[00:00:00] Speaker 05:
Our second case this morning is number 22 1482 Purdue Pharma LP versus Collegium Pharmaceuticals.

[00:01:04] Speaker 05:
Ms.

[00:01:04] Speaker 05:
Sweezy, am I pronouncing that right?

[00:01:06] Speaker 00:
Absolutely, Your Honor.

[00:01:08] Speaker 00:
Thank you.

[00:01:09] Speaker 00:
Good morning.

[00:01:10] Speaker 00:
May it please the court?

[00:01:12] Speaker 00:
Our appeal presents common ground on two critical points that I'd like to make clear.

[00:01:17] Speaker 00:
First, everybody agrees that Congress enacted and expressed statutory deadline for the timely and expedient issuance

[00:01:26] Speaker 00:
of a final written decision.

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And second, everybody agrees that the board here missed that deadline and missed it by 19 and a half months.

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So the question, and where the parties diverge, is what are the consequences of the board missing its deadline?

[00:01:41] Speaker 04:
What does the statute say are the consequences?

[00:01:45] Speaker 00:
Your Honor, the statute specifically says and directs the board that it has to issue.

[00:01:51] Speaker 04:
No, but what does the statute say are the consequences if it doesn't comply with that deadline?

[00:01:58] Speaker 00:
Your Honor, we can agree that there isn't that kind of statement in the statute.

[00:02:02] Speaker 04:
So what do you do with Barnhart, which directly says, if a statute does not specify a consequence for noncompliance with statutory timing provisions, the federal courts will not, in the ordinary course, impose their own coercive sanction?

[00:02:17] Speaker 00:
Yes, Your Honor.

[00:02:17] Speaker 04:
Isn't that directly on point?

[00:02:18] Speaker 00:
that is directly on point, and that case law was in place when Congress started drafting the AIA.

[00:02:24] Speaker 00:
So I think that's exactly a great case to look at.

[00:02:27] Speaker 04:
Congress didn't put in any consequence.

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They didn't say the PTAB shall have no authority to issue a decision after 18 months or 12 months.

[00:02:42] Speaker 04:
It doesn't say that.

[00:02:44] Speaker 04:
If it had said that, we wouldn't be here.

[00:02:47] Speaker 00:
Yes, perhaps, Your Honor, but we are here because under the Barnhart test itself, Barnhart makes clear that we are looking for Congress's intent.

[00:02:58] Speaker 00:
And it's not that kind of simple search.

[00:03:00] Speaker 00:
That is the test that Collegium and the board have offered to the court, that you do some sort of near word search in the statute.

[00:03:07] Speaker 00:
But before Barnhart, Barnhart, and after Barnhart, and Congress knew this.

[00:03:12] Speaker 04:
Well, we're always looking for Congress's intent, but we start when we're looking for Congress's intent.

[00:03:17] Speaker 04:
with the plain language of the statute.

[00:03:21] Speaker 04:
Would you agree there's nothing in the plain language of the statute that specifies a consequence if the PTAB doesn't comply with the timing provision?

[00:03:30] Speaker 04:
Where in the plain language of the statute does it indicate a consequence?

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In this statute, Congress itself took into its own hands any exception.

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to the statutory deadline.

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And I do want to also make clear, because it's important to always evaluate a statute in the context of when Congress was legislating it.

[00:03:47] Speaker 00:
And we have here this entire scheme of- I don't see how that helps you.

[00:03:51] Speaker 04:
I mean, because of these Supreme Court cases, it's been made very clear to Congress that if they want the agency to not have authority to do something after a prescribed time period has elapsed, they have to put that specific language in the statute, not just put in certain exceptions that

[00:04:07] Speaker 04:
allow for extension of time, or put stuff in the legislative history.

[00:04:12] Speaker 00:
Respectfully, Your Honor, I disagree that that's the test.

[00:04:15] Speaker 00:
Because up through Barnhart, up through this court's case law.

[00:04:17] Speaker 04:
Can you point to me any case where an agency who has a language like this, that's the same language that's talking about Barnhart, where there's shall do something within a time period is held to lack authority to do it, absent some other express language?

[00:04:34] Speaker 00:
Each of the cases that looked at

[00:04:36] Speaker 00:
agency directives from Congress about doing shall do something, did not have a statute like this before them.

[00:04:43] Speaker 00:
And under the case law... That was my question, though.

[00:04:46] Speaker 04:
Can you point to me cases where there wasn't

[00:04:49] Speaker 04:
language about lacking authority or the like, where the courts have nonetheless said, we can infer from whatever else in the statute or the statutory Congress or legislative history that Congress meant them to lack authority after the time period had expired.

[00:05:05] Speaker 04:
Or are all the cases against you on the time period?

