[00:00:11] Speaker 05:
I'm just gonna say, let's stop.

[00:00:37] Speaker 02:
We will hear argument next in Merck, Sharp, and Domey Corp.

[00:00:44] Speaker 02:
against amnial pharmaceuticals, numbers 17-1560.

[00:00:58] Speaker 01:
Mr. Barzoukas.

[00:00:59] Speaker 01:
Good morning, Your Honors.

[00:01:00] Speaker 01:
May it please the Court?

[00:01:02] Speaker 01:
Nicholas Barzoukas with co-counsel Lisa Thomas on behalf of Merck and Company.

[00:01:08] Speaker 01:
This is a case that we believe presents a very important issue with respect to Hatch-Watzman cases.

[00:01:14] Speaker 02:
And it's an issue that can affect a particular... It would help me a lot if you could in extremely short order forget for a minute the legal questions and go date by date with the batches that are at issue, say what they were, what happened between them,

[00:01:36] Speaker 02:
starting a little bit with the exhibit and batches and the commercial batches, but mostly focusing on what started happening in January of, was it 2016?

[00:01:48] Speaker 02:
Absolutely.

[00:01:49] Speaker 01:
Because it's more than a little bit confusing.

[00:01:53] Speaker 01:
So to kind of start the history, obviously, Emil filed an ANDA to make a generic version of the drug nasonets containing mometazone furosate.

[00:02:04] Speaker 01:
It originally filed its ANDA

[00:02:06] Speaker 01:
And with that ANDA, it submitted, among other things, the three exhibit batches that are talked about in this case.

[00:02:14] Speaker 01:
Those are the three exhibit batches.

[00:02:15] Speaker 01:
Those were completed, I believe, sometime in 2013, a long time ago.

[00:02:21] Speaker 01:
At the time, that was a different ANDA, because this same ANDA was amended in 2016.

[00:02:28] Speaker 01:
Now, Amil submitted those exhibit batches back in 2013.

[00:02:33] Speaker 01:
Eventually, he got a complete and own file.

[00:02:36] Speaker 01:
Merck received notification of this, and we filed the Hatch-Waxman patent infringement case.

[00:02:44] Speaker 01:
At that same time, Amil had what they called a commercial batch size product that was a larger batch than these exhibit batches.

[00:02:54] Speaker 01:
And you may have seen that in the briefings called the 157 batch.

[00:02:59] Speaker 01:
Amnio had never provided that particular batch to Merck in discovery.

[00:03:06] Speaker 01:
And at some point, when Merck realized they had provided it, this is in 2015.

[00:03:11] Speaker 01:
That was not given to the FDA?

[00:03:16] Speaker 01:
The batches are never given to FDA.

[00:03:18] Speaker 01:
However, data from the batches are usually used.

[00:03:24] Speaker 04:
follow through.

[00:03:24] Speaker 04:
You started off by telling us about the first end and the exhibit batches, and that data was given to FDA.

[00:03:31] Speaker 01:
Data was used for that, for the FDA.

[00:03:33] Speaker 04:
And then before the end, it was amended, right?

[00:03:36] Speaker 04:
The commercial batches did?

[00:03:38] Speaker 01:
They had made a commercial batch called the 157 batch.

[00:03:41] Speaker 01:
It's referred to as the 157 batch in the Greek.

[00:03:42] Speaker 01:
That's a thousand kilogram batch?

[00:03:44] Speaker 01:
A thousand kilogram batch.

[00:03:46] Speaker 01:
Okay.

[00:03:46] Speaker 01:
And Amil had never provided samples of that batch to Merck.

[00:03:50] Speaker 01:
Once it was realized they had actually made that batch,

[00:03:54] Speaker 01:
We went to the court and asked the court to force Anmiel to give us samples of that batch.

[00:04:00] Speaker 04:
Because that, at the time... Was there an outstanding discovery order against Anmiel at the time they produced the commercial batch?

[00:04:07] Speaker 01:
Absolutely.

[00:04:08] Speaker 01:
For everything they had... When was that?

[00:04:10] Speaker 04:
When was... And you say you filed your suit on the first hand in 2013?

[00:04:14] Speaker 04:
I think it was 15.

[00:04:17] Speaker 01:
It was in 2015.

[00:04:18] Speaker 01:
The exhibit batches were made in 2013.

[00:04:22] Speaker 04:
Right.

[00:04:23] Speaker 04:
When was the discovery order?

[00:04:27] Speaker 01:
The discovery request, you know, I don't have the date right now, but it would have gone... I'm looking at one in December 2015.

[00:04:34] Speaker 01:
The discovery request would have gone out shortly after the lawsuit was filed.

[00:04:38] Speaker 01:
We actually held hearings.

[00:04:40] Speaker 04:
I was just pointing out when you said, well, they never gave you the commercial batch.

[00:04:44] Speaker 04:
I was trying to... You got the commercial batch in due course.

[00:04:48] Speaker 01:
We had to go to the court toward the end of 2015, and there had to be order to give us the actual 157 batch.

[00:04:57] Speaker 02:
And now we're up to January 2016, and things start happening with day numbers.

[00:05:01] Speaker 01:
Things start happening with breakneck speed.

[00:05:04] Speaker 01:
So shortly after, a little bit more than a week after they were ordered by the court, by the district court, to give us the 157 batch, they say, oh, forget that batch now that we have to give it to you.

[00:05:16] Speaker 01:
We're going to change and we're going to modify our ANA.

[00:05:21] Speaker 01:
And we're going to file amendments.

[00:05:24] Speaker 01:
And by the way, the FDA had asked us to make another batch.

[00:05:27] Speaker 01:
This is the infamous in the briefing, the 16001 batch.

[00:05:35] Speaker 01:
And that's when they let us know about this.

[00:05:37] Speaker 01:
And by the way, we'll amend the ANDA, and now we'll make our commercial size batch a 100 kilogram batch.

[00:05:44] Speaker 01:
So what we have, things start happening in breakneck speed.

[00:05:47] Speaker 01:
The court orders them to give us any commercial size batches that they produce in response to the FDA.

[00:05:56] Speaker 01:
So they start in January to make the 16001 batch.

[00:06:02] Speaker 01:
They go through the first part of the process of making it, which involves putting the different ingredients, mixing them, stirring the pot with different mixers.

[00:06:10] Speaker 01:
This is not just mixing things lightly.

[00:06:13] Speaker 01:
These are high-speed blenders on industrial scale.

[00:06:17] Speaker 01:
And they get to a point where the first part of the process is finished, and that happens on January 11th, 2016.

[00:06:27] Speaker 01:
And that's when they drew the samples that they gave us for the case, which are the 16001 day one samples.

[00:06:35] Speaker 02:
January 11th samples.

[00:06:37] Speaker 01:
Exactly.

[00:06:37] Speaker 02:
Day one samples.

[00:06:38] Speaker 02:
Then what?

[00:06:39] Speaker 01:
Then unbeknownst to us, they told us, here are your samples from our commercial bulk whole batch.

[00:06:44] Speaker 01:
That's what they called it at the time to us.

[00:06:46] Speaker 02:
Made it with 100 kilogram vats.

[00:06:48] Speaker 01:
Yes.

[00:06:48] Speaker 01:
And they told us, this is the samples from our batch.

[00:06:55] Speaker 01:
They never told us these

[00:06:56] Speaker 01:
the batch of the processing had been finished or anything like that.

[00:07:00] Speaker 01:
So this is now unbeknownst to us in this period until on January 14th, they restart this batch, and on January 15th, they actually remove another set of samples.

[00:07:13] Speaker 01:
which are called the day four samples, the 16001 day four samples.

[00:07:18] Speaker 02:
I'm sorry, that's on the 15th, even though that's actually the fifth day if day one is the 11th.

[00:07:25] Speaker 01:
Well, I think they look at it in between the different days.

[00:07:29] Speaker 02:
And in order to get to that sample, was there mixing between January 11th and January 14th?

[00:07:37] Speaker 01:
There was mixing, and that's actually a judicial admission they made in a stipulation they filed with court.

[00:07:42] Speaker 01:
Okay.

[00:07:44] Speaker 02:
And that's what's called the day four.

[00:07:47] Speaker 01:
That's called the day four, the day four samples, the day four samples.

[00:07:52] Speaker 01:
And by the way, they got data from those day four samples and submitted those to the FDA.

[00:07:58] Speaker 01:
Now on the 15th also, they proceeded and they bottled some of the, they actually finished the entire process and put it in the actual bottles, the spray bottles, because it's a nasal spray.

[00:08:12] Speaker 01:
And now all of this is happening under no.

[00:08:15] Speaker 01:
Does that have a different name?

[00:08:17] Speaker 02:
That's called the 16001A.

[00:08:19] Speaker 02:
And was there any difference, any additional mixing between the creation of day four and the A?

[00:08:27] Speaker 01:
And there's still a little bit of mixing because as they put it in the bottles, they have to mix it again.

[00:08:33] Speaker 02:
And you eventually

[00:08:37] Speaker 02:
in May at least, asked for what?

[00:08:40] Speaker 02:
Day four and A?

[00:08:41] Speaker 01:
Actually, it's a little bit worse than that because in February after, you know, we thought we had gotten the final, we needed some more samples.

[00:08:47] Speaker 01:
Say, hey, give us some more of your final batch you made for the FDA.

[00:08:51] Speaker 01:
Now they have finished all the processing, they still give us the day one sample.

[00:08:56] Speaker 01:
Again, we have no idea that they hadn't finished it.

[00:08:58] Speaker 01:
At the same time, they're producing documents to us.

[00:09:01] Speaker 01:
The documents go down through March.

[00:09:04] Speaker 01:
Around March 10th, they keep producing documents.

[00:09:06] Speaker 02:
And there are some documents, some batch records in February that indicate that there existed these day four and A samples.

[00:09:17] Speaker 01:
Correct.

[00:09:17] Speaker 01:
They would have been created at that time, but we didn't get complete discovery until March 10th.

[00:09:22] Speaker 00:
So you got the documents on March 10th that would have indicated that there were other batches in existence.

[00:09:27] Speaker 01:
I don't know exactly what, but we got their completed document production related to that on March 10th.

[00:09:33] Speaker 04:
Now this was all in January of 2016, right?

[00:09:38] Speaker 01:
That's in the early part of the sentence, January through March of 2016.

[00:09:42] Speaker 04:
Right.

[00:09:43] Speaker 04:
And so you were given the, when were you given the day one samples?

[00:09:50] Speaker 01:
The first, the first part of them, we got them January, they sent it to us on January 11th.

[00:09:55] Speaker 04:
You, what, you got them on January 11th?

[00:09:57] Speaker 04:
Yes.

[00:09:59] Speaker 00:
So now, what happens... Can I ask you a question about the 1601A?

[00:10:04] Speaker 01:
16001A.

[00:10:06] Speaker 00:
Yeah, 16001A batch.

[00:10:08] Speaker 00:
So was that ever, was data collected from that and was that provided to the FDA or the data from that sample?

[00:10:15] Speaker 01:
They got data, the last data we know for sure they gave to the FDA.

[00:10:19] Speaker 01:
We don't know what they've done since, but they definitely gave data to the FDA from the day four sample.

[00:10:24] Speaker 00:
But not from the 16001A samples?

[00:10:28] Speaker 01:
Not that we know from their production, but they definitely did it from the day four samples, which have a four-day period and more mixing.

[00:10:35] Speaker 04:
At some point in time, your client became aware of the day four sample and the 16001A.

[00:10:42] Speaker 01:
Well, the way we did is because when they filed their responsive rebuttal expert reports, all of a sudden they had one expert that provided a report

[00:10:54] Speaker 01:
that actually used data and cited data from the 16001 day four samples.

[00:11:00] Speaker 01:
And we're like, wait a minute, what's this?

