I mean, wouldn't a more reasonable construction of batches to mean that it has to be a representative batch and not that you have to look to future batches to see if there's infringement?

[00:12:17] Speaker 01:
Well, first of all, Your Honor, I don't believe the claim one of the 727 requires sufficient mixing.

[00:12:22] Speaker 01:
It's a product claim.

[00:12:24] Speaker 01:
It was issued by the Patent Office as a product claim.

[00:12:26] Speaker 01:
The reasons from allowance from the examiner was a patent claim.

[00:12:30] Speaker 01:
The prior art that was being distinguished over was a product, the TOVI API.

[00:12:36] Speaker 01:
And we were required to add a specific limitation, base, having a base, and that distinguished API.

[00:12:42] Speaker 01:
I understand that, and you'll have time to argue that.

[00:12:45] Speaker 03:
But let's just stick with the batches thing for a minute, because it does seem to me very odd to have a claim that says, in order to determine infringement, you have to look to future production.

[00:12:55] Speaker 03:
to determine whether there's been infringement.

[00:12:57] Speaker 03:
And that does seem to me to create a potential indefiniteness problem, which one would avoid if you gave the representative batch construction to this.

[00:13:07] Speaker 01:
I think, Your Honor, pharmaceutical batches requires either a representative batch or you look at all batches made by a compounding process.

[00:13:17] Speaker 01:
I don't think you have an issue about some future 31, 38 batch.

[00:13:20] Speaker 01:
I can tell, counsel said she puts a product on the table.

[00:13:24] Speaker 01:
I can measure that product and I can get an ASP9 value.

[00:13:28] Speaker 01:
If that ASP9 value is below 0.6, that product infringes and it meets the other limitations of claim one of the 727, that infringes.

[00:13:38] Speaker 01:
If they make a second batch under the same process, I can look at that.

[00:13:42] Speaker 01:
I can measure that.

[00:13:43] Speaker 01:
If it has an ASP9 below, a maximum of 0.6, it too infringes.

[00:13:47] Speaker 01:
Every batch infringes as long as you keep making under the same process and you keep having an ASP9

[00:13:54] Speaker 01:
below .6.

[00:13:55] Speaker 01:
I will agree that with respect to the 343 patent, which is a product by process claim, that in that claim you do need efficient mixing.

[00:14:04] Speaker 01:
And then if you meet the limitations of efficient mixing.

[00:14:07] Speaker 01:
So what happens when your 21st batch exceeds .6?

[00:14:14] Speaker 01:
Assuming you've used the same process, and we're talking about 727 patent, which in our view has no

[00:14:23] Speaker 01:
efficient or inefficient limitation, then all those batches don't infringe.

[00:14:30] Speaker 02:
You found a dead cat, in other words.

[00:14:33] Speaker 01:
But the problem is that we know that these processes everyone's using are efficient.

[00:14:38] Speaker 01:
They are getting better.

[00:14:39] Speaker 01:
The nature is that you are perfecting.

[00:14:42] Speaker 01:
There's evidence in this case that Mylan, they made a first batch to CBM 0901.

[00:14:48] Speaker 01:
It had a 1.33 Asp9 level.

[00:14:50] Speaker 01:
They said it was not representative.

[00:14:52] Speaker 01:
They went back.

[00:14:53] Speaker 01:
They improved.

[00:14:54] Speaker 01:
They actually called it better stirring, efficient stirring.

[00:14:57] Speaker 01:
And that had an asinine value of 0.3 or 0.2.

[00:15:04] Speaker 01:
And we know.

[00:15:05] Speaker 01:
And the court found, Judge Santy found, that that was representative.

[00:15:09] Speaker 01:
And they found that that infringed under synovian.

[00:15:12] Speaker 01:
And then, Judge Hughes, you asked a question about what if someone changed something.

[00:15:16] Speaker 01:
That synovian actually addresses that very question.

[00:15:18] Speaker 01:
That's not the inquiry if you might do something in the future.

[00:15:22] Speaker 01:
In the Sedovian, it had a limit of, I think, 0 to 0.6 was the spec.

[00:15:27] Speaker 03:
Is your position that, in the example of 31 batches, that you can't tell whether batch 16 infringes until you produce all 31 batches and see that they're all within the 0.6 limitation?

