[00:00:00] Speaker 04:
First case is Regents of the University of Minnesota versus Gilead Sciences, 2021-2168, from Mr. Haug.

[00:00:09] Speaker 03:
If it please the court, Edgar Haug from Haug Partners for the Appellant, the Regents of the University of Minnesota.

[00:00:17] Speaker 03:
Good morning.

[00:00:19] Speaker 03:
We seek reversal of the board's decision, finding the claims of the 830 patent

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invalid over the Sophia reference on the grounds that there was a lack of written description.

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We believe there was legal error there by the board for failing to find ipsis verbis support for challenge claim one, which is the claim one of the 830 patent.

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Ipsis verbis, this is the opposite of the provisional disclosure

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that you want to rely on as a written description of 830 is a compendium of organic chemistry.

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It's got everything in it.

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The provisional application, P1, is a very broad disclosure, no question.

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And claim one there is a very broad genus claim.

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However, the claim at issue here and the disclosure at issue here that we focus on is claim 47 with its multiple dependencies.

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Multiple dependencies.

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to possibly find the written description for 830.

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It is explicitly disclosed, Your Honor, if you start with claim 47 and you follow through those multiple dependencies, you will find, and it's clearly set forth on page 12 in our brief, that if you go through five or six dependent claims, you find all the substituents together as claimed in challenge claim one.

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Only if someone told you which of the manifold choices one should make.

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I think the patent attorneys who drafted the claim in the provisional application are informing you how to do that.

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Together with, there's also testimony from Dr. Brancalli, which is another issue on this appeal, where he says Opposa would understand

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looking at the P1 and P2 disclosures, that it would lead them right through the claims to challenge claim one.

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There's no question here, Your Honor, and I think the board got very confused here, because when you follow claim 47 with its multiple dependencies, they're disclosing many multiple sub-generic.

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And the board came to the conclusion that there was no ipsis verbis support, therefore we have to go

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to a blazemarks test.

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Legal error in that step, because under Ariad, which is controlling here, under Ariad, if you show that there are common structural features to all the species, or the subgenera in this case, within that genus, that satisfies Ariad and shows possession of the invention.

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The board here never even addressed that, and they went right to the blazemarks test.

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So would you contend that the formula one of the provisional is patentable if that were the scope of the claim?

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You mean in the original claim one, the broad claim one?

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I think it would.

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I think it would satisfy written description.

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However, the checks and balances that we are all very well aware of.

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I think you have an enablement problem, for example.

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Why would it satisfy written description?

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Because it's clearly disclosed.

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The inventor wrote out the claim and everything included in that claim.

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So that clearly evidences and shows that the inventor was in possession of that invention.

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Whether or not it's patentable is the next question.

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But here, Claim 47 is a much, much restricted, much narrower claim, even though it is by itself a broad claim, no question.

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But Claim 47 is much narrower than original Claim 1.

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And Claim 47, if you follow through the multiple dependencies, which I think the court, as a matter of law, you have to do, and the board didn't do properly,

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If you follow through, you will wind up.

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You have to come to challenge claim one.

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As I was starting to say, there are multiple other subgenera that you can also follow through, the multiple dependencies.

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However, there was an extensive debate in this case about how many embodiments are disclosed here.

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UMN, University of Minnesota, contends it's 168 subgenera, possibly 300.

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Gilead started at $7.5 million.

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Then they went down by $3 million to $4.5 million.

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And now I'm not even sure they think it matters.

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In other words, it doesn't matter.

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It's not a question of how many embodiments are embraced by claims.

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It's whether or not they're disclosed properly under Ariad, whether there's evidence within the four corners of the spectrum.

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that the inventor was in possession.

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And clearly, he was.

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determining what the invention is here so that we can ask whether there was a disclosure of possession of the invention.

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Is the invention here, the invention described on appendix 546, the present invention provides compounds that act as antiviral or anticancer agents?

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That is the invention.

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OK, so what is it about the 168

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that distinguishes them in terms of potential antiviral or anticancer properties from the broad scope of Formula 1.

