[00:00:00] Speaker 03:
In the last case, it is Merck Serrano versus TWI Pharmaceuticals, number 25-1463.

[00:00:06] Speaker 03:
Welcome back, Mr. Fleming.

[00:00:10] Speaker 00:
Thank you again, Judge Hughes.

[00:00:12] Speaker 00:
May it please the court, Mark Fleming from Willmar Hale.

[00:00:14] Speaker 03:
Let me give him a minute to settle.

[00:00:16] Speaker 03:
Very well.

[00:00:17] Speaker 00:
Tell me when you're ready.

[00:00:23] Speaker 03:
While we have that minute, I trust you're not going to go over inventorship.

[00:00:27] Speaker 03:
But I'm not going to prevent him from making his arguments so you can reply.

[00:00:30] Speaker 03:
But I think that arguments are fairly similar.

[00:00:34] Speaker 00:
There are a couple of points, if I may, where I think it's illustrative to show the board fell even further into error in this case that are different.

[00:00:42] Speaker 00:
So if I may, I'd like to touch on those, but I don't plan on retreading old ground unless the court has questions, obviously.

[00:00:50] Speaker 00:
I suspect, I hope, my plan is to reserve more time for rebuttal and I may not even use that if needed.

[00:01:03] Speaker 03:
Mr. Fleming?

[00:01:04] Speaker 00:
Thank you very much, Your Honor.

[00:01:05] Speaker 00:
May it please the court?

[00:01:06] Speaker 00:
Mark Fleming from WilmerHale with Jennifer Graber and Gary Fox, again, on behalf of Merck Sorono.

[00:01:12] Speaker 00:
As I said, I won't retread things that we've talked about in the prior case, but I think the board fell even further into error here in at least three particular rights.

[00:01:22] Speaker 01:
But let me just get one housekeeping question answered by you before you go into the alleged errors you're going to identify.

[00:01:28] Speaker 01:
So it's same patents, right?

[00:01:30] Speaker 01:
Yes.

[00:01:30] Speaker 01:
All of the claims that were in the prior appeal are here, right?

[00:01:34] Speaker 01:
Plus additional claims.

[00:01:35] Speaker 00:
Correct.

[00:01:36] Speaker 01:
And then at least one overlapping reference, right?

[00:01:38] Speaker 01:
Just to kind of set the stage.

[00:01:40] Speaker 00:
Yes.

[00:01:40] Speaker 00:
The asserted Bodo reference, which we don't think is prior, are a different secondary reference.

[00:01:44] Speaker 00:
Rice instead of Stelmasiak.

[00:01:45] Speaker 00:
That's absolutely correct.

[00:01:46] Speaker 00:
I'd say three things, if I may, on the point that the dosing regimen in Bodor is not by another and therefore not prior art.

[00:01:54] Speaker 00:
Here, the board's violation of the rule of reason went even further, because it demanded that we provide not only evidence of specific contributions by Dr. DeLuca, but by each Serrano inventor.

[00:02:05] Speaker 00:
And that was quite remarkable, because the board actually found that three of the inventors, Drs.

[00:02:10] Speaker 00:
Munafo, Lopez-Breznahan, and Etier,

[00:02:13] Speaker 00:
are identified in the Amsterdam minutes as participants from the Sorono team, and that Dr. Monoffo and Dr. Lopez Bresnahan are copied on the regulatory briefing document from December 2003.

[00:02:24] Speaker 00:
And it called those two documents the most probative evidence for regimens discussed by the Sorono inventors.

[00:02:31] Speaker 00:
So this is a very extreme version of requiring us to point to a specific type of evidence, which is legal error under the rule of reason.

[00:02:40] Speaker 00:
Second, the board faulted us, and this is another legal error, for not disproving a speculation by TWI that there were some unnamed Serono scientists out there that also contributed to the disclosure in Bodor.

[00:02:54] Speaker 00:
That's an improper shifting of the burden.

[00:02:55] Speaker 00:
If TWI thought

[00:02:57] Speaker 00:
that other people contributed to the Bodor disclosure other than the Serrano inventors.

[00:03:02] Speaker 00:
It was TWI's burden to prove that.

[00:03:04] Speaker 00:
It certainly was not our burden to come forward on a burden of production to refute a claim that they had provided no evidence for.

[00:03:11] Speaker 00:
And then third, the board downplayed the sworn statements of Dr. Bodor and Dr. Dandeker because they couldn't remember the source of their information that the Serono scientists invented for the dosing regimen.

[00:03:25] Speaker 00:
Again, that's an error for a burden of production.

[00:03:27] Speaker 00:
We're not supposed to be evaluating credibility.

