[00:00:35] Speaker 05:
Morning, your honors.

[00:00:38] Speaker 05:
Thomas Fletcher for the Appellant Genentech.

[00:00:44] Speaker 05:
The board here committed two errors.

[00:00:46] Speaker 05:
It construed the patent erroneously, and even if your honors were to find that its construction were correct, its obviousness analysis was deficient.

[00:00:57] Speaker 05:
I'll start off with the claim construction error.

[00:01:01] Speaker 05:
The patented issue here concerns the use of an anti-cancer therapy.

[00:01:07] Speaker 00:
Well, let me just go into the claim construction here.

[00:01:09] Speaker 00:
I'm having a hard time.

[00:01:11] Speaker 00:
I guess I understand maybe it's a little confusing about what the board said, because I think what the board's construction that it adopted, if you put Hespera's construction, your construction, and the board's construction, the board's construction seems really

[00:01:28] Speaker 00:
right and very close.

[00:01:30] Speaker 00:
It diverges from your construction only because it uses more precise language offered by your expert.

[00:01:38] Speaker 00:
to the, your expert said a targeted investigation directed specifically.

[00:01:44] Speaker 00:
So they substituted your expert's language for the language you had in your construction.

[00:01:49] Speaker 00:
And I don't see any difference between to determine whether a GI perforation exists to confirming the presence or absence of a GI perforation.

[00:01:59] Speaker 00:
So I understand the board said we're rejecting both constructions, but I'm not seeing a lot of

[00:02:06] Speaker 00:
daylight for argument that there's some problem with the board's construction.

[00:02:12] Speaker 00:
All right?

[00:02:12] Speaker 00:
So you can tell me why I'm wrong, but I'm missing something here.

[00:02:16] Speaker 05:
I think we're all missing something here, Your Honors, because the board was explicit in rejecting Genentech's proposed construction.

[00:02:23] Speaker 00:
OK.

[00:02:24] Speaker 00:
That's true.

[00:02:25] Speaker 00:
But what do you say to the points that I just said?

[00:02:27] Speaker 00:
Is not the language in the board specifically

[00:02:32] Speaker 00:
adopted from what Dr. Morris was your guy right correct your honor all right he referred explained specifically GI preparation to require a targeted event specific evaluation there's all this language in

[00:02:49] Speaker 00:
even though the construction that you proposed itself talks about taking diagnostic steps, there's all this language in your documents that refer to a targeted investigation directed specifically.

[00:03:03] Speaker 00:
So while the board may have rejected the precise bottom line construction you offered, it seems to me what they came up with was entirely consistent and parroted what you were arguing about.

[00:03:15] Speaker 05:
And if I can attempt to illuminate the difference between those positions that I believe exists.

[00:03:23] Speaker 05:
The ordinary meaning of assessing for any condition is some sort of targeted investigation for that condition.

[00:03:33] Speaker 05:
That's what Dr. Morse explained in his declaration.

[00:03:35] Speaker 00:
A targeted investigation directed specifically to confirming whether there's a jury.

[00:03:42] Speaker 05:
Any condition.

[00:03:43] Speaker 05:
That's what he's explaining.

[00:03:45] Speaker 05:
It's at Appendix 1572.

[00:03:46] Speaker 00:
Yeah, but we're talking about the GI perforation here.

[00:03:50] Speaker 05:
And now we're talking about GI perforation.

[00:03:51] Speaker 00:
Okay, exactly.

[00:03:52] Speaker 05:
And to do that, sorry.

[00:03:54] Speaker 00:
Go ahead, go ahead.

[00:03:55] Speaker 05:
And to do that, to find out whether a patient has a GI perforation requires diagnostic steps.

[00:04:02] Speaker 05:
That's what the targeted investigation is when it comes to a GI perforation.

[00:04:07] Speaker 05:
Because simply doing a physical exam, which consists of touching the belly.

[00:04:13] Speaker 00:
Well, what do you mean by diagnostic, Seth?

