[00:00:00] Speaker 04:
The next case is 25-1210, Merck Serrano versus Hopewell Farmer of Interest.

[00:00:07] Speaker 04:
Mr. Fleming, when you're ready.

[00:00:08] Speaker 01:
Good morning and may it please the court, Mark Fleming from Wilmer Hale together with Jennifer Graver and Gary Fox on behalf of Merck Serrano.

[00:00:16] Speaker 01:
The Merck Serono Inventors came up with a dosing regimen for multiple sclerosis different from anything the field had done.

[00:00:24] Speaker 01:
No reference alone or in combination.

[00:00:27] Speaker 01:
Disclosed treatment with these amounts of cladribine in an induction dose, followed by nothing for eight to 10 months, and then the claimed maintenance dose.

[00:00:36] Speaker 01:
And the record is clear that the IVACS scientists, doctors Bodor and Dandeker,

[00:00:41] Speaker 01:
didn't invent any dosing regimen at all.

[00:00:43] Speaker 01:
They swore under oath that they didn't.

[00:00:46] Speaker 01:
They disclosed part of the Serono inventor's method, but only part of it in their own patent application, but they didn't claim it because they derived it from the Serono inventors.

[00:00:55] Speaker 01:
The board nonetheless treated their disclosure as prior art, and that's legal error for a number of reasons.

[00:01:00] Speaker 01:
And if you agree with that, you can reverse without addressing anything else in these appeals.

[00:01:04] Speaker 01:
But the board separately erred in finding a motivation to combine and reasonable expectation of success.

[00:01:11] Speaker 01:
The most the board could say was that the claimed regimen, and specifically the claimed maintenance dose and interval, were logical, or in Hopewell's words, feasible, but not that a skilled artisan would be motivated to pursue it or reasonably expect success in doing so.

[00:01:27] Speaker 01:
Indeed, the art discouraged.

[00:01:29] Speaker 01:
the claimed method precisely because of concerns about cladribene's ineffectiveness and toxicity, nothing pointed to skilled artisan for the claimed regimen other than hindsight.

[00:01:38] Speaker 01:
So I'd like to address those two points.

[00:01:39] Speaker 01:
If time allows, I'd also address claim construction.

[00:01:42] Speaker 00:
First, the board- What's the best case to support your argument that Bodor's, is that how you pronounce it?

[00:01:47] Speaker 00:
Bodor, yeah.

[00:01:48] Speaker 00:
Yeah.

[00:01:48] Speaker 00:
Bodor's dosing regimen is not a disclosure by another.

[00:01:52] Speaker 01:
I would start with applied materials.

[00:01:55] Speaker 01:
where this court said, and I'll quote it so that we're clear about it, even though an application and a patent have been conceived by different invented entities, if they share one or more persons as joint inventors,

[00:02:06] Speaker 01:
The 102E exclusion for a patent granted to another is not necessarily satisfied.

[00:02:11] Speaker 01:
Similarly, in Allergan after that, this court considered a patent that was co-invented by two scientists, Dr. Vandenberg and Dr. Woodward.

[00:02:20] Speaker 01:
And in deciding whether the earlier references were by another or not, the court only asked whether they were the work of Dr. Vandenberg and hers alone.

[00:02:28] Speaker 01:
The court never considered nor did it matter whether Dr. Woodward had contributed to it.

[00:02:32] Speaker 01:
And here our evidence is much stronger than it was in either of those two cases.

[00:02:37] Speaker 01:
It's clear that at least one of the Merck inventors conceived of the relevant disclosure in Bodor, and it was legal error to require us to provide evidence of a specific contribution

[00:02:47] Speaker 01:
by one of the inventors, Dr. DeLuca.

[00:02:50] Speaker 01:
I'll say, though, that even if we did have a burden of production as to that, and that's the only burden we could have had as the patent owner, is a burden of production.

[00:02:59] Speaker 01:
We certainly satisfied that as well.

[00:03:01] Speaker 01:
In fact, we provided far more evidence than Dr. Katz did in the in Ray Katz case.

[00:03:06] Speaker 01:
And in Katz, this court said that his declaration was enough not just to meet a burden of production, but to win the entire case.

[00:03:13] Speaker 01:
Here we have Dr. Monoffo saying very clearly in his declaration that Dr. De Luca contributed to our development of a proposed dosing regimen and that the four inventors, including Dr. De Luca, designed the specific regimen as disclosed in Bodor.

[00:03:28] Speaker 01:
And remember, as this court said in Google versus IPA very recently,

[00:03:31] Speaker 01:
An acknowledgment of Dr. DeLuca's technical contributions doesn't need to be highly specific.

[00:03:37] Speaker 01:
In Google, all that the statement was was that the co-inventor assisted with technical problems at the application level.

[00:03:43] Speaker 00:
And here, Dr. Monopoli- What is the record support for what contribution Dr. DeLuca made?

[00:03:48] Speaker 00:
to disclosures in order.

[00:03:50] Speaker 01:
So the difficulty, Judge Cunningham, is that we were not required to show a particular form of direct evidence of specific contributions by any inventor.

