[00:00:00] Speaker 01:
Motion for the admission of one of my law clerks to our federal circuit bar.

[00:00:06] Speaker 01:
So for this purpose, I will be making the motion and therefore recuse myself from the panel, which will decide whether to grant the motion or not.

[00:00:15] Speaker 01:
So James, please stand up.

[00:00:18] Speaker 01:
I move the admission of James Michael Lyons, who's a member of the bar and is in good standing with the highest court of New York.

[00:00:25] Speaker 01:
I have knowledge of his credentials and am satisfied that he possesses the necessary qualifications.

[00:00:32] Speaker 01:
So James has been my clerk for 19 to 20 months now.

[00:00:36] Speaker 01:
On multiple occasions his clerkship has gotten extended and he's been very gracious in willing to do that.

[00:00:44] Speaker 01:
He has been a wonderful asset to the chambers.

[00:00:47] Speaker 01:
He's very calm, keeps everything calm, which I need and it's wonderful.

[00:00:52] Speaker 01:
But he brings just a wealth of knowledge.

[00:00:55] Speaker 01:
Before me, he clerked on the district court with great distinction.

[00:00:59] Speaker 01:
He worked for several years as a lawyer.

[00:01:03] Speaker 01:
And in the time he's been with me, he has written a number of really fabulous opinions, helped me write really fabulous opinions.

[00:01:13] Speaker 01:
And I really, more than anything, just enjoyed getting to know him.

[00:01:17] Speaker 01:
And I have learned more about the state of Maine than I ever thought I would.

[00:01:22] Speaker 01:
And I sometimes refer to him as a maniac, and he is constantly correcting me that that's not what people from Maine call themselves.

[00:01:30] Speaker 01:
But it has been my great privilege to have him as my law clerk, and I know that he will be an upstanding and valuable member of our bar, so I make the motion for his admission.

[00:01:41] Speaker 01:
Judge Wallach, you're presiding for that purpose?

[00:01:42] Speaker 02:
Well, I'll take the witness on for it, dear.

[00:01:44] Speaker 02:
Do you say lobster and chowder?

[00:01:47] Speaker 02:
No, Your Honor.

[00:01:49] Speaker 02:
Well, okay.

[00:01:50] Speaker 02:
Judge Tan, do you have any questions?

[00:01:53] Speaker 09:
Mr. Lyons served his time.

[00:01:55] Speaker 09:
He earned the right to be a member of parliament.

[00:01:58] Speaker 02:
I could take that personally.

[00:02:03] Speaker 02:
However you want to take it.

[00:02:05] Speaker 02:
Then the motion's granted.

[00:02:07] Speaker 01:
Wonderful.

[00:02:07] Speaker 01:
Please turn and our courtroom deputy will swear you in.

[00:02:10] Speaker 03:
I do.

[00:02:24] Speaker 01:
So now with some additional business, our only case on the docket this morning is 2-019-1147 BTG International Limited versus Amnial Pharmaceuticals.

[00:02:43] Speaker 01:
Mr. Fella, please proceed.

[00:02:47] Speaker 06:
Thank you, Your Honor.

[00:02:48] Speaker 06:
May it please the Court

[00:02:51] Speaker 06:
a treatment method claimed in the 438 patent revolutionized the treatment of advanced prostate cancer.

[00:02:57] Speaker 02:
Mr. Jarrell, you're not going to like my first question, but you'll answer it for me.

[00:03:03] Speaker 02:
This appeal consolidates the PTAB in the district court proceedings.

[00:03:07] Speaker 02:
If we affirm the PTAB's claim construction, that renders the rest of the appeal moved, right?

[00:03:12] Speaker 06:
No, I don't think it does, Your Honor, for a couple of reasons.

[00:03:15] Speaker 06:
The first is

[00:03:17] Speaker 06:
As we suggested in our reply brief when the appellees raised the mootness question, Janssen may have a cause of action for basically the period of statutory exclusivity that it lost prematurely, if we're right about what 315E2 means.

[00:03:33] Speaker 06:
That hasn't been explored.

[00:03:35] Speaker 06:
We would submit that that should be explored on remit.

[00:03:38] Speaker 06:
Beyond that, though, I think if you put that aside, if you affirm the P tab

[00:03:46] Speaker 06:
I think you could avoid, you could choose to avoid the 315E2 issue, but you wouldn't be required to.

[00:03:53] Speaker 06:
I think you would have the power to decide it.

[00:03:54] Speaker 06:
It's not moot in any sort of a jurisdiction.

[00:03:58] Speaker 01:
Why the heck would we want to decide that question if it's not necessary to the resolution of the case?

[00:04:04] Speaker 01:
It is a large issue of statutory interpretation.

[00:04:07] Speaker 01:
It seems like doctrines like, say, constitutional avoidance ring in my ears.

[00:04:13] Speaker 01:
when I think about something like this and think if there is a very narrow way to decide this case, why should we decide it, go the extra step unnecessarily, unrequired, and decide a really bigger important issue?

[00:04:28] Speaker 06:
Well, it is precisely because it is a big important issue, Your Honor, that I think you should decide it.

[00:04:34] Speaker 06:
This court, as do other appellate courts, it's not at all unusual for the court

[00:04:39] Speaker 06:
to say, well, although we technically don't have to reach this issue having decided this other issue, this is an issue on which lower courts and litigants need guidance.

[00:04:49] Speaker 06:
And that is particularly true.

[00:04:52] Speaker 01:
But why?

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I have never seen a case other than this one which has raised this issue or in which it has been a problem.

[00:05:01] Speaker 01:
So do you have any evidence to suggest to me that this is a pervasive issue that is arising in a number of cases?

[00:05:07] Speaker 01:
I didn't see it in your briefing.

[00:05:09] Speaker 06:
Well, we did point out in our briefs that another district court and an ITC ALJ have read the statute our way.

[00:05:17] Speaker 01:
That is that... Well, that would suggest that it's really not an issue, because that would suggest that there's one aberrational court that may have read it incorrectly in your view, but that incorrect decision is entirely mooted by the PTO action.

[00:05:31] Speaker 01:
So why should I reach out and decide that issue when all of the other

[00:05:37] Speaker 01:
courts to have addressed it have actually agreed with you.

[00:05:40] Speaker 06:
Well, clearly, all the other courts haven't because the district court here didn't.

[00:05:44] Speaker 06:
All the other courts.

[00:05:46] Speaker 06:
I misunderstood.

[00:05:48] Speaker 06:
And also, I think that you have an amicus.

[00:05:53] Speaker 06:
Actually, you have amici on both sides of the issue, I think, pointing out that there is a legitimate dispute here about we have the amicus who filed on behalf of the appellees.

[00:06:04] Speaker 06:
basically saying that this is going to bring the Hatch-Waxman Act to its knees if you don't clarify exactly what this statute means.

[00:06:12] Speaker 06:
On the other hand, we have the PTO of basically saying you should apply this, as we do, saying you should apply this statute as written.

[00:06:18] Speaker 06:
So there is a, as Your Honor said, it's an important issue squarely presented here.

[00:06:23] Speaker 06:
It's not moot as the Supreme Court decisions like already versus Nike and Cardinal Chemical make clear.

[00:06:30] Speaker 01:
But I guess I still am not seeing the evidence.

[00:06:32] Speaker 01:
I hear your rhetoric.

[00:06:34] Speaker 01:
But I'm not seeing the evidence that this is an important issue beyond the fact that it's just an interesting question of statutory interpretation.

[00:06:41] Speaker 01:
And what I mean by important is the impact this issue is having on existing litigation.

[00:06:46] Speaker 01:
I don't personally see evidence that there are lots of courts struggling with it or making the wrong decision, or there's one court that potentially made the wrong decision in your view, and that entire decision would be mooted

[00:07:00] Speaker 01:
we could even vacate it by virtue of its being mooted in this case.

[00:07:05] Speaker 01:
So I am not sure that anything you've said to me justifies the need to add clarity to the law and that there are really a lot of people impacted by this.

[00:07:16] Speaker 06:
Well, Your Honor, I can't point you to dozens of cases coming out the other way.

[00:07:21] Speaker 06:
What I can tell you is obviously one court did in this case.

[00:07:25] Speaker 06:
Also, if you look at, and it was not in the briefs before this court, although it is in the district court briefing, there are, I think it's fair to say, dozens of district court opinions where the issue isn't squarely presented because you didn't have the precise lineup of the parties that we have here.

[00:07:43] Speaker 06:
But the courts describe the statute in ways that really cut both ways.

[00:07:48] Speaker 06:
Some describe it in terms that it's an estoppel that applies broadly.

[00:07:53] Speaker 01:
But in none of those cases is the issue present.

[00:07:55] Speaker 01:
So why in the world would this panel not wait till a case where it actually matters to decide it?

[00:07:59] Speaker 06:
Well, as I said, you could avoid the question.

[00:08:03] Speaker 06:
The problem, I think, is if you wait, in the meantime, the uncertainty persists.

[00:08:09] Speaker 06:
And you have district courts in cases where there's an IPR proceeding either going on or where a final written decision has issued, not knowing

[00:08:20] Speaker 06:
What is the proper way to handle infringement allegations?

[00:08:23] Speaker 06:
And so you have basically the danger of multiple litigation of the invalidity issues when that's exactly what, under our view, Congress meant to prevent in 315E2.

[00:08:33] Speaker 09:
When the patent board issued three different IPR decisions in January of 2018 finding all of the claims of this patent unpatentable, why didn't the district court just stop any further work on the district court action?

[00:08:49] Speaker 09:
Why didn't the district court just stay the state of the district court action right then and there?

[00:08:54] Speaker 06:
Well, we filed a motion in the district court saying you shouldn't consider invalidity anymore because of 315E2 and the issuance of the final written decisions.

[00:09:06] Speaker 06:
There was still the infringement issue.

[00:09:08] Speaker 06:
Right.

[00:09:09] Speaker 09:
But my larger point is, why keep going with any aspect of the district court litigation, given that there were now three different decisions

[00:09:19] Speaker 09:
finding three different rationales for finding all of the claims unpatentable.