[00:11:03] Speaker 04:
And at the same time... What date was that?

[00:11:06] Speaker 04:
That would have been... That your client became aware of the existence of the day four in the 01A.

[00:11:21] Speaker 01:
That would have been on April

[00:11:23] Speaker 01:
25th was when their rebuttal reports were due.

[00:11:28] Speaker 01:
And that's appendix page 40, DI 115.

[00:11:34] Speaker 04:
Now after that date, April 25th and before, you had a hearing on June 7th when all this topic was being discussed in great detail.

[00:11:45] Speaker 02:
So even May 25th, it wasn't the discovery conference on May 25th.

[00:11:49] Speaker 01:
There were a number of discovery conferences.

[00:11:52] Speaker 02:
When did these issues first become a topic of

[00:11:56] Speaker 02:
of communications either between the parties or with the judge.

[00:11:59] Speaker 01:
So we received their rebuttal expert reports and all of a sudden we see that they have data that have been submitted to the FDA from the day four samples, which we never had gotten.

[00:12:10] Speaker 01:
And we also see that they criticize our expert for opening the bottle because they gave us those samples from day one in actual little screw top bottles as opposed to a nasal spray.

[00:12:22] Speaker 01:
And we say, wait a minute, why are they, how do they have data from day four, which they never gave us any, you know, this is data we didn't have.

[00:12:30] Speaker 01:
How did they, samples that we didn't have for this data.

[00:12:34] Speaker 01:
And then they also, why are they criticizing our expert for opening the bottle with a screw top?

[00:12:40] Speaker 01:
That's what they gave it us.

[00:12:41] Speaker 01:
And that made us, prompted us to go back carefully through all their batch records that they had given us in March and say, wait a minute, they actually completed this production

[00:12:52] Speaker 01:
and actually put product in the nasal spray bottles, which is the finished version of the product.

[00:12:58] Speaker 04:
Did you then move the court for production?

[00:13:02] Speaker 04:
You had an outstanding discovery order from way back, right?

[00:13:07] Speaker 01:
We absolutely did.

[00:13:08] Speaker 04:
When did you go to the court and say, hey, they have something they haven't given us?

[00:13:13] Speaker 01:
We went, we went immediately to the court and we started having hearings.

[00:13:18] Speaker 01:
Well, give me some dates and some records.

[00:13:20] Speaker 01:
So, for example, we had an emergency motion on May 9th.

[00:13:25] Speaker 01:
And that's on Appendix page 112, paragraph 1.

[00:13:32] Speaker 01:
We had a second emergency motion on May 13th.

[00:13:37] Speaker 01:
It's in Appendix page 112.

[00:13:38] Speaker 01:
What's the emergency motion?

[00:13:40] Speaker 04:
Did the emergency motion ask for these particular things?

[00:13:43] Speaker 01:
Yes, absolutely, because we were telling, what we were telling the court.

[00:13:46] Speaker 04:
Can you show me where in that motion?

[00:13:51] Speaker 04:
And it's 112, it goes 114, 115.

[00:13:56] Speaker 01:
Yeah, this reflects that this motion, the motions are not, the motions in this court, Your Honor, are made by email.

[00:14:02] Speaker 04:
I'm just trying to see word as you are actually saying to the judge, hey, they've got something that's covered by a discovery order, and they haven't given it to us.

[00:14:09] Speaker 01:
But, I mean, I can actually do one better for that, because in one of these pre-trial hearings, and we have the transcript of that, which is in Appendix 128, and it's on pages 26 to line 15.

[00:14:26] Speaker 01:
128 of the appendix.

[00:14:28] Speaker 01:
It's appendix 128.

[00:14:30] Speaker 01:
That's during a hearing.

[00:14:32] Speaker 01:
And that, the trial court was actually troubled about this issue.

[00:14:36] Speaker 04:
Well, she said it had been better for process if they provided both samples, but they didn't.

[00:14:40] Speaker 04:
My question is sort of at what point did you ask for them?

[00:14:43] Speaker 04:
Did you point out that you wanted them to be given over?

[00:14:48] Speaker 01:
Okay.

[00:14:48] Speaker 01:
We had asked early in discovery, and in fact, back in December,

[00:14:53] Speaker 01:
We had a court order specifically saying that they were to produce to us the representative commercial batches sent to the FDA.

[00:15:05] Speaker 01:
And that's an appendix page 82 paragraph.

[00:15:09] Speaker 04:
I don't know if they didn't send in the day four stuff to the FDA.

[00:15:12] Speaker 01:
They send data.

[00:15:14] Speaker 01:
No samples actually get sent to the FDA.

[00:15:16] Speaker 01:
But they send data from the day four samples to the FDA.

[00:15:21] Speaker 01:
They actually, and we have an admission on that, and that is actually.

[00:15:36] Speaker 01:
If you look in the appendix.

[00:15:46] Speaker 01:
On page 116.

[00:15:54] Speaker 01:
It's on paragraph 28 at the very bottom of the page.

[00:15:57] Speaker 01:
And this is a stipulation they submitted to the courts of constitutional judicial admission.

[00:16:03] Speaker 01:
On January 15, 2016, additional samples were drawn from the 200 liter mixing tank referenced in the exhibit batch protocol for FDA testing by Amil.

[00:16:16] Speaker 04:
Now, they were drawn.

[00:16:18] Speaker 04:
I'm sorry?

[00:16:20] Speaker 04:
Additional samples were drawn.

[00:16:22] Speaker 04:
And is that the day 14 stuff?

[00:16:24] Speaker 04:
Day four.

[00:16:25] Speaker 01:
Yeah, that's the day four samples.

[00:16:27] Speaker 01:
OK.

[00:16:27] Speaker 01:
That's exactly.

[00:16:28] Speaker 01:
So they used it for FDA testing.

[00:16:31] Speaker 01:
That's with respect to those day four samples.

[00:16:34] Speaker 01:
And actually, I can take you to their amended ANDA.

[00:16:36] Speaker 01:
And that's an appendix.

[00:16:38] Speaker 04:
This is a statement of facts regarding it and just saying that they drew the sample, right?

[00:16:42] Speaker 01:
For testing for FDA, though.

[00:16:43] Speaker 01:
To test it for the FDA.

[00:16:45] Speaker 01:
And then if you go to the appendix,

[00:16:47] Speaker 01:
on page 2197 in the joint appendix.

[00:16:53] Speaker 01:
That's part of their, a page 2197.

[00:17:04] Speaker 02:
All of which is under confidentiality.

[00:17:07] Speaker 01:
Yes.

[00:17:08] Speaker 01:
So I'm not going to read anything.

[00:17:09] Speaker 01:
What does that show?

[00:17:11] Speaker 02:
What do you want us to look at?

[00:17:12] Speaker 01:
So if you look, there is a table that starts on the,

[00:17:16] Speaker 01:
bottom part of the page and carries over.

[00:17:19] Speaker 01:
And you will see that it refers to the batch 16001.

[00:17:24] Speaker 01:
And on the very right-hand column, you will see all that is data from the testing they're referred to on that paragraph 1028 of their stipulation, and that was submitted to FDA.

[00:17:40] Speaker 00:
You had referred earlier to a court order in December requiring Amriel to give all commercial batches, I guess, that had been submitted to the FDA, and then you were going to give a site.

[00:17:54] Speaker 00:
What was that site?

[00:17:55] Speaker 01:
Yes.

[00:17:57] Speaker 01:
That's in DI95 in the case, and it's reflected in appendix page 82, paragraph 1B again.

[00:18:05] Speaker 04:
So at what point did you understand that data had been submitted to the FDA?

[00:18:11] Speaker 01:
once that data had been submitted to the FDA, when we received their rebuttal reports, and we saw they were trying to use... From their expert report?

[00:18:23] Speaker 01:
From their expert report.

[00:18:24] Speaker 04:
They ended up withdrawing that expert report, but that's how we knew they had actually... You saw that data, and you knew it had been submitted to the FDA back in that earlier period of time, April 25.

[00:18:41] Speaker 01:
That would have been the time period where we were starting to figure that out.

[00:18:48] Speaker 04:
And yet when the judge tells you what I want to see is what's been submitted to FDA, you didn't point out to her that that had been submitted to FDA.

[00:18:57] Speaker 04:
Well, at the time... She said that and didn't say it directly.

[00:19:01] Speaker 01:
See, at the time, we had no reason to think that what they'd given to us, because they were under order and they hadn't told the court... And then you hadn't been given something that had been given to the FDA.

[00:19:11] Speaker 01:
Actually, we didn't at the time, because what they gave us, they gave us what they told us was their product in those bottles.

[00:19:17] Speaker 04:
They didn't tell us we drew... As of April, right, you knew that they had material on day four that they had given to the FDA.

[00:19:29] Speaker 01:
As of April, we had reason to look on and we went immediately to the court with an emergency motion telling the court, look, they have material here.

[00:19:43] Speaker 01:
that is more advanced and they gave us... I'm sorry, we're trying to get at it.

[00:19:47] Speaker 04:
The judge realizes that there's a moving target here.

[00:19:53] Speaker 04:
But the judge says to you at a hearing on May 26th, what I want to make sure is I'm spending my time destroying it, which is relevant, that the data presented to me is the same data presented to the FDA.

[00:20:06] Speaker 04:
That's all I'm asking.

[00:20:08] Speaker 04:
That's what she says, but you do not say to her later, a couple of weeks later at a hearing, before the trial, well, they've got something they gave the FDA that they're not giving us.

[00:20:18] Speaker 01:
No, we have told her that a number of times.

[00:20:21] Speaker 01:
We actually had three hearings where we specifically said they have materials where they have given, where they have given, in a minute I can actually... I don't mean to push you, but I'm just trying to get inside of Judge Robinson's mind if I can.

[00:20:38] Speaker 04:
She's asking for all the data that's gone to the FDA.

[00:20:43] Speaker 01:
She's asking for all the data to make sure that we have everything that reflects data that's gone to the FDA.

[00:20:50] Speaker 01:
But I think the patent aspect of this, and I think the district court had some confusion here, is that if you look at the case law, what's at issue here is that we're supposed to test the final product.

[00:21:07] Speaker 02:
I doubt that that's what the case law says.

[00:21:09] Speaker 02:
I think what the case law says is that you have to have evidence that shows what's in the final product.

[00:21:16] Speaker 02:
It doesn't say it has to be direct evidence.

[00:21:19] Speaker 02:
I gather that at the core of what Judge Robinson did was to say, it's late in the day.

[00:21:25] Speaker 02:
If they have to give you something they didn't give you that may well be closer to the final product, there's going to be a cost.

[00:21:32] Speaker 02:
There's going to be a cost of delay because it's going to have to be testing.

[00:21:36] Speaker 02:
You have to justify that cost.

[00:21:38] Speaker 02:
I'm going to let you try to justify that cost at trial by showing me that there is good enough reason to think that testing the day one, which you have had for a while, is not really reliably indicative of what you would discover if you could test day four and the A. And then she concludes, you didn't show me that, and therefore I can draw a conclusion about

[00:22:08] Speaker 02:
the final product from the evidence we have, which is the day one.

[00:22:13] Speaker 02:
Now, why is there an abuse in all of that?

[00:22:17] Speaker 01:
I will respectfully disagree.

[00:22:20] Speaker 01:
I will tell you exactly why.

[00:22:23] Speaker 01:
It's because I actually do believe the case law specifically directs us that in an ENDA case, we're supposed to look at the finished product, and that's the fairing case, the fairing the watch in case.

[00:22:36] Speaker 01:
There what we have is we have the patent sheet.

[00:22:39] Speaker 02:
You're supposed to determine what the final product would be and whether it would fit under the patent.

[00:22:46] Speaker 02:
That doesn't necessarily mean that you have to determine it by having the final product in hand and examining it.