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Well, again, the 168 subgenera embraced by claim 47 are much narrower than claim 1.

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And I also point out there were three other IPRs filed here by Gilead.

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I understand that it's narrower, but I'm just asking in terms of the likelihood of antiviral, anti-cancer activity.

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Is there anything in the prosecution history here that shows that the 168 are more likely to have antiviral or anticancer properties than the very broad formula 1 genes?

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I think there is.

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If you look at NP2, it explicitly describes specific values for the various different substituents that are claimed in Challenge Claim 1.

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And those specific values are taken together

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show the efficacy that claim 47, or that subgenera that we're now talking about, has for the treatment of the cancer or the tumors, as you are asking, Judge Dyke.

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And I was starting to say, there were three other IPRs here which were denied based on prior art with respect to this claim.

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A claim to a very broad genus of chemical compounds requires a representative disclosure of species within the scope of the claim.

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You're not arguing even that the provisional has that.

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The provisional has, what, maybe 23 compounds named.

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out of millions and millions within the scope of the broad claims?

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But you're not arguing specific population.

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No, we're not arguing.

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There's a variety of species.

[00:08:06] Speaker 02:
We're not.

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I think we need.

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There are no examples here within the scope of claim one of the third patent, right?

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I think that's correct in the sense that there isn't a specific example directed to that.

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There are examples using different substituents, certainly.

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And there's disclosure in NP2 for specific values that do reinforce and do set forth all the substituents that challenge claim one as taken together for the whole claim.

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It's all there.

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And the board went into this blaze marks test.

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You mean it's all there in terms of substituents, but not particular compounds?

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There are no particular, correct, other than, well, each substituent, if you take the substituent as the compound, I think those compounds are recited.

[00:08:57] Speaker 04:
Well, you've got an R1, R2, R3, 4, 7, X. And each one is a multitude of possibilities.

[00:09:05] Speaker 03:
Well, there are multiple possibilities, but it's not undue multiple possibilities.

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And again, it's a question of written description, Your Honor.

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What was the inventor in possession of what he's claiming in Challenge Claim 1?

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And when you look at Claim 1 and you put it against Claim 47 and go through the multiple dependencies, there's one-to-one correspondence.

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There's nothing missing.

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Unlike Inrei Rushik.

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unlike Fujikawa or Novozymes, which are all cases that the board relied on, cited and relied on and misapplied.

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Rushek, genus, the species claimed is not disclosed.

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Not the case here.

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The same with Fujikawa.

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There was a genus, subgenus, then they tried to claim something that was not disclosed.

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Not the case here.

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No design goes to functional limitations.

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Not the case here.

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In the 830 pattern, R2 was halo.

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In the provisional disclosure, yes, halo was there, but with a whole lot of other substituents.

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So that's hardly a description of halo in conjunction with R3 being hydroxy.

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and R5 being amino acid, when each of those, again, is described in the provisional document as consisting of an enormous number of possibilities?

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I think the claim 47 and its multiple dependent claims do call out R2, I believe it is, being halo.

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That isn't challenge claim one.

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It's right there.

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It's claimed.

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And yes, there are other alternatives in the specification.

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And this is another error the board made, because they said, well, you have to show preference.

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You have to show that halo is better than hydroxy.

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The law doesn't require that, not in written description, not under the blaze marks test at all.

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That was a mistake.

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The law requires that you have to disclose the embodiment you're claiming, which we do, together with multiple other embodiments.

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If I stay with the blaze mark analogy and Judge, Honorable Judge Rich's metaphor, blazing the trail to the tree, clearly there's a trail that goes from claim 47 and its multiple dependencies right to challenge claim one.

[00:11:28] Speaker 02:
Don't the blaze marks have to take you to compounds that have antiviral or anticancer property?

[00:11:39] Speaker 03:
Well, I think all of these compounds have that.

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There is no challenge here on utility, for example.

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There's no challenge here on enablement.

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What is the answer to my question?

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In terms of the blaze marks analysis, do you have to have blaze marks that lead you to compounds that have antiviral or anticancer properties?

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I think the answer is yes, if that's what you're claiming.