[00:09:25] Speaker 09:
Why keep going?

[00:09:26] Speaker 09:
Why go ahead and have a full trial?

[00:09:29] Speaker 06:
Well, certainly, obviously, as I said, we didn't think invalidity should be tried at that point.

[00:09:35] Speaker 06:
I don't think anybody asked the court to suspend proceedings on the infringement part of the case pending, I assume what Your Honor's point is, waiting till the appeals from the final written decisions ran their course.

[00:09:49] Speaker 06:
and then just enter judgment one way or the other.

[00:09:51] Speaker 01:
We're just wondering why you didn't move or stay in the district court of all of this.

[00:09:58] Speaker 01:
That seems like the most logical way to have proceeded, especially given what you say is necessary to avoid, which is duplicative litigation between the PTO and the district court.

[00:10:10] Speaker 06:
Well, and had invalidity been the only issue, it would have been a different situation.

[00:10:14] Speaker 06:
But we still had to prove infringement, and obviously,

[00:10:18] Speaker 06:
Our intention, as I'm standing here today, proves, was to challenge the PTO determinations, the PTAB determinations on invalidity.

[00:10:27] Speaker 06:
And if we succeed on that and infringement hadn't been tried, then you'd go back for a trial.

[00:10:34] Speaker 01:
And meanwhile, the 30 months... You could have obviated, you could have obviated all of the parade of horribles you're suggesting to me could possibly exist by simply moving to stay in the district court.

[00:10:46] Speaker 01:
and you know that's so so you want us to go out of our way to decide an issue of statutory interpretation which no other court but this one has in your view decided wrongly and all the other courts are deciding it correctly you nonetheless want this court to tackle it challenge it go through it and adjudicate it and resolve it even though it's unnecessary in this case and you're saying because it could cause duplicative litigation of problems in the future

[00:11:12] Speaker 01:
But I think that we've just shown multiple ways in which that could be avoided by the parties.

[00:11:18] Speaker 01:
And so I'm not certain that you have by any means justified why this court should reach out to decide an issue that's unnecessary in a case.

[00:11:28] Speaker 06:
Well, Your Honor, the duplicative litigation part of it was considering invalidity.

[00:11:33] Speaker 06:
The infringement part was not duplicative.

[00:11:36] Speaker 06:
The only place that could be heard was in the district court.

[00:11:39] Speaker 06:
Now, certainly, if the court had stayed the case,

[00:11:43] Speaker 01:
And obviously... Yes, but your client shouldn't want to be paying for lawyer services to resolve infringement of a patent for which multiple IPRs have been granted across all of the claims.

[00:11:55] Speaker 01:
Why is it in your client's best interest to proceed even with the infringement portion given that the PTO could well invalidate granted that they accepted IPR on multiple IPRs challenging all of the claims

[00:12:10] Speaker 01:
that the chances are, at the end of the day, they're going to invalidate it.

[00:12:12] Speaker 01:
Why would anybody but the lawyers for your client make out by your client not staying in this case?

[00:12:18] Speaker 06:
Well, Your Honor, I can assure you that the lawyers didn't drive any decisions.

[00:12:22] Speaker 06:
It was clearly the client's decision.

[00:12:24] Speaker 01:
Well, clients are not always smart.

[00:12:26] Speaker 06:
Well, my clients are, but that's a separate topic.

[00:12:31] Speaker 06:
Your Honor, the... It's your job to rein them in.

[00:12:35] Speaker 02:
as anybody who's been in private practice knows that it's not... Let me take you somewhere else for a moment, if I may, Mr. Trela.

[00:12:44] Speaker 02:
Is claim one of the 438 patent representative?

[00:12:48] Speaker 06:
I believe it is, Your Honor, yes.

[00:12:49] Speaker 02:
Okay.

[00:12:51] Speaker 02:
You cite in a section titled definitions, the patent explains, you're at 30 of your deliberate

[00:12:57] Speaker 02:
As used here in and less otherwise defined, the terms treat, treating, and treatment include the eradication, removal, modification, management, or control of a tumor, primary, regional, or metastatic cancer cells or tissue.

[00:13:14] Speaker 02:
Can't management reasonably be interpreted as keeping the patient in shape to continue treatment?

[00:13:21] Speaker 06:
I don't think so, Your Honor.

[00:13:22] Speaker 06:
Why?

[00:13:23] Speaker 06:
Well, because it says it doesn't say

[00:13:26] Speaker 06:
Management obviously doesn't say management of the patient.

[00:13:28] Speaker 06:
It also doesn't say management of the cancer.

[00:13:30] Speaker 06:
It says management of the tumor, the cancer cells, and the tissues.

[00:13:35] Speaker 06:
And I think that means.

[00:13:36] Speaker 02:
If you're doing a broad interpretation of what reasonably can be interpreted of management, why doesn't that include keeping the person in a condition such that you can do those other things to the tumor?

[00:13:50] Speaker 02:
Which of course brings in everything else.

[00:13:54] Speaker 06:
Exactly.

[00:13:55] Speaker 06:
For several reasons, Your Honor.

[00:13:57] Speaker 06:
One is, as I said, I think the focus on tissue tumors, cells, I think argues against it.

[00:14:04] Speaker 06:
It may not preclude it, but I think it argues against it.

[00:14:06] Speaker 06:
The other point is that the entire patent, there's not any mention at all of side effects of pain, palliation, anything like that.

[00:14:15] Speaker 06:
It's all focused strictly on treating the cancer.

[00:14:19] Speaker 06:
The definition of therapeutically effective amount

[00:14:23] Speaker 06:
When the patent talks about how much of each of the different agents should be administered, it's an amount effective to treat the cancer.

[00:14:30] Speaker 06:
So I think in the context of this patent, even the control or management language there, I think is focused on treatment of the cancer itself, meaning the cells, tissue, tumors.

[00:14:42] Speaker 09:
The specification defines the second agent to be combined with the CYP inhibitor as being either an anti-cancer agent or a steroid.

[00:14:52] Speaker 06:
Correct.

[00:14:53] Speaker 09:
So that suggests that steroid is not necessarily the same thing as an anti-cancer agent.

[00:15:00] Speaker 06:
Well, I think I have a couple of responses.

[00:15:03] Speaker 06:
One is the amount of the steroid that is to be given is an amount that is effective to treat the cancer.

[00:15:11] Speaker 06:
So even if- But that can include management.

[00:15:14] Speaker 06:
Well, that circles back.

[00:15:15] Speaker 06:
It obviously circles back to what treating means.

[00:15:18] Speaker 06:
But I think Judge Chen's question may be a little bit broader than that.

[00:15:21] Speaker 02:
It's an or question, yes.

[00:15:22] Speaker 06:
Right.

[00:15:23] Speaker 06:
Right.

[00:15:25] Speaker 06:
And it says, you know, the amount effective to treat the cancer.

[00:15:29] Speaker 06:
So even though steroids, obviously steroids can have all sorts of other effects, none of them are mentioned here.

[00:15:35] Speaker 06:
And what it's talking about is the use of the steroid to treat the cancer, putting to one side what treat means in this context.

[00:15:43] Speaker 09:
So you want me to read anti-cancer effect or anti-cancer agent or steroid as

[00:15:51] Speaker 09:
being translated to anti-cancer agent or another kind of anti-cancer agent called a steroid?

[00:15:59] Speaker 06:
Well, I think particularly in the context here where we're talking about prednisone, and prednisone is included as an anti-cancer agent, because anti-cancer agents include antibiotics.

[00:16:11] Speaker 06:
Antibiotics are defined to include prednisone.

[00:16:14] Speaker 06:
So I think in the context of this specification and these claims, in fact,

[00:16:20] Speaker 06:
It does mean anti-cancer agent, a CYP in 17 inhibitor, plus another anti-cancer agent, in this case prednisone.

[00:16:29] Speaker 09:
And I think... Well, then why did the specification say anti-cancer agent or steroids?

[00:16:34] Speaker 09:
That's what I don't understand from... It couldn't reasonably be read that way.

[00:16:39] Speaker 06:
Well, I don't... I think the explanation for why the specification is as it is is the specification is quite a bit broader than the claims.

[00:16:49] Speaker 06:
The specification, as your honor noted, talks about steroids.

[00:16:52] Speaker 06:
I don't know.

[00:16:52] Speaker 09:
The claim is pretty broad.

[00:16:54] Speaker 09:
It says, treat cancer using element one, element two over a period.

[00:17:00] Speaker 06:
Well, except that it's saying exactly what element one and element two are.

[00:17:05] Speaker 06:
Whereas the specification, obviously, is talking about all sorts of different agents, some of which may have anti-cancer effects alone, some of which may only have them, as prednisone does when used in combination.

[00:17:17] Speaker 01:
Well, time out.

[00:17:18] Speaker 01:
I'm not sure that I understand that to be the record in this case.

[00:17:21] Speaker 01:
And the one thing that was bothering me is that your briefing fails to entirely address the Lockhart IPR and the separate finding, which I'll say spans pages 349 to 351 of the brief of the appendix, wherein the PTO makes an express finding that Sartor establishes that prognosone alone was being used effectively in some kinds of patients to treat prostate cancer.

[00:17:47] Speaker 01:
Even under your construction of the claims, that is an independent fact-finding in that IPR, which invalidates all the claims, and I can't see that you addressed it anywhere in your briefing.

[00:17:58] Speaker 06:
Well, I think we did, Your Honor, and we did it in a couple of ways.

[00:18:01] Speaker 06:
First of all... Where?

[00:18:02] Speaker 01:
Why don't you tell me where in your briefing you addressed that separate fact-finding that is an independent basis for affirming the entire PTO decision, even under your claim construction?

[00:18:18] Speaker 01:
If you want to do it on rebuttal, you can.

[00:18:20] Speaker 06:
Do you want to do that?

[00:18:21] Speaker 01:
I'm going to restore rebuttal time.