[00:03:29] Speaker 00:
We're supposed to be taking the evidence as true and deciding whether if taken as true, it corroborates Dr. Monoffo's overall account.

[00:03:36] Speaker 00:
Not remembering the source is not a basis for discounting their testimony at this stage.

[00:03:41] Speaker 00:
With regard to the separate Duncan parking issue, I'll note TWI, like Hopewell, doesn't offer any evidence at all that Drs.

[00:03:49] Speaker 00:
Vodor or Dandeker conceived of a 10-milligram dose.

[00:03:53] Speaker 00:
And it's important to distinguish here between the dose, which is 10 milligrams of cladribine, and the dosage form, which is the tablet that the IVAC scientists, Drs.

[00:04:03] Speaker 00:
Vodor and Dandeker, were charged with making by the Serono team.

[00:04:07] Speaker 00:
And the dosage form is not clean.

[00:04:10] Speaker 00:
in these claims.

[00:04:12] Speaker 00:
It just has to be an oral formulation.

[00:04:14] Speaker 00:
It could be a liquid, it could be a 3-milligram tablet, it could be a 5-milligram tablet.

[00:04:18] Speaker 00:
You could do it lots of different ways.

[00:04:20] Speaker 00:
So the fact that they came up with that

[00:04:23] Speaker 00:
And the fact that they made those tablets does not satisfy the Duncan parking test.

[00:04:29] Speaker 00:
The most the TWI is going to be able to say is that the record is silent on who came up with a 10 milligram dose.

[00:04:36] Speaker 00:
We don't think the record is silent.

[00:04:37] Speaker 00:
We think we've put in plenty of evidence, certainly enough for a burden of production.

[00:04:40] Speaker 00:
But even if you give them their argument that the record is silent on who came up with it, that means they fail in their burden of persuasion.

[00:04:47] Speaker 00:
With respect to non-obviousness, Judge Cunningham, you're absolutely right.

[00:04:50] Speaker 00:
We're talking about a different secondary reference.

[00:04:51] Speaker 00:
But there are some findings with respect to BODOR that the board made here that I think are pretty important.

[00:04:57] Speaker 00:
In rejecting the anticipation argument that TWI makes, this is an argument unique to them.

[00:05:02] Speaker 00:
Hopewell didn't argue anticipation.

[00:05:04] Speaker 00:
The board rejected it.

[00:05:05] Speaker 00:
And the board said, BODOR does not disclose retreatment.

[00:05:09] Speaker 00:
and any subsequent maintenance period and dosing amount is at best speculative, based on Bodor's disclosure.

[00:05:16] Speaker 00:
That's page 36 of the appendix.

[00:05:19] Speaker 00:
And the board literally said, and this is highly unusual, this is page 50, that TWI's obviousness theory was that a skilled artisan would choose dose and interval through, quote, trial and error.

[00:05:30] Speaker 00:
And TWI's expert Dr. Greenberg likewise admitted, and this is 2089 and 90, paragraph 117 of his declaration, a maintenance phase could either be an increase, a reduction, or a continuation of the particular treatment dose of the induction phase.

[00:05:46] Speaker 00:
And then he says that Bodor simply instructs practitioners to apply whatever regimen would be deemed appropriate.

[00:05:53] Speaker 00:
That is throwing darts.

[00:05:54] Speaker 00:
In fact, it's almost literally throwing darts, particularly when you consider- Can you repeat that page number that you gave me?

[00:05:58] Speaker 00:
Of course, in fact, I'll read it to you verbatim.

[00:06:00] Speaker 00:
It's 2089 of the appendix in the TWI case.

[00:06:10] Speaker 00:
You look at paragraph 117, and if you go to the sentence that begins six lines down,

[00:06:22] Speaker 00:
If you're with me, I'll make sure that I've got the right language for you.

[00:06:24] Speaker 00:
The sentence begins, Bodor is silent on exactly what parameters would apply to the dosing regimen of the maintenance phase, and instead instructs practitioners to apply whatever regimen would be deemed appropriate.

[00:06:37] Speaker 00:
And then if you skip down to the bottom of that page,

[00:06:41] Speaker 00:
Bodor discloses a maintenance phase that, and then going to the top of 2090, could either be an increased reduction or continuation of the particular treatment dose of the induction phase, bold italic, as decided by a treating physician in concomitance with continuous evaluation.

[00:06:58] Speaker 00:
This is honestly not guidance at all.

[00:07:03] Speaker 00:
This is saying, you know, they would have figured it out somehow.

[00:07:06] Speaker 00:
How?

[00:07:07] Speaker 00:
Why?

[00:07:07] Speaker 00:
Looking at what criteria?