[00:03:59] Speaker 01:
This is a rule of reason case.

[00:04:00] Speaker 01:
And so all we needed to show at the burden of production level was enough evidence that would support as credible Dr. Monoffo's overall account of the situation.

[00:04:10] Speaker 01:
This court said that in NFC and Fleming v. S Court and cases like that.

[00:04:13] Speaker 01:
And so if you compare it to what was done in Google versus IPA, for instance, not only was there Dr. Munafo's declaration, which explicitly states in paragraphs 21 and 34 that Dr. DeLuca contributed to the dosing regimen, you also have his testimony being corroborated by the Amsterdam minutes and the briefing document from December 2003.

[00:04:35] Speaker 01:
You also have the fact that before Amsterdam, Dr. Bodor filed two provisionals that didn't include the dosing regimen

[00:04:43] Speaker 01:
at all.

[00:04:44] Speaker 01:
The dosing regimen only came into the vote order.

[00:04:46] Speaker 00:
So is it fair to say, then, that you can't separately identify to me what Dr. DeLuca's contribution would have been?

[00:04:52] Speaker 01:
I mean, on this record, I can't, because we didn't think we had to.

[00:04:56] Speaker 01:
And we don't think, under the law, that we have to.

[00:04:59] Speaker 01:
The rule of reason, I mean, this court said in NFC, there's no particular formula that an inventor must follow.

[00:05:05] Speaker 01:
We don't need a high degree of corroboration.

[00:05:08] Speaker 01:
We certainly don't need specific evidence of each inventor's

[00:05:11] Speaker 01:
contribution.

[00:05:12] Speaker 01:
This isn't a correction of inventorship case under Section 256, right?

[00:05:16] Speaker 01:
And when you look at the Patent Office's practice in the MPEP and the other cases that we identified, none of them have situations that break out by inventor the specific contributions.

[00:05:27] Speaker 01:
It's sufficient to just say, particularly when we're just talking about a burden of production, here is evidence that if believed will show that each of these people contributed to the disclosure.

[00:05:37] Speaker 01:
Now, if they had evidence on the other side, maybe they could carry their burden of persuasion.

[00:05:41] Speaker 01:
But I'll note, neither appellee, not Hopewell in this case and not TWI in the next case, put in any evidence on the other side suggesting that anybody else contributed to this disclosure.

[00:05:53] Speaker 01:
And certainly not that Dr. DeLuca didn't contribute to it.

[00:05:55] Speaker 01:
So you have all the evidence on this is on our side, nothing whatsoever on the other side.

[00:06:00] Speaker 01:
And when you're talking about a burden of production, which is all that we had as patent owner, we certainly met that and the board erred in finding otherwise.

[00:06:07] Speaker 01:
Now, if you disagree with me on that, at the very least, we were entitled to notice that the board was going to adopt a rule different from what the agency had previously said was the rule in the NPEP so that we could develop a record that Judge Cunningham might answer the specific question that you just asked me.

[00:06:23] Speaker 01:
This record doesn't answer it because we didn't think we had to.

[00:06:27] Speaker 01:
There's one other point on this that needs to be addressed, and that's the board's alternative finding under the Duncan parking case that doctors Bodor and Dandeker supposedly actually did themselves contribute to the dosing regimen, even though they denied under oath that they didn't do that.

[00:06:42] Speaker 01:
There were two legal errors in the board's analysis.

[00:06:46] Speaker 01:
One is at the first step of the Duncan parking case, the board should have confined its inquiry to the portions of Bodor that were relied on as prior art

[00:06:55] Speaker 01:
to read onto Merck's claim limitations.

[00:06:58] Speaker 01:
The board incorrectly expanded its view to look at material that Hopewell had cited as evidence of motivation to combine and reasonable expectation of success.

[00:07:07] Speaker 01:
Nobody has cited any case suggesting that that's proper, and it would produce absurd results because you'd have a situation where the same reference might be prior art to the same patent claim

[00:07:17] Speaker 01:
in an obviousness case but not in an anticipation case because of course motivation to combine and reasonable expectation of success are irrelevant when it comes to anticipation.

[00:07:25] Speaker 01:
That's relevant here actually because TWI, the appellee in the next case, is raising an anticipation challenge.

[00:07:32] Speaker 01:
And so you could have a situation where in analyzing, in doing the Duncan parking analysis, you'd be looking at a different corpus of material for one challenge versus another, and you'd wind up with a situation where the same reference was and was not prior art, depending on whether you were talking about 102 or 103.

[00:07:47] Speaker 01:
That would be absurd.

[00:07:48] Speaker 01:
I know of no case that allows that.

[00:07:50] Speaker 01:
It would certainly be a terrible idea.

[00:07:51] Speaker 01:
At the second step of Duncan Parking, Hopewell failed to show that the idea of a 10-milligram dose of cladribine was conceived by either Dr. Bode or Dr. Dandeker.

[00:08:04] Speaker 01:
The most that they pointed to was evidence that they made the tablet after the Serono team told them to do it.

[00:08:12] Speaker 01:
And in fact, the most that Hopewell, and for that matter TWI, can argue

[00:08:16] Speaker 01:
is that the record is silent.