[00:15:43] Speaker 01:
If batches 0 are 1 to 16, if they're all below 0.6, they infringe.

[00:15:48] Speaker 01:
17 infringes, 18.

[00:15:50] Speaker 01:
I agree that if you get to 31,

[00:15:52] Speaker 01:
then it changes.

[00:15:53] Speaker 01:
Something you have to look perhaps at what changed in the process.

[00:15:56] Speaker 01:
Maybe something's different.

[00:15:57] Speaker 01:
Maybe it wasn't the same process.

[00:15:59] Speaker 01:
But if you use the same process and you have ASCII levels below 0.6, you infringe.

[00:16:05] Speaker 02:
And you can tell at the time of... If you use the same process and 31 doesn't infringe, does that mean, retroactively, that the process itself is inefficient?

[00:16:18] Speaker 02:
I'm sorry.

[00:16:19] Speaker 02:
If 31

[00:16:19] Speaker 02:
If 31 is over 0.6, and it's non-infringing, and you say, well, then the other batches aren't infringing, does it also mean that the process used on its face must have been inefficient, assuming it's the same?

[00:16:37] Speaker 02:
Not that there's an aberration that we talked about before.

[00:16:40] Speaker 01:
You have to look.

[00:16:41] Speaker 01:
Efficient mixing is actually a mixing step within the compounding process.

[00:16:45] Speaker 01:
And so our construction is minimizing as much

[00:16:49] Speaker 01:
You would look at what the asinine was at that level or at that stage perhaps.

[00:16:53] Speaker 01:
But I think it would not fall within the claim because you'd have a maximum asinine above 0.6.

[00:16:59] Speaker 03:
But let me try to be clear because I don't want the record to be unclear about this.

[00:17:04] Speaker 03:
You have 31 batches that are accused of infringing batch 16 and batch 31 is out of spec and it's over 0.6.

[00:17:16] Speaker 03:
Does that change the fact that 16

[00:17:18] Speaker 03:
infringes.

[00:17:21] Speaker 01:
At the time you made batch 16 and you measured the S9 and it was below .6 and assuming 1 to 15 or 1 to 16 are all below .6, those infringe.

[00:17:32] Speaker 01:
I'm agreeing that if you make a future batch, batch 31, then one would argue, and that's what the prior art was.

[00:17:39] Speaker 01:
The prior art was the 89 batches.

[00:17:42] Speaker 01:
And that's why the claim limitation requires all.

[00:17:45] Speaker 03:
Yes.

[00:17:47] Speaker 03:
Does batch 16 infringe if batch 31 does not?

[00:17:54] Speaker 01:
The claim says pharmaceutical batches, you look at all.

[00:17:57] Speaker 01:
So all the batches would not infringe.

[00:18:00] Speaker 01:
None of the batches infringe?

[00:18:01] Speaker 01:
The claim says all.

[00:18:03] Speaker 02:
If one does not infringe?

[00:18:04] Speaker 01:
Correct.

[00:18:07] Speaker 02:
Okay.

[00:18:07] Speaker 02:
And you're not bothered by the word may in the patent?

[00:18:11] Speaker 02:
The word may include?

[00:18:14] Speaker 02:
In that last sentence, as I recall, it says, may include all that.

[00:18:18] Speaker 01:
I think the may is the either or.

[00:18:20] Speaker 01:
So if you have a representative exhibit batch, like the ANDA situation, you look at that one batch, and you look for its representative qualities with respect to aspenine levels, impurities, et cetera.

[00:18:32] Speaker 01:
If you make more than one batch, the claim, as defined, you have to look at all.

[00:18:38] Speaker 01:
But you can do it.

[00:18:39] Speaker 01:
You can measure.

[00:18:40] Speaker 01:
So you know whether you're in or you're out.

[00:18:41] Speaker 01:
It's not indefinite.

[00:18:44] Speaker 01:
When you're making batch 16, you can't determine whether you're in or out.

[00:18:48] Speaker 01:
You can measure the asinine of 16.

[00:18:50] Speaker 01:
Yes, you can, Your Honor.

[00:18:51] Speaker 03:
And if it has a .6... It doesn't infringe if 31 doesn't.

[00:18:55] Speaker 03:
You can't tell whether 16 infringes until you produce all 31 batches.

[00:19:00] Speaker 01:
But that's the definition of pharmaceutical batches, all batches.