[00:22:53] Speaker 02:
There can be indirect evidence if it's good enough.

[00:22:56] Speaker 01:
There can be, but the indirect evidence cannot be an incomplete product.

[00:23:00] Speaker 01:
And we do have a factual finding from the court here

[00:23:04] Speaker 01:
that she heard the expert testimony and she did specifically hold, and it's a factual finding that has not been disputed on appeal, that additional and faster mixing does indeed cause or tends to promote the conversion of the non-infringing form of this active ingredient to the infringing form of the active ingredient.

[00:23:29] Speaker 01:
So I do think when we have, on one hand, a finding that says,

[00:23:34] Speaker 01:
that, you know, she finds that additional mixing, she believes the expert that says additional mixing does tend to promote the conversion to the infringing form.

[00:23:44] Speaker 01:
What we have here is an intermediate that we know was mixed, and that's by their own admission and by, by the process record, the process records that are in evidence.

[00:23:54] Speaker 01:
And we know that's been substantial mixing after that point.

[00:23:58] Speaker 01:
I don't understand how you can say

[00:24:01] Speaker 01:
to a patentee, well, too bad if you didn't have good enough evidence because we gave you something that was further processed in a way that the fact finding by the district court says that particular further processing may have caused the conversion.

[00:24:17] Speaker 01:
I mean, frankly, I don't see how we can prove

[00:24:20] Speaker 01:
that this wouldn't matter, how anybody could know it wouldn't matter when we do know that the additional mixing could cause it and what we have is an incomplete product.

[00:24:33] Speaker 01:
And this is, I believe, particularly problematic when we know that the finished product was sitting in their warehouse.

[00:24:42] Speaker 01:
And here's an additional problem, and this is why I believe the district court in the end was confused.

[00:24:49] Speaker 01:
The district court not only considered... Well, I mean, they finished it.

[00:24:53] Speaker 04:
You have to put all the facts in, the finished product sitting in the warehouse, and they were saying, we're never going to market that stuff.

[00:25:00] Speaker 04:
We're not going to have things sit for four days before we put in the bottle.

[00:25:04] Speaker 04:
Well... We're trying to look at something representative of the product that's going to go into the public domain, right?

[00:25:09] Speaker 01:
They say in their brief on page 10 that this is not what they're going to do.

[00:25:13] Speaker 01:
However, that's incorrect.

[00:25:16] Speaker 01:
Because their actual process, and remember, in an end of case, what we have to look at... Would that matter under Sinovian?

[00:25:23] Speaker 01:
Absolutely would matter under Sinovian.

[00:25:25] Speaker 01:
Absolutely.

[00:25:26] Speaker 02:
No, no, no.

[00:25:26] Speaker 02:
I mean, if they say, sorry, we're allowed to do this by the application, but we're not going to, I thought Sinovian says, we don't really care whether... Absolutely.

[00:25:34] Speaker 01:
It's what you can do.

[00:25:36] Speaker 01:
It's what you can do.

[00:25:37] Speaker 01:
They can say all they want, they're not going to do it.

[00:25:39] Speaker 01:
And Your Honors, I would direct you to the appendix on page 3410.

[00:25:43] Speaker 01:
And there you can actually see what's their master production record in their amended ANDA.

[00:25:50] Speaker 01:
And it specifically says maximum bulk suspension whole time is not more than four days.

[00:25:57] Speaker 01:
So even though they say in their briefing, which is just attorney argument, oh, we're not going to hold it.

[00:26:01] Speaker 01:
That's not really our process to hold it for four days.

[00:26:04] Speaker 01:
Their ANDA says they can hold it for four days.

[00:26:06] Speaker 01:
That's why this particular batch was so relevant.

[00:26:09] Speaker 01:
It's an under-synonym.

[00:26:10] Speaker 00:
The other batch is relevant, too, though, right?

[00:26:13] Speaker 00:
Isn't the day one batch relevant as well since it also falls within the specification in the sense that it says you can hold it up to four days.

[00:26:25] Speaker 00:
But the day one is relevant because that's up to four days as well.

[00:26:29] Speaker 01:
So let's say they made one relevant day three.

[00:26:32] Speaker 01:
Let's say they made one batch and they only held it one day and then they bottled it, right?

[00:26:38] Speaker 01:
That would be irrelevant, but at the same time, during an ANDA case, during a Hatch-Waxman case, if they had made other batches that they held for four days, because that's something they're allowed to do under their ANDA, and you're exactly correct, Your Honor, under synovian, if anything they can do under their ANDA infringes, then we have a Hatch-Waxman infringing act.

[00:26:59] Speaker 00:
You know?

[00:27:00] Speaker 00:
I'm a little confused by your brief.

[00:27:01] Speaker 00:
I understand what you're saying here today, but I'm a little confused by your brief because your brief

[00:27:05] Speaker 00:
reads as if it's framed as if you're saying the day one data was some sort of intermediate product.

[00:27:11] Speaker 00:
It's not the final product.

[00:27:12] Speaker 00:
It's not the product according to the end of spec.

[00:27:15] Speaker 00:
I need to have the day four sample.

[00:27:18] Speaker 00:
But I don't know that I appreciate that.

[00:27:23] Speaker 00:
I don't see you arguing that there's an abuse of discretion by the district court judge

[00:27:28] Speaker 00:
and not allowing you to have the discovery.

[00:27:31] Speaker 01:
There is, well, I think there is something that led to a legal error, because what we have, we have an infringement case where what we examine is not the actual product, but an intermediate.

[00:27:40] Speaker 01:
Now, the reason that they won in the way they gave it to us is not even a product.

[00:27:45] Speaker 01:
Because let's assume they had actually held it until day one, but then gone through their bottling protocol to end up putting it in the bottle, which includes more mixing.

[00:27:54] Speaker 01:
That would have been a final product under a different version, right?

[00:27:57] Speaker 01:
Because they would have done the hold only for one day instead of doing the hold for four days.

[00:28:03] Speaker 01:
But what they did here, what they took out of on January 11, 2016, what they took out, they didn't finish bottling that.

[00:28:12] Speaker 01:
They just went into the vat and pulled out an incomplete product that was never bottled.

[00:28:19] Speaker 01:
you know, an incomplete, in-process product.

[00:28:22] Speaker 01:
He had never followed the final steps.

[00:28:24] Speaker 01:
And in this case, where the processing matters as to whether we have an infringing product or not, and we know it matters because we have a fact-finding from the district court that says additional mixing does matter.

[00:28:38] Speaker 01:
And again, I think that's very important because they never contested this fact-finding.

[00:28:45] Speaker 00:
What you actually said is the court concludes that generally additional or faster mixing tends to promote conversion of MFA to MFM.

[00:28:53] Speaker 00:
Did she say that in the context, though, of the product?

[00:28:56] Speaker 00:
Or did she just say generally in the context of anything, you know, additional mixing?

[00:29:02] Speaker 00:
Because her opinion in multiple places says you've shown something, you've shown me that something could happen in the conversion from MFA to MFM, but maybe not in the context of the product at issue.

[00:29:15] Speaker 01:
Let's take it as a general, well, the testimony all on that was in respect to what happens in the process on the product of the issue.

[00:29:23] Speaker 01:
The question is, we can't prove it, we can't prove that it happened in this case unless we have their final product.

[00:29:33] Speaker 02:
What you just said, I guess, as I was coming into this argument struck me as the

[00:29:39] Speaker 02:
core of the issue.

[00:29:42] Speaker 02:
Could you actually have proved it?

[00:29:44] Speaker 02:
I understand you would have one argument if what you said is science recognizes that there is no close reliable substitute for examining the end product.

[00:29:56] Speaker 02:
it's not clear to me whether that's this situation.

[00:30:00] Speaker 02:
To say that in general there is a tendency of mixing to promote conversion does not necessarily imply that the amount of mixing that they did between one and four and then the additional mixing from four to the bottle, that that would likely have any changing effect.

[00:30:23] Speaker 02:
And the question is,

[00:30:25] Speaker 02:
You were given an opportunity to prove that.

[00:30:28] Speaker 02:
Why wasn't Judge Robinson within her fact-finding discretion entitled to say, you could have proved it,

[00:30:39] Speaker 02:
but you didn't prove it, and therefore, I will infer about day four and A from what we know about one.

[00:30:49] Speaker 01:
Because it's inappropriate to render conclusions about the final product by looking at the intermediate.

[00:30:56] Speaker 01:
And I'll explain why.

[00:30:58] Speaker 01:
If we look at the Faring v. Watson case, right?

[00:31:01] Speaker 01:
In that case, the roles were a little bit reversed, because what happened there is the branded company, the patentee, took an intermediate

[00:31:09] Speaker 01:
of the generic company, and they tried to say, these granules that were uncoded, because the dissolution profile meets a certain spec, it infringes our patent.

[00:31:23] Speaker 01:
And what this court said in that instance was, wait a minute, you can't prove infringement by looking at an intermediate.

[00:31:32] Speaker 01:
There's no need to go to tie whether

[00:31:36] Speaker 01:
there is a link between that intermediate and the final product, especially in a situation where you have a final product, you test the final product to prove infringement.

[00:31:46] Speaker 01:
To put the patentee in a position where we have to, with absolute specificity, prove that the additional mixing in this particular instance would have caused conversion is, I frankly believe, almost an impossibility because it's putting us in a position of having to say,

[00:32:04] Speaker 01:
what would happen in this industrial process that we cannot replicate.

[00:32:09] Speaker 01:
We do believe, actually, that the fact that Judge Robinson found that additional mixing with this ingredient does tend to promote conversion actually shows us that what happens here is the processing level and degree matters.

[00:32:25] Speaker 01:
We have a finding that says, in essence, processing matters here.

[00:32:29] Speaker 01:
And what we do know for a fact, without anybody

[00:32:32] Speaker 01:
arguing against it, is that what we had to test versus the finished product, which under Glaxo, under Abbott, under all the caseloads, what is supposed to be looked at is what is the final product under all patent law.

[00:32:47] Speaker 01:
What we have is a final product that we know has undergone further processing, including further mixing from what they gave us.

[00:32:54] Speaker 04:
Is there any final product here at all?

[00:32:56] Speaker 04:
Aren't they all intermediate?

[00:32:58] Speaker 04:
I'm sorry.

[00:32:59] Speaker 04:
Was there any final product here in suit, or they're all intermediates?

[00:33:05] Speaker 01:
So, the so-called exhibit batches we talked about, those were actually finished through and packaged, but at the same time, what we have for those is we have the fact, and we have a finding again from the district court, that those were not mixed according to the ANDA process.

[00:33:24] Speaker 01:
And she says she actually specifically found those were mixed at one-half to one-third the minimum allowable speed.

[00:33:32] Speaker 01:
So those were not mixed according to the ANDA process.

[00:33:35] Speaker 04:
So what we're saying is if one and a half... So the exhibit batch was out, the commercial batch was out, right?

[00:33:42] Speaker 04:
And from your perspective, all of the day one to through day four intermediates.

[00:33:47] Speaker 01:
Well, the day four is an intermediate too.

[00:33:49] Speaker 01:
It's a better intermediate, right?

[00:33:52] Speaker 01:
It has received more mixing, so it's closer to the final product.

[00:33:56] Speaker 04:
It certainly is something... What I hear you be saying is there is nothing, this case doesn't present any product that could be legally said to be representative of what was going to be marketed.

[00:34:08] Speaker 04:
in what was actually tested, that is correct, especially with knowledge that... You're saying for purposes of infringement, you're entitled to test something that is representative of what's going to market.

[00:34:21] Speaker 01:
Exactly, Your Honor.

[00:34:22] Speaker 04:
You have an entitlement to that.

[00:34:24] Speaker 04:
You're saying in this case, there's a total absence of that evidence, like this case could not have gone to trial legally.