[00:04:16] Speaker 00:
Just the CT scan?

[00:04:17] Speaker 00:
Well, that's the dispute, and we can agree or disagree on that.

[00:04:21] Speaker 00:
But if you're saying that the difference between this is he should be limited exclusively to the CT scan.

[00:04:29] Speaker 00:
So is that what the dispute is here?

[00:04:31] Speaker 05:
I think that's part of it, Your Honor.

[00:04:33] Speaker 05:
As we explained, any diagnostic steps would be encompassed within the meaning of this claim limitation.

[00:04:39] Speaker 05:
It can be a CT or an X-ray.

[00:04:41] Speaker 05:
Those are the two ways that our expert radiologist explained one would typically figure out whether there is an effect.

[00:04:48] Speaker 00:
Is there anything in the 115 patent that limits assessments to diagnostics like CT scans or X-rays?

[00:04:57] Speaker 05:
No, I think that just comes from the ordinary meaning of what it means to assess for this condition.

[00:05:02] Speaker 05:
This patent concerns the recognition as we progressed through the clinical development of this drug that there is a potentially dangerous but very rare side effect.

[00:05:16] Speaker 05:
And that in order to use this drug safely, it is prudent to assess patients for this very rare condition that people don't ordinarily assess patients for.

[00:05:27] Speaker 05:
So that's the nature of the invention that arises from the phase three clinical trial here.

[00:05:32] Speaker 05:
How radiologists and oncologists cooperate to do this assessment is known in the art.

[00:05:40] Speaker 05:
It didn't need to be explained in the written description because we weren't inventing new diagnostic means.

[00:05:45] Speaker 05:
We were using them in connection with the use of this drug.

[00:05:50] Speaker 05:
So when the board says that it's rejecting our construction, I think we have to understand that the board thinks its construction encompasses taking diagnostic steps or something else.

[00:06:03] Speaker 05:
And it's unclear what that something else is.

[00:06:06] Speaker 05:
The board's analysis at pages six and seven of the appendix is rather thin when it comes to explaining what its construction means.

[00:06:17] Speaker 03:
What difference does it make as long as whatever that investigation is, is directed specifically toward confirming the presence or absence of GI corporation?

[00:06:28] Speaker 05:
Well, and I think this leads into the obviousness error, Your Honor.

[00:06:32] Speaker 05:
So if we proceed to Appendix 20, the one page of obviousness analysis with which the Board took down this patent, the thing that jumps out on a first reading of that single page is that the Board's construction is nowhere to be found.

[00:06:47] Speaker 05:
If you go to Appendix page 20 and read the entirety of the analysis, there's no discussion of this targeted investigation that the Board just said its claim construction entails.

[00:06:58] Speaker 05:
Instead, the board starts off by saying, we agree with Appendix Page 20.

[00:07:08] Speaker 00:
Okay, that's, that's not, I misunderstood what you said.

[00:07:11] Speaker 00:
There's ten pages that precedes that, that talks about this analysis, this part and parcel of the analysis, right?

[00:07:18] Speaker 05:
So I would disagree with that, Your Honor.

[00:07:19] Speaker 05:
I think the ten pages that preceded are the Board's summary of what the parties had argued.

[00:07:25] Speaker 00:
I think this Court has made... Okay, well, it's not worth us getting into debate over that semantic.

[00:07:30] Speaker 00:
So, okay, proceed.

[00:07:31] Speaker 00:
That's fine.

[00:07:32] Speaker 05:
Okay.

[00:07:33] Speaker 05:
So we see in page 20 in the Board's analysis that

[00:07:37] Speaker 05:
this claim construction that it has adopted is nowhere applied.

[00:07:42] Speaker 05:
Instead, it says, we think the invention is obvious because we credit Dr. Nuget's testimony as petitioner's expert, that the standard of care and knowledge of the person of ordinary skill would have guided a physician to assess patients, and that this would begin with evaluating symptoms like nausea or abdominal pain.