[00:18:23] Speaker 01:
It's a complicated case.

[00:18:24] Speaker 06:
It is.

[00:18:25] Speaker 06:
But I'll find you the exact pages, and I'll give you that on rebuttal.

[00:18:28] Speaker 06:
But if I can take a minute now, I think I can address what I believe we said in the brief, which is a couple of things.

[00:18:36] Speaker 06:
One is the board didn't suggest, and at least don't suggest,

[00:18:42] Speaker 06:
that the board applied that, let's call it, the alternate claim construction when it addressed objective indicia.

[00:18:47] Speaker 06:
And it clearly did not focus solely on abiraterone alone as the anti-cancer element of the invention.

[00:18:54] Speaker 06:
There's no suggestion anywhere in this discussion of objective indicia that it was applying, let's call it, the walk heart or the alternative claim construction.

[00:19:02] Speaker 06:
The other thing is that even as to what the board said about Sartor and supposed anti-cancer effects of prednisone, and there are

[00:19:11] Speaker 06:
There are problems with that, but I won't go into those right now.

[00:19:15] Speaker 06:
The board never found that there was a reasonable expectation of success in providing a cancer treatment in which prednisone in the combination has an anti-cancer effect.

[00:19:29] Speaker 01:
And in fact, it could not have made that finding because... Can you explain to me how the claim construction affected

[00:19:38] Speaker 01:
the boards were infected, in your view, the board's analysis of the objective considerations.

[00:19:43] Speaker 01:
There was some commercial success evidence.

[00:19:45] Speaker 01:
There was this unexpected or long felt need.

[00:19:47] Speaker 01:
Tell me how, show me in the board opinion, how you believe that their wrong headed claim construction led them to the wrong conclusion about this objective indicia.

[00:20:01] Speaker 06:
Sure.

[00:20:02] Speaker 06:
Let me take, just as an example,

[00:20:05] Speaker 06:
the board's discussion of unmet need.

[00:20:07] Speaker 01:
Show me what page in the board's opinion, please.

[00:20:10] Speaker 06:
Well, let's look at, and I think they're all the same on this, Appendix 366.

[00:20:15] Speaker 06:
That's in Lockhart.

[00:20:23] Speaker 06:
And so what the board says is,

[00:20:25] Speaker 06:
And here, again, it's focusing solely on abiraterone, saying there was no unmet need because abiraterone had been available and underutilized for a decade.

[00:20:37] Speaker 06:
And so that showed that there was no unmet need for an abiraterone-based therapy.

[00:20:42] Speaker 06:
But the problem is the therapy is not limited to abiraterone.

[00:20:46] Speaker 06:
It's abiraterone plus prednisone with both.

[00:20:48] Speaker 01:
But you can say that, but you directed me to page 366, and I'm looking at the section on lung felt need.

[00:20:55] Speaker 01:
And in every single sentence, the board says administering abiraterone, acetate, and prognosone.

[00:21:01] Speaker 01:
So I don't understand how their analysis could be read the way you just articulated it in court when they are careful to link the two together in their discussion.

[00:21:10] Speaker 06:
Well, because I think if you look at the analysis, what they're saying is abiraterone was underutilized.

[00:21:16] Speaker 06:
And that shows that there was no unmet need.

[00:21:19] Speaker 06:
But that's not the relevant inquiry because the long felt need was not for a treatment based on abiraterone.

[00:21:25] Speaker 06:
It was for a treatment that was effective.

[00:21:27] Speaker 06:
And it was only because of the combination and the anti-cancer effect of prednisone that that need was met by this claimed invention.

[00:21:36] Speaker 06:
Another example, Your Honor, is commercial success.

[00:21:40] Speaker 06:
There, the board completely discounted any anti-cancer effect of prednisone and essentially said commercial success was driven by aberraterone.

[00:21:49] Speaker 06:
Aberraterone was in the prior art.

[00:21:50] Speaker 06:
Therefore, the commercial success was not attributable.

[00:21:55] Speaker 01:
But see, the thing is, you're saying these things out loud in court, but I'm looking on page 367, both abiraterone and prognosone were well-known in the prior art, as was administering prognosone with other anti-cancer agents, including inhibitors and other things.

[00:22:07] Speaker 01:
It seems to me, and then it talks about zygote sales, I mean, I don't know, are driven by the benefits of adding prognosone to the treatment of abiraterone acetate.

[00:22:20] Speaker 01:
Is that, I mean, is that the sentence that you think supports the flawed reasoning?

[00:22:24] Speaker 01:
I am just struggling to see how your vision of the claim construction rendered the fact findings on objective considerations infected and wrong.

[00:22:37] Speaker 01:
I don't, I believe it's certainly possible that could happen, but in the opinion itself, the board seems to link them together.

[00:22:43] Speaker 01:
So what, if you could help me by pointing me to the board's opinions, say, well, this is exactly where they went wrong.

[00:22:49] Speaker 01:
Not like in the abstract, we think they went wrong.

[00:22:51] Speaker 01:
This is where they went wrong.

[00:22:53] Speaker 06:
OK, Judge Moore, the section you were just looking at, let's look at appendix pages 369 to 370.

[00:23:02] Speaker 06:
And what the board is saying there, it's talking about at the bottom of 369, it's talking about supposedly the purpose of administering prednisone to deal with side effects.

[00:23:20] Speaker 06:
And then it says, at the bottom, this literature's discussion acknowledges the previously known roles of abiraterone, SGA, and prednisone.

[00:23:27] Speaker 06:
And the discussion of a corticosteroid generally contradicts the specific anti-cancer role of prednisone, argued by Pat Noehner.

[00:23:33] Speaker 06:
Well, that's the claim construction issue right there.

[00:23:36] Speaker 06:
And that's right at the heart of the court's, I'm sorry, the board's analysis of commercial success.

[00:23:41] Speaker 06:
So that's the problem.

[00:23:42] Speaker 06:
That's an example of the problem, Your Honor, where I think the claim construction.

[00:23:46] Speaker 01:
I'm sorry.

[00:23:47] Speaker 01:
Please go ahead.

[00:23:47] Speaker 06:
OK.

[00:23:48] Speaker 09:
Your label for your product doesn't say anything about prednisone serving as an anti-cancer agent or as killing cancer cells.

[00:23:58] Speaker 09:
It only talks.

[00:23:59] Speaker 09:
There's some place in the label that talks about how it's used to handle the side effects of taking the barotera.

[00:24:08] Speaker 06:
Well, the indications and usage part of the label, which is the important part, I mean, for these purposes, talks about the common... Am I misunderstanding something?

[00:24:17] Speaker 09:
Is there anything anywhere in the label that says the prednisone itself is killing cancer cells?

[00:24:26] Speaker 09:
No, I don't think there's anything in the label that says that prednisone itself is killing... But there is something in the label somewhere that says this prednisone is quite handy because it

[00:24:36] Speaker 09:
you can deal with reducing the side effects from taking the laboratory.

[00:24:40] Speaker 06:
I think that's right.

[00:24:41] Speaker 06:
But what the FDA approved in the indications and usage is the use of the combination to treat metastatic castration resistant prostate cancer.

[00:24:52] Speaker 06:
And it is the combination that was evaluated and the combination that was approved for its anti-cancer effects.

[00:24:58] Speaker 06:
As the district court found in the infringement part of the decision, the label precisely tracks the claim language.

[00:25:04] Speaker 09:
So can I take you back to trying to understand what is an anti-cancer agent?

[00:25:09] Speaker 09:
Sure.

[00:25:10] Speaker 09:
In the spec it says, column four, the term anti-cancer agent is any therapeutic agent that directly or indirectly kills cancer cells or directly or indirectly prohibits, stops, or reduces the proliferation of cancer cells.

[00:25:26] Speaker 09:
Yes.

[00:25:27] Speaker 09:
So I think I understand what directly means, but could you elaborate on what it means to

[00:25:34] Speaker 09:
indirectly kill cancer cells or indirectly prohibit, stop or reduce the proliferation of cancer cells?

[00:25:40] Speaker 06:
Sure.

[00:25:40] Speaker 09:
Because I could imagine one theory of indirectly being there's a main event drug, maybe it's a beradurone, that does all the direct killing, but it's not tolerable on its own for a patient.

[00:25:57] Speaker 09:
And so now you need something else to handle all the side effects that comes with the main event drug.

[00:26:03] Speaker 09:
And that could be something like a glucocorticoid that compensates for loss of hormone that comes with taking the inhibitor.

[00:26:15] Speaker 09:
So why wouldn't that be understood as perhaps indirectly assisting in the treatment of cancer and killing or prohibiting the promotion of further cancer cells?

[00:26:27] Speaker 06:
Well, for a couple of reasons, Your Honor.

[00:26:29] Speaker 06:
One is I think there's not the broadest reasonable interpretation.

[00:26:32] Speaker 06:
Understood.

[00:26:33] Speaker 06:
There's nothing in the specification that makes any reference to any of those side effects, or pain relief, or anything like that.

[00:26:40] Speaker 06:
So there's no suggestion that that is included in the notion.

[00:26:44] Speaker 09:
But I don't see anything in the spec which is not that long in terms of going through the science, right?

[00:26:50] Speaker 09:
Explaining what does it mean to be indirectly dealing with cancer.

[00:26:55] Speaker 02:
Well, I think I- There's nothing in the spec unless you read treatment in a way different than you really.

[00:27:00] Speaker 06:
Well, you have to read it differently than I read it, and you have to add a lot, I suggest.

[00:27:05] Speaker 06:
But Judge Chen, to your question, and I will say that I don't think that there is expert testimony in the record on this, but I will tell you what I think directly and indirectly mean here.

[00:27:16] Speaker 06:
Directly, I think, means what's called a cytotoxic effect.

[00:27:20] Speaker 06:
Actually, it's a poison for those cells, which is much like chemotherapy.

[00:27:25] Speaker 06:
That's the way chemotherapy works.