[00:07:09] Speaker 00:
And TWI, by the way, didn't even make the lymphocyte level argument that you heard from Mr. Rosenbaum.

[00:07:13] Speaker 00:
They didn't make that argument at all in this case.

[00:07:16] Speaker 00:
Now, the board violated the APA by coming up with it on its own, sua sponte, without giving us a chance to respond to it.

[00:07:21] Speaker 00:
But they have no evidence that a skilled artisan would optimize based on anything.

[00:07:25] Speaker 00:
This is literally saying it would be whatever is deemed appropriate.

[00:07:28] Speaker 00:
And this court has never said that that's enough to show obviousness.

[00:07:31] Speaker 00:
The Rice reference, the secondary reference for its part, actually teaches away from the claimed invention because it says you have to wait at least 12 months after the induction period, from the last dose in the induction period, before you start retreating again for safety reasons.

[00:07:46] Speaker 00:
And it's silent as to what you'd actually retreat with, at what dose, at what frequency.

[00:07:51] Speaker 00:
Dr. Greenberg admitted this.

[00:07:52] Speaker 00:
The board didn't address this evidence at all, even though it detracted from its conclusion, and so it was required to address it under the APA.

[00:08:00] Speaker 00:
So this isn't a battle of the experts.

[00:08:02] Speaker 00:
I mean, the evidence, I don't think, can fairly be disputed.

[00:08:06] Speaker 00:
Rice didn't show clinical efficacy, said that.

[00:08:09] Speaker 00:
Rice taught away from retreating before 12 months.

[00:08:13] Speaker 00:
Our claims are do it after 8 to 10 months.

[00:08:15] Speaker 00:
Rice taught away from that.

[00:08:17] Speaker 00:
And Dr. Greenberg admitted that Rice doesn't disclose a retreatment dose at all.

[00:08:22] Speaker 00:
The board didn't explain why it rejected that evidence.

[00:08:24] Speaker 00:
We also have, in this case, an argument about unexpected results.

[00:08:28] Speaker 00:
We have it in the other case, too, but we didn't brief it in this court, but we have it here.

[00:08:31] Speaker 00:
The clarity extension study and later follow-on studies showed that after the first two years of treatment, patients have long-lasting benefits up to a mean of over 10 years.

[00:08:43] Speaker 00:
The board recognized this was unexpected.

[00:08:46] Speaker 00:
On page 63, the board nonetheless discounted this because it thought we should have compared the results to Bodor.

[00:08:54] Speaker 00:
which is a stark legal error under Millennium, because Bodor doesn't have any results.

[00:08:59] Speaker 00:
Bodor, again, was not claiming a regime for treatment.

[00:09:04] Speaker 00:
It was just claiming the tablets.

[00:09:06] Speaker 00:
So it didn't have a clinical trial.

[00:09:07] Speaker 00:
It wasn't able to say what the results of its tablet or the disclosed regimen actually were.

[00:09:12] Speaker 00:
are expert compared to the results to the studies that actually have results, like Rice and Romine.

[00:09:18] Speaker 00:
And the board found that Rice didn't report results that were favorable to the same extent.

[00:09:23] Speaker 00:
It's on page 62.

[00:09:24] Speaker 00:
So properly considering the unexpected results here would have made a significant difference, not least because it refutes the board's view that a skilled artisan could just have routinely optimized their way to the claimed invention.

[00:09:37] Speaker 00:
If that were the case, these results would not have been unexpected.

[00:09:41] Speaker 00:
The claim construction arguments are just the same.

[00:09:43] Speaker 00:
The plain language of the claims requires dosing based on patient weight.

[00:09:46] Speaker 00:
The board recognized that in this very case by initially denying institution.

[00:09:51] Speaker 00:
The board changed its mind, but cited no basis in the intrinsic record for doing so.

[00:09:55] Speaker 00:
And in fact, it didn't even mention its prior reasoning.

[00:09:57] Speaker 00:
We think the correct way to construe the claims is requiring that the dose be selected in milligrams per kilogram based on patient weight.

[00:10:05] Speaker 00:
And the case should be remanded under that claim for destruction.

[00:10:08] Speaker 00:
But again, unless the court has further questions, we think the right way to decide this is the easiest way.

[00:10:14] Speaker 00:
And I think the best way for the development of the law, frankly, is to clear up the way to deal with buy another.

[00:10:19] Speaker 00:
And we think the NPEP got it right based on this court's cases.

[00:10:23] Speaker 00:
And under that view, Bodor is not prior art.

[00:10:25] Speaker 00:
And that's the end of both of them.

[00:10:28] Speaker 00:
If there are no further questions at this time, I hope not to need five minutes for rebuttal, but I'll reserve it with the court's permission.