[00:08:08] Speaker 05:
we've already seen that the patent scope doesn't encompass just assessing for symptoms.

[00:08:15] Speaker 05:
It actually requires some investigation regarding GI perforation.

[00:08:20] Speaker 05:
And the other thing about this page, besides not including the board's claim construction, is that it cites none of the patent owner's evidence here.

[00:08:30] Speaker 05:
And we laid out at length in our papers and in our appeal brief how

[00:08:36] Speaker 05:
All of these points are disputed and controverted.

[00:08:39] Speaker 05:
How Dr. Nuget himself admitted that just because a cancer patient presents with nausea, you don't send them off for CT scanning to see if they have a GI perforation.

[00:08:49] Speaker 05:
Most cancer patients are nauseous.

[00:08:52] Speaker 05:
Most cancer patients have discomfort in the abdomen.

[00:08:55] Speaker 05:
That's where they have colorectal cancer.

[00:08:58] Speaker 05:
It's something else entirely to then take the next step of doing an investigation for GI perforation.

[00:09:06] Speaker 05:
This sentence that follows where the board says we are persuaded that an assessment necessarily begins with evaluating patients for symptoms and in the event of a showing of such signs that the physician would have assessed the patient for GI perforation.

[00:09:25] Speaker 05:
Again, the

[00:09:26] Speaker 05:
Construction isn't here.

[00:09:28] Speaker 05:
It's unclear whether they're suggesting that the person of ordinary skill would have sent this patient off for imaging.

[00:09:35] Speaker 05:
But what's unclear about the board's statement here is

[00:09:40] Speaker 05:
Are they hypothesizing a patient who is presented with only nausea or only abdominal pain?

[00:09:47] Speaker 05:
In which case, I think the record evidence that they don't cite shows, in fact, doctors do not send such patients out for GI perforation assessment.

[00:09:55] Speaker 00:
But the claim language itself just uses the word assessing.

[00:10:00] Speaker 00:
So we're trying to get into an enormously granular level about what that means.

[00:10:07] Speaker 00:
It says assessing the patient.

[00:10:08] Speaker 00:
It doesn't deal with, it doesn't outline.

[00:10:11] Speaker 00:
Is there something in the patent that describes what symptoms you have to show that leads you to take a test?

[00:10:16] Speaker 00:
I guess I understand what you're saying.

[00:10:18] Speaker 00:
I'm just not kind of clear on why that's relevant to anything here.

[00:10:22] Speaker 05:
Certainly, I think, as I mentioned, the patent concerns the clinical trials.

[00:10:27] Speaker 05:
It doesn't concern the standard of care for how you diagnose

[00:10:33] Speaker 05:
problems that your patients are having.

[00:10:36] Speaker 05:
And so as Dr. Morse laid out, the ordinary meaning in this context of assessing for GI perforation is you actually need to do diagnostic imaging.

[00:10:47] Speaker 05:
You need an x-ray that shows the free air in the abdomen, that shows that air is leaking from the perforated colon and into your abdomen.

[00:10:55] Speaker 05:
or you need the CT scan that shows that, and that's a radiological inquiry.

[00:10:59] Speaker 05:
You can't know that just from asking the patient how they're feeling.

[00:11:05] Speaker 03:
But the board goes on, on page 20, to say, after the sentence you just read, it says, guiding that physician would have been the knowledge that GI cancers and systemic chemotherapy each were known to be causally related to GI perforation.

[00:11:25] Speaker 05:
The board does say that, and I'd like to wrap up briefly.

[00:11:28] Speaker 05:
And they cite a lot of transcript sites for that proposition.

[00:11:33] Speaker 05:
They cite a lot of the petitioner's evidence, none of the patent owner's evidence.

[00:11:38] Speaker 02:
They don't... Well, I mean, they're not allowed to do that.

[00:11:40] Speaker 02:
They're the ones who get to weigh the evidence, not us.