[00:08:18] Speaker 01:
We don't know who came up with the idea for a 10-milligram dose.

[00:08:22] Speaker 01:
Well, if the record is silent, that means they can't carry their burden of persuasion.

[00:08:25] Speaker 01:
A record in equipoise supports us as the patent owner.

[00:08:28] Speaker 01:
It is fatal to their position.

[00:08:30] Speaker 01:
But we think there's plenty of evidence that it was Dr. Monoffo and his colleagues at Serono who conceived of the 10-milligram dose.

[00:08:36] Speaker 01:
The Amsterdam minutes show that the IVAC scientists were working on 3 milligrams until they were told by Serono, start working on 10 milligrams, and then they continued with that.

[00:08:45] Speaker 02:
Going back to by another issue, as I understand it, the board felt that there was just insufficient evidence to show Dr. DeLuca's contribution to the disclosure in the vote over of reference.

[00:09:03] Speaker 02:
And that that meant that that disclosure was by a different inventive entity.

[00:09:12] Speaker 02:
What's wrong with that?

[00:09:13] Speaker 01:
So there are two things wrong with that, Your Honor.

[00:09:16] Speaker 01:
The first is that that's not the test.

[00:09:19] Speaker 01:
As in the cases that I exerted in responding to Judge Cunningham's question, as long as one or more joint inventors contributed or conceived of the relevant Bodor disclosure, that's enough.

[00:09:31] Speaker 01:
And that's what we proved by showing that Dr. Munafo, and also Dr. ETA, and Dr. Lopez Bresnahan contributed to that.

[00:09:37] Speaker 01:
We weren't required to show anything specific as to Dr. Bodor.

[00:09:40] Speaker 01:
But even if you disagree with me on that, the alternative is,

[00:09:43] Speaker 01:
We did put in enough evidence for a burden of production.

[00:09:47] Speaker 01:
Judge Lynn, you're absolutely right as to what the board purported to find, which is we didn't show what Dr. DeLuca contributed.

[00:09:53] Speaker 01:
We were not required to show anything.

[00:09:56] Speaker 01:
All we were required to do as a burden of production was to put forward enough evidence that, if taken as true,

[00:10:04] Speaker 01:
would support Dr. Monoffo's statement, which he makes unequivocally in paragraph 34 of his declaration on page 7586 of the appendix, that he and Dr. Lopez-Breznahan, with the support of doctors ETA and DeLuca, designed a regiment for treating MS

[00:10:20] Speaker 01:
By administering oral cladribene 10-milligram tablets five to seven days per month, two months, followed by the 10-month cladribene-free period, that's the Bodor disclosure.

[00:10:29] Speaker 01:
If you believe that, we have met whatever burden of production we could possibly have had.

[00:10:33] Speaker 01:
In fact, if you believe it, then they've failed to carry their burden of persuasion.

[00:10:37] Speaker 01:
The problem is that the board required us to prove our case at a time when all we had to do was provide a burden of production.

[00:10:43] Speaker 01:
under a rule that we thought, the NPEP rule, suggested we didn't need to prove what Dr. or didn't even need to put in evidence as to what Dr. DeLuca had done.

[00:10:51] Speaker 01:
With respect to non-obviousness, if I may, obviously if the court reverses because Bodor is in prior art, you don't need to think about obviousness because all of the invalidity grounds here depend on Bodor being prior art.

[00:11:03] Speaker 01:
In the alternative, though, there are legal errors in the obviousness analysis.

[00:11:07] Speaker 01:
And the primary one is, the most the board could say is that it would have been logical, or within the artisan's skill, or there were reasons to consider using Bodor's disclosure as a starting point for the maintenance dose.

[00:11:21] Speaker 01:
Remember, the claimed regimen here is an unusual dosing regimen.

[00:11:25] Speaker 01:
And it's not just saying, you know,

[00:11:26] Speaker 01:
take a pill that used to be taken once a week, cut it in half, and take it twice a week.

[00:11:29] Speaker 01:
This is very unusual.

[00:11:30] Speaker 01:
It says take the pill five times in the first week, then pause until the next month, take it five times in the second week, then take nothing for eight to ten months, and then start again and do the regimen again.

[00:11:44] Speaker 01:
using the same dosing interval.

[00:11:46] Speaker 01:
Nobody was doing that and there was no motivation that could have been found to do that under a proper analysis because nothing in the prior art gave you a reason to retreat with cladribine at the claimed dose using the same frequency.

[00:11:58] Speaker 01:
There were an infinite number of possibilities you could have chosen.

[00:12:02] Speaker 01:
for a maintenance period after the cladribine-free period, the studies that did do re-treatment, and there aren't many of them, but the ones that are in the record did so either at a much lower dose, like stelmasiac, or much later, at least 12 months later, up to 22 months later in rice, or only if there was disease progression, such that the patient was getting worse and he needed to do something, like rice and romaine.

[00:12:25] Speaker 01:
And the board recognized the reason

[00:12:27] Speaker 01:
that the art was so cautious about retreatment with cladribine was because of safety concerns with its use.