[00:34:30] Speaker 01:
Well, that's what we tried to avoid.

[00:34:32] Speaker 04:
We do believe that... I didn't see any motion to that effect.

[00:34:35] Speaker 04:
I didn't...

[00:34:36] Speaker 04:
And Judge Robinson's musings and her agony of what was going on, I didn't see her being presented with it, saying, you can't go to trial, ma'am, because you do not have.

[00:34:46] Speaker 04:
You have not given us the opportunity to test a representative sample.

[00:34:51] Speaker 01:
There were probably about three hearings.

[00:34:54] Speaker 01:
I'll be happy to provide you with sites.

[00:34:56] Speaker 01:
I mean, I don't have them right now.

[00:34:57] Speaker 01:
There were three hearings where that was the topic.

[00:35:01] Speaker 01:
trying to tell her, look, we need to get this finished product to test it.

[00:35:06] Speaker 01:
And if you look, in fact, where she said, it's a fact of life that people don't always make the best decisions.

[00:35:11] Speaker 01:
It would have been better for the process if Amil had provided both samples, but they didn't.

[00:35:17] Speaker 01:
She closes that paragraph by saying, but I won't push the trial.

[00:35:20] Speaker 01:
Because she was focused, and sometimes it's perhaps... Is day four an intermediate?

[00:35:25] Speaker 01:
Day four is actually still an intermediate, but it's closer.

[00:35:30] Speaker 01:
I know, but from your perspective, that's no good either.

[00:35:34] Speaker 04:
You're asking for something that's no good as a matter of law.

[00:35:39] Speaker 01:
We believe that 1601A is actually the closest thing to the product and what should be tested.

[00:35:46] Speaker 01:
In the absence of that,

[00:35:48] Speaker 01:
And because her order had said they were under an order to give us everything they used for the FDA, and we did know that 1601 day four samples had been used for the FDA but they didn't give us, those were actually a better substitute than something that goes several steps before the final product.

[00:36:07] Speaker 01:
I think we need to switch over to the other side now.

[00:36:10] Speaker 02:
We've got 20 minutes over, and you should please add that to Mr. Meloro's time if you need it.

[00:36:21] Speaker 02:
I think quite a lot of the extra time was taken up by at least what I consider precisely laying the table, so maybe you won't need the whole thing.

[00:36:30] Speaker 02:
But we might ask you a few questions.

[00:36:33] Speaker 03:
Thank you, Your Honor.

[00:36:34] Speaker 03:
It may please the Court.

[00:36:36] Speaker 03:
Thomas Smiloro for AMNEO.

[00:36:38] Speaker 03:
The judgment of non-infringement should be affirmed because Judge Robinson, the district court, clearly found that there was no conversion, no proof of conversion from MFA to MFM.

[00:36:51] Speaker 03:
There was no clear error in the fact findings.

[00:36:55] Speaker 03:
The testing of the 16001 samples by Dr. Matzger was proven not to show conversion.

[00:37:04] Speaker 02:
I'm sorry, the samples, he tested, is it he?

[00:37:10] Speaker 02:
He tested just the day one samples.

[00:37:12] Speaker 03:
The day one samples.

[00:37:12] Speaker 02:
Right, so he didn't have the day four sample or the A sample.

[00:37:16] Speaker 03:
That's correct, Your Honor.

[00:37:17] Speaker 02:
So am I misunderstanding what at least, how I think of the core dispute here is the question is, does it matter that they did not have the opportunity to test

[00:37:32] Speaker 02:
two samples that were closer to the final, one of the final products that is permitted under the ANDA, namely a wait to day four product.

[00:37:45] Speaker 02:
And whether it matters that they didn't or whether Judge Robinson could find

[00:37:52] Speaker 02:
they had an opportunity to show that it mattered, namely the difference between the day one sample and the two later samples.

[00:38:00] Speaker 02:
They could have shown it, they didn't show it, and therefore it doesn't matter that they didn't have the second and third.

[00:38:07] Speaker 03:
It doesn't matter that they didn't have the second and third, the day four samples, and the 001A samples.

[00:38:14] Speaker 02:
Now why is that

[00:38:17] Speaker 02:
given that there is actually a finding that additional mixing, tell me if I've got the language wrong, because I think the language matters quite a lot here, tends to cause more, to enhance conversion.

[00:38:33] Speaker 03:
The language I believe you're referring to is at A14 and... It's actually at A13.

[00:38:41] Speaker 03:
Sorry, A13 and the court

[00:38:46] Speaker 03:
says the court concludes that generally, generally, additional or faster mixing tends to promote conversion of MFA to MFM.

[00:38:56] Speaker 03:
The court did provide Merck with opportunity at trial to attempt to show that the 001A samples, that there would have been

[00:39:10] Speaker 03:
some more conversion, some conversion from MFA to MFM.

[00:39:14] Speaker 03:
She, Judge Robinson, specifically said that she would permit Merck to even have additional trial time.

[00:39:20] Speaker 02:
As the Court knows, trials are done where... So how would they have been able to do that in a scientifically reliable way without having the four

[00:39:35] Speaker 02:
the day four or the bottled four samples to test, to compare them to the day one.

[00:39:41] Speaker 03:
Well, in the end, and remembering it's Merck's burden, they didn't even try and they're expert.

[00:39:48] Speaker 02:
I'm sorry, I just, you tell me if I'm just misfocusing.

[00:39:53] Speaker 02:
It seems to me if she said, I will give you the opportunity to prove something that scientifically you cannot prove,

[00:40:00] Speaker 02:
that's not much of an opportunity.

[00:40:02] Speaker 02:
So tell me why science would have allowed them to prove that the mixing of the sort that was going on as you moved from day one to day four, and as you moved from day four to the A samples, why that could really have mattered.

[00:40:26] Speaker 02:
How would they have done that?

[00:40:28] Speaker 03:
They could have done

[00:40:30] Speaker 03:
testing with material that they had.

[00:40:33] Speaker 03:
They could have done testing within samples that they had or samples that they might have made.

[00:40:41] Speaker 03:
What kind of testing?

[00:40:43] Speaker 03:
The record doesn't reflect the kind of testing that Merck may have done.

[00:40:49] Speaker 00:
What the record reflects is... Are you aware of anything that they could have done?

[00:40:53] Speaker 03:
The testing that they could have done would have been to take some of the samples that they had, for example, and subjected them to more mixing.

[00:41:01] Speaker 03:
Some testing that they could have done was actually observational type testing.

[00:41:05] Speaker 04:
It would have been day four mixing, because it's the day four mixing sample that we're talking about as having been an error in its exclusion, not something else.

[00:41:17] Speaker 04:
So to answer the presiding judge's question, what could they have done to what they have there other than to, because they didn't have day four detached.

[00:41:29] Speaker 03:
They had day one samples on day four.

[00:41:32] Speaker 03:
So in essence, they had day four samples.

[00:41:35] Speaker 03:
Day four mixing.

[00:41:36] Speaker 02:
And how much did they know about the rate and duration of the mixing that you all did between day one and day four?

[00:41:49] Speaker 03:
I believe they had the full details of all that by

[00:41:52] Speaker 03:
I'll take council's representation March 10th.

[00:41:54] Speaker 02:
And this, that was mixing in 100 kilogram volumes?

[00:42:02] Speaker 03:
Correct, your honor.

[00:42:03] Speaker 02:
Could they, I assume that they did not have 100 kilograms of your day one product?

[00:42:09] Speaker 03:
They did not have, I don't know the max.

[00:42:12] Speaker 02:
could they with some, I'm going to assume, much smaller amount have replicated the duration and speed and I don't know whether it was intermittent or replicated the mixing that you did in the 100 gram volumes

[00:42:33] Speaker 02:
Could they have replicated that in the smaller volumes that they had in a way that would allow the conclusion to be drawn as to what was actually happening in your larger volume?

[00:42:45] Speaker 03:
They could have and should have tried.

[00:42:47] Speaker 03:
They didn't do anything.

[00:42:49] Speaker 00:
I will submit that... Could they have done that even given that trial was six weeks later and expert reports had already been prepared?

[00:42:58] Speaker 00:
Does that change your view on whether they could have done it?

[00:43:01] Speaker 03:
The timing was more than sufficient to permit it.

[00:43:05] Speaker 03:
The testing could have happened as soon as June, January 12th when the samples were provided.

[00:43:13] Speaker 03:
They could have taken some portion of those samples, tested them as is.

[00:43:17] Speaker 03:
They could have tested

[00:43:18] Speaker 03:
further by mixing other aspects.

[00:43:22] Speaker 04:
What reason would they have had to do that?

[00:43:24] Speaker 04:
Did they know about the day four at that point in time?

[00:43:27] Speaker 03:
They knew about it by the beginning of March, Your Honor, or they had the information in their hands by the beginning of March.

[00:43:32] Speaker 04:
So the January date, you just mentioned, is irrelevant.

[00:43:35] Speaker 03:
Well, they could have done further testing.

[00:43:37] Speaker 04:
They wouldn't have had any reason to do that, to look for it, because they didn't know you did the day four.

[00:43:42] Speaker 03:
Well, they knew what they had was not packaged because of the nature in which they got it.

[00:43:46] Speaker 03:
It was in a screw-top bottle.

[00:43:48] Speaker 03:
and they had the manufacturing specifications from the ANDA, so they knew that packaging would provide some additional mixing in the course of packaging.

[00:43:58] Speaker 03:
So they had in their hands the information from which they would have known that the bulk day one material they had would be subject to some further mixing if bottled.

[00:44:08] Speaker 02:
I don't know if this matters, but as I understand it,

[00:44:12] Speaker 02:
between day one and the spray bottles, there are two mixings.

[00:44:19] Speaker 02:
There's the one from day one to day four, and then there's the one from day four to bottling.

[00:44:24] Speaker 02:
Is it right or wrong that that second mixing is much, much, much, much smaller than the first mixing from one to four?

[00:44:33] Speaker 03:
There can be two mixings if you go to day four before bottling, so that you don't have to be two mixings.

[00:44:40] Speaker 03:
if there are two mixings.

[00:44:42] Speaker 02:
Right, but just in terms of when they got the sealed little bottles of day one, they knew that's not how it was gonna go onto the CVS shelf.

[00:44:52] Speaker 02:
So they may have known that when

[00:44:55] Speaker 02:
when they're put into the spray bottles, there's a bit of additional mixing, but may have thought that's really, that's not gonna be a lot.

[00:45:05] Speaker 02:
But they didn't know about what might have been a much more meaningful amount of mixing in the day one, day four process.

[00:45:13] Speaker 02:
When did they first learn, as far as the record tells us, about the amount of mixing that took place between day one and day four?

[00:45:23] Speaker 03:
they would have had that information by March the 10th.

[00:45:27] Speaker 02:
That's all part of that February document.

[00:45:30] Speaker 03:
As a matter of fact, the additional, as the court put it, little mixing in the bottling.

[00:45:35] Speaker 03:
I'm just wondering if that's... That additional mixing in the bottling is what counsel says is the entirety of the problem here.

[00:45:43] Speaker 03:
Because remember, everything else that Merck argues comes before the bottling is not the finished product.

[00:45:50] Speaker 03:
And so it is only that last bit of mixing that Merck says makes all the difference in the world because they didn't get those samples.

[00:45:57] Speaker 02:
Right, but as I think you heard me say, I'm not at this point at least persuaded that our case law says you must have and look at and actually have eyes on the finished product in order to make a determination about the finished product.

[00:46:15] Speaker 02:
So on the assumption that the

[00:46:18] Speaker 02:
The required determination is one about the finished product.

[00:46:21] Speaker 02:
The question is, how close to that did they have something that would enable them to draw a reliable conclusion?