[00:27:27] Speaker 06:
Indirect, I think, means as

[00:27:29] Speaker 06:
in this invention, cutting off the supply of hormones that those cells need to survive.

[00:27:35] Speaker 06:
I think that would be an indirect effect on the cancer cells or tissue.

[00:27:39] Speaker 06:
The direct effect would be you directly poison them with, for example, a chemo-type agent.

[00:27:45] Speaker 06:
I think that's what that means in that context.

[00:27:49] Speaker 01:
OK.

[00:27:49] Speaker 01:
Thank you, Mr. Trello.

[00:27:50] Speaker 01:
Let's hear from the collection of people on the other side.

[00:27:55] Speaker 01:
Mr. Krauss, are you going first?

[00:27:59] Speaker 01:
Oh, you're sitting over here.

[00:28:08] Speaker 05:
May it please the Court?

[00:28:09] Speaker 05:
The USPTO is here at the Court's invitation to address the questions related to the... I have a logistical question first.

[00:28:17] Speaker 09:
The Board issued all three IPR final written decisions in January of 2018.

[00:28:22] Speaker 09:
The Patent Order filed its rehearing requests in February of 2018.

[00:28:28] Speaker 09:
For some strange reason that I don't understand, and there's no earthly justification I can think of a good reason, the board lollygagged and took 10 full months before it issued its rehearing decisions in December of 2018.

[00:28:46] Speaker 09:
Why in the world did it take so long for the board to issue its rehearing decisions?

[00:28:52] Speaker 01:
In fact, it only seemed to happen after our order may have, my guess, prompted

[00:28:58] Speaker 01:
those decisions.

[00:29:01] Speaker 05:
I honestly don't know the answer to either of those questions.

[00:29:05] Speaker 05:
The board aspires to answer rehearing requests.

[00:29:08] Speaker 09:
I mean, don't you think it's a little embarrassing?

[00:29:11] Speaker 09:
I mean, the board certainly was well aware that there was a concurrent litigation going on.

[00:29:16] Speaker 09:
You know, it understands it needs to be working with special dispatch.

[00:29:21] Speaker 09:
I mean, it took about as long as it takes for a regular dinner parties review itself to be completed, for it to handle a rehearing request.

[00:29:32] Speaker 09:
It doesn't make any sense.

[00:29:34] Speaker 05:
Well, I haven't looked at the underlying merits of this case.

[00:29:36] Speaker 05:
I understand it is a complicated case.

[00:29:38] Speaker 05:
There might have been different views within the board panel itself.

[00:29:42] Speaker 05:
There is no absolute deadline.

[00:29:45] Speaker 05:
I'm sure the board did its best to get the

[00:29:47] Speaker 05:
decision issued in a timely manner.

[00:29:49] Speaker 05:
I can convey your concerns to board management, but I don't have much

[00:29:55] Speaker 05:
standing here to say, standing here before you today to say, to explain what happened.

[00:29:59] Speaker 01:
So unlike IPRs where there are certain timelines that the PTO is required to comply with for completion, are you telling me there is absolutely no timeline placed on rehearing decisions?

[00:30:10] Speaker 05:
There's no statutory timeline.

[00:30:12] Speaker 01:
There's an aspiration.

[00:30:13] Speaker 01:
Or regulatory?

[00:30:13] Speaker 01:
I believe the trial practice... No, is there a regulatory timeline placed on it?

[00:30:17] Speaker 05:
I don't believe there's a regulatory timeline.

[00:30:18] Speaker 01:
Wouldn't that seem to significantly undermine Congress's goal

[00:30:23] Speaker 01:
to have an expeditious and fully resolved IPR proceeding within the PTO to avoid unnecessary duplicative district court litigation?

[00:30:31] Speaker 05:
I think it potentially can.

[00:30:34] Speaker 01:
Like in this case?

[00:30:35] Speaker 01:
Don't you think it did?

[00:30:36] Speaker 05:
This case is extremely unusual for many reasons.

[00:30:39] Speaker 01:
No, do you think it did in this case?

[00:30:42] Speaker 05:
In this case, it would have been better if they had issued it sooner, and we could have gotten to the invalidity arguments before this court sooner.

[00:30:48] Speaker 01:
And it would have avoided a lot of unnecessary litigation and briefing, right?

[00:30:53] Speaker 05:
I believe that's correct.

[00:30:55] Speaker 01:
And how long did it take for the board to resolve the entire underlying IPR in this case?

[00:31:01] Speaker 05:
There were issues in this case involving Joinder of multiple parties.

[00:31:06] Speaker 05:
It was a very complex case arising out of a Hatch-Waxman dispute.

[00:31:10] Speaker 05:
In the Joinder situation, the deadlines also are off.

[00:31:15] Speaker 05:
So again, it took longer than usual.

[00:31:17] Speaker 05:
That's why this is a very unusual

[00:31:19] Speaker 05:
case for resolving or even for evaluating.

[00:31:21] Speaker 09:
What made the hearing request so unusual?

[00:31:26] Speaker 01:
The opinion certainly doesn't give any indication that anybody was struggling with anything.

[00:31:30] Speaker 05:
I only know from the fact that it took a long time that something must have been going on.

[00:31:37] Speaker 01:
Do you know how long it normally takes for panels?

[00:31:40] Speaker 01:
Are you aware within the agency of how long it normally takes for panels to deal with hearing requests?

[00:31:45] Speaker 05:
I believe normally it takes

[00:31:49] Speaker 05:
in the time frame of the aspirational two months.

[00:31:51] Speaker 05:
Rehearing requests often are just a check on the board to make sure that they didn't overlook something or misapprehend the law, and they can normally get them done in a timely manner.

[00:32:03] Speaker 05:
I don't know what happened in this case.

[00:32:04] Speaker 09:
Is it your sense that 10 months is an outlier for the board?

[00:32:10] Speaker 09:
That would be my... I'm trying to understand how meaningful is this so-called aspirational goal of yours

[00:32:18] Speaker 09:
respond to a re-hearing request in one month or two months.

[00:32:22] Speaker 05:
I am not aware of statistics on the time to re-hearing, so I'd rather not speculate on that.

[00:32:30] Speaker 05:
But my basic belief from seeing re-hearing requests is that they're done reasonably promptly.

[00:32:37] Speaker 01:
I share Judge Chen's concern, which when a panel is aware of a concurrent district court ongoing litigation,

[00:32:47] Speaker 01:
why they wouldn't promptly turn to that particular rehearing request.

[00:32:53] Speaker 01:
Not all IPRs and rehearings have concurrent district court litigations, but here there was one that the panel board were clearly aware of.

[00:33:02] Speaker 01:
I baffled.

[00:33:06] Speaker 05:
Your Honor, it seems like a fair point, and I will take it back to board management.

[00:33:10] Speaker 05:
Board management, yes.

[00:33:12] Speaker 01:
okay it is something you'd like to address your time right now but i'm going to give you a chance to address something you'd like to say something.

[00:33:20] Speaker 05:
I'm here at the court's invitation.

[00:33:22] Speaker 05:
I heard several... Now you know why.

[00:33:27] Speaker 01:
In the future you might want to think twice about accepting those invitations.

[00:33:31] Speaker 05:
Well I was very interested in the issues that we were asked to respond to and I'm happy to respond to those.

[00:33:37] Speaker 05:
I'm not going to presume to

[00:33:38] Speaker 05:
tell the court how to deal with the avoidance doctrines.

[00:33:40] Speaker 05:
I understand the exchange that you had with Mr. Trela before me.

[00:33:44] Speaker 05:
But we do think the estoppel provisions are important.

[00:33:47] Speaker 05:
There is some uncertainty about them.

[00:33:50] Speaker 05:
The bar at large, patentees, petitioners could benefit from getting this court's views on estoppel.

[00:33:55] Speaker 05:
And I guess I'll say, just in broad terms, I'm not sure how far we'll go with this.

[00:34:00] Speaker 05:
But the plain language is very clear on both of the issues, the two primary issues we addressed, the successful petitioner issue and the final written decision.

[00:34:07] Speaker 05:
And the arguments on the other side are almost all policy arguments.

[00:34:10] Speaker 05:
And those are, I would say, really are all policy arguments.

[00:34:13] Speaker 05:
And those arguments really should be addressed.

[00:34:15] Speaker 09:
Do you think those policy arguments make sense?

[00:34:17] Speaker 09:
Do you think this is a common sense outcome, what you're advocating for in terms of your conception of the statute?

[00:34:23] Speaker 05:
Yes, ours is a very common sense outcome.

[00:34:26] Speaker 05:
The policy arguments.

[00:34:27] Speaker 09:
Do you all know the outcome here, to block the defendants from persisting with its

[00:34:35] Speaker 09:
The very same invalidity arguments have prevailed on in front of the board three different ways.

[00:34:40] Speaker 05:
It's perfectly consistent with Congress's intent to avoid duplicative

[00:34:44] Speaker 08:
litigation once but now is it now the petitioners have been deprived of their ability to uh... to a position that they actually prevailed on it's not that they lost but they won so to me you know you say it's common sense but to me i would think common sense goes the other way so can you explain to me why it's common sense to deprive and take away from the defendants a position that they prevailed on in another tribunal

[00:35:12] Speaker 05:
It has to do with the very fact that there are two tribunals at issue here.

[00:35:15] Speaker 05:
The petitioner here chose to get the faster, less expensive, more expert tribunal.

[00:35:22] Speaker 09:
Yeah, look where that got them in your view.

[00:35:24] Speaker 05:
The petitioner was successful.

[00:35:25] Speaker 09:
And in the normal case... Successful, but again, you extend out the logic of the current fact pattern, they would be enjoined from commercially marketing their product.

[00:35:40] Speaker 09:
under your understanding of the statute.

[00:35:42] Speaker 05:
But not at all.

[00:35:43] Speaker 05:
As Your Honor suggested, the district court could very easily have addressed an issue to stay in this case and any other case where this might arise.

[00:35:51] Speaker 05:
And that probably is the best result.

[00:35:52] Speaker 05:
Those were the policy arguments should be addressed.