[00:12:32] Speaker 01:
It was known to have toxicity problems.

[00:12:34] Speaker 01:
The board ignored all these cautions, ignored all these concerns, and simply said, citing no evidence, that retreating at the claimed dose and the claimed interval, that's how it would happen.

[00:12:44] Speaker 01:
That was throwing darts at a dartboard with the benefit of hindsight only.

[00:12:48] Speaker 01:
And it's similar with respect to reasonable expectation of success.

[00:12:52] Speaker 01:
All the board said, this is page 63 of the appendix, was that a skilled artisan would have optimized the duration and dosing of the maintenance period as appropriate.

[00:13:01] Speaker 01:
This reminds me of nothing so much as the court's decision in in re cyclobenzaprine, where it may have been obvious to experiment with this, modifying parameters as appropriate, but nothing indicates a reasonable expectation that an experiment like this would succeed.

[00:13:14] Speaker 01:
There were so many options that could have been chosen and widespread skepticism in the field about it.

[00:13:20] Speaker 01:
I would say one, I see I'm into the rebuttal time, so I don't want to overstay my welcome.

[00:13:25] Speaker 01:
I'll just say one thing about claim construction, if I may.

[00:13:28] Speaker 01:
The claims are recognized, and the board initially recognized,

[00:13:32] Speaker 01:
in the TWI IPRs that the total dosage is based on the weight of the patient.

[00:13:36] Speaker 01:
It's expressed in milligrams per kilogram.

[00:13:38] Speaker 01:
Everybody in the field knows that's dosing based on the weight of the patient.

[00:13:43] Speaker 01:
The specification makes clear that the dose is selected based on patient weight.

[00:13:48] Speaker 01:
They have no response to the intrinsic evidence.

[00:13:50] Speaker 01:
The board wrongly thought we were trying to import a limitation.

[00:13:53] Speaker 01:
Of course, we're not trying to do that.

[00:13:54] Speaker 01:
Just because a claimed invention typically takes place in a particular environment doesn't mean you're trying to add limitations.

[00:14:00] Speaker 01:
It's Rambas versus Infineon.

[00:14:02] Speaker 01:
So we would suggest that, at the very least, the court should remand for reconsideration under the correct claim construction.

[00:14:09] Speaker 01:
But we believe the easiest way through this case, and both these cases, frankly, is to reverse and say that Bodor is not prior art.

[00:14:15] Speaker 01:
With the court's permission, I deserve the balance of my time.

[00:14:18] Speaker 04:
Thank you, Mr. Flome.

[00:14:21] Speaker 04:
Mr. Siegfried?

[00:14:28] Speaker 05:
May it please the court, JC Rosendahl on behalf of Hopewell.

[00:14:31] Speaker 04:
Oh, sorry.

[00:14:33] Speaker 04:
I'm on the wrong case.

[00:14:35] Speaker 04:
I moved on.

[00:14:36] Speaker 04:
Thank you, Mr. Rosendahl.

[00:14:38] Speaker 05:
Merck's appeal is built on a proposed legal rule about the meaning of by another that defies almost 60 years of precedent from this court and its predecessor.

[00:14:50] Speaker 05:
But the court doesn't even need to address that rule in order to affirm the board's finding of obviousness here, because Merck's proposed new legal rule only deals with half of its problem.

[00:15:00] Speaker 05:
Merck's new legal rule is designed to address the problem that Dr. DeLuca, who was Merck's chief IP counsel, has made no discernible contribution to the relevant portions of the boat order reference.

[00:15:12] Speaker 05:
But even under Merck's new rule, they would still have to deal with the board's findings, but Drs.

[00:15:18] Speaker 05:
Boder and Dandeker did contribute to the relevant portions of the records, of which they were, of course, the named authors.

[00:15:25] Speaker 05:
And there's ample evidence in the record to support those findings.

[00:15:30] Speaker 03:
Did they specifically disclaim any involvement?

[00:15:34] Speaker 03:
in the part of the reference that is at issue?

[00:15:39] Speaker 05:
No.

[00:15:39] Speaker 05:
What they said was they did say that they were not inventors of the dosing regimen.

[00:15:45] Speaker 05:
They also said in their depositions, however, that they were not lawyers.

[00:15:49] Speaker 05:
They didn't understand what the meaning of inventorship is as a legal matter.

[00:15:54] Speaker 05:
And we have testimony from Dr. Mnafo, who is a named inventor on the challenge claims, who said that the specific dosage form from Boder and Dandeker was something that was considered

[00:16:04] Speaker 05:
in the development of the regimen, which of course makes sense, because how are you going to figure out how to dose something if you don't know what it is that you're dosing?

[00:16:11] Speaker 05:
And so when we look at the famous six-line passage that's in dispute here,

[00:16:16] Speaker 05:
Right in the middle of the passage is it's envisioned that for the treatment of multiple sclerosis, 10 milligrams of cladribine in the instant complex cladribine cyclodextrin complex in the instant solid dosage form will be administered, and it goes on.