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compound that has antiviral, yes, I think the answer would be yes.

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And in this case, they clearly do have blaze marks, a blaze mark.

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As I said, and this is dealt with extensively in our briefs.

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I'm into my rebuttal time.

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It's dealt with extensively in the briefs that the board misapplied the blaze marks test.

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They required preferences.

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There were no preferences required.

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You just have to disclose it.

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And under the Burnley-Trofellis case, you only have to do that, and then a posit can select what they want.

[00:12:39] Speaker 01:
It's there.

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Are you also arguing the Blasemarks test shouldn't have been relied on at all?

[00:12:44] Speaker 03:
Yes.

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Because they should have found ipsis verbis support.

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They didn't need to get to the Blasemarks test.

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But the board found that there was no ipsis verbis support and said, therefore, we are going right to the blazemarks test.

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They skipped over Ariad and didn't look at whether there were common structural features here in these claims, which they should have done.

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And had they done that, they should have found ipsis verbis support.

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That was legal error.

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Instead, they went to the blazemarks test.

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And even the application of the blazemarks test was done erroneously.

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They added conditions to it that the law doesn't require, preferences.

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And they got into the numerical limits and started talking about 168 is too many, and they relied on rushing.

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It's not about numbers.

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It's not about numbers.

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And again, and here, and then, of course, we also take the position that they violated the APA Act, in particular, by not addressing very key arguments that were made by the parties, particularly UMN,

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about the IMAC decision, which is the same patent, which is invalidating this patent, and the same set of facts, very comparable set of facts.

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In the IMAC case, you had 12,400 compounds disclosed.

[00:14:03] Speaker 04:
Counsel, you have a blaze mark in front of you.

[00:14:06] Speaker 03:
I do.

[00:14:06] Speaker 04:
Thank you.

[00:14:08] Speaker 04:
Mr. McBride.

[00:14:10] Speaker 00:
May it please the court, Scott McBride from Bartlebeck on behalf of Gilead Sciences.

[00:14:14] Speaker 00:
Your honors, this is a case where the written description requirement worked exactly as it was intended.

[00:14:22] Speaker 00:
We have here a patent prosecution that, after 10 years in front of the Patent Office, added, for the first time, a claim to a subgenus of compounds designed to capture Gilead's then only recently developed drug compound, an approved drug compound, Cifospavir.

[00:14:37] Speaker 00:
It's a subgenus of compounds that, as a whole, is found nowhere in any of the priority documents.

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of the 24 so-called representative compounds fall within this claim subgenus.

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And there is no data for any compound within this claim subgenus.

[00:14:53] Speaker 01:
What about the argument that you can trace claim 47 back through these multiple dependent claims, and you could come up with a compound that meets the current claim?

[00:15:05] Speaker 00:
You can, your honor, with hindsight, as the board found, you can go through the sort of tangled spider web of multiple dependencies, and you can find a combination that would give the claim subgenus.

[00:15:17] Speaker 00:
But that kind of hindsight mixing and matching of choices off the laundry list of options in the multiple dependencies

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is what Fujikawa said did not give written description to any one of those choices and that this court in FWP found with similar multiple dependency formats was inadequate to provide written description for a specific subgenus or species within a subgenus.

[00:15:40] Speaker 04:
Now, counsel, if the provisional application had had this very broad genus, and if it were identical to the genus in 530, would that have been an adequate written description?

[00:15:57] Speaker 04:
I'm sorry, 830.

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Would that have been an adequate written description of the claim in 830?

[00:16:03] Speaker 00:
If they'd actually written out 830 claim one as a provisional claim in P1,

[00:16:10] Speaker 00:
It would depend, Your Honor.

[00:16:11] Speaker 00:
We'd certainly be in a different world if we'd be much closer in the sense that there would actually be ipsis verbis disclosure of the claimed subgenus.

[00:16:20] Speaker 00:
And in most, if not all, instances, that proves to be enough, especially if we're talking about ipsis verbis disclosure of a species.

[00:16:28] Speaker 00:
But I don't know that a naked ipsis-verbus disclosure would necessarily overcome all the other problems that this patent has with respect to the breadth and lack of specificity of the disclosure.