[00:10:35] Speaker 00:
Thank you, counsel.

[00:10:35] Speaker 00:
Thank you, Your Honor.

[00:10:38] Speaker 03:
Mr. Segrist.

[00:10:40] Speaker 02:
May it please the court, Philip Sigrist for the Appellee TWI.

[00:10:46] Speaker 02:
I'd like to start by giving a little bit of the history on this.

[00:10:49] Speaker 02:
I want to make sure we don't lose the forest for the trees and take details of who did what.

[00:10:55] Speaker 02:
And then talk about applied materials, because I think there's some more detail that needs to be discussed there.

[00:10:59] Speaker 02:
And then talk about the evidence that was submitted on this inventorship issue.

[00:11:04] Speaker 02:
Any questions you have, please interrupt me and I'll try to get directly to them.

[00:11:10] Speaker 02:
was originally being developed not by IVACs, which is where Bodor and Danica are from, not by, I'm sorry, not by Serono, which is where the named emitters are from.

[00:11:25] Speaker 02:
It's being developed by Scripps.

[00:11:27] Speaker 02:
And then Scripps assigned that to IVACs, not to Serono, to IVACs.

[00:11:35] Speaker 02:
And IVACs brought in Serono as a licensee.

[00:11:39] Speaker 02:
This is all from the materials that they submitted.

[00:11:41] Speaker 02:
So this is not a case where

[00:11:43] Speaker 02:
IVAX is just there to manufacture a 10-milligram tablet.

[00:11:47] Speaker 02:
IVAX was developing the oral dosing formulation.

[00:11:51] Speaker 02:
And I'll get into more detail.

[00:11:52] Speaker 02:
That's reflected in the documents they submitted for corroboration.

[00:11:56] Speaker 02:
And that's the whole point of this patent, was the oral dosing formulation on this regimen.

[00:12:02] Speaker 02:
The schedule was not new.

[00:12:04] Speaker 02:
You already had prior art to disclose

[00:12:07] Speaker 02:
do it five to seven days a month, and then wait five to seven days for a month, wait the next month do it five to seven days.

[00:12:16] Speaker 02:
That's in the prior art, but it wasn't there for an oral formulation.

[00:12:19] Speaker 02:
It was there for intravenous injection.

[00:12:23] Speaker 02:
So these two companies were working together, but they didn't pursue a joint patent.

[00:12:28] Speaker 02:
They kept it separate, which is fine.

[00:12:31] Speaker 02:
They can do that.

[00:12:32] Speaker 02:
They don't get the benefits of things like section 103 provision that you've got a common assignee on the patents.

[00:12:38] Speaker 02:
The references aren't available as prior art on the 103, but they didn't do that.

[00:12:42] Speaker 02:
They said, we're each going to go our own way.

[00:12:43] Speaker 02:
Now, Bodor was then cited against these patents during the prosecution.

[00:12:52] Speaker 02:
And the examiner said there, and this is why it was allowed over Baudoir, that what Baudoir does not disclose is that the maintenance period is less than the induction period.

[00:13:09] Speaker 02:
That's the distinction the examiner drew.

[00:13:12] Speaker 02:
This discusses more detail in our brief pages 11 through 16.

[00:13:15] Speaker 02:
But that particular language.

[00:13:18] Speaker 02:
that the examiner pointed to is appendix pages 1391 through 92 and appendix page 1928.

[00:13:26] Speaker 02:
The reason I'm focusing on that language is because that's not in the challenge claims.

[00:13:32] Speaker 02:
That's the limitation in the claims we did not challenge, that the maintenance period is less than the induction period.

[00:13:39] Speaker 02:
In the challenge claims, they're the same.

[00:13:42] Speaker 02:
So under the examiner's analysis,

[00:13:45] Speaker 02:
Vodor wasn't missing anything, because the examiner agreed with our position that the maintenance period was implied in Vodor.

[00:13:53] Speaker 02:
Now, that was our anticipation challenge.

[00:13:57] Speaker 02:
We didn't cross the field on anticipation.

[00:13:59] Speaker 02:
We think we're right on it.

[00:14:00] Speaker 02:
It's the same result.

[00:14:01] Speaker 02:
But we want to focus on the obviousness analysis.

[00:14:05] Speaker 02:
And I do want to talk about applied materials, because that language is confusing, where it talks about different inventive entities conceived.

[00:14:15] Speaker 02:
And it's confusing because when it's talking about inventive entities conceived, it's not talking about the disclosure.

[00:14:23] Speaker 02:
It's talking about the named inventors on those patents, because the named inventors match up with the claims.

[00:14:32] Speaker 02:
In applied materials, both of those patents came from the same original disclosure.