[00:16:32] Speaker 05:
And as the board correctly observed, if you take out the part about the 10 milligrams of cladribine in the instant dosage form, you have six lines that don't make any sense.

[00:16:42] Speaker 05:
So to say that they didn't contribute

[00:16:44] Speaker 05:
to the part of the reference that we're relying on just doesn't make sense.

[00:16:49] Speaker 04:
So let's assume I don't buy that argument, but I do agree with you on the board's application and the law as to inventorship that it requires all four to be shown as inventors in that portion of Godor.

[00:17:05] Speaker 04:
What about

[00:17:06] Speaker 04:
their argument that there's plenty of evidence that was put forth by them that's sufficient to establish by the rule of reason that Dr. DeLuca

[00:17:19] Speaker 04:
was part of that portion of Bodor.

[00:17:25] Speaker 04:
This is a substantial evidence question, I think.

[00:17:28] Speaker 04:
Is it?

[00:17:28] Speaker 05:
Well, no, Your Honor.

[00:17:30] Speaker 05:
Actually, it's... Really?

[00:17:32] Speaker 04:
Well, I thought that was helpful to you.

[00:17:35] Speaker 04:
Hang on.

[00:17:36] Speaker 05:
I just want to be clear about what the standard is.

[00:17:38] Speaker 05:
The question of

[00:17:39] Speaker 05:
who contributed to the relevant portion of Bodor, this court has treated as analogous to the question of inventorship as a question of law based on underlying facts.

[00:17:49] Speaker 05:
And of course the underlying facts are of course then.

[00:17:52] Speaker 04:
I think Mr. Fleming argued that even if the board got the law right that the board got the fact wrong because Mr. DeLuca did

[00:18:01] Speaker 04:
based upon some of the evidence put forth contribute to BODOR.

[00:18:06] Speaker 04:
Is the board's decision on that, which I think they said he didn't, supported by substantial evidence?

[00:18:13] Speaker 04:
What is that evidence?

[00:18:14] Speaker 05:
Yes, the board's decision on that is supported by ample substantial evidence.

[00:18:18] Speaker 05:
The only evidence that they have

[00:18:23] Speaker 05:
to support the idea that De Luca contributed anything is a conclusory statement from Munafo, one of the inventors, that essentially De Luca was on the team.

[00:18:34] Speaker 05:
All right, now this court has required corroboration of conclusory statements of inventorship.

[00:18:40] Speaker 05:
And in this case, we don't have any corroboration.

[00:18:43] Speaker 05:
In fact, when he was deposed, Dr. Munafo, who is the source of the supposed contribution by De Luca, said that

[00:18:54] Speaker 05:
Well, what he said, Dr. Monoffo, at 4884-85 at his deposition, he said he was not able

[00:19:23] Speaker 05:
He said, he said to Luca.

[00:19:25] Speaker 05:
I'm on page 4884, De Luca was working in the company Serono for long, but in a department remote to mine.

[00:19:31] Speaker 05:
I'm not able to say in detail what his contribution was.

[00:19:34] Speaker 05:
And then there were some objections.

[00:19:35] Speaker 05:
And then on page 4885, he said, as I said, his department was remote to mine.

[00:19:40] Speaker 05:
I'm not aware of his, how you call it, personal intellectual contribution.

[00:19:44] Speaker 05:
I cannot give details on that besides the fact that his department was also represented in the project team.

[00:19:52] Speaker 05:
So what we know is that,

[00:19:54] Speaker 05:
Dr. DeLuca's team somehow was involved in the project.

[00:19:59] Speaker 05:
And we know that it was a big team because Dr. Munafo at Appendix 75-79 said, my team at Ceromo included my co-inventors and many others.

[00:20:09] Speaker 05:
So the mere fact that people were on the team doesn't tell us that they were contributing in any meaningful way to Bodor.

[00:20:16] Speaker 05:
And then when we asked, well, what shows that DeLuca contributed anything to Bodor, they point to two potentially corroborating documents.

[00:20:23] Speaker 05:
One of them is draft minutes from a meeting that Dr. DeLuca did not attend.

[00:20:28] Speaker 05:
And the only thing that the meeting minutes have to say about him, there's the mention of a deluca.

[00:20:35] Speaker 05:
It's not clear that it's the same deluca.

[00:20:37] Speaker 05:
And what it says is that someone is supposed to facilitate contact with this deluca, which suggests that he's not been involved in any way up to that point.

[00:20:45] Speaker 05:
And then we have another briefing document about cladribine that doesn't mention him at all.

[00:20:51] Speaker 05:
That's it.

[00:20:54] Speaker 05:
Boder and Dandeker said they didn't know anything about DeLuca.

[00:20:57] Speaker 05:
There's no evidence of any contribution by him other than that his department was somehow represented on the large project team that admittedly involved a lot of people other than the named inventors.

[00:21:09] Speaker 04:
Can I take you back to the legal standard now?

[00:21:13] Speaker 04:
Mr. Fleming cited a couple of cases that he said, from us, it supports the view that only one inventor has to have overlap between the two references for it to be not by another.

[00:21:25] Speaker 04:
What's your best case law to support your position?