[00:46:30] Speaker 02:
Not them to draw it, but the district court to draw a reliable conclusion about it.

[00:46:35] Speaker 02:
And that includes, so they are, what they had was two steps away from the spray bottle version, not just one.

[00:46:45] Speaker 03:
It was one step away from what you could have to the finished product under the ANDA, but it was two steps away in this particular instance.

[00:46:53] Speaker 03:
You could have one step from day one to bottling, or you could have two steps, day one, then day four, then bottling.

[00:47:01] Speaker 03:
So in this instance,

[00:47:03] Speaker 03:
What they had was two steps.

[00:47:06] Speaker 03:
And what they had, they tested, and there was no conversion from MFA to MFM in that product.

[00:47:13] Speaker 03:
And they took no additional steps, despite knowing from the district court that they would be given opportunities to make proof.

[00:47:22] Speaker 03:
They offered nothing.

[00:47:24] Speaker 03:
They made no effort.

[00:47:25] Speaker 03:
They made no attempt at all to see if any further processing of the material they had would make any difference whatsoever.

[00:47:33] Speaker 03:
And in fact, their expert said that his testimony was theoretical.

[00:47:38] Speaker 03:
This was Dr. Trout.

[00:47:40] Speaker 03:
And that you would need to do testing, and they did no testing whatsoever.

[00:47:46] Speaker 00:
But he meant he would need to do testing on the day four data and the batch A data, right?

[00:47:51] Speaker 00:
Isn't that what he meant?

[00:47:55] Speaker 03:
No, I think Dr. Trout gave more fundamental testimony.

[00:47:59] Speaker 00:
You said that he said that he would have to do testing.

[00:48:02] Speaker 00:
What kind of testing was he referring to?

[00:48:05] Speaker 03:
He said that you would need to do testing on specific systems and that he didn't attempt any tests on amniol system and that he had not considered the Chen reference and that sometimes agitation actually decreases nucleation, doesn't increase it.

[00:48:23] Speaker 03:
It was also interesting here that

[00:48:25] Speaker 03:
Dr. Rogers looked at the data from Dr. Marquardt, who was Merck's expert, who testified about the 16001.

[00:48:34] Speaker 02:
Dr. Rogers was your guy?

[00:48:36] Speaker 03:
Yes.

[00:48:36] Speaker 03:
And Dr. Rogers looked at the data and showed that if you looked at the samples that Dr. Marquardt tested over time, there was absolutely no growth in what Dr. Marquardt thought and testified was the converted MFM.

[00:48:55] Speaker 03:
So if there was conversion going on here, over time, the experts said it would be increasing and you would see more conversion over time.

[00:49:08] Speaker 03:
And there was, I believe, a seven-week gap or passage of time from the beginning of Dr. Marquardt's testing to the end of Dr. Marquardt's testing.

[00:49:18] Speaker 03:
And Dr. Rogers said there was nothing indicating at all that there was any

[00:49:25] Speaker 03:
growth, there was any increased nucleation, there was any conversion going on here.

[00:49:30] Speaker 03:
So the real world, if this material was already converting on day one because the product converts, then over the course of seven weeks, one would have expected to see more.

[00:49:48] Speaker 03:
And in fact, there was nothing that Dr. Rogers saw, and that was unrebutted at trial.

[00:49:53] Speaker 03:
Dr. Marquardt didn't come back and say, no, I looked after seven weeks.

[00:49:58] Speaker 03:
And in fact, it was growing.

[00:50:00] Speaker 03:
The reality of the situation is there is no conversion.

[00:50:04] Speaker 03:
The samples were provided from the day one.

[00:50:07] Speaker 03:
Those samples were tested.

[00:50:09] Speaker 03:
There was no effort by Merck to do anything more with them.

[00:50:12] Speaker 03:
But data was generated over an extended period of time.

[00:50:16] Speaker 03:
And that testimony from Dr. Rogers is at A298.

[00:50:22] Speaker 00:
Given K-Cord's order in December that AMNAIL was to give all commercial batches that had been provided on which data had been provided to the FDA that it was supposed to produce them, why weren't the day four batches produced?

[00:50:39] Speaker 03:
Because the day four batches were the same material as the day one batches.

[00:50:44] Speaker 03:
There was just a homogenization of the material on day four so that they could be retested.

[00:50:50] Speaker 04:
The purpose of this test... They've gotten four days older, right?

[00:50:55] Speaker 03:
That's correct.

[00:50:55] Speaker 03:
They got four days older.

[00:50:56] Speaker 04:
Isn't that the evidence that the process of the chemical of the change occurs over time?

[00:51:03] Speaker 03:
If there is conversion, over time the conversion should decrease.

[00:51:07] Speaker 04:
It escalates over time.

[00:51:09] Speaker 03:
It should, according to Dr. Rogers, if you're having it.

[00:51:12] Speaker 04:
Right.

[00:51:12] Speaker 04:
So if you tested the A1, the day one samples today,

[00:51:18] Speaker 04:
Would the scientists accept, would they expect the test results to be exactly what they were when they were tested two, three years ago?

[00:51:28] Speaker 03:
There are shelf life that I think is two years.

[00:51:31] Speaker 04:
Don't just forget about the shelf life.

[00:51:32] Speaker 04:
Say, for example, if I test them at the end of the shelf life, would the test be the same as you test them on the day you bought it?

[00:51:38] Speaker 03:
Within the specifications of the product, it should be the same if the shelf life is meaningful at two years.

[00:51:44] Speaker 04:
And there wouldn't have been any further conversion?

[00:51:47] Speaker 03:
Well, if you have conversion of MFA to MFM, you would expect that conversion to continue and grow over time.

[00:51:54] Speaker 04:
That's what I mean.

[00:51:55] Speaker 04:
So you might find more in the later product.

[00:52:00] Speaker 03:
And Merck had those samples for six months before trial.

[00:52:03] Speaker 04:
So the question here is whether there was a difference between one day and four days.

[00:52:09] Speaker 03:
And the evidence is that Dr. Marquardt, overlooking it over seven weeks, saw no difference.

[00:52:15] Speaker 04:
Right, but I thought the questions that the presiding judge was asking, in essence, was whether or not the three extra four extra days really mattered.

[00:52:24] Speaker 03:
It wouldn't matter here.

[00:52:25] Speaker 04:
Judge Robinson gave them the opportunity to prove why it might have mattered.

[00:52:32] Speaker 03:
She did.

[00:52:32] Speaker 04:
And their answer was, well, as you noticed yourself, Your Honor, over time, conversion escalates.

[00:52:41] Speaker 03:
Over time, conversion escalates if it's there.

[00:52:45] Speaker 04:
It would be expected to escalate.

[00:52:47] Speaker 04:
Four days is time.

[00:52:49] Speaker 03:
Four days is time is four days that Merck has.

[00:52:51] Speaker 04:
Plus the fact there's been some more jiggling.

[00:52:54] Speaker 04:
There's been some additional agitation, and agitation also escalates conversion.

[00:52:59] Speaker 03:
The material, well there is, the evidence is there is no conversion here.

[00:53:04] Speaker 03:
And the four-day passage of time is a four-day passage of time, both in Merck's lab.

[00:53:10] Speaker 04:
The evidence says there's no conversion on the three-peak as to day one.

[00:53:14] Speaker 04:
But the question is, how do we know what... I think the way I heard the question the presiding judge was putting is whether or not the option that Judge Robinson gave to Merck is illusory.

[00:53:27] Speaker 04:
How could they possibly prove

[00:53:31] Speaker 04:
that day four was different from day one, unless they can test day four, when their operative thesis is that over time and agitation, you enhance the conversion.

[00:53:43] Speaker 04:
And the response to that is that Merck had those opportunities both to do their own testing and... Well, then you go back and they say, well, they could have done their own testing on this stuff you gave them earlier, day one, but then you realize they would have had to have done some extrapolation because it wasn't exactly the same as day four stuff.

[00:54:01] Speaker 04:
So they would have had to do some mathematics and create a construct that said what we're doing is equal to what day four would look like if we tested it.

[00:54:12] Speaker 04:
And you would have objected to that up one side and down the other side.

[00:54:15] Speaker 04:
Oh, no, no, no, that's not a good comparison.

[00:54:18] Speaker 03:
What would have happened if Merck actually tried to present evidence is it would have been subject to cross-examination as to how representative it was.

[00:54:25] Speaker 04:
And if they came up with representative testing... But that would be because they were using separate representative as opposed to the real product, which is what they're asking for.

[00:54:34] Speaker 03:
And the opportunity that they were given at trial was to show that there was something meaningful about not having those 16-001A samples.

[00:54:43] Speaker 03:
And so I don't think that the district court would have expected

[00:54:46] Speaker 03:
a perfect replication of 100% to even get them in the ballpark of saying that the 16001A samples mattered here.

[00:54:55] Speaker 03:
What Judge Robinson wanted to see was evidence that was something more than a theoretical argument that this might happen.

[00:55:02] Speaker 02:
You said something before, and maybe, and I don't, I didn't quite get it, about Dr. Marquardt.

[00:55:09] Speaker 02:
Was it looked at something and nothing happened over seven weeks?

[00:55:15] Speaker 02:
What was that?

[00:55:16] Speaker 03:
So this was Dr. Rogers' testimony.

[00:55:17] Speaker 03:
If I said Dr. Marquardt, I misspoke.

[00:55:20] Speaker 03:
No, no, you probably didn't.

[00:55:22] Speaker 03:
So at day 298, Dr. Rogers testified that he looked at the underlying data.

[00:55:28] Speaker 03:
Dr. Marquardt thought that in three of the seven samples that he tested, he saw conversion.

[00:55:36] Speaker 03:
And Dr. Rogers said he looked at additional samples taken over time and that he would have expected

[00:55:45] Speaker 03:
to see growth, which in fact, what Dr. Marquardt was seeing was conversion.

[00:55:50] Speaker 02:
So Rogers was looking at what exactly?

[00:55:53] Speaker 03:
Underlying data from Dr. Marquardt.

[00:55:56] Speaker 03:
Amniel's expert, Dr. Rogers, looked at Merck's expert's underlying data.

[00:56:01] Speaker 02:
Okay, and Dr. Marquardt's data was exactly of what?

[00:56:09] Speaker 02:
About what?

[00:56:10] Speaker 03:
This was the sampling of the 16.001 day one batches.

[00:56:15] Speaker 02:
And so he was looking at day one batches on day 14 and day 33 and day 48 and day 57.

[00:56:24] Speaker 02:
Is that what you're talking about?

[00:56:26] Speaker 03:
It was an analysis that went out.

[00:56:28] Speaker 02:
Single batch, what happened to that batch over time.

[00:56:33] Speaker 02:
I think we need like 15 more minutes because I think you didn't add the 20 minutes to his 15 minutes.

[00:56:41] Speaker 03:
Thanks.

[00:56:41] Speaker 03:
So these were sample preparations happening over time.

[00:56:45] Speaker 03:
So, in that sense... But all day one.

[00:56:48] Speaker 03:
All day one.

[00:56:49] Speaker 02:
Right.

[00:56:49] Speaker 02:
And what's at issue here, as I understand it, is that if there's early additional mixing, the mixing that occurred... I mean, I'm about to ask you about this.

[00:57:00] Speaker 02:
about between day one and day four, that that might have made a change that would change the trajectory into day 43 and 58 and 94 and 122 and 730 to, and we don't know what that difference would have been.

[00:57:22] Speaker 03:
The mixing on day four

[00:57:26] Speaker 03:
is designed to make the sample homogeneous.

[00:57:29] Speaker 02:
Right, you use the term just homogenization before.

[00:57:33] Speaker 02:
Can you describe what the record tells us about what kind of mixing occurs at what rate, what duration, when between day one and day four?

[00:57:43] Speaker 03:
I will find that site for you.