[00:35:54] Speaker 05:
If the petitioner thinks there's a bad result here, they can explain that to the district court.

[00:35:59] Speaker 05:
The district court more than likely would issue a stay.

[00:36:02] Speaker 05:
The other place a petitioner can go if they have a problem with this, and I think it may only occur in Hatch-Waxman,

[00:36:08] Speaker 05:
and shouldn't even occur, there would be to go to Congress, which is equipped to deal with the balance between.

[00:36:13] Speaker 01:
I know.

[00:36:13] Speaker 01:
I felt like this case was a bit of the perfect storm in my mind.

[00:36:17] Speaker 01:
And what I mean by that is I don't see how this situation presents itself hardly ever, because I feel like most district courts would issue stays in circumstances like this, which moots this issue.

[00:36:29] Speaker 01:
I also feel like the PTO usually acts quite expeditiously, and there aren't

[00:36:34] Speaker 01:
I mean, how many petitions for rehearing are generally filed within the PTO other than for simply delay tactics potentially?

[00:36:43] Speaker 01:
You can't speculate on whether they're for delay tactics.

[00:36:45] Speaker 01:
How many rehearing petitions are filed within the PTO?

[00:36:48] Speaker 05:
I don't have an answer to that.

[00:36:50] Speaker 05:
I think there is a standard that must be met.

[00:36:53] Speaker 05:
They have to make an argument that the panel actually overlooked something or misapprehended some point of law.

[00:36:58] Speaker 01:
You don't have any sense.

[00:36:59] Speaker 01:
You can't tell me in your experience less than half or less than 20 percent.

[00:37:05] Speaker 01:
I'll tell you right now.

[00:37:06] Speaker 01:
Rehearing petitions to the federal circuit?

[00:37:07] Speaker 01:
Every case.

[00:37:08] Speaker 01:
Every single one.

[00:37:09] Speaker 05:
Okay.

[00:37:10] Speaker 01:
So what's your sense?

[00:37:12] Speaker 05:
I guess in the range of half, I think.

[00:37:15] Speaker 05:
But it's a guess.

[00:37:16] Speaker 05:
I'd have to check with the board to see what the statistics are.

[00:37:19] Speaker 01:
The reason I'm trying to wrap my brain around Mr. Trela's argument that there's a real problem here and that we need to reach the statutory interpretation issue, otherwise there's going to be real impact on real people out there.

[00:37:31] Speaker 01:
And I was suspicious of the correctness of those assertions, both because the district court could easily grant a stay, which would obviate this problem in its entirety and probably should have.

[00:37:41] Speaker 01:
And of course, the refusal to grant a stay in that case could have even been nameless to us, right?

[00:37:45] Speaker 01:
And so we could do something, if necessary, as we have in the past in circumstances like that.

[00:37:50] Speaker 01:
But in any event, a stay was a very real possibility.

[00:37:53] Speaker 01:
And the other thing is, I just don't see how often it's going to be the case that the PTO drags its feet, as long as it did in this particular set of circumstances, such that we end up in the situation that we're in.

[00:38:04] Speaker 01:
Because normally, these IPRs move a lot quicker.

[00:38:07] Speaker 01:
And so what I was trying to gauge from you

[00:38:09] Speaker 01:
The only open-ended avenue that I was aware of was rehearing, where there's no actual time limit.

[00:38:16] Speaker 01:
And so I'm trying to gauge, get a sense of how real is this problem that Mr. Trela has in this case.

[00:38:22] Speaker 05:
I agree with you that it's not very real, because even if there have been delays in rehearing decisions, this issue has not presented itself before.

[00:38:29] Speaker 05:
We haven't encountered it before this case.

[00:38:32] Speaker 05:
The AIA has been in place for six or seven years now.

[00:38:35] Speaker 05:
So I don't think it's a common problem.

[00:38:37] Speaker 05:
I do think litigants, especially on the Hatch-Waxman side and the litigants and the filers, could benefit from understanding what the rule is.

[00:38:47] Speaker 05:
If the rule is as we say, that might be a motivation for them to file their andas a little bit earlier.

[00:38:54] Speaker 05:
But again, that may well be beyond the scope of what this court needs to rule on here.

[00:38:58] Speaker 07:
To file their andas a bit earlier or to file their IPRs a bit earlier?

[00:39:03] Speaker 05:
I'm sorry.

[00:39:03] Speaker 05:
That's why I meant to file the IPRs a little bit

[00:39:05] Speaker 05:
as soon as possible so as to get the result contemporaneously with the litigation.

[00:39:13] Speaker 00:
Okay, thank you Mr. Krauss.

[00:39:15] Speaker 00:
Let's hear from Mr. Kelly.

[00:39:25] Speaker 04:
May I please support?

[00:39:26] Speaker 04:
Good morning, Your Honours.

[00:39:28] Speaker 09:
As the court is aware from the discussions today we've all seen there's a lot of different ways that this case can be resolved and I'm I'm happy that Mr. Trelleges... Just a quick question, did your side file a motion to stay the district court action once the IPR decisions came out last January 2018?

[00:39:44] Speaker 04:
No your honor, neither side filed such a motion.

[00:39:46] Speaker 09:
Okay, how come?

[00:39:47] Speaker 09:
I would think it would have been the right instinct for your side to try to stay the district court action and then let the IPRs

[00:39:57] Speaker 09:
play themselves out through rehearing and then federal circuit appeal?

[00:40:01] Speaker 04:
Well, Your Honor, the motion in Lemonay was raised early and resolved early by the district court during the hearing, actually, I believe.

[00:40:09] Speaker 04:
And so it was not in our interest to stay that case because we actually wanted to get to a resolution of that case because we have a very, very strong and validity case.

[00:40:16] Speaker 04:
We wanted to get to the issue.

[00:40:18] Speaker 04:
As to whether or not a stay would have theoretically worked for either side, I'm not sure it would have in this case because at the time

[00:40:25] Speaker 04:
it came up in the district court, the Hatch-Waxman 30-month stay was in existence at that point.

[00:40:31] Speaker 04:
And the 30-month stay can be adjusted, either lengthened or shortened, based on the parties' activities in the case.

[00:40:37] Speaker 04:
So if one side wants to slow down the case, the district court can theoretically extend the 30-month stay.

[00:40:42] Speaker 04:
And if the other side wants to do something the other way, the district court can theoretically slow down the 30-month stay.

[00:40:50] Speaker 04:
So you have the background issue of the 30-month stay

[00:40:53] Speaker 04:
in effect at the time this was happening at the district court.

[00:40:56] Speaker 04:
That 30-month stay expired right about the time the district court issued its decision in this case, I think, in October of 2002.

[00:41:03] Speaker 09:
So, OK, so you saw a risk that the 30-month stay might get extended out to, I don't know, a 40-month stay.

[00:41:11] Speaker 04:
No, Your Honor, I didn't mean to suggest that we didn't do it because we saw a risk.

[00:41:16] Speaker 04:
We liked what was happening in the district court.

[00:41:19] Speaker 04:
I suppose we could have asked for a stay, but we had a very strong case.

[00:41:23] Speaker 04:
We realized that by raising this issue in the district court, we were putting ourselves at risk a little bit.

[00:41:28] Speaker 04:
They could have theoretically won at the district court.

[00:41:30] Speaker 04:
And if they won on the invalidity issue at the district court, there would be a stay in place right now.

[00:41:34] Speaker 04:
And that stay would last as long as they could slow down the PTAB cases, which they've already proven their ability to do quite well.

[00:41:40] Speaker 04:
And so what we wanted to do is get to the end of the case so that we could go onto the market.

[00:41:45] Speaker 02:
What was your expectation based on past experience on the amount of time reharing would take?

[00:41:51] Speaker 04:
I have no idea why this re-hearing decision took this long.

[00:41:55] Speaker 04:
I'm aware of re-hearing decisions taking, in fact, much longer than this.

[00:42:00] Speaker 04:
On remand, I've heard of cases extending a long time, but I trust that this is an outlier, and I believe it to be an outlier.

[00:42:06] Speaker 04:
But that doesn't mean that we should just trust that there won't be an outlier in the next case.

[00:42:11] Speaker 04:
And incidentally, as to the amount of re-hearing requests,

[00:42:15] Speaker 04:
My sense is that it's well below 50%, not that it's at 50%.

[00:42:18] Speaker 01:
It's like solicitor day at the PTO.

[00:42:20] Speaker 01:
I just realized we've got three of you involved in this.

[00:42:22] Speaker 01:
One on each side and one on the bench.

[00:42:24] Speaker 04:
I apologize for that.

[00:42:25] Speaker 01:
We've got to get it right, right?

[00:42:26] Speaker 01:
We've got three solicitors weighing in.

[00:42:28] Speaker 04:
And at least two of us disagree.

[00:42:32] Speaker 04:
At least two of us.

[00:42:36] Speaker 04:
So I want to just address one issue quickly before I let it slip away.

[00:42:40] Speaker 04:
Mr. Trela referred to the secondary considerations.

[00:42:42] Speaker 04:
And this is, as far as I can tell,

[00:42:44] Speaker 04:
the only argument as to how a different claim construction could possibly matter to the PTAB cases, because we know it can't matter because we have the walk hard IPR where the board specifically made findings about the teachings of Sartori.

[00:42:57] Speaker 01:
Unless he is right, which I'm hoping he'll maybe readdress on rebuttal, unless he's right that there was some impact on the secondary consideration evidence.

[00:43:08] Speaker 01:
I mean, that would be the only thing.

[00:43:11] Speaker 01:
I will tell you, I read the Wachart exactly that way.

[00:43:14] Speaker 01:
I turned him right to the pages of it.

[00:43:16] Speaker 01:
And I read it as creating an independent basis for affirming this IPR decision, regardless of claim construction.

[00:43:24] Speaker 01:
But in his response to me was not so much that I was wrong in how I read it.

[00:43:28] Speaker 01:
It was more that, yes, but if they're still right about claim construction, he believes that the secondary consideration determinations were impacted by claim construction.