[00:11:43] Speaker 05:
And they have to document to you that they have, in fact, weighed the evidence.

[00:11:47] Speaker 02:
And that's what is... And they just did, because they explained their conclusion and they cited the evidence in support.

[00:11:52] Speaker 05:
and they didn't say why they disagree with what we said.

[00:11:55] Speaker 02:
That's opinion writing.

[00:11:56] Speaker 02:
We don't require them to go into that level of detail to establish a reasoning.

[00:12:01] Speaker 02:
We need their conclusion and what reasoning supports it.

[00:12:04] Speaker 05:
And I respectfully disagree, Your Honor.

[00:12:06] Speaker 05:
I think your Cutsforth decision, your Google decision, has set a threshold that Your Honor is expecting.

[00:12:12] Speaker 02:
The threshold is the APA.

[00:12:13] Speaker 02:
And it may be applied differently in different cases.

[00:12:16] Speaker 02:
But the bottom foundation of the APA is the agency has to

[00:12:21] Speaker 02:
explain its conclusion and explain the reasoning supporting it.

[00:12:25] Speaker 02:
It doesn't have to specifically address each and every argument raised by the person it's rejecting.

[00:12:31] Speaker 02:
And it set forth its conclusion here.

[00:12:34] Speaker 02:
It set forth the evidence in support of it.

[00:12:37] Speaker 02:
That's enough.

[00:12:38] Speaker 02:
The fact that you might have wanted them to explain why you're wrong doesn't mean that they didn't satisfy the APA.

[00:12:44] Speaker 02:
I don't see what the point is here.

[00:12:46] Speaker 05:
If I could wrap up with one final error.

[00:12:50] Speaker 05:
If you then flip to appendix page 21, the board says, we note that secondary considerations have not been asserted in this case.

[00:12:58] Speaker 05:
That was simply incorrect.

[00:13:00] Speaker 05:
At appendix page 200, we laid out in our patent owner response the objective and issue of non-obviousness here that I think under

[00:13:09] Speaker 05:
minds and obliterates many of the findings that they made.

[00:13:12] Speaker 05:
The issue here is that oncologists never seen GI perforation before in the context of treating these sorts of patients.

[00:13:21] Speaker 05:
When Genentech went to the National Cancer Institute and explained we have a problem in our phase three clinical trials, our drug, which would go on to establish a new standard of care for the treatment of cancer, our drug does seem to have this problem.

[00:13:37] Speaker 05:
And the National Cancer Institute's reaction was to immediately disseminate a letter to all of the oncologists participating in the many clinical trials using this drug to warn them about, and I'll quote the National Cancer Institute, an unexpected side effect.

[00:13:57] Speaker 05:
That objective, contemporaneous, not a dispute of the experts in 2017 and 2018, but a statement from the government in 2003 that this is unexpected is critical evidence that has to be evaluated.

[00:14:12] Speaker 05:
And here the board said it didn't exist.

[00:14:15] Speaker 00:
Well, I actually, this takes some time to go through the details of this, but

[00:14:23] Speaker 00:
We went through it.

[00:14:24] Speaker 00:
I mean, one, I do think that the board, and I can't put my hands on it now, but Dr. Nuget did talk about this evidence.

[00:14:32] Speaker 00:
I think the reason that the board may have said that, nonetheless having dealt with the evidence you're talking about, is because your only citation is under a heading that doesn't say anything about secondary considerations.

[00:14:46] Speaker 00:
It talks about some chemotherapy paper.

[00:14:49] Speaker 00:
patients experience GI perforations does not enter the invention obvious and that's page 198 and so forth and then at the very end of that so you're talking about all this evidence and at the very end you have one paragraph the only one I could find page 200 that talks about objective indicia at all and that paragraph

[00:15:13] Speaker 00:
is a few citations and one sentence.

[00:15:17] Speaker 00:
NCI's response to the discovery, blah, blah, and the changes to clinical trials provide unbiased contemporaneous evidence of non-obviousness.