[00:14:39] Speaker 02:
You had continuations, divisions, continuations in part.

[00:14:43] Speaker 02:
And the tribunal below had held that claims in the later patent were anticipated by the disclosure in the earlier patent, all of which claimed priority to the same disclosure.

[00:14:56] Speaker 02:
And that's what the Federal Circuit was talking about.

[00:14:59] Speaker 02:
The court below had said, well, you named different inventors on this earlier patent.

[00:15:05] Speaker 02:
Then you named them a later patent.

[00:15:07] Speaker 02:
And therefore, it's a different inventive entity.

[00:15:09] Speaker 02:
And the court said, no, that's not right.

[00:15:12] Speaker 02:
It doesn't matter.

[00:15:14] Speaker 02:
who contributed to the claims in each patent.

[00:15:17] Speaker 02:
What matters is whether the invented entity in the patent being challenged, that's who contributed to the disclosure in the earlier patent.

[00:15:27] Speaker 02:
And the court said that because you found anticipation, you're saying that every claim element was disclosed.

[00:15:34] Speaker 02:
And if every claim element was disclosed on something that's claiming priority to that same document, then it's not available as prior art.

[00:15:42] Speaker 02:
And that's all that that meant.

[00:15:43] Speaker 02:
It wasn't saying you only have to have some of the same people.

[00:15:48] Speaker 02:
Now, you can have a situation where the previous application, the disclosure is made by one of the later joint inventors, but it has to be a disclosure of the joint invention.

[00:16:01] Speaker 02:
And then if it's a disclosure of the joint invention by only one of them, later when they file the application, and they're not claiming that joint invention, a later application claiming the joint invention, then that may not be available.

[00:16:14] Speaker 02:
But only if the entity making the entity

[00:16:19] Speaker 02:
who developed the subject matter being disclosed is the same.

[00:16:24] Speaker 02:
It's got to be the same as the inventive entity later.

[00:16:27] Speaker 02:
That's a common theme of patent law.

[00:16:29] Speaker 02:
And it's in the land case.

[00:16:32] Speaker 02:
You can't decide land that way if it's sufficient, or at least one of the joint inventors, to have made the disclosure.

[00:16:39] Speaker 02:
And it's in the Katz case as well, which I think makes it even more clear, where Judge Rich was describing,

[00:16:45] Speaker 02:
The joint entity is different.

[00:16:47] Speaker 02:
There's a different entity from each individual.

[00:16:51] Speaker 02:
And if the individual makes a disclosure of the joint invention, then that's a disclosure from the joint entity, even though it was written by one of them.

[00:17:01] Speaker 02:
But if you're talking about what one person did and what another person did,

[00:17:05] Speaker 02:
That's available as prior art because that's by another.

[00:17:08] Speaker 02:
It's not by the joint named inventors, which is what you have to have, which what their evidence didn't show.

[00:17:18] Speaker 02:
That's about what their evidence did show.

[00:17:27] Speaker 02:
When before you have a fairly concisory statement from Monophobe.

[00:17:31] Speaker 02:
Where it really breaks down is on the documents they point to as corroboration.

[00:17:35] Speaker 02:
There is no lab notebooks or no development documents.

[00:17:40] Speaker 02:
We tried to get discovery on this.

[00:17:41] Speaker 02:
PTAB said you don't need discovery for an IPR.

[00:17:44] Speaker 02:
There's no invention disclosure statements.

[00:17:47] Speaker 02:
There's nothing showing the communication of this directly from Serono to IVAX.

[00:17:52] Speaker 02:
What you have, three documents.

[00:17:54] Speaker 02:
One of them is a product development agreement.

[00:17:56] Speaker 02:
This is the agreement where IVAX licensed Serono and that agreement

[00:18:04] Speaker 02:
IVACS is the licensor.

[00:18:06] Speaker 02:
They're the ones who are developing an oral formulation.

[00:18:09] Speaker 02:
This is on page appendix 5938.

[00:18:11] Speaker 02:
It's in recital F. On the first page of that agreement, it says that IVACS is developing the oral formulation.

[00:18:18] Speaker 02:
Now, counsel pointed out that the claims recite an oral formulation.

[00:18:25] Speaker 02:
and not necessarily just a 10-milligram?

[00:18:28] Speaker 02:
Well, I'm actually the one developing oral formulation, not just 10-milligram or 3-milligram.

[00:18:34] Speaker 02:
Not necessarily did it in the form of tablets, but the product development agreement that they're pointing to as corroboration

[00:18:42] Speaker 02:
actually shows our case.

[00:18:43] Speaker 02:
It shows that the IVACs inventors were the ones who were developing the oral formulation.