[00:57:45] Speaker 03:
I don't have it.

[00:57:46] Speaker 02:
Well, maybe you can even just describe it without giving the site at the moment.

[00:57:49] Speaker 03:
It is taking the samples from day one

[00:57:53] Speaker 03:
and mixing so that the material is designed to be homogenous so that what you test on day four is representative in case the material, I'll use the term settling, if there's anything that's happened.

[00:58:08] Speaker 02:
Is that a process that's going on for the entire 72 hours between day one and day four or just before you do the sample at hour 72?

[00:58:15] Speaker 03:
It's just before you do the sampling on day four.

[00:58:19] Speaker 02:
And is it, I don't know.

[00:58:20] Speaker 02:
a gentle stirring or something more vigorous?

[00:58:27] Speaker 03:
I don't know that it's a stirring.

[00:58:32] Speaker 02:
That's the opposite of the scientifically precise term, but I guess I'm trying to get a sense of how much mixing there was that even could have changed.

[00:58:46] Speaker 02:
the day one versus day four.

[00:58:50] Speaker 03:
The mixing that was done on day four, let me see if I can find the exact citation for the court so that you can see what the response is.

[00:58:59] Speaker 04:
What's the purpose of the mixing?

[00:59:02] Speaker 03:
On day four, the purpose of the mixing is to ensure that the sample is homogenous for testing.

[00:59:08] Speaker 04:
So it's all the ingredients haven't separated and whatnot.

[00:59:11] Speaker 04:
You're mixing it exactly.

[00:59:13] Speaker 03:
And the data that Dr. Rogers looked at and testified about on 8298, he also mixed.

[00:59:19] Speaker 03:
so that it would be homogenous, or Dr. Marquardt mixed so that it would be homogenous.

[00:59:24] Speaker 02:
I'm not saying that the two mixings were the same, but I am saying that the purpose- And they were at different times, so at least conceivably an early mixing could spark the beginning of something that would then kind of exponentially compound

[00:59:40] Speaker 03:
I don't believe there was any record evidence that that was a possibility.

[00:59:43] Speaker 00:
I was going to ask you, is there any testimony at all to support the idea that early mixing is more significant than early no mixing?

[00:59:49] Speaker 03:
I don't recall any evidence that early mixing in day four for homogenization purposes would be any different than the mixing for homogenization purposes that Dr. Marquardt did with his samples.

[01:00:01] Speaker 00:
But there is some testimony in the record that once you have some conversion occurring,

[01:00:08] Speaker 00:
then the conversion would happen.

[01:00:11] Speaker 03:
It should progress.

[01:00:14] Speaker 00:
It should progress as the equilibrium changes.

[01:00:16] Speaker 03:
I think the experts agreed that if you have conversion, it should progress.

[01:00:21] Speaker 04:
Under your theory, if Merck had succeeded with the invitation given to it by Judge Robinson, they would have come forward with some form of scientific

[01:00:32] Speaker 04:
information based on some further testing of day one sample saying, look here, see, it does convert more.

[01:00:42] Speaker 04:
And so then Judge Robinson would have said, OK, you've met your burden.

[01:00:46] Speaker 04:
I'm not going to have the trial.

[01:00:47] Speaker 04:
I'm going to stop the trial.

[01:00:49] Speaker 04:
Because she's making this proof at the bench trial, right?

[01:00:52] Speaker 04:
Correct.

[01:00:52] Speaker 04:
She would have said, I'm going to stop the bench trial.

[01:00:54] Speaker 04:
We're going to cancel it.

[01:00:55] Speaker 04:
We're going to go back.

[01:00:56] Speaker 04:
And you've got to give them day four.

[01:00:59] Speaker 04:
And then we'll start the trial again.

[01:01:00] Speaker 03:
That presumably is one.

[01:01:02] Speaker 04:
That's what would have happened.

[01:01:03] Speaker 03:
That's one result that could have happened.

[01:01:05] Speaker 03:
And Judge Robinson did not limit the proof that Merck could offer in any way.

[01:01:10] Speaker 03:
Testing the day one samples would have been a very logical thing for Merck to have done, further processing and testing.

[01:01:17] Speaker 03:
They still had the exhibit batches.

[01:01:19] Speaker 03:
They could have done some further testing and analysis with those.

[01:01:23] Speaker 03:
They could have made up their own samples and tried to show how that was providing informative information to the court.

[01:01:29] Speaker 02:
The district court did not in any way... Did they have enough information about... I guess they did.

[01:01:37] Speaker 02:
That's their product, right?

[01:01:38] Speaker 02:
About how to... Well, did they have enough information about how you made day one that in their own labs or production facilities, they could have made a 100-gram batch of your product?

[01:01:49] Speaker 03:
They could have made MFA.

[01:01:51] Speaker 03:
They couldn't have made it using the exact equipment.

[01:01:53] Speaker 03:
And I think the parties' experts agree that the exact equipment can matter, but

[01:02:00] Speaker 03:
That's for an exact, exact replication.

[01:02:02] Speaker 03:
There was absolutely no effort to generate any evidence at all to show Judge Robinson that there was smoke here that should be pursued.

[01:02:11] Speaker 03:
There was zero.

[01:02:14] Speaker 03:
There was zero offer of proof beyond theory.

[01:02:18] Speaker 04:
And between the date upon which Merck was given the invitation and the date the trial started was what?

[01:02:24] Speaker 04:
What's the time period in which they had jumped forward?

[01:02:28] Speaker 03:
The 25th of May, I believe, was the last discovery conference where the court made clear that the trial would go forward.

[01:02:36] Speaker 03:
The information was in Merck's hands from early March.

[01:02:39] Speaker 03:
And the information, according to Merck, they affirmatively knew about the information much before then.

[01:02:48] Speaker 02:
And I think Judge Stoll asked you this question before, but I don't remember the answer.

[01:02:54] Speaker 02:
Why didn't you give them the day four and the A in January 15th?

[01:03:00] Speaker 03:
The day four was essentially the same as the day one.

[01:03:04] Speaker 03:
It was just resuspended for testing purposes for the FDA wanted to see data on day one and day four.

[01:03:11] Speaker 02:
Was there or was there not an outstanding discovery request for anything that, what was the outstanding discovery request?

[01:03:22] Speaker 03:
I believe it was referenced

[01:03:24] Speaker 03:
during the earlier questioning of counsel for Merck, and it's at A82, at 1B, further representative commercial batches sent to the FDA.

[01:03:42] Speaker 03:
And the day one samples satisfied that obligation.

[01:03:49] Speaker 03:
And when Merck argued for the day four samples... That's because you didn't consider the commercial batch?

[01:03:57] Speaker 04:
The day four samples were given to FDA, according to the record.

[01:04:02] Speaker 03:
They were considered by Amual to be the same as the day one samples.

[01:04:07] Speaker 02:
What was given to the FDA?

[01:04:09] Speaker 03:
Records of or batches of?

[01:04:11] Speaker 03:
Records related to testing, I'm sorry, not the batches themselves.

[01:04:14] Speaker 02:
So what this means is not what it actually says.

[01:04:18] Speaker 02:
make available to Merck samples of any further batches sent to the FDA.

[01:04:24] Speaker 02:
I gather you didn't actually send any batches to the FDA.

[01:04:27] Speaker 03:
I'm not aware of the material actually going to the FDA, just data that was tested, data generated from testing the material.

[01:04:36] Speaker 03:
And so the production of the 001 day one samples was deemed by Amniel to satisfy

[01:04:44] Speaker 04:
That your adversary pointed to us when his argument achieved day four data that was given to FDA.

[01:04:55] Speaker 03:
It was, and that data was given to Merck with the production in February and March.

[01:05:06] Speaker 03:
The amnial view, and it was fully aired in the district court, was that the day one and the day four samples, it's the same material.

[01:05:13] Speaker 03:
It is the material that's going to be put in the bottles and sold.

[01:05:18] Speaker 03:
Merck says that there was some further processing.

[01:05:22] Speaker 03:
All that happened on day four was making sure it was uniform.

[01:05:25] Speaker 02:
Another way to say that is you agree that there was some further processing.

[01:05:31] Speaker 02:
You disagree about the potential significance of that,

[01:05:36] Speaker 02:
But there was some, what you call just homogenization and whatever else takes place as you put it into the little spray bottles.

[01:05:46] Speaker 02:
So there is a difference.

[01:05:47] Speaker 02:
The only question is whether it's of any significance.

[01:05:50] Speaker 02:
And now, by the time this kind of ripened into a dispute in front of Judge Robinson, there was this kind of what do we do now question about scientific

[01:06:04] Speaker 02:
uncertainty about whether this mattered or not and a looming trial deadline.

[01:06:11] Speaker 03:
And Judge Robinson did what district judges are empowered to do.

[01:06:15] Speaker 03:
She managed the discovery process and the trial process.

[01:06:19] Speaker 03:
She was clearly very aware of the competing considerations and prejudices to both parties.

[01:06:26] Speaker 02:
Can I ask if in the middle of the trial, the way Judge Clevenger was talking about or even on

[01:06:34] Speaker 02:
May 25th, she had said, okay, you've got to give them the day four samples.

[01:06:41] Speaker 02:
And the day four samples at that point would have been day 124 samples or something.

[01:06:48] Speaker 02:
And what then would have had to happen for the parties to prepare

[01:06:55] Speaker 02:
to through expert reports or further testing or something to assess the significance of this new batch.

[01:07:06] Speaker 03:
I don't think that was discussed specifically with the district court, but the expectation would be that both parties experts might then do some further testing.

[01:07:15] Speaker 03:
prepare some further expert reports.

[01:07:17] Speaker 02:
And did both parties agree that that process would have taken such time as necessitated a delay of the trial?

[01:07:26] Speaker 03:
I think that the district court and both parties contemplated that the trial could not go forward on the schedule that was in place at that point in time.

[01:07:35] Speaker 03:
And that led to the discussion where Judge Robinson said, we're going to keep the trial date, we're going to go forward with the evidence we have now, but I'm going to give you

[01:07:44] Speaker 03:
every opportunity, including more trial time, if necessary, to show me why this is not relevant evidence for me to decide the case on, because the district court wanted to be sure that she was very, very comfortable that the case she was deciding was a case that was representative of Amniel's product.

[01:08:04] Speaker 03:
And after listening to the experts for two days, airing of all the issues, the district court made fact findings not subject to any clear error.

[01:08:13] Speaker 03:
that in fact she was trying and deciding the right case and that she had the relevant evidence knowing that the O01A samples had been out there and hadn't been provided to Merck.

[01:08:25] Speaker 03:
The district court's fact findings on those issues after listening to the experts for both sides were not clearly erroneous and for that reason the judgment should be affirmed.

[01:08:34] Speaker 00:
I want to ask you another question going back to something we were just talking about.

[01:08:38] Speaker 00:
Okay, I assume you have

[01:08:40] Speaker 00:
a lot of ANDA experience.

[01:08:41] Speaker 00:
So I'm hoping you can help me with this.

[01:08:43] Speaker 00:
So it's a basic question, which is just that from the perspective of the FDA, would it, in looking at the ANDA application, have considered the day four batch as being a different batch than the day one batch?

[01:09:00] Speaker 03:
I think it would not have considered it to be a different

[01:09:04] Speaker 03:
batch, I think the reason for the testing was the FDA wanted to see that the day one and day four material shared, I'll say, common characteristics so that the possibility that the product could be held for four days before bottling

[01:09:22] Speaker 04:
under the end of manufacturing specifications, would it make a difference?

[01:09:28] Speaker 04:
My understanding is that request came from the FDA initially.

[01:09:35] Speaker 03:
We want to make sure your product's not changing significantly over those four days.

[01:09:39] Speaker 02:
But was there any focus on the question of conversion from MFA to MFM?