[00:15:27] Speaker 00:
That's it.

[00:15:29] Speaker 00:
So I think the board treated this evidence in another context, which is essentially the way you treated it.

[00:15:35] Speaker 00:
So that's my understanding of why the board would have said that.

[00:15:40] Speaker 00:
made that stark statement in this case.

[00:15:43] Speaker 00:
Why do you think I'm wrong?

[00:15:44] Speaker 05:
I don't know how I could have been more explicit.

[00:15:49] Speaker 00:
Am I right that this paragraph on 200 is the only place where you mention in this whole thing you actually cite to calling this objective indicia?

[00:15:58] Speaker 05:
Well, we get a single brief before the Patent Office, our Patent Honor Response, and this is it at Appendix 200.

[00:16:05] Speaker 05:
You're correct.

[00:16:06] Speaker 05:
That's the pin site where we say,

[00:16:09] Speaker 05:
The effect of the inventor's discovery on the trial serves as objective indicia of the non-obviousness of the claimed methods.

[00:16:16] Speaker 05:
Then we cite multiple cases, and we discuss this evidence.

[00:16:22] Speaker 05:
I suppose next time I could use a section heading, but I think we certainly presented this argument, and I know I talked about it at length at the hearing as well.

[00:16:34] Speaker 05:
And I think this

[00:16:37] Speaker 05:
statement by the board that they apparently didn't understand that this is objective in the issue of non-obviousness.

[00:16:46] Speaker 00:
Rejected it and they really need to take this into account Well, I mean, it's not my point is that I'm not sure they didn't take the evidence into account And they acknowledged your arguments that a person skilled in the art would not have expected The rate of preparations to be as high as it was And so they dealt with it kind of under a different heading and using different words that's the way I read their opinion but

[00:17:12] Speaker 00:
No, no, we're not talking about anything about commercial success Longfield made industry praise none of that stuff, right?

[00:17:19] Speaker 00:
That's correct

[00:17:42] Speaker 04:
May I proceed?

[00:17:43] Speaker 04:
May it please the court, Thomas Maloro for Haspera.

[00:17:47] Speaker 04:
The board's decision was amply supported by the evidence in this case.

[00:17:52] Speaker 04:
And in fact, the obviousness analysis not only involved a discussion of the party's respective evidence and arguments, but then included an analysis on obviousness that cited to both parties' evidence.

[00:18:06] Speaker 04:
I think counsel mentioned that.

[00:18:07] Speaker 00:
And what do you make of the sentence about secondary consideration?

[00:18:11] Speaker 04:
The sentence about secondary considerations is exactly the case in the sense that there was no cognizable secondary considerations that were put forward.

[00:18:22] Speaker 04:
There was one paragraph, I think the court pointed to it, at A-200 in the patent owner response.

[00:18:29] Speaker 04:
But there was absolutely no allegation that there was a nexus between the supposed unexpected result and the novel feature of the claim, which is the assessing limitation of the claim.

[00:18:41] Speaker 04:
And in fact, the evidence that was cited there was this NCI cancer letter.

[00:18:50] Speaker 04:
And that letter was, in fact, referenced by the panel at the final hearing.

[00:18:55] Speaker 04:
I was asked a question about it at final hearing, so the board was well aware of that.

[00:19:02] Speaker 04:
And interestingly, both in that letter, at appendix 2039,

[00:19:09] Speaker 04:
There were no changes made to the assessments to be done to the patients.

[00:19:14] Speaker 04:
There was no change in the care to the patients.

[00:19:18] Speaker 04:
There were no changes made to the treatment of the patients or enrollment of the patients.

[00:19:23] Speaker 04:
There was simply an identification that this had been seen.

[00:19:28] Speaker 04:
And Dr. Morris, the expert for Genentech, confirmed that his practice of assessing patients for GI perforation has been the same throughout his career.

[00:19:39] Speaker 04:
And that was at appendix 1157 to 58.