[00:18:50] Speaker 02:
And so when Dr. Bodor and Dandeker testified that they didn't develop the regimen, that's because they weren't looking at the oral formulation as being part of the regimen.

[00:18:59] Speaker 02:
They were just looking at the schedule.

[00:19:01] Speaker 02:
That's what they thought it meant by regimen.

[00:19:03] Speaker 02:
And they didn't develop the schedule.

[00:19:04] Speaker 02:
In fact, really, Serono didn't develop the schedule either.

[00:19:08] Speaker 02:
The schedule had been out there.

[00:19:10] Speaker 02:
It was in the other references incorporated by reference in BODOR.

[00:19:14] Speaker 02:
What was new was using the schedule for an oral dosing form.

[00:19:19] Speaker 02:
The next document is the briefing document.

[00:19:26] Speaker 02:
One other thing is that the

[00:19:32] Speaker 02:
The licensees to RONO, their obligation under the agreement was to run the clinical trials.

[00:19:37] Speaker 02:
That's why they developed a briefing document, for example.

[00:19:39] Speaker 02:
All the regulatory approvals are involved in that in Europe or in the United States or wherever they're going to run them.

[00:19:47] Speaker 02:
That's where they come up with the specific schedule, because that's what has to go into the clinical trials.

[00:19:52] Speaker 02:
You have to spell that out to get approval for it.

[00:19:54] Speaker 02:
But that was their obligation, was clinical trials.

[00:19:56] Speaker 02:
That's on page 5955 of that same joint document.

[00:20:05] Speaker 02:
The next one they point to is this briefing document.

[00:20:07] Speaker 02:
That's the document to get approval to do the, it was just a draft.

[00:20:10] Speaker 02:
I was not one to submit it, to get approval to do the clinical trials.

[00:20:15] Speaker 02:
The briefing document is not invention disclosure.

[00:20:18] Speaker 02:
It's summarizing

[00:20:19] Speaker 02:
all the work that's gone on before.

[00:20:21] Speaker 02:
It talks about the work that Scripps did before.

[00:20:24] Speaker 02:
It talks about the different safety standards.

[00:20:26] Speaker 02:
Nothing in the briefing document indicates any contribution by the named inventors to the briefing document.

[00:20:33] Speaker 02:
Now, the named inventors are listed on the first page of the cover email that distributes that briefing document.

[00:20:40] Speaker 03:
Mr. Segrist, I'm not sure that this is something that's open for me to decide, but I've been thinking about the policy implications of this.

[00:20:50] Speaker 03:
And so I understand why it makes sense that if you have two inventors on an earlier disclosure that

[00:21:02] Speaker 03:
if one of those people then tries to file a patent on it, they shouldn't be able to do that.

[00:21:08] Speaker 03:
That earlier one is by another because it was invented by the two and not just the one.

[00:21:15] Speaker 03:
I don't understand the policy ongoing the other way, which is like this case where you have, let's just assume three of the four people on the patent were the inventors in the earlier disclosure.

[00:21:28] Speaker 03:
the fourth wasn't.

[00:21:30] Speaker 03:
What policy reason is there for saying those three people who are on this other disclosure don't get the benefit of the one-year rule just because another person is added in?

[00:21:40] Speaker 03:
It still encompasses all of the inventors of the earlier one plus instead of

[00:21:47] Speaker 03:
all of the inventors minus.

[00:21:49] Speaker 03:
And it seems to me that there's different policy implications there.

[00:21:52] Speaker 02:
There may be some different policy implications, but that's the way the law.

[00:21:56] Speaker 03:
No, no, no.

[00:21:57] Speaker 03:
But that's what I want to know.

[00:21:59] Speaker 03:
I agree with you.

[00:22:00] Speaker 03:
I may not be able to do anything with this, because if I read the case law the way you read the case law, I think you might be right.

[00:22:08] Speaker 03:
But why is our case law right?

[00:22:09] Speaker 02:
Well, and part of the policy may be because the statute used to be different, right?

[00:22:14] Speaker 02:
Your patent term wasn't from filing.

[00:22:18] Speaker 02:
It was from the issue.

[00:22:19] Speaker 02:
And you could stretch things out by adding other inventors.

[00:22:22] Speaker 02:
And there were reasons for not doing that.

[00:22:24] Speaker 02:
And we've updated the statute since then with things like the Amendment 103.

[00:22:27] Speaker 02:
So if you've got a common obligation of assignment, it's not available.

[00:22:32] Speaker 02:
prior art under 103.

[00:22:34] Speaker 02:
So there have been policy positions taken to address that concern and Congress has taken notes.

[00:22:41] Speaker 02:
But there's really nothing for this court to do to change at least 60 years and probably a lot more law on having to have

[00:22:49] Speaker 02:
the same entity.