[01:09:44] Speaker 02:
That is, I can imagine, and I'm just

[01:09:46] Speaker 02:
It seems to me the FDA could request the day four to make sure there's no change relevant to FDA purposes, but not relevant to MFA, to MFM purposes.

[01:09:56] Speaker 02:
Do we know anything about the reasons that the FDA thought that that day one to day four might be relevant?

[01:10:03] Speaker 03:
I don't know that the FDA specifically said we want this test because we want to make sure there's no conversion.

[01:10:10] Speaker 04:
Does the FDA care if there's conversion?

[01:10:12] Speaker 03:
The FDA should care if there's conversion.

[01:10:15] Speaker 03:
And in fact, the product that's being sold is a product that the FDA is content is MFA and not MFM.

[01:10:25] Speaker 03:
Now, I don't know what all the back and forth is after the product manufacturing is over.

[01:10:32] Speaker 02:
But if that's right, then it seems that the fact that the FDA wanted this testing

[01:10:39] Speaker 02:
and should care about the very patent issue that we're talking about suggests that it was perhaps inappropriately presumptuous for you to think that they didn't need day the other side.

[01:10:54] Speaker 02:
Merck didn't really need to see day four because it might actually be relevant to an issue that both the patent inquiry and the FDA inquiry cared about.

[01:11:06] Speaker 03:
Well, I don't think there was a specific care from the FDA on that.

[01:11:11] Speaker 02:
No, but you just said what the FDA had in front of it and needed to make sure the product would represent was a MFA, not MFM product.

[01:11:24] Speaker 02:
So the FDA cared that there wasn't going to be conversion in the two-year life.

[01:11:30] Speaker 03:
They would have cared if they thought it was a concern, but there was no evidence that there was

[01:11:35] Speaker 03:
any concern at any point in time during the process.

[01:11:38] Speaker 03:
If FDA had come and said, we're concerned about conversion, please do a test to make sure there's no conversion, that would have been a very different circumstance than the case we have.

[01:11:47] Speaker 03:
The case was, you can hold your product for four days.

[01:11:50] Speaker 03:
We want you to look at it after four days and make sure we don't have problems here.

[01:11:55] Speaker 00:
What do you mean by problems?

[01:11:56] Speaker 03:
I was going to say if I could speak generally about that.

[01:11:58] Speaker 03:
There were some characteristics that the

[01:12:02] Speaker 02:
Is this the page in the appendix that we were looking at?

[01:12:06] Speaker 03:
2197, I believe.

[01:12:07] Speaker 02:
That table that we can't talk about the details of, those are the kind of characteristics that need to be checked or something?

[01:12:17] Speaker 03:
That's right.

[01:12:18] Speaker 03:
Now, one of the characteristics that was checked was that there was a band at 1725, which is consistent with MFA.

[01:12:31] Speaker 00:
If that is here, you think that's on this page?

[01:12:34] Speaker 03:
It is.

[01:12:34] Speaker 02:
Okay.

[01:12:35] Speaker 02:
Can I ask, is this, suppose that we thought in the writing of our opinion that it would be extremely useful to be able to quote, refer to this, is this something that you all can

[01:12:54] Speaker 02:
wave confidentiality on?

[01:12:56] Speaker 03:
We are and would just simply request that the court only quote what it believes is necessary.

[01:13:02] Speaker 02:
And this is your information right?

[01:13:04] Speaker 02:
It is Amniel's information.

[01:13:06] Speaker 03:
That's correct.

[01:13:08] Speaker 03:
Thank you.

[01:13:12] Speaker 03:
If there are any further questions I'd be happy to entertain them.

[01:13:17] Speaker 04:
As I understand at the very bottom line your position is that

[01:13:22] Speaker 04:
In the circumstances, which we've now had, thanks to both of you, an opportunity to sort of get a feel as if we were there while it was happening, that in the circumstances, Judge Robinson knew that there was a potential problem with regard to Merck not having had an opportunity at an earlier stage in the game to assess day four or the day four that got bottled in the end, let me see, 01A.

[01:13:48] Speaker 04:
And so she says, I'm not gonna stop right now.

[01:13:52] Speaker 04:
because perhaps she had a suspicion in her mind that it didn't really matter.

[01:13:56] Speaker 04:
She said, nobody's proven to me that it really matters.

[01:13:59] Speaker 04:
Here, Burke, you've got an opportunity.

[01:14:01] Speaker 04:
A trial will happen in a month or two or three months.

[01:14:05] Speaker 04:
Give it your best shot to convince me that I'm wrong.

[01:14:08] Speaker 04:
that's your perspective, and that that offer was not illusory.

[01:14:12] Speaker 04:
That offer had a meaningful opportunity to Merck to go into its laboratories and do some testing to be able to come and make what you might call a prima facie showing that they were fully entitled to test day four and day four a bottle.

[01:14:26] Speaker 04:
and that that was the offer that was made, Merck did not respond to the argument.

[01:14:32] Speaker 04:
Merck did not bring in evidence showing that it had made some preliminary testings to satisfy what I call the prima facie test.

[01:14:41] Speaker 04:
And therefore, she said, excuse me, I did not err in not having compelled you to give over those two items.

[01:14:49] Speaker 03:
That's your case.

[01:14:52] Speaker 03:
That summarizes a lot of what I said.

[01:14:54] Speaker 03:
Now, Merck did respond.

[01:14:56] Speaker 04:
Am I reviewing all that for abuse of discretion?

[01:14:59] Speaker 04:
That's a question I haven't asked anyone of you earlier.

[01:15:01] Speaker 03:
What's the test?

[01:15:03] Speaker 03:
You're reviewing for abuse of discretion.

[01:15:06] Speaker 03:
Judge Robinson's decision to manage the docket that way, manage the trial schedule that way, manage the discovery issues that way, that is abuse of discretion.

[01:15:14] Speaker 03:
With respect to this specific issue, did Merck convince Judge Robinson that there was some relevance to the 001A samples?

[01:15:24] Speaker 03:
I think those are fact-finding subject to a clear error standard within that abuse of discretion.

[01:15:30] Speaker 04:
Thought I had characterized what I thought your position was that she gave them an opportunity to come forward with factual material that would prove that she should require the trial to stop so as to be able to test day four and day four bottle, but they did not bring forward that testimony.

[01:15:50] Speaker 03:
They brought forth, to be fair, they brought forth expert testimony on theories.

[01:15:55] Speaker 04:
Well, that's what she said, it was theoretical.

[01:15:58] Speaker 04:
Yeah, they brought forth no... Factual information, and so we would review that.

[01:16:02] Speaker 04:
Did they or didn't they bring forward factual information?

[01:16:05] Speaker 04:
The record doesn't show any factual information.

[01:16:08] Speaker 03:
The record certainly doesn't show that.

[01:16:10] Speaker 03:
That's right.

[01:16:11] Speaker 04:
And Judge Robinson's... I'm just trying to see if it really does collapse to an abuse of discretion evidentiary ruling as opposed to collapsing into... I mean, there are some mixed questions of law along here, because Merck's omnibus argument is, well, the right samples were never put in play.

[01:16:29] Speaker 03:
They try to make the legal argument.

[01:16:32] Speaker 04:
I think, you know, the Glaxo case and other cases make clear that as long as you're considering the relevant evidence, there's no... I think we have to walk through a legal minefield that Merck has presented to us, and if we come through that legal minefield saying there was no error of law, and you reduce it right down to the question of, well, did she make a mistake?

[01:16:53] Speaker 04:
What was the basis really of her ruling in her mind at the end?

[01:16:58] Speaker 04:
Was it an evidentiary call?

[01:17:00] Speaker 04:
Because Merck hadn't come forward to give her a reason to believe that she needed to allow the testimony to come in.

[01:17:08] Speaker 03:
That's right.

[01:17:09] Speaker 03:
And there are subsidiary arguments about the evidence they did present, which they sort of walked away from that evidence today, saying they can't prove anything.

[01:17:17] Speaker 03:
But at trial, they tried to prove that the evidence they had on the 001-day-1 samples was

[01:17:23] Speaker 03:
showing conversion.

[01:17:25] Speaker 03:
Judge Robinson found no conversion.

[01:17:27] Speaker 03:
That's a clear error standard on appeal.

[01:17:30] Speaker 03:
But this issue of the O01A samples, that's an abuse of discretion.

[01:17:34] Speaker 03:
That's classic discovery and docket management.

[01:17:38] Speaker 03:
And Judge Robinson drew what was a very fair line understanding the impact on both parties here and had the trial go forward but gave Merck every opportunity

[01:17:53] Speaker 03:
to provide the information that would lead her to make the conclusion that that trial would have to stop or be postponed or be adjourned or be redone potentially.

[01:18:06] Speaker 03:
This was not an illusory or hollow offer that the district court made.

[01:18:13] Speaker 00:
I want to ask you just one question.

[01:18:14] Speaker 00:
You seem to be distinguishing between an abuse of discretion and clearly erroneous.

[01:18:19] Speaker 00:
But it's my understanding that a district court would abuse its discretion by relying on clearly erroneous facts.

[01:18:27] Speaker 00:
That's my understanding as well.

[01:18:28] Speaker 00:
Relying on a clear error of law.

[01:18:29] Speaker 00:
So I'm not sure if it matters.

[01:18:30] Speaker 03:
What's your response to that?

[01:18:32] Speaker 03:
My understanding is that a clear error can be an abuse of discretion.

[01:18:37] Speaker 03:
But the tests, obviously, are slightly

[01:18:40] Speaker 03:
different in terms of what can in the aggregate constituted.

[01:18:45] Speaker 03:
Thank you.

[01:18:47] Speaker 02:
Five minutes.

[01:18:52] Speaker 02:
I think I'm actually going to stick to five minutes here.

[01:18:54] Speaker 01:
Let me, let me start with what I notice is one concern you'll have, which is whether Merck had ever actually asked for this final product.

[01:19:01] Speaker 01:
And of course we had.

[01:19:03] Speaker 01:
And if you would turn to page 79 of the joint appendix, there's a court order in another instance ordering a meal to produce things to us.

[01:19:10] Speaker 01:
And it reproduces our production request 15s, which cover samples.

[01:19:15] Speaker 01:
It's on paragraph five on the top of appendix page 79, manufactured in accordance with the procedures for a meals and a product.

[01:19:25] Speaker 01:
That would have covered the 1601A samples that weren't given to us.

[01:19:30] Speaker 01:
Now, I'm a little bit, you know, we're here talking whether Merck should, they're talking about whether Merck should actually make a product on its own to test, which would lead to an

[01:19:40] Speaker 01:
incredible confusion and disastrous trial, because they would object to everything, when we actually have their end of product sitting in a warehouse, and is what we should have got.

[01:19:51] Speaker 01:
And the other question that I've noticed some concern about is what Merck told Judge Robinson about this.

[01:19:58] Speaker 01:
And as soon as we figured out they had actually continued the process on the Batch 1601, we went repeatedly to her.

[01:20:05] Speaker 01:
So, for example,

[01:20:08] Speaker 01:
On the June 7th pre-trial conference, we specifically told her, and that's on DI 189 during the pre-trial conference, we told her that the case is supposed to be upon the product they are seeking approval from the FDA for.

[01:20:23] Speaker 01:
And even in the post-trial briefing, we kept emphasizing Ananda case is supposed to be about the actual product.

[01:20:36] Speaker 01:
And let me go back to what the law is and come up on your last question about whether is this an abuse of discretion or is this a legal error?

[01:20:45] Speaker 01:
You are correct.

[01:20:46] Speaker 01:
A judge gets to make calls on discovery, and those are subject to abuse of discretion.

[01:20:52] Speaker 01:
However, when those calls end up causing an error in law, we have to look at the legal error of the patent case.