[00:43:39] Speaker 04:
Right, so I understood that to be his argument today as well, which is that if the claim construction is somehow constricted or narrowed beyond what the board found, that they need to do over on... No, beyond if the claim construction is not what he's arguing today it should be.

[00:43:56] Speaker 04:
Right, I guess that's what I meant to say.

[00:43:58] Speaker 04:
The board construed the claims under BRI to a certain extent, and they are now arguing that it needs to be narrower, that treating needs to be anti-cancer treating only, and that because it's narrower,

[00:44:09] Speaker 04:
that affects the case, and we know it doesn't affect the principal case because we have the Walker IPR.

[00:44:16] Speaker 04:
Okay, so when we get into the secondary considerations, the question is, does the, does the anti-cancer treatment requirement that they want to write into that claim, does it affect the secondary considerations to the extent that we need to do over?

[00:44:27] Speaker 04:
And what he pointed you to today, and what I'd like to address just really quickly, is the language at the top of page 370.

[00:44:34] Speaker 04:
And this is the sentence that actually begins on 369.

[00:44:37] Speaker 04:
So at the bottom of 369, the board writes, this literature's discussion acknowledges the previously known roles of aberraterone, acetate, and prednisone, and the discussion of a corticosteroid generally contradicts the specific anti-cancer role of prednisone argued by patent owner.

[00:45:04] Speaker 04:
And what that shows us is that the board was not just thinking about this anti-cancer alternative in the principal part of the 103, but had still had it on its mind when it got into the secondary considerations.

[00:45:16] Speaker 04:
So the very sentence he pointed us to demonstrates that the board was actually thinking about the anti-cancer notion of prednisone that they're arguing.

[00:45:25] Speaker 09:
And so it... But can you translate what this statement means, the discussion of the

[00:45:29] Speaker 09:
corticosteroid generally contradicts the specific anti-cancer role of prednisone argued by the patent owner?

[00:45:38] Speaker 09:
I mean, yes, it acknowledges the patent owner's argument of the anti-cancer role of prednisone, but I don't quite... Can you explain what the sentence means?

[00:45:48] Speaker 04:
I think what they're getting at there is that

[00:45:51] Speaker 04:
Janssen had made an argument about commercial success, that because we have commercial success, this defeats the logic behind the obvious in this case, the standard commercial success approach.

[00:46:01] Speaker 04:
And there's two answers to that.

[00:46:03] Speaker 04:
The first is the blocking pattern, which is actually the more powerful answer.

[00:46:06] Speaker 04:
But the second answer is that what they attribute the success to is defeated by the fact that the prior art, if there was success, already understood the need

[00:46:18] Speaker 04:
for a glucocorticoid like prednisone in this treatment method.

[00:46:22] Speaker 04:
And because the prior already understood that, that any success that they had might have been coming from that use of prednisone, even though... Have you understood that from Sartor, or understood that just generally to reduce side effects?

[00:46:37] Speaker 04:
Understood that from evidence other than Sartor, because Sartor teaches us about the anti-cancer effects.

[00:46:42] Speaker 04:
And so what the board is saying here is, look, even if you have commercial success,

[00:46:47] Speaker 04:
It's not clear that the commercial success is from the anti-cancer effects, which you are now arguing.

[00:46:53] Speaker 04:
But in fact, it's from the known palliative effects that the prior art talked about in a lot of different ways.

[00:46:59] Speaker 04:
That's my understanding of what the board is saying here, which is just another piece of evidence that the secondary consideration issues, just like the main 103 issue, does not need a remand, even if this court should disagree with the board's claim construction.

[00:47:15] Speaker 02:
But it also goes back to the meaning of treatment.

[00:47:19] Speaker 04:
It does, Your Honor.

[00:47:20] Speaker 04:
And so I'd like to address that right now, I guess.

[00:47:23] Speaker 04:
Because Judge Chen, you raised this morning the issue about an anti-cancer agent or an antibiotic.

[00:47:31] Speaker 04:
Or a steroid.

[00:47:32] Speaker 04:
I'm sorry, or a steroid.

[00:47:33] Speaker 04:
And that's exactly how the board looked at this case.

[00:47:35] Speaker 04:
The board said, well, it's clearly not directed to the second agent being an anti-cancer agent, because it presents it in the alternative.

[00:47:42] Speaker 04:
But there's another rationale that we can rely on, and that's in column four of the patent.

[00:47:47] Speaker 04:
In column four of the patent, it discusses the need, what refractory cancer means.

[00:47:53] Speaker 04:
And it says refractory cancer is a cancer that is not responding to an anti-cancer treatment.

[00:47:58] Speaker 04:
They specifically, the inventors, specifically narrowed what they meant by treatment in that column of the patent to a particular type of treatment, and that's anti-cancer treatment.

[00:48:07] Speaker 04:
And I can point the court director to that.

[00:48:10] Speaker 04:
That's on.

[00:48:12] Speaker 04:
column four, which is in the record at page 759.

[00:48:19] Speaker 04:
And the paragraph that begins at line 23 says, as used herein, and unless otherwise defined, the phrase refractory cancer means cancer that is not responding to an anti-cancer treatment.

[00:48:32] Speaker 04:
So when the inventors wanted to talk about a type of treatment that was anti-cancer, they knew how to say it.

[00:48:37] Speaker 04:
Just as when they wanted to talk about

[00:48:40] Speaker 04:
an ingredient in their drug that was specifically anti-cancer versus a steroid, they knew how to do it.

[00:48:46] Speaker 04:
So the board was on very solid ground when they said treating in the 438 patent extends beyond anti-cancer treatments.

[00:48:57] Speaker 04:
And so if the court has no more questions on that, I'll just turn to 315E2, which is the court understand that pretty clearly it does not need to be reached in this case.

[00:49:05] Speaker 09:
Before we go on

[00:49:07] Speaker 09:
I did see in a couple places in the blue brief, I guess under the reasonable expectation success section, where they do talk about Sartre and how maybe Sartre isn't clear enough or clean enough in giving one a motivation to add prednisone for some kind of anti-cancer effect.

[00:49:31] Speaker 09:
So could you just respond to that?

[00:49:34] Speaker 04:
Sure, and I think what they pointed to at the parts of the brief your honor is looking at is testimony, perhaps in the declarations, that they think suggests that people skilled in the prior art would not have believed that Sartor, or I should say that prednisone, has an anti-cancer effect.

[00:49:51] Speaker 04:
So what they're doing there is they're pointing to evidence that they say is contradictory.

[00:49:54] Speaker 04:
And my response to that would be there may have been evidence that they perceived to be contradictory, and it may or may not have been contradictory, but that was all before the board.

[00:50:03] Speaker 04:
The board saw the evidence that they pointed to the board, and the board saw Sartor, and the board made a finding.

[00:50:08] Speaker 04:
And the board's finding was that it was recognized in the art that prednisone had an anti-cancer effect.

[00:50:14] Speaker 04:
And that finding is supported by substantial evidence, and that substantial evidence is Sartor.

[00:50:19] Speaker 04:
So the fact that they want to suggest that this court should reweigh the evidence, we don't think is persuasive.

[00:50:25] Speaker 04:
And then pages 350, 351, and I think all the way to 359,

[00:50:29] Speaker 04:
That is the board's discussion of reasonable expectation of success in the Walkhart IPR.

[00:50:34] Speaker 04:
And the board doesn't just talk about it at the beginning of that.

[00:50:37] Speaker 04:
It talks about it at the end.

[00:50:38] Speaker 04:
So throughout that discussion of what one skilled in the art would have expected, the board is alternatively pointing to Sartor's teaching.

[00:50:45] Speaker 04:
So even if this court would somehow conclude that the BRI, the broadest reasonable interpretation that the board reached, should somehow have been narrower, notwithstanding what it says pretty clearly in the specification,

[00:50:58] Speaker 04:
It still doesn't matter.

[00:50:59] Speaker 04:
It still doesn't matter because the one place where they brought it up, and we would say that they've actually waived that issue because of the Amerigen IPR, the one place they brought it up, the board actually addressed it.

[00:51:13] Speaker 09:
Is there any evidence in the record that anyone was actually discouraged by the so-called blocking patent from investigating how to use the Barrett drone?

[00:51:27] Speaker 04:
I guess if the court is asking, is there affirmative evidence that someone was dying to conduct these studies, and they said, well, we just can't because of this blocking patent, I'm not aware of evidence like that.

[00:51:41] Speaker 04:
I think the problem is we have the blocking patent.

[00:51:44] Speaker 04:
So we have the exclusive right, and we have the fact that no one did it.

[00:51:48] Speaker 04:
And so based on the blocking patent and this court's case law about it, that's enough to suggest, well, there was an impediment.

[00:51:54] Speaker 04:
You would not have done it.

[00:51:55] Speaker 04:
And by the way, there wasn't just a blocking patent.

[00:51:57] Speaker 04:
But there's also the approval that they had.

[00:52:00] Speaker 04:
The FDA approval.

[00:52:03] Speaker 04:
And their response to the blocking patent is that they may have tried to license it.

[00:52:07] Speaker 04:
But the fact that they could not entice someone to pay whatever they were seeking in their royalty rate to get someone to do these experiments does not overcome the fact that why would someone pursue a treatment alternative that they absolutely couldn't engage in because it's blocked by a patent.

[00:52:25] Speaker 04:
A patent that we don't have to wrestle with the scope of the claims in that earlier patent and whether it might have blocked or might not have blocked.

[00:52:31] Speaker 04:
It was blocking aberratoron.

[00:52:32] Speaker 04:
That was the purpose of that patent.

[00:52:34] Speaker 04:
So no one could enter the field by combining aberratoron with anything else.

[00:52:38] Speaker 09:
I'm just trying to understand the state of the case law.

[00:52:41] Speaker 09:
The case law doesn't say that the existence of a blocking patent per se neutralizes commercial success evidence, right?

[00:52:51] Speaker 04:
Not necessarily, Your Honor, but I think that where case law has gone is it depends on what is actually blocked and how many patents there are.