[00:22:51] Speaker 03:
So the issues we have here are, I mean, I'm sure they're going to keep coming up in pre-AIA cases, but they're not going to happen anymore in the first-to-file patents.

[00:23:04] Speaker 02:
I would think it would be less of an issue.

[00:23:08] Speaker 02:
I can't hear it to you that you'll never see something like that come up under first-to-file, but I do think it would be less of an issue.

[00:23:18] Speaker 02:
And the policy reason is once the three have put it out there and not claimed it, that goes to the public domain.

[00:23:29] Speaker 02:
And adding a fourth person then to collaborate doesn't take that out because it wasn't that inventive entities prior work that's being disclosed.

[00:23:40] Speaker 02:
So that's why you get the benefit of the one year is because it is the invented entity.

[00:23:45] Speaker 02:
that came along later that did the subsequent patent or that got the claims in the subsequent patent.

[00:23:57] Speaker 02:
I do want to go back to that briefing document and then the Amsterdam minutes because I disagree with one thing that counsel was saying.

[00:24:07] Speaker 02:
He's saying we have no evidence about or that we didn't argue

[00:24:10] Speaker 02:
that Dandeker and Vodor conceived, they did conceive the oral formulation.

[00:24:16] Speaker 02:
That's what they claimed in their patent, is the oral formulation.

[00:24:20] Speaker 02:
And we said that in our brief.

[00:24:21] Speaker 02:
I think they were cited page 27 of our response.

[00:24:24] Speaker 02:
But we didn't say there's no evidence, I think.

[00:24:28] Speaker 02:
We said they didn't come forward with evidence of who did what.

[00:24:32] Speaker 02:
We also said that Vodor and Dandeker did conceive of the oral formulation.

[00:24:41] Speaker 02:
briefing documents, nothing in that that ties it to particular inventors.

[00:24:45] Speaker 02:
Yogesh Dandekar is also listed on that cover email because he was participating in providing information to that as well.

[00:24:52] Speaker 02:
You look at the Amsterdam minutes, though this work is interesting.

[00:24:55] Speaker 02:
Dandekar is on that too.

[00:24:57] Speaker 02:
He was at that meeting.

[00:25:00] Speaker 02:
It confirms that he discussed the formulation developments and the patents that IVACS was filing.

[00:25:07] Speaker 02:
This is on page 6036 of the appendix.

[00:25:10] Speaker 02:
So they knew that the oral formulations were IVACS and that they were filing those patents.

[00:25:17] Speaker 02:
It confirms that Dandeker would make a 10-milligram tablet in addition to the 3-milligram tablet already proposed.

[00:25:26] Speaker 02:
Merck is arguing that make here just means there's simply the manufacturers of it.

[00:25:31] Speaker 02:
That's not what make means here.

[00:25:33] Speaker 02:
I'm actually the one developing oral formulations.

[00:25:36] Speaker 02:
Now, by this point, they had developed the oral formulation that was being used in tablets.

[00:25:40] Speaker 02:
So it was really just a re-machining process at that point.

[00:25:43] Speaker 02:
But they're the ones who conceived of all of that, conceived of the oral formulation forms.

[00:25:48] Speaker 02:
And that's what these claims require.

[00:25:49] Speaker 02:
I say that I'm out of time.

[00:25:51] Speaker 03:
Thank you.

[00:25:52] Speaker 03:
We've heard a lot of argument in this case, and it's been helpful, but I guess you're out of time.

[00:25:58] Speaker 03:
And Mr. Fleming, if you have specific things you want to respond to.

[00:26:01] Speaker 00:
There are only three things I'd like to say.

[00:26:04] Speaker 00:
Number one is to the extent, and I know your question didn't say this, but to the extent there's something in your mind thinking this is just going to go away once the AIA, the pre-AIA period is over, this issue could come up through 2039.

[00:26:16] Speaker 00:
It's going to be around for a while.

[00:26:18] Speaker 00:
Mr. Rosendahl's colleagues at the Stern Kessler firm wrote an article that we cite in the other case saying that pre-AIA law will govern

[00:26:25] Speaker 00:
patents with priority dates back to 2013.

[00:26:27] Speaker 00:
They're good for 20 years.

[00:26:29] Speaker 00:
It takes you to 2033, and then you have a six year look back for an infringement case.

[00:26:32] Speaker 00:
So you could go to 2039.

[00:26:34] Speaker 00:
So this is an issue that really would benefit from this court's guidance.

[00:26:38] Speaker 00:
There's been a lot of talk about applied materials, and Mr. Seagrest made an argument that

[00:26:43] Speaker 00:
You know, supposedly the earlier patent in that case fully disclosed the invention in the later patent.