[00:21:29] Speaker 05:
Well, the granddaddy of all cases is Inray Land from this court's predecessor in the 1960s.

[00:21:36] Speaker 05:
And if the rule were, as Merck

[00:21:39] Speaker 05:
uh... is suggesting that in really and could not have come out the way that it came out right that was a case where uh... landon rogers renamed inventors on the challenge patent

[00:21:48] Speaker 05:
There was a prior art patent to Land.

[00:21:50] Speaker 05:
There was a prior art patent to Rogers.

[00:21:52] Speaker 05:
And it was found that both of those were by another with respect to the Land and Rogers invention.

[00:21:58] Speaker 05:
So the proposition that it's enough to have just one co-inventor and you get home free is not the law, and it never has been.

[00:22:06] Speaker 05:
This court stated in Riverwood in 2003, and again

[00:22:11] Speaker 05:
quoted the same passage in American in 2017, what is significant is not merely the differences in the listed inventors, but whether the portions of the reference relied on his prior arc and the subject matter of the claims in question represent the work of a common inventive entity.

[00:22:29] Speaker 05:
And it's clear that common inventive entity means the exact same set of.

[00:22:33] Speaker 05:
So it's black-letter law that you have to have the same people.

[00:22:36] Speaker 02:
I'm happy to... We have a statement in Applied Materials that even though an application and a patent have been conceived by different inventive entities, if they share one or more persons as joint inventors, the 102E exclusion for a patent granted to another is not necessarily satisfied.

[00:22:56] Speaker 02:
Now that's 102E, and you're talking about one inventor.

[00:23:02] Speaker 05:
Right, but what that means is that if you look at the prior art and they have the same inventive entity or one common inventor, the question still remains.

[00:23:25] Speaker 05:
Let me back up.

[00:23:28] Speaker 05:
The first thing that you need to do in the analysis is see whether they have the same inventive entity or not.

[00:23:33] Speaker 05:
And if it turns out that they do, usually the analysis is done.

[00:23:39] Speaker 05:
If it turns out that the prior art reference has a different inventive entity, then the question becomes, who is responsible for the disclosure of the particular portions that are being relied on for the invalidity challenge?

[00:23:52] Speaker 05:
That's the lesson of this court's cases.

[00:23:54] Speaker 02:
Well, Mr. Fleming suggests that it would be satisfied if there was at least one in the prior document.

[00:24:01] Speaker 05:
No, but the point is, this is the sort of the sleight of hand that appears repeatedly in Merck's arguments on this point.

[00:24:09] Speaker 05:
What the court says is, first you look to see if the inventive entities are the same.

[00:24:13] Speaker 05:
If they're not the same, that doesn't mean that the inquiry is over.

[00:24:19] Speaker 05:
What it means is that you then need to go and figure out for the particular disclosures that are at issue whether the inventive entities are the same.

[00:24:27] Speaker 02:
And this is what LAND stands for.

[00:24:29] Speaker 05:
And this is what LAND stands for.

[00:24:30] Speaker 05:
And it's also in the two cases that

[00:24:35] Speaker 04:
So hypothetically in this case, if, and I don't think they tried to show this, but if they'd shown that even though Dr. DeLuca was named on the patent, that the three people, other people, were the ones, the only ones that were the inventors of the specific claims or whatever we're talking about here that's repeated in Bodor, that that might be not by another.

[00:25:03] Speaker 04:
Maybe Dr. DeLuca didn't contribute to that specific part.

[00:25:07] Speaker 04:
He contributed to something else.

[00:25:09] Speaker 04:
But they did an attempt to show that Dr. DeLuca didn't contribute.

[00:25:13] Speaker 04:
I think their argument is that he did.

[00:25:16] Speaker 05:
Your Honor is absolutely right on all of that.

[00:25:19] Speaker 05:
They have never suggested that DeLuca did not contribute to all of the claims that are of interest.

[00:25:24] Speaker 05:
And the point that Your Honor has just made, I think, is illustrated

[00:25:27] Speaker 05:
in footnote two of this court's decision in Duncan Parking.

[00:25:31] Speaker 05:
What we saw there was a situation where there was a patent to King, Hunter, Hall, and Jones.

[00:25:40] Speaker 05:
And the prior art was by King and Schwartz.

[00:25:44] Speaker 05:
And what the court found, or what the board found and the court accepted, was that some of the claims were actually the work of King alone, and in order to

[00:25:56] Speaker 05:
to make the prior art

[00:25:59] Speaker 05:
The relevant question for those claims was, did King contribute alone to the prior art disclosure?

[00:26:06] Speaker 05:
And for the other claims, which were admittedly by King, Hunter, Hall, and Jones, the question was, did the portion of the prior art that was relevant, was that the work of King, Hunter, Hall, and Jones?

[00:26:16] Speaker 05:
And so you're always looking sort of piece by piece at who contributed to which claims and who contributed to the parts that are being used to render invalid those claims.

[00:26:27] Speaker 00:
What I also thought I heard a Postal Counsel arguing, though, was which one of you needs to actually give that information in terms of who contributed.