[00:52:58] Speaker 04:
I would submit that this case is a little bit different because we have one ingredient that we can identify by its chemical structure, and that chemical structure is exactly what's the content of the exclusive right in the blocking patent.

[00:53:11] Speaker 04:
So someone just, they just simply can't get there.

[00:53:13] Speaker 04:
And whatever evidence that they have about licensing, that is evidence that the district court considered.

[00:53:19] Speaker 04:
That's evidence that the board looked at.

[00:53:20] Speaker 01:
I'd love to see you turn to 315 if you don't mind.

[00:53:23] Speaker 04:
I'd be happy to.

[00:53:26] Speaker 04:
So let me start with where the government and Janssen have basically put all their eggs in the basket of saying this is a venue selection provision.

[00:53:38] Speaker 01:
I don't care how they label it.

[00:53:42] Speaker 01:
Why isn't the plain language of this, you may not assert,

[00:53:48] Speaker 01:
Either a civil litigation action arising in Holland Park under 1338.

[00:53:53] Speaker 01:
Why?

[00:53:53] Speaker 01:
I don't understand.

[00:53:55] Speaker 01:
I mean, the language seems really clear.

[00:53:57] Speaker 01:
You can't assert any ground the petitioner raised or Riesley could have raised during the IPR.

[00:54:03] Speaker 01:
I don't know.

[00:54:04] Speaker 01:
That language seems really plain on its face.

[00:54:08] Speaker 04:
And, Your Honor, it comes under the heading of estoppel.

[00:54:11] Speaker 04:
And we know that other portions of Title 35, or at least one other portion of Title 35,

[00:54:15] Speaker 04:
refers to the estoppel that's created by 315E2.

[00:54:19] Speaker 04:
So we believe, as we've briefed, that the word estoppel carries with it the meaning of estoppel.

[00:54:25] Speaker 04:
And so you have to interpret those words in the overall scheme as to what estoppel is actually being created.

[00:54:33] Speaker 01:
And I'll keep going.

[00:54:37] Speaker 04:
I just want to recognize it.

[00:54:40] Speaker 01:
I don't understand.

[00:54:42] Speaker 01:
You just keep saying the word estoppel over and over as though that answers my question.

[00:54:45] Speaker 01:
I don't get it.

[00:54:47] Speaker 04:
Because, Your Honor, if it's an estoppel provision, you have to consider how it's actually creating the estoppel.

[00:54:53] Speaker 02:
Because it's grounded in equity.

[00:54:55] Speaker 04:
Right.

[00:54:55] Speaker 04:
Well, it's grounded.

[00:54:57] Speaker 04:
We bring with it the baggage of estoppel as it's used in the district courts and as it's used in equity and where it has come from.

[00:55:03] Speaker 04:
And we also look at how the words that Your Honor is looking at actually function in the statute.

[00:55:07] Speaker 02:
We merge law and equity in these courts.

[00:55:11] Speaker 02:
So as a consequence, because it's grounded in equity, what you're saying is when the word is used, it must necessarily imply its history.

[00:55:21] Speaker 04:
It imply its history and also how we should view the rest of the words in that section.

[00:55:26] Speaker 04:
And so if I will embrace for a second their understanding of the words in the section and I think the understanding that your court was pointing to and explain why it is that that doesn't actually make their

[00:55:39] Speaker 04:
and make any estoppel actually arise.

[00:55:42] Speaker 04:
If we lost, if the petitioner lost at the board, the reason the words of 315E to create estoppel is because of the overlay of the presumption of validity in the district court.

[00:55:55] Speaker 04:
If our hands are tied, we turn to the district court, we cannot raise what we just lost at the board over, then we lose at the district court.

[00:56:05] Speaker 04:
And the reason we lose at the district court

[00:56:07] Speaker 04:
is the presumption of validity kicks in, and that patent is invalid.

[00:56:11] Speaker 04:
I'm sorry, valid.

[00:56:12] Speaker 04:
If you, not invalid, I should say.

[00:56:14] Speaker 04:
If you flip it upside down, so if we were to have one at the T-tab, as we did, if our hands are tied, that does not create any estoppel.

[00:56:25] Speaker 04:
And whatever happens in that case, if they want to say, as the government did well, it does at the end of the day.

[00:56:31] Speaker 04:
At the end of the day, it does.

[00:56:33] Speaker 04:
Because at the end of the day,

[00:56:34] Speaker 04:
If this court affirms a certificate issues, those claims will essentially evaporate, and the co-pending district court case will go away.

[00:56:42] Speaker 01:
That happens later.

[00:56:43] Speaker 01:
One of the problems that I have with your argument is I'm not sure how it makes sense, because you're saying, well, estoppel isn't just, it doesn't apply to all arguments you raised.

[00:56:57] Speaker 01:
It only applies to all arguments you raised and lost on.

[00:57:00] Speaker 01:
Right?

[00:57:01] Speaker 01:
That's your argument.

[00:57:03] Speaker 04:
No, our argument, Your Honor, respectfully, is that the estoppel of 315E2 doesn't, in any logical sense, ever apply to anything someone raised or could have raised or anything, if they're the winner.

[00:57:15] Speaker 04:
It just doesn't apply to them, because that's not how estoppel works.

[00:57:19] Speaker 04:
When you go into court and you win on an issue, that doesn't create any estoppel for you.

[00:57:25] Speaker 04:
In a classical sense, in a logical sense, as the government would say, I think, in an intuitive sense, the fact that you won

[00:57:31] Speaker 04:
You're not, if you're just trying to apply it and we weren't even trying to do that.

[00:57:36] Speaker 09:
Mr. Kelly, what if Congress did intend to make it a choice of venue provision?

[00:57:43] Speaker 09:
What other words would it have used other than the words that it used?

[00:57:50] Speaker 04:
It would have used words that clearly cut off the district court litigation so as to avoid duplicative tribunals and what they would have done first of all is they wouldn't have triggered it by the final written decision.

[00:57:58] Speaker 04:
They would have triggered

[00:58:00] Speaker 04:
estoppel by the institution decision.

[00:58:02] Speaker 04:
Because the only reason we need to know that there's a final written decision in order to apply estoppel, frankly, is we need to know who won or lost.

[00:58:11] Speaker 09:
So if the statute said if the petitioner in IPR of a claim in a patent results in an institution of that IPR request, then that petitioner may not assert any ground of

[00:58:29] Speaker 09:
invalidity that the petitioner raised or could have raised during the IPR?

[00:58:36] Speaker 04:
Something like that.

[00:58:37] Speaker 09:
To me, that doesn't really move the ball, whether it replaced the words final written decision under 318A with institution decision.

[00:58:46] Speaker 04:
It moves the ball remarkably, Your Honor.

[00:58:48] Speaker 04:
It gets it to where they think it is.

[00:58:50] Speaker 04:
So what they keep saying is once you choose a path, that's your path.

[00:58:54] Speaker 04:
and it cuts off the litigation.

[00:58:55] Speaker 04:
That's not how 315E2 works.

[00:58:57] Speaker 04:
You have to walk all the way down the path under their theory and get to the end of the path, and then it cuts off the walk that you took on the first path.

[00:59:04] Speaker 04:
That doesn't make any sense.

[00:59:06] Speaker 04:
So I think what Your Honor said, if I understood it would have worked, that they could have said, once an IPR is instituted, a district court shall not consider any invalidity arguments raised in the IPR or could have been raised in the IPR.

[00:59:18] Speaker 04:
That would be a venue choice provision.

[00:59:20] Speaker 04:
That's not what this says.

[00:59:21] Speaker 04:
It says, if there's an IPR,

[00:59:23] Speaker 04:
and it gets to the very end, and there's a final written decision, then this kicks in.

[00:59:28] Speaker 04:
The only thing that we know based on that final written decision is who the winner is and who the loser is.

[00:59:36] Speaker 01:
Just like you pointed out that Section E has the header estoppel, and you would like me to insert the word collateral before estoppel, even though Congress didn't.

[00:59:43] Speaker 01:
And you would like me to believe that Congress embraced the common law of collateral estoppel when they used the word estoppel, even though there are other kinds of estoppel other than collateral estoppel.

[00:59:52] Speaker 01:
The section begins at section 315 and the title of it is called relation to other proceedings or actions.

[01:00:00] Speaker 01:
So if the umbrella of all of section 315 is delineating between the relationship and articulating the relationship between multiple proceedings and if section A2 is all about staying a civil action as a matter of right if the IPR is filed first and everything, why isn't this exactly

[01:00:21] Speaker 01:
what they are alleging it is, which is Congress's attempt to delineate when one case should move forward and not the other, or when one should move forward and not the other.

[01:00:34] Speaker 01:
Why isn't pretty much most of what's contained within 315, including the title of the whole section and the stay of civil litigation action and everything else, the attempt by Congress to convey quite clearly that they don't want these duplicative litigations going forward?

[01:00:49] Speaker 01:
And if that's how I read,

[01:00:50] Speaker 01:
not just the language of 315E2, which is how I read the language of 315E2, but even if it weren't how I read it, why take it in context with everything else?

[01:01:01] Speaker 01:
Wouldn't I overall look at this provision as one in which Congress was attempting to make clear we don't want these duplicative litigations?

[01:01:10] Speaker 04:
Because the statute is more complicated than that.

[01:01:12] Speaker 04:
Because there are a number of paragraphs.

[01:01:14] Speaker 01:
You want me to look at the word estoppel in E, and you want that

[01:01:19] Speaker 01:
to dictate how I understand E2.

[01:01:21] Speaker 01:
But you don't want me to read the language in section, the title of section 315, even though this is section 315 E2.

[01:01:27] Speaker 01:
You want me to read E and use it to interpret 2 in the way you want, but not 315?

[01:01:34] Speaker 04:
No, Your Honor.

[01:01:35] Speaker 04:
All of 315 has different provisions in it.

[01:01:38] Speaker 04:
And we recognize that estoppel is related to how one proceeding affects another proceeding.