[00:19:41] Speaker 04:
Dr. Nuget confirmed the same.

[00:19:45] Speaker 04:
And in fact, the Avastin label

[00:19:48] Speaker 04:
doesn't require any assessing for GI perforation.

[00:19:52] Speaker 04:
And Dr. Morse confirmed that at Appendix 1154.

[00:19:56] Speaker 04:
So what we have was an observation of an inherent property of the drug, and in fact an obvious property of the drug, for which no change was made.

[00:20:08] Speaker 04:
And therefore, this is not cognizable evidence of an unexpected result of practicing the claimed invention, which includes the assessing limitation.

[00:20:19] Speaker 04:
And in fact, there's no evidence that assessing was ever done any differently before or after the observation was made.

[00:20:27] Speaker 04:
So the board was absolutely correct in treating this issue

[00:20:34] Speaker 04:
with all the attention that Genentech gave it, quite frankly, which was virtually none.

[00:20:40] Speaker 04:
It was a throwaway sentence and paragraph in their papers, which the panel was well aware of and cannot give rise to secondary considerations that would in any way overcome the obviousness.

[00:20:58] Speaker 04:
In terms of the evidence on obviousness, the panel cited

[00:21:03] Speaker 04:
Not only Dr. Nuget, but for example, when it

[00:21:08] Speaker 04:
determined that GI cancers and systemic chemotherapy were each known to be causally related to GI perforation.

[00:21:16] Speaker 04:
They cited two of Genentech's experts on that.

[00:21:20] Speaker 04:
One was Dr. Levy at Appendix 1386, where she was the radiologist, and she had testified that she had seen GI perforations that she concluded were caused by or associated with the tumors in cancer patients.

[00:21:38] Speaker 04:
Likewise, Dr. Morse, at appendix 1183, who was Genentech's oncologist, admitted that data showed that GI perforation was, in fact, associated with chemotherapy.

[00:21:53] Speaker 04:
And there was independent literature, more than just Dr. Nuget's testimony on that point.

[00:21:58] Speaker 04:
The Kennedy and Spence reference at appendix 529 cited both chemotherapy and tumors as being associated with GI perforation.

[00:22:09] Speaker 04:
Combining that with the seriousness of GI perforation, Kennedy and Spence reported at appendix 531 a 40% death rate.

[00:22:19] Speaker 04:
One skilled in the art, the physician would have been motivated to do the assessment for GI perforation.

[00:22:25] Speaker 04:
Beyond that, there was evidence that VEGF is a growth factor that helps to promote repair of GI injury.

[00:22:37] Speaker 04:
And Bevacizumab is a so-called anti-VEGF antibody.

[00:22:42] Speaker 04:
And there was a reference to a paper from Matsui, which indicated that the anti-VEGF antibodies

[00:22:49] Speaker 04:
could impede the repair of the GI wall.

[00:22:52] Speaker 04:
So one skilled in the art, even in addition to the information about tumors and chemotherapy being associated with GI perforation, would have understood that the anti-VEGF antibody could also be playing a dangerous role.

[00:23:09] Speaker 04:
I think I have cut into the government's time if there are other questions.

[00:23:13] Speaker 00:
Well, you haven't, but that's OK.

[00:23:14] Speaker 00:
We've been running you at the clock at 10 minutes and leaving the government with five.

[00:23:18] Speaker 00:
But let me just ask you a housekeeping question, which is, I think in the statement of related cases, is there a pending district court case that's been stayed because of this?

[00:23:27] Speaker 00:
Or is it just peripheral district court litigation?

[00:23:31] Speaker 04:
There is a pending district court litigation, but the district court case has not been stayed.

[00:23:35] Speaker 04:
It's ongoing.

[00:23:37] Speaker 04:
other district court cases not involving our company and none of them have been stayed to my knowledge.

[00:23:44] Speaker 00:
And so you have one case that's ongoing.

[00:23:47] Speaker 04:
We do.

[00:23:47] Speaker 00:
And what stage is that?