[01:21:01] Speaker 01:
And our position is that taking into consideration what's in effect is not the product

[01:21:09] Speaker 01:
in order to determine or not determine whether it infringes is legal error.

[01:21:13] Speaker 01:
And I'm going to go back to Faring, which is the closest case from this court, is Faring v. Watson.

[01:21:20] Speaker 01:
It's the closest case because it was a case, again, the roles were reversed, but the patentee was trying to use an intermediate.

[01:21:27] Speaker 01:
And this court said the un-coded course of Watson's generic product is misplaced.

[01:21:35] Speaker 01:
The infringement evaluation is concerned only with the final coded commercial acid tablets for which Watson sought and was granted FDA approval.

[01:21:52] Speaker 01:
So in Ananda case, we're not looking at intermediates.

[01:21:55] Speaker 01:
We're supposed to look at the actual product.

[01:21:58] Speaker 01:
And that is the law.

[01:21:59] Speaker 01:
So her decisions, if you want to isolate them, you can look at them isolated.

[01:22:04] Speaker 01:
But what it led to is an ultimate judgment that's based upon a determination of infringement or non-infringement that's not based on the product.

[01:22:12] Speaker 00:
If I don't agree with you that day one wasn't intermediate, don't you still have an argument?

[01:22:17] Speaker 00:
Because you could still argue to me

[01:22:18] Speaker 00:
Yes, but we need to be able to look at day four, because even if day one didn't infringe, day four could infringe.

[01:22:25] Speaker 01:
Exactly, and I'm very glad you brought that up, because there were some points made that day four isn't that different.

[01:22:31] Speaker 01:
It's just four days, and the mixing is just stirring it up.

[01:22:34] Speaker 01:
The mixing is very substantial, and in fact, the mixing that occurs on day four that happened, and this is from their records,

[01:22:43] Speaker 01:
On January 15th... Are you reading from something that we can look at?

[01:22:47] Speaker 01:
So I'm actually reading from a trial exhibit that's not in the appendix.

[01:22:50] Speaker 01:
I can, however, hand it over, obviously, to counsel and to Mr. Green.

[01:22:53] Speaker 02:
What's the number?

[01:22:54] Speaker 01:
So it's plaintiff's trial exhibit number 98, and I can provide copies of that.

[01:23:00] Speaker 02:
Will that be on PACER or does it have a lot of yellow markings on it?

[01:23:05] Speaker 01:
It won't be.

[01:23:05] Speaker 01:
It's a summary exhibit that's based on their confidential information.

[01:23:10] Speaker 02:
Okay.

[01:23:11] Speaker 02:
Can you submit it and confer with counsel on the other side about whether appropriate completeness of submissions is satisfied?

[01:23:22] Speaker 02:
No, I don't mean right now.

[01:23:23] Speaker 02:
I mean afterwards.

[01:23:25] Speaker 01:
But what happened is so that the hundred kilogram vat was mixed for

[01:23:31] Speaker 01:
20 minutes at 820 RPMs.

[01:23:35] Speaker 01:
This is very violent mixing.

[01:23:37] Speaker 01:
And that's what the testimony was saying, that this type of mixing is exactly what can cause the conversion.

[01:23:43] Speaker 01:
The other issue is that... Which sample was that?

[01:23:46] Speaker 01:
This was between the day one and the day four for the 16001.

[01:23:50] Speaker 01:
You said 100 minutes?

[01:23:53] Speaker 01:
This is what was 20 minutes at 140 RPMs.

[01:23:55] Speaker 01:
800 something.

[01:23:58] Speaker 01:
800, I'm sorry, 840, that's right.

[01:24:01] Speaker 02:
And this was, do I understand it from this term, Laura, this would have been basically just before the samples were drawn.

[01:24:09] Speaker 01:
Exactly.

[01:24:12] Speaker 01:
The other point that was placed, this idea that somehow Merck should have, and I think Judge Cleminger referred to this as an illusory.

[01:24:19] Speaker 04:
When did you learn that?

[01:24:20] Speaker 04:
So you knew about this early on.

[01:24:24] Speaker 04:
You could have replicated that in your own lab.

[01:24:28] Speaker 01:
I'm glad you mentioned that, because that's about what I was getting ready to go to.

[01:24:32] Speaker 01:
We actually can't replicate their industrial process.

[01:24:35] Speaker 01:
For one, we didn't have 100 kilograms of the material.

[01:24:38] Speaker 01:
For another matter,

[01:24:40] Speaker 01:
It matters a lot in this, exactly for example, the shape, the material of the container, the shape of the impaler that does the agitation, all of this matters.

[01:24:50] Speaker 01:
chemical engineers that spend their lives to make sure these processes are specifically precise.

[01:24:56] Speaker 01:
For example, when the FDA approves a product to come out of a certain facility, you can't change a little piece of equipment without getting approval.

[01:25:04] Speaker 01:
And that's exactly because these processes change.

[01:25:07] Speaker 01:
You can't just do them in somebody else's equipment with other materials in a different place.

[01:25:13] Speaker 01:
And in fact, there's unrebutted testimony on this.

[01:25:15] Speaker 01:
from Merck's chemical engineer expert, Professor MIT, who works with manufacturing processes at pharmaceutical plants, and it's an appendix page to... So your view is that her invitation to you to do this testing was a trap for the unwary.

[01:25:31] Speaker 01:
I think when you said illusory is exactly correct.

[01:25:35] Speaker 01:
There was

[01:25:36] Speaker 01:
The fact that she found we actually proved that additional mixing causes it is a great result and we really can't have anything more than that because there's no way we can actually recreate

[01:25:46] Speaker 01:
what they do in their plant with their machines.

[01:25:50] Speaker 01:
And that's the exact problem.

[01:25:51] Speaker 01:
We could try to take all this off.

[01:25:53] Speaker 01:
And by the way, you're exactly right.

[01:25:54] Speaker 01:
Had we done it, and it would have been correct.

[01:25:57] Speaker 01:
It would have criticized every little thing we did.

[01:25:59] Speaker 04:
It would have led to another...

[01:26:06] Speaker 04:
that you would have made, that she would have said, okay, you convinced me that day four might make a difference, therefore, give it over and let you test it.

[01:26:13] Speaker 01:
And this is where it's, I think, a little bit bizarre reading the opinion, because she did find that the additional mixing tends to cause conversion.

[01:26:22] Speaker 01:
But then she found it wasn't specific enough.

[01:26:25] Speaker 04:
Well, it can't... She could have said your arguments were fair already.

[01:26:29] Speaker 04:
By the time she got to hear you having given you an invitation that she thought was to let you come up with something scientific,

[01:26:36] Speaker 04:
You didn't come up with something hard science, so she's saying you're theoretical.

[01:26:39] Speaker 01:
This was scientific.

[01:26:40] Speaker 01:
By the way, if we had tried to reproduce the entire process, which is pretty much impossible somewhere else, that would still be theoretical, because everything in that process would not match what happened to the actual product in this case, what happens to the product as it's being made in the plant.

[01:26:57] Speaker 02:
It seems to me what Anmiel would say is that would not constitute proof

[01:27:04] Speaker 02:
of the final fact, but it would be possibly, as Judge Clevenger said, a pretty suggestive prima facie case that it was worth looking at the actual difference between four and one and that you couldn't have done stuff to do that

[01:27:25] Speaker 02:
to reach that level, which you didn't do.

[01:27:28] Speaker 01:
Well, keep in mind, we're talking about recreating.

[01:27:30] Speaker 01:
I need stuff in the most precise sense.

[01:27:32] Speaker 01:
We're talking about recreating an industrial process.

[01:27:35] Speaker 01:
So finding a plant that can be done, this is not something that you just undertake willy-nilly.

[01:27:40] Speaker 01:
We're not talking about just shaking the bottle, because that doesn't recreate the process.

[01:27:45] Speaker 01:
We're talking about running an entire industrial process in a plant.

[01:27:51] Speaker 01:
which wouldn't be their plan.

[01:27:52] Speaker 01:
And I don't think, by the way, they would agree that that actually proved anything, because they would say, that's not the product.

[01:27:57] Speaker 01:
We don't know.

[01:27:58] Speaker 04:
This is interesting, but you didn't make this showing to Judge Robinson.

[01:28:02] Speaker 04:
You didn't come up and say at the trial, you made this invitation to us, Judge, and we thought that was a really nice thing for you to do.

[01:28:08] Speaker 04:
And we went back and guess what?

[01:28:10] Speaker 01:
We've got all these problems.

[01:28:13] Speaker 01:
Actually, we did.

[01:28:14] Speaker 01:
And our expert described exactly to her why that's not possible.

[01:28:18] Speaker 01:
And it's on Appendix page 202.

[01:28:20] Speaker 01:
This is unrebutted testimony.

[01:28:23] Speaker 01:
And that's on Appendix page 202.

[01:28:26] Speaker 04:
And the testimony on pages... What's he saying?

[01:28:29] Speaker 04:
He's a trap, right?

[01:28:35] Speaker 01:
So the question is, toward the bottom of page 207,

[01:28:39] Speaker 01:
And why did you not design any experiments to confirm your opinions?

[01:28:45] Speaker 01:
I think he provides a lengthy answer.

[01:28:47] Speaker 01:
Okay, well, first of all, my opinion is that increased mixing, it's vigorous mixing significantly, causes conversion.

[01:28:57] Speaker 01:
And he goes on to describe exactly that reproducing an industrial process is not

[01:29:09] Speaker 01:
something that's feasible.

[01:29:11] Speaker 04:
Where does he say that?

[01:29:13] Speaker 04:
Line what?

[01:29:15] Speaker 04:
Page 208?

[01:29:16] Speaker 02:
On page 6.

[01:29:17] Speaker 02:
208.

[01:29:18] Speaker 02:
Right, but there's a substantial gap between couldn't reproduce the industrial process and couldn't undertake a variety of experiments that would tend to be suggestive, would point in a direction that would tell you we really do have to have the actual sample.

[01:29:39] Speaker 01:
keep in mind that we're talking literally as trial is coming up.

[01:29:43] Speaker 01:
And the simplest thing frankly would have been.

[01:29:45] Speaker 01:
That's right.

[01:29:46] Speaker 02:
But by the time this came up, the simplest thing was no longer an option because they didn't do what they should have done in January.

[01:29:54] Speaker 01:
And that's the point that I think though matters.

[01:29:56] Speaker 01:
And Judge Robinson had to deal with that.

[01:29:58] Speaker 01:
That's correct.

[01:29:59] Speaker 01:
And sometimes, as you know, trial judges get

[01:30:02] Speaker 01:
laser beam focused on trial dates.

[01:30:04] Speaker 01:
And I think, in the end, that's what happened here.

[01:30:07] Speaker 01:
But what we can't have is, I think, something that says, in a Hatch-Waxman case, it's okay for the generic to withhold what's the final product that should actually be tested.

[01:30:18] Speaker 01:
And somehow, then, that, we end up testing an intermediate, which I do believe the law of this circuit is that shouldn't be what the infringement of the decision is based on.

[01:30:30] Speaker 01:
And then what we end up with is a Hatch-Waxman case that kind of becomes meaningless, even though it's still, at this point, very important.

[01:30:37] Speaker 01:
Because, for example, let's say in

[01:30:42] Speaker 01:
Two months, in two months we test.

[01:30:44] Speaker 02:
I have a feeling that we're going around in circles now and we've been well over five minutes unless you think you actually have something new to tell me.

[01:30:53] Speaker 01:
The only thing I'll say is that we just asked for a remand and the actual samples of the ANDA product for testing for the Hatch-Waxman kits.

[01:31:02] Speaker 02:
Thank you very much.

[01:31:03] Speaker 02:
Thank you and thanks to Boat Council.

[01:31:04] Speaker 02:
It's been very instructive.