[01:01:45] Speaker 04:
We're not saying it's not.

[01:01:47] Speaker 04:
to say that they're all choice of venue provisions ignores the fact that Congress did actually put in choice of venue provisions.

[01:01:55] Speaker 01:
Do you agree that A2 is a choice of venue provision?

[01:01:58] Speaker 04:
No, Your Honor, I wouldn't agree that A2 is a choice of venue provision.

[01:02:11] Speaker 01:
So what do you think A2 is?

[01:02:15] Speaker 01:
It says if there's a civil action

[01:02:17] Speaker 01:
it was filed after an IPR, civil action shall be automatically stayed.

[01:02:22] Speaker 01:
And it gives a number of exceptions.

[01:02:23] Speaker 01:
But why isn't that a clear indication by Congress that it intends only one to move forward at a time and not both to move forward simultaneously?

[01:02:31] Speaker 04:
So if the mandatory stay provision is actually triggered and not overcome by any of those other things, then yes, that would be compelling the district court to stop and the PTAB moving forward.

[01:02:42] Speaker 04:
And then 315A1,

[01:02:44] Speaker 04:
if the DJ action is filed first, that would bar the inter-party review.

[01:02:50] Speaker 04:
Those are choice of venue provisions.

[01:02:52] Speaker 04:
And then if we skip down to- Do you mean DJ?

[01:02:55] Speaker 01:
You said DJ.

[01:02:57] Speaker 04:
I don't- Yes.

[01:03:00] Speaker 01:
Oh, OK.

[01:03:00] Speaker 04:
Yes, that's right.

[01:03:01] Speaker 04:
That's what that means.

[01:03:03] Speaker 04:
An inter-party review may not be instituted before the- Yes, yes, yes.

[01:03:05] Speaker 04:
I get it now.

[01:03:06] Speaker 04:
So then we get down to 315B.

[01:03:08] Speaker 04:
315B is where we get the one-year bar from.

[01:03:11] Speaker 04:
So we know that if you are a defendant and you're sued,

[01:03:15] Speaker 04:
under 315B, you can't move forward after one year.

[01:03:18] Speaker 04:
And so those are where Congress is saying this can happen or that can happen.

[01:03:23] Speaker 04:
Those are the choice of venue provisions.

[01:03:25] Speaker 04:
315E2 is simply not a choice of venue provision.

[01:03:27] Speaker 04:
It's not telling you that district court, you have to stop.

[01:03:31] Speaker 04:
Once we know the PTAB is going to make a decision, there's nothing else for the district court to do.

[01:03:34] Speaker 01:
Is there anything else you wanted to address?

[01:03:36] Speaker 01:
I understand your arguments on this.

[01:03:37] Speaker 01:
Is there anything else that you think we need to hear about before we let Mr. Trela get up and have his rebuttal time?

[01:03:46] Speaker 04:
No.

[01:03:47] Speaker 01:
Excellent.

[01:03:48] Speaker 01:
Thank you.

[01:03:49] Speaker 01:
We'll give you, like, your whole five minutes of rebuttal time.

[01:03:53] Speaker 01:
I hope you don't have to use all of it.

[01:03:55] Speaker 06:
Well, I will try not to, Your Honor, but I can't make any promises, I'm afraid.

[01:03:59] Speaker 06:
We won't let you run over, though.

[01:04:02] Speaker 06:
Well, let me pick up with 315E2 really briefly.

[01:04:04] Speaker 06:
A couple of things on that.

[01:04:06] Speaker 06:
One is, as I think Your Honor pointed out, the heading that they're relying on, first of all, you only look at headings if there's ambiguity.

[01:04:12] Speaker 06:
The law's very clear on that.

[01:04:14] Speaker 06:
The heading they're relying on is estoppel, not collateral estoppel, which is the way that they want the court to read it.

[01:04:19] Speaker 06:
The other thing that they completely ignore is the predecessor statute, which said exactly what they want this one to say, and Congress changed it.

[01:04:29] Speaker 06:
Change is presumed to have meaning.

[01:04:31] Speaker 02:
The other thing is that the argument... That's like Sutherland on statutory construction.

[01:04:36] Speaker 02:
Is the legislature also presumed to have common sense?

[01:04:40] Speaker 01:
If you cite that, do you have to do it with a Southern accent?

[01:04:43] Speaker 01:
Southern was from the South, I think.

[01:04:46] Speaker 06:
Well, Your Honor, I don't know if there's a presumption about common sense.

[01:04:48] Speaker 06:
There is a presumption that the plain language of the statute should be applied.

[01:04:53] Speaker 06:
And the plain language here is pretty clear.

[01:04:56] Speaker 02:
The other thing is the- It says in Southern, the legislature is presumed to have a rational purpose.

[01:05:01] Speaker 06:
True.

[01:05:01] Speaker 06:
And there is a rational purpose here.

[01:05:04] Speaker 06:
Once the agency is deciding an issue, courts shouldn't get into it.

[01:05:07] Speaker 06:
And that gets to the institution decision point.

[01:05:10] Speaker 06:
And I'm not completely sure I followed that, but under 317A, the fact that an institution decision was made doesn't inevitably mean that a final written decision is going to follow.

[01:05:20] Speaker 06:
So you need the final written decision.

[01:05:22] Speaker 06:
And it's not just because you need to know who won.

[01:05:25] Speaker 06:
It's because you need to know, is the agency going to decide validity?

[01:05:28] Speaker 06:
Now, on the Wacard alternative claim construction point, first, Judge Moore, to answer your question, our opening brief pages 37 to 38, reply pages 10 to 11,

[01:05:39] Speaker 06:
We do, in fact, address that.

[01:05:42] Speaker 06:
And our argument on that is not limited just to objective indicia.

[01:05:47] Speaker 06:
It also goes to reasonable expectation of success.

[01:05:50] Speaker 06:
The board, although it said that the 1998 Sartor reference might have led one of ordinary skill to expect that prednisone would have an anti-cancer effect, the board never found that one of ordinary skill would reasonably expect the combination

[01:06:09] Speaker 06:
that the prednisone in the combination would have an anti-cancer effect along with abiraterone.

[01:06:14] Speaker 06:
And in fact, it could not have made that finding because the petitioners told the board it couldn't make that finding.

[01:06:21] Speaker 06:
Just as an example, in the Amerigen petition, and this is at 29303 of the appendix, it told the board in the 1980s there was a belief that prednisone might be useful for treating prostate cancer.

[01:06:36] Speaker 06:
But by 2006, it was known that prednisone was not effective as an anti-cancer agent.

[01:06:42] Speaker 06:
They say the same thing at 29,342.

[01:06:44] Speaker 06:
And each of the petitioner's experts took the position that one of ordinary skill would not have expected prednisone in the combination in 2006 to have an anti-cancer effect.

[01:06:55] Speaker 06:
We cite that in our blue brief at pages 38 to 39, and we quote some of them.

[01:07:00] Speaker 06:
But if you look at those references in the appendix, they're very clear on that.

[01:07:05] Speaker 06:
There was no expectation of success in achieving these claims with prednisone having an anti-cancer effect.

[01:07:12] Speaker 06:
Another thing I wanted to turn to.

[01:07:15] Speaker 09:
What about the statement that prednisone alone led to an average decline of 33% in PSA responses after initiating prednisone for up to six months?

[01:07:25] Speaker 06:
A couple of things with that, and that's, I think, from Sartor 1998.

[01:07:30] Speaker 06:
By 2006, even Sartor himself recognized that prednisone alone did not have anti-cancer efficacy.

[01:07:38] Speaker 06:
Also, the standard for looking at PSA had completely changed.

[01:07:42] Speaker 06:
Drops of 33 percent were not considered.

[01:07:44] Speaker 06:
There wasn't even a reportable response.

[01:07:46] Speaker 06:
You needed a response of at least 50 percent of a certain duration before it was even considered evidence of activity, much less efficacy in treating cancer.

[01:07:55] Speaker 06:
So by the time, and as Amerigen recognized, early on, there was this thinking that prednisone might have an anti-cancer effect.

[01:08:03] Speaker 06:
But by 2006, that had been completely dissipated.

[01:08:06] Speaker 06:
And 2006 is the relevant time.

[01:08:09] Speaker 06:
Now on the, there was also a claim.

[01:08:12] Speaker 01:
So you think that we need to overturn the board's fact finding related to

[01:08:19] Speaker 01:
Sartor reasonably standing for the proposition that administrating a prednisone is tolerated and effective in a subset of cancer patients?

[01:08:25] Speaker 06:
No, I don't think you need to overturn that.

[01:08:27] Speaker 06:
I think you should, but I don't think you need to.

[01:08:29] Speaker 01:
But you didn't argue for us to, so.

[01:08:30] Speaker 06:
Well, then I guess you shouldn't.

[01:08:34] Speaker 06:
But that's not the finding the board needed.

[01:08:36] Speaker 06:
The finding was a reasonable expectation of success in achieving the claimed invention.

[01:08:40] Speaker 06:
The claimed invention is the combination with prednisone having anti-cancer effect in the combination.

[01:08:46] Speaker 06:
Their experts said that was not the reasonable expectation at the time.

[01:08:50] Speaker 06:
Now, on the claim construction issue, Mr. Kelly referred to column four and the reference to anti-cancer treatment.

[01:08:58] Speaker 06:
But what he loses sight of is that prednisone is expressly defined to be an anti-cancer agent.

[01:09:06] Speaker 06:
So everything he said about this supposed distinction between steroids and anti-cancer agents

[01:09:14] Speaker 06:
Whatever it applies to, it does not apply to prednisone, and prednisone is what's in the claims.

[01:09:19] Speaker 06:
And I'm out of time, and I'm not going to run over.

[01:09:21] Speaker 01:
Well done.

[01:09:22] Speaker 01:
I thank all counsel for their argument.

[01:09:23] Speaker 01:
It was very helpful to the court today.

[01:09:25] Speaker 06:
Thank you, Ron.