[00:23:49] Speaker 04:
It's it's at a excuse me a relatively early stage in terms of discovery.

[00:23:55] Speaker 04:
There's been no trial schedule set yet.

[00:23:58] Speaker 00:
All right.

[00:23:59] Speaker 00:
Thank you.

[00:23:59] Speaker 04:
Thank you.

[00:24:10] Speaker 00:
You're back.

[00:24:11] Speaker 01:
I'm back, Your Honor.

[00:24:11] Speaker 01:
Good morning.

[00:24:12] Speaker 01:
Courtney Dixon for the government.

[00:24:15] Speaker 01:
We've intervened on the constitutional issues.

[00:24:17] Speaker 00:
Some of these have a wrinkle to them, like the one we talked about the other day when the application was issued after the AAR.

[00:24:25] Speaker 00:
Certainly.

[00:24:27] Speaker 00:
that are different about this patent in terms of timing and so forth.

[00:24:31] Speaker 01:
Not that I'm aware of, Your Honor.

[00:24:32] Speaker 00:
It's not likely.

[00:24:32] Speaker 00:
So this is clearly a retroactive.

[00:24:33] Speaker 01:
I think so, Your Honor.

[00:24:34] Speaker 01:
And of course, I'm happy to address any questions that Your Honors have.

[00:24:37] Speaker 01:
The parties haven't raised any issues today.

[00:24:40] Speaker 01:
And we've intervened in a lot of these cases.

[00:24:42] Speaker 01:
And Your Honors have been on a lot of these cases.

[00:24:44] Speaker 01:
So I won't waste any more of it.

[00:24:45] Speaker 02:
I don't want to waste too much time.

[00:24:46] Speaker 02:
But can I ask you a little bit about more?

[00:24:48] Speaker 02:
I think either you or one of your colleagues and I had a colleague read about that a couple months ago.

[00:24:52] Speaker 02:
I believe that was my colleague, Your Honor, yes.

[00:24:53] Speaker 02:
I still don't understand why Horn would support the argument they're making, which is that retroactive application is unconstitutional per se, because Horn dealt with this specific administrative scheme that displaced

[00:25:08] Speaker 02:
the Court of Federal Claims jurisdiction.

[00:25:10] Speaker 02:
I think it specifically noted something to that effect.

[00:25:12] Speaker 02:
But Horn also was just saying, look, when we're fining you, we're not going to make you pay the fine, which is in lieu of the property, the raisins, and then go to the Court of Federal Claims to get it.

[00:25:22] Speaker 02:
That doesn't make any sense.

[00:25:24] Speaker 02:
But it's still all about getting just compensation for taking physical property, not rendering the statute per se unconstitutional.

[00:25:31] Speaker 02:
Isn't that the better reading of Horn?

[00:25:33] Speaker 01:
I would agree with your honor on, in terms of the merits of the horn were certainly different in the posture here.

[00:25:37] Speaker 02:
But isn't that why they, even if they had a valid takings claim here, the PTO didn't find them or do anything that made them pay over money.

[00:25:48] Speaker 02:
I mean, cause I don't think they're talking about the examination fees.

[00:25:51] Speaker 02:
They just want the statute declared unconstitutional.

[00:25:54] Speaker 02:
Isn't the remedy if they think their patent has been taken in the court of federal claims.

[00:25:59] Speaker 01:
I don't want to speak necessarily to jurisdiction as opposed to whether it's in the court of the claims.

[00:26:03] Speaker 02:
I know your colleague did it last time, but doesn't that make sense to you?

[00:26:06] Speaker 01:
We haven't briefed that, Your Honor, and so I hesitate to do that.

[00:26:08] Speaker 02:
I know, but you clearly have thought about it because I asked about it two months ago, or at least you should have.

[00:26:14] Speaker 02:
And I think that, I mean, thinking through Your Honor's question, I think it's just a very odd takings claim to me, that I don't see takings claims outside of horn, which makes sense because the government actually imposed a fine, which is a proxy for the taking of the raisins.