[00:16:38] Speaker 04:
And you don't think it would have needed a sufficient number of examples populating the scope of the genus?

[00:16:45] Speaker 00:
Exactly.

[00:16:45] Speaker 00:
When we talk about the highly bespoke

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fact-dependent inquiry for written description, we're looking at the context of the specification as a whole.

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And having examples within the scope of the sub-genus written out would be the kind of context that would say, yes, in our inquiry 20 years later, we would say, yes, this inventor is showing a special interest, is showing that they conceived and possessed this invention.

[00:17:09] Speaker 00:
That's exactly what's missing here.

[00:17:12] Speaker 02:
Well, is a special interest

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The test is the test of possession of the invention, whether the claim subject matter has antiviral or anti-cancer properties.

[00:17:25] Speaker 02:
It's not just, I mean, you can't get a patent on the compound without relating it to the utility.

[00:17:33] Speaker 00:
Certainly not, Your Honor.

[00:17:34] Speaker 00:
I mean, one of the requirements in whether or not it gets folded into a written description inquiry or we treat it entirely separately, it certainly would have to show some utility for the

[00:17:44] Speaker 00:
millions, billions, quadrillions of compounds that would fall within the claim.

[00:17:48] Speaker 02:
Okay, but is there anything here to suggest that the 168 are more likely to have the desired properties than the full scope of Formula 1?

[00:18:01] Speaker 00:
No, Your Honor.

[00:18:02] Speaker 00:
I mean, if you look at the data they have, they have an in vitro assay on three compounds, which has already been described and will fall within 830 Claim 1.

[00:18:11] Speaker 00:
But it's a very narrow set of compounds.

[00:18:14] Speaker 00:
I would argue it doesn't provide any guidance for a person of skill as to where, in the broad chemical space of the different 168-subgen area, you are likely, if even possible, going to find activity.

[00:18:26] Speaker 04:
But proof of utility isn't required here.

[00:18:30] Speaker 04:
Utility isn't being challenged, right?

[00:18:31] Speaker 00:
No, utility has not been challenged, Your Honor.

[00:18:33] Speaker 04:
It's written description.

[00:18:34] Speaker 00:
It's written description, which, again, it's very context-dependent, very fact-dependent inquiry.

[00:18:41] Speaker 00:
So you would be looking not just at this, in your hypothetical, not just the sort of naked ipsis verbus disclosure, where someone just wrote down a bunch of possibilities without showing anywhere else in the specification that they'd actually had possession of those.

[00:18:55] Speaker 01:
Is it this way a person with ordinary sclerosis would not think that this was disclosed because it's not ipsis verbus, it takes some effort to get there and you combine that with the fact that there's nothing saying it would hit antiviral and anticancer activity that supports the conclusion that it's not expressly or not that a fact finder could find that

[00:19:19] Speaker 01:
someone wasn't in possession of that invention.

[00:19:22] Speaker 01:
Is that what you would find, too?

[00:19:23] Speaker 00:
I would agree.

[00:19:24] Speaker 00:
You could look at that as another way of seeing this.

[00:19:28] Speaker 00:
I think, from our perspective,

[00:19:31] Speaker 00:
The lack of Ipsis verbus disclosure just screams out from the beginning, starting with Claim 47, because it only limits or makes any selections at R7 and is completely silent about everything else.

[00:19:43] Speaker 01:
I hear you, but in a simple invention, that might not be a problem.

[00:19:47] Speaker 00:
That might not be a problem, Your Honor.

[00:19:49] Speaker 00:
That's correct.

[00:19:50] Speaker 01:
Based on the context.

[00:19:51] Speaker 00:
Based on the context.

[00:19:52] Speaker 00:
Because again, we have to...

[00:19:56] Speaker 00:
We struggle here 20 years later to go back and look at a very broad disclosure of a very broad formula one genus and then this narrower but still broad claim subgenus and have to ask, you know, where in this

[00:20:09] Speaker 00:
specification of P1 and MP2, do we find some signal that the inventor believed he had conceived of and possessed and invented this particular subgenus?