[00:26:36] Speaker 00:
I sense that, and maybe he'll be able to clarify it on rebuttal, that he would say, you should be the party in charge of that as opposed to him.

[00:26:45] Speaker 00:
But I want you to respond directly to that.

[00:26:46] Speaker 05:
Sure.

[00:26:46] Speaker 05:
Under the burden shifting framework that this court set out in Google,

[00:26:51] Speaker 05:
Obviously the burden is on us at the end of the day to prove invalidity.

[00:26:55] Speaker 05:
The burden is also on us to come up with a prima facie case that the prior artist by another.

[00:26:59] Speaker 05:
We satisfied that burden easily here because Boder and Dandeker are named on the prior art.

[00:27:03] Speaker 05:
They're not named on the challenge claims.

[00:27:05] Speaker 05:
Then the burden shifts to them, and the burden is to go forward with evidence that, if credited, would be sufficient to show that the relevant inventive entity is responsible for the relevant portions of the document.

[00:27:21] Speaker 05:
And what they need to show is told to us by Duncan Parking.

[00:27:24] Speaker 05:
They need to show that the other person's contribution is significant enough

[00:27:28] Speaker 05:
to render him a joint inventor of the applied portions of the reference patent.

[00:27:33] Speaker 05:
That's what's missing here.

[00:27:35] Speaker 05:
In the Google case itself, I was surprised to hear my friend invoke that as an example of the rule of reason, because in that case, the would-be additional inventor, Dr. Moran, was an author on the main prior art reference.

[00:27:51] Speaker 05:
He also put in a declaration explaining his contributions to the claimed invention.

[00:27:58] Speaker 05:
the other inventors admitted that he had made a contribution both to the reference and to the invention.

[00:28:05] Speaker 05:
And what Merck is trying to read that case for is like, oh, well, all the inventors have to say is, well, they made some contribution.

[00:28:12] Speaker 05:
That would be true if Dr. DeLuca were an author of Bodor.

[00:28:15] Speaker 05:
And if he had put in a declaration explaining in detail his contribution to Bodor, this would be a very different case.

[00:28:21] Speaker 05:
But to suggest that a conclusory declaration by an inventor that somebody's department was represented on a team is enough to satisfy the Duncan parking standard, I think, is not something that the court should accept.

[00:28:35] Speaker 05:
I have only a little bit of time left.

[00:28:37] Speaker 05:
I'm happy to very quickly address the question of obviousness and claim construction.

[00:28:46] Speaker 05:
This is essentially a battle of the experts, and the board credited our experts' testimony that there would have been ample reasons for people to consider retreating.

[00:28:55] Speaker 05:
I think the fundamental issue here is that multiple sclerosis is a chronic disease, and cladribine is known from the prior art to have only temporary effects.

[00:29:07] Speaker 05:
And so we see in the prior art that people who were treated with cladribine do well for

[00:29:12] Speaker 05:
And then they tend to relapse.

[00:29:14] Speaker 05:
And there is ample testimony that one would retreat people in order to not only to treat the relapses, but to reduce the rate of relapse and to prevent future relapses.

[00:29:24] Speaker 05:
And the way that the dose would be optimized would be by measuring lymphocyte counts, which everyone agrees is a standard measure that is taken in multiple sclerosis patients.

[00:29:35] Speaker 05:
And at the risk of oversimplifying somewhat,

[00:29:38] Speaker 05:
You'd like to give as much of this stuff as you can to people without degrading their immune systems to the point where they have problems with their immune system.

[00:29:47] Speaker 05:
I see that I'm out of time.

[00:29:48] Speaker 05:
If the court has any questions about claim construction, I'm happy to address them.

[00:29:51] Speaker 04:
Thank you.

[00:29:58] Speaker 04:
Mr. Philbing, you've got about a minute, but I'll give you a little leeway on the inventorship

[00:30:05] Speaker 04:
issues if you promise not to completely repeat your arguments again in the next case.

[00:30:10] Speaker 01:
The last thing I want to do is do not plan to repeat anything.

[00:30:14] Speaker 01:
And if I do, you can call me on it as I know you will.

[00:30:19] Speaker 01:
I'd like to start, Judge Hughes, if I may, with the hypothetical that you asked my colleague, and try to answer it this way.

[00:30:25] Speaker 01:
The whole reason we didn't try to show that Dr. DeLuca contributed to the patent claims as opposed to the disclosure is it doesn't really matter.

[00:30:35] Speaker 01:
Assume you're right.

[00:30:36] Speaker 01:
Assume that your hypothetical is correct, that the three co-inventors contributed to what's in the Bodor disclosure and that Dr. DeLuca contributed to what else was in the patent claims.

[00:30:46] Speaker 01:
What would be the point of withholding a patent in that circumstance?

[00:30:50] Speaker 01:
you'd just be punishing the three co-inventors for collaborating with Dr. De Luca on what was later claimed and what they invented, and what Dr. Boder and Dandeker have expressly said, we did not invent, we didn't claim.

[00:31:01] Speaker 01:
This is a dosing regimen.

[00:31:02] Speaker 01:
The Serono team was working on that.