[00:26:29] Speaker 02:
and also had a specific administrative scheme up there that every other takings claim when somebody the government takes your property they're allowed to do it they just have to pay compensation right well I agree with your honor in the sense that this is not the average takings claim I mean to think through your honors question maybe in another way is

[00:26:47] Speaker 02:
Are you aware of any case where, and I don't think Horne is the case, where the Supreme Court, or really any circuit court has said it, a statute is unconstitutional because it takes property.

[00:27:01] Speaker 01:
Is the government allowed to take property under the Fifth Amendment?

[00:27:04] Speaker 01:
It just has to pay just compensation.

[00:27:05] Speaker 01:
Yes, Your Honor, I would agree.

[00:27:06] Speaker 01:
I think, thinking through your question, the reason why we think there's no takings clause claim here obviously is because, one, there's no valid property interest after this court has agreed with the board, and that's only when the patent will be canceled.

[00:27:16] Speaker 01:
But also, and to think through Your Honor's question, even to the extent that you were saying, okay, now someone has to pay just compensation, after the patent has been canceled, the compensation owed would presumably be zero.

[00:27:26] Speaker 01:
And so it's difficult to think of a Takings Clause claim in this context.

[00:27:30] Speaker 01:
So I would agree with Your Honor that I don't think that they've cited any case, and I'm not aware of any case that looks like this in the Takings Clause context.

[00:27:36] Speaker 01:
Thank you very much.

[00:27:49] Speaker 05:
To respond briefly to the points that my colleagues have made, the APA does require that the board actually give parties the opportunity to be heard and provide a reasoned decision.

[00:28:07] Speaker 05:
The board certainly credited petitioner's evidence, but it said nothing about our evidence.

[00:28:12] Speaker 00:
So when you're making that argument, you're making it about the final decision.

[00:28:15] Speaker 00:
Because you make another argument about the fact that they did a claim construction that was new and different.

[00:28:21] Speaker 05:
Yeah, I'm talking about the obviousness analysis.

[00:28:23] Speaker 05:
Yes, Your Honor.

[00:28:25] Speaker 05:
And I want to emphasize something that this court said in the Google versus Intellectual Ventures case, when the board sent one of these final decisions back for remand.

[00:28:36] Speaker 05:
Court was critical in multiple places.

[00:28:39] Speaker 05:
It said, the board did not acknowledge any of Google's evidence, let alone explain why it considered such evidence unconvincing.

[00:28:50] Speaker 05:
In another spot, the Federal Circuit emphasized that stating a disagreement with Google, however, does not amount to a satisfactory explanation of the findings.

[00:29:01] Speaker 05:
Here we heard from Hospira about all these reasons that it thinks it would have been obvious for a clinician in 2003 who's giving bevacizumab to a patient to subsequently assess that patient for GI perforation.

[00:29:16] Speaker 05:
We vigorously disputed that.

[00:29:18] Speaker 05:
And I think the objective condition we submitted goes directly to that battle of the experts when the National Cancer Institute said, this is unexpected.

[00:29:29] Speaker 05:
What the board found, what the board explained is, oh, it would have been obvious to check for this because of these known associations.

[00:29:37] Speaker 05:
That's not what the National Cancer Institute thought.

[00:29:39] Speaker 05:
The National Cancer Institute thought this was unexpected.

[00:29:42] Speaker 05:
And so perhaps on remand, we'll lose again.

[00:29:44] Speaker 05:
But what we're entitled to under the APA is an explanation for why the board believes HOSPIRRA and not Genentech, and not just a recitation of the evidence that HOSPIRRA has marshaled with no explanation, in fact, a denial of the fact that we've presented any evidence whatsoever.

[00:30:07] Speaker 00:
Thank you, members.

[00:30:08] Speaker 00:
Thank you.

[00:30:09] Speaker 00:
We thank both sides, and the case is submitted.