[00:20:18] Speaker 00:
And the multiple dependent claims don't get us there.

[00:20:21] Speaker 00:
And you can see it even more when you turn to MP2 and the specific values, because they remove all the dependencies.

[00:20:27] Speaker 00:
So there isn't even

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There's no path whatsoever.

[00:20:30] Speaker 00:
It's literally multiple independent choices at each position with no connection between them.

[00:20:36] Speaker 00:
And the university has said that the multiple dependent claims and the specific values of NP2 are essentially one and the same.

[00:20:43] Speaker 00:
They are mirror images of each other.

[00:20:46] Speaker 00:
So Your Honor, for these reasons, unless there are any further questions, we would ask that the panel affirm the board's decision of invalidity.

[00:20:53] Speaker 04:
Thank you, Mr. McBride and Mr. Hawley.

[00:20:56] Speaker 04:
We'll give you two minutes for a follow-up.

[00:20:59] Speaker 03:
Thank you.

[00:21:00] Speaker 03:
Again, to your honor, to Judge Dyke, to your question, claim one here that we're talking about does not claim any anticancer or antiviral

[00:21:12] Speaker 03:
effects.

[00:21:13] Speaker 03:
That is a utility issue, perhaps, and maybe an enablement issue.

[00:21:17] Speaker 02:
But those are not in this case.

[00:21:19] Speaker 02:
It is described.

[00:21:23] Speaker 02:
Compounds that act as antiviral or anticancer agents.

[00:21:26] Speaker 02:
That's the invention, right?

[00:21:27] Speaker 02:
Correct.

[00:21:28] Speaker 02:
It is.

[00:21:29] Speaker 02:
And a very profound invention.

[00:21:31] Speaker 02:
You have possession of the invention, so described.

[00:21:35] Speaker 03:
It is described in the specification.

[00:21:37] Speaker 03:
Dr. Wagner did make the discovery concerning

[00:21:41] Speaker 03:
nucleoside phosphoramidates.

[00:21:43] Speaker 03:
And it's an impact on the H-HINT1 enzyme that is clearly described in the patent.

[00:21:49] Speaker 03:
It was a great discovery.

[00:21:51] Speaker 03:
And he claimed it with multiple subgenera, which is far narrower than original claim one.

[00:21:59] Speaker 03:
And I heard my colleague, I think, pretty much admit that if we just claim claim one, that might satisfy written description.

[00:22:08] Speaker 03:
Here's this huge claim.

[00:22:11] Speaker 03:
that probably is not valid, maybe, for a host of other reasons.

[00:22:16] Speaker 03:
But that's not the issue here.

[00:22:18] Speaker 03:
And that's why they did put Claim 47 in.

[00:22:21] Speaker 03:
This is typical pharmaceutical prosecution practice.

[00:22:24] Speaker 03:
You start with a big genus.

[00:22:26] Speaker 03:
You don't really expect to get a claim that broad, maybe.

[00:22:30] Speaker 03:
But then you bring it down as you continue to look, and it evolves.

[00:22:35] Speaker 03:
And that's what happened here.

[00:22:36] Speaker 03:
And Claim 47 claims the subgenera.

[00:22:39] Speaker 03:
We say 168.

[00:22:40] Speaker 03:
And just because there are 168 disclosed sub genera, clearly explicitly disclosed, it's not legally proper to say you disclosed too many, therefore you disclosed nothing.

[00:22:58] Speaker 03:
And that is what the board did here.

[00:23:00] Speaker 03:
They said, you may have disclosed one, but you also disclosed all these others.

[00:23:05] Speaker 03:
And now I can't find my way through the forest.

[00:23:07] Speaker 03:
And so therefore,

[00:23:09] Speaker 03:
Dr. Wagner lost all of his claims to all of his subgenera that have a common structural feature throughout and consistent with area.

[00:23:21] Speaker 03:
Thank you very much.

[00:23:22] Speaker 04:
Thank you, Mr. Hogan.

[00:23:24] Speaker 04:
The case is submitted.