[00:31:04] Speaker 01:
So there's no policy reason for the approach that's being put forward here.

[00:31:09] Speaker 01:
Judge Lin, in Ray Land, the holding, the core reasoning of that case is you look at the facts, you look at the evidence.

[00:31:16] Speaker 01:
Land was a highly idiosyncratic case.

[00:31:18] Speaker 01:
It was Mr. Land's and Mr. Rogers' own prior patent that was being asserted against their effort to extend their monopoly by coming in jointly.

[00:31:26] Speaker 01:
Frankly, I think it would be very good for this court to clear up the law in this area because there have been a number of different articulations of the right standard.

[00:31:34] Speaker 01:
At the very least, we think the language that I quoted in Judge Lynn that you repeated from applied material suggested that our reading of it was reasonable and the MPEP's reading of it was reasonable.

[00:31:44] Speaker 01:
If we were wrong about it, the APA allowed us the right to have notice of it so we could develop the record that my colleague now suggests that we should have

[00:31:51] Speaker 02:
I will certainly give you the argument that this is not as clear as it could be.

[00:31:58] Speaker 01:
That's an understatement, Judge Lynn.

[00:31:59] Speaker 01:
I completely agree with that.

[00:32:01] Speaker 01:
With respect to the Bodor Declaration, so what we've been calling the Duncan parking issue, which is of course a separate issue,

[00:32:07] Speaker 01:
Towards the end of his argument, Mr. Rosanel was suggesting that Duncan parking was somehow relevant to whether Dr. DeLuca contributed to the disclosure.

[00:32:14] Speaker 01:
That's two different issues.

[00:32:16] Speaker 01:
The Duncan parking question is whether Dr. Bodor or Dr. Dandeker contributed to the dosing regimen, even though they said under oath that they didn't.

[00:32:25] Speaker 01:
I'll point out, he mentioned the cyclodextrin complex that doctors Boder and Daniker did try to patent.

[00:32:31] Speaker 01:
That's not claimed in our patent.

[00:32:32] Speaker 01:
That's the whole point.

[00:32:33] Speaker 01:
This is like in Ray Matthews, right?

[00:32:35] Speaker 01:
Mr. Matthews invents a circuit.

[00:32:37] Speaker 01:
Mr. Dewey invents a protective device.

[00:32:39] Speaker 01:
He discloses a protective device and says this works very well with the Matthews circuit.

[00:32:43] Speaker 01:
That's not prior art to Matthews because he's just disclosing what Dr. Matthews came up with.

[00:32:48] Speaker 01:
When they invent a cyclodextrin complex and they disclose that, but then they say this will work well in this dosing method,

[00:32:54] Speaker 01:
That's not prior art to the inventors who came up with the dosing method.

[00:32:58] Speaker 01:
This wasn't a battle of the experts because there simply was, and it's very notable, Mr. Rosendahl was very careful.

[00:33:06] Speaker 01:
He said that the art showed that you would retreat with cladriby.

[00:33:11] Speaker 01:
Now I'm willing to spot him that, arguendo.

[00:33:13] Speaker 01:
Let's assume he's right about that.

[00:33:14] Speaker 01:
that the prior art indicated you should retreat with cladribine.

[00:33:18] Speaker 01:
Nothing suggested that you should retreat at this particular dose using this particular interval over this particular period of time.

[00:33:26] Speaker 01:
All of the references approached it in a different way, either with a smaller dose, or waiting longer because of the toxicity effects, or doing it only when the patient got worse and needed something.

[00:33:37] Speaker 01:
This lymphocyte level argument, the idea that you could optimize by looking at the patient's lymphocyte levels,

[00:33:44] Speaker 01:
The board and their own expert, Dr. Miller, admitted lymphocyte levels don't tell you anything about whether the disease is being treated.

[00:33:52] Speaker 01:
It doesn't correlate to efficacy.

[00:33:54] Speaker 01:
So saying that there's a connection between how much cladribine you take and your lymphocyte levels does not tell you whether the disease is being treated.

[00:34:01] Speaker 01:
And remember, this is an issue of motivation to combine.

[00:34:03] Speaker 01:
Why would a skilled artisan

[00:34:05] Speaker 01:
say, I'm going to retreat at this particular level and watch the lymphocyte levels if that's not going to tell me whether my patient is going to get better or not.

[00:34:15] Speaker 01:
This is just, once again, throwing darts at a dartboard.

[00:34:17] Speaker 01:
It's in-ray cyclobenzaprine.

[00:34:19] Speaker 01:
The board erred in law as a legal matter in reaching this conclusion.

[00:34:23] Speaker 01:
We didn't hear anything about claim construction.

[00:34:25] Speaker 01:
I may have an opportunity in the next case to address that further if needed.

[00:34:28] Speaker 01:
Unless the court has questions at this time, we'll be seeing you again very shortly.

[00:34:32] Speaker 01:
Thank you.

[00:34:33] Speaker 01:
Thank you, Your Honor.

[00:34:34] Speaker 04:
Thank you both, Counselor.

[00:34:34] Speaker 04:
The case is submitted.