[00:19:03] Speaker 01:
I agree with that.

[00:19:13] Speaker 01:
I'd like to go back just a bit on whether the pharmaceutical batches includes efficient mixing, because I don't think it does.

[00:19:20] Speaker 01:
And we heard about a clear avowal.

[00:19:24] Speaker 01:
There was no disavowal.

[00:19:26] Speaker 01:
And actually, it's in our papers.

[00:19:28] Speaker 01:
But the argument is that there was a TOBY reference which was being cited.

[00:19:32] Speaker 01:
It was API.

[00:19:33] Speaker 01:
It was a product.

[00:19:35] Speaker 01:
And that when that product was not differential from the product of the 727,

[00:19:41] Speaker 01:
And when you looked at the product of the 727, including a base and other properties, it was different.

[00:19:49] Speaker 01:
And the prior art at the time was the 89 batches, all batches, and that was distinguishable again by the 727.

[00:19:57] Speaker 01:
And the district court in Illinois and the district court in New Jersey have both found that the pharmaceutical batches of the 727 goes just to a product.

[00:20:09] Speaker 01:
And as we found in Illinois, that Mylan infringes that product.

[00:20:14] Speaker 01:
I would also like to raise, we had issues with respect to the summary judgment decision that Judge Saneve had.

[00:20:21] Speaker 01:
And in that decision, she ruled on summary judgment that Mylan's exhibit batch used more efficient mixing than example four.

[00:20:32] Speaker 01:
She actually determined that Mylan did not practice example four.

[00:20:37] Speaker 01:
It was more inefficient.

[00:20:39] Speaker 01:
We believe that to be a finding fact.

[00:20:41] Speaker 01:
She ignored material facts that we raised as to the properties and processes they used, and we believe that that should not have been decided on summary judgment, and we believe that should be vacated.

[00:20:58] Speaker 01:
I haven't heard anything about their enablement armament with respect to claims two and three, so I'll leave that alone.

[00:21:03] Speaker 01:
I think our papers are sufficient on that.

[00:21:05] Speaker 01:
We'll pass the baton unless you have another question.

[00:21:08] Speaker 01:
Okay, thank you.

[00:21:16] Speaker 00:
Thank you, Your Honor.

[00:21:17] Speaker 00:
A couple of points.

[00:21:20] Speaker 00:
Mr. Fleming's answers to his question, to the bench's questions actually highlight a key point and it's in Milan's briefing, but how is it that you determine whether or not that 16th batch is infringing or whether or not that same 16th batch is invalidating for the on-sale bar?

[00:21:35] Speaker 00:
And that's the problem that this construction really raises, is that you're applying a standard for a hypothetical number of batches that are created in the future.

[00:21:44] Speaker 00:
But you already have the data, according to TMC, so you can't retroactively apply that same analysis.

[00:21:50] Speaker 00:
So for the representative batch, TMC made batches that they called representative, put them on stability, and later sold them.

[00:21:57] Speaker 00:
Two of those batches had ASF9 levels of less than 0.6%.

[00:22:03] Speaker 00:
If representative, you just need one representative batch, that batch would be representative of all batches to be made.

[00:22:09] Speaker 00:
You need to look at the process by which it's made in order to determine whether or not you have an improved angiomax or original angiomax.

[00:22:17] Speaker 00:
And Judge Sainey did find that Mylan's mixing process is more inefficient than example four.

[00:22:25] Speaker 00:
And she looked at the two criteria that were highlighted between example four and example five and made that finding.

[00:22:31] Speaker 00:
And example two,

[00:22:33] Speaker 00:
has differences in volumes between example two and example four, and still calls it inefficient mixing.

[00:22:38] Speaker 00:
So to the extent the patent teaches what is inefficient mixing, it teaches what Mylan's process is.

[00:22:44] Speaker 00:
And for that reason, we think her summary judgment motion should be affirmed.

[00:22:53] Speaker 00:
If your honors don't have any further questions.

[00:22:56] Speaker 03:
Thank you.

[00:22:57] Speaker 00:
Thank you.

[00:22:57] Speaker 03:
Thank you, Ms.

[00:22:58] Speaker 03:
Butterworth.

[00:22:58] Speaker 03:
Thank both counsel.

[00:22:59] Speaker 03:
The case is submitted.

[00:23:01] Speaker 03:
Thank you.