[00:26:49] Speaker 00:
It's actually really interesting and really worth looking at those two patents.

[00:26:53] Speaker 00:
They're back from the time when patents were very short.

[00:26:55] Speaker 00:
They're only about five pages long.

[00:26:57] Speaker 00:
And you can see it's very clear that the second patent, which added Mr. Locke as a new inventor, comparable to the situation that's being argued here where it's supposedly Dr. DeLuca was added later.

[00:27:09] Speaker 00:
We don't agree with that, but let's assume that that's the case.

[00:27:12] Speaker 00:
The patent that includes Mr. Locke had a lot of discussion of and actually claimed crystal and wafers that have little or no crystallographic slip.

[00:27:24] Speaker 00:
None of that is in the earlier 712 patent.

[00:27:27] Speaker 00:
The 313 patent, which comes later, is remarkable.

[00:27:29] Speaker 00:
It adds two brand new figures.

[00:27:31] Speaker 00:
It has multiple paragraphs at the end of the patent.

[00:27:34] Speaker 00:
And all the language about wafers and crystals and lacking a crystallographic slip is new in the 313 patent.

[00:27:40] Speaker 00:
So there is no way

[00:27:42] Speaker 00:
that the court actually thought that the invention in the 313 patent was fully disclosed in the 712 patent.

[00:27:50] Speaker 00:
The sentence that Mr. Segress talks about starts with the word if.

[00:27:54] Speaker 00:
It is a contingent statement.

[00:27:55] Speaker 00:
It's hypothetical.

[00:27:57] Speaker 00:
And the court got to the result the way it got to it.

[00:28:00] Speaker 00:
But it is not the case that Mr. Locke's invention regarding wafers and the lack of crystallographic slip was fully disclosed in the prior disclosure.

[00:28:12] Speaker 00:
And that's why we think that case significantly helps us.

[00:28:15] Speaker 00:
And even if we're wrong about that, I've touched a little bit on the NPP, but let me just read the passages that we thought we could rely on as practitioners in front of the PTO.

[00:28:26] Speaker 00:
2136.05b, a rejection can be overcome, quote, by showing that the disclosure is a description of the inventor's or at least one joint inventor's previous work.

[00:28:37] Speaker 00:
7.1501c, a rejection may be removed by submission of evidence establishing, dot dot dot,

[00:28:44] Speaker 00:
that the knowledge of the relevant subject matter came from the inventor or at least one joint inventor.

[00:28:49] Speaker 00:
The same language appears in 716.10 and 2132.01.

[00:28:52] Speaker 00:
I know it's not binding precedent.

[00:28:55] Speaker 00:
We're not citing it that way.

[00:28:56] Speaker 00:
But we're showing that the PTO read the cases the way we read the cases.

[00:29:00] Speaker 00:
And that's what we have relied on and what patent examiners and the board, in other cases, have relied on as the correct articulation of the law.

[00:29:07] Speaker 00:
And one of the reasons for it, Your Honor, is the policy reason that Judge Hughes, you articulated in your question to counsel, which is what is the point of... It's not as though the inventors here are trying to take something away from Drs.

[00:29:18] Speaker 00:
Bodorodandiker that they rightly invented.

[00:29:20] Speaker 00:
It's not like the situation where

[00:29:21] Speaker 00:
Frankly, Dr. Katz was trying to be a sole inventor of something that his grad students arguably contributed to and put in a declaration, or King and Schwartz and Duncan Parking.

[00:29:31] Speaker 00:
Here you just have the addition of someone who contributed, arguendo, something to the ultimate patent.

[00:29:37] Speaker 00:
There is no reason to interpret the law that way.

[00:29:39] Speaker 00:
The statute just says, buy others.

[00:29:41] Speaker 00:
For Mr. Seacrest to stand up here and say, oh, Congress just wrote an unfair statute, they didn't.

[00:29:45] Speaker 00:
It just says, buy others.

[00:29:46] Speaker 00:
It's up to this court to interpret that language.

[00:29:48] Speaker 00:
And we think it's perfectly fair to interpret it the way the MPEP has interpreted it for years, or at the very least to say, you know, we're going to decide that Mr. Seagrest is right, but there was no notice of this.

[00:29:59] Speaker 00:
And therefore, Merck should be given a chance to develop a record on remand to meet the rule that is contrary to everything that had been indicated in both this court's recent cases and in the MPEP.

[00:30:10] Speaker 00:
I know there's been a lot in these cases this morning.

[00:30:12] Speaker 00:
If the court has any further questions, I'd be happy to address them.

[00:30:15] Speaker 03:
Otherwise, I thank the court very much for its attention.