[00:05:10] Speaker 00:
In their ultimate outcome, they come out in terms of finding that Congress there did not mean the statute to be binding and authority to end.

[00:05:19] Speaker 00:
But the case is set for the test.

[00:05:22] Speaker 00:
And under that test, it is clear here that Congress, when it was replacing inter-party re-examinations that had this loose, toothless, special dispatch standard that wasn't working, Congress was very dissatisfied with the years that those proceedings took.

[00:05:38] Speaker 00:
And it tells us entire sessions.

[00:05:40] Speaker 04:
They were so dissatisfied, and they wanted the agency to comply with the time period at all costs.

[00:05:45] Speaker 04:
Why didn't it put in language that was very clear that that would have been effective after Barnhart and all these cases?

[00:05:51] Speaker 04:
That the PTAB shall lack authority to issue a decision after one year, except in these limited circumstances.

[00:05:59] Speaker 00:
The case law doesn't demand Congress use any particular... No, I'm not asking whether it demands, although I think you're wrong on that.

[00:06:05] Speaker 04:
But if Congress was so concerned, as you say, about this loosey-goosey standard, then why didn't it make itself clear

[00:06:13] Speaker 04:
that the PTAB would lack authority if it didn't comply with the time deadline.

[00:06:17] Speaker 04:
It knew how to do it.

[00:06:20] Speaker 00:
Your Honor, I believe it did.

[00:06:22] Speaker 00:
And I can give you some specific points from the legislative history.

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And what we have to evaluate is what was Congress's goal in enacting this statute.

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In all of this case law, if it were as simple, respectfully, as looking in the statute for a specific statement that Collegium and the board are looking for, we would not have the extensive discourse that we have in the cases

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that evaluate what was Congress doing.

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In the words of Dolan, what are the purposes that a time limit is designed to serve?

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And in this case, we have a very long, lengthy period where Congress was drafting and ultimately enacting the American Vents Act against a backdrop of a loose standard

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that Congress did not like.

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It was not working.

[00:07:05] Speaker 00:
Can I ask you something?

[00:07:07] Speaker 02:
It is probably typically the case whenever Congress imposes a time limit.

[00:07:11] Speaker 02:
It's because they're frustrated that the process isn't going as quickly as they want it to.

[00:07:17] Speaker 02:
So they put in a time limit.

[00:07:18] Speaker 02:
What makes this time limit so much more special than the time limit you see in cases like Brock?

[00:07:25] Speaker 00:
Exactly, because this is not an ordinary deadline.

[00:07:28] Speaker 00:
This is not an ordinary time limit.

[00:07:30] Speaker 00:
This is not an ordinary statute.

[00:07:31] Speaker 02:
I'm not seeing it yet, so why not?

[00:07:34] Speaker 00:
Yes, I just wanted to make sure that we see this statute differently.

[00:07:38] Speaker 00:
And why not is because Congress set up a scheme here.

[00:07:42] Speaker 00:
It was enacting these new AIA patent review mechanisms, IPRs and PGRs, to work concurrently with district court litigation.

[00:07:50] Speaker 00:
And it had a system, it had an inter-parties re-examination system where it intended to do precisely that, but it saw how ineffective that was.

[00:07:58] Speaker 00:
It wasn't possible.

[00:07:59] Speaker 02:
I think this happened in prime source, didn't it?

[00:08:01] Speaker 02:
In prime source, Congress was frustrated by this lack of speed in the presidential election.

[00:08:08] Speaker 02:
Why isn't that the same?

[00:08:10] Speaker 02:
Why isn't that same as what we see here?

[00:08:13] Speaker 00:
In prime source, which came from this court's Trans-Pacific decision, there was actually a very limited issue there before the court, which was when the president acted... Well, are they Trans-Pacific then?

[00:08:25] Speaker 02:
Sure.

[00:08:25] Speaker 02:
They involve the same statutory scheme, is my point.

[00:08:28] Speaker 02:
I'm just having a hard time understanding why the urgency here is different, the need to have quick action by

[00:08:40] Speaker 02:
into the president or an agency.

[00:08:43] Speaker 02:
Why it's so different here?

[00:08:44] Speaker 02:
What is it that makes you think IPRs are so much more special?

[00:08:49] Speaker 00:
Okay.

[00:08:49] Speaker 00:
I'll answer the Trans-Pacific Prime Source question and then also answer what's here.

[00:08:53] Speaker 00:
So in Trans-Pacific and the Prime Source case, the president there actually did timely act within the period and envisioned a plan.

[00:09:03] Speaker 00:
And it was the challenge was that the president later modified that plan outside the period.

[00:09:09] Speaker 00:
But the plan was consistent.

[00:09:11] Speaker 00:
This court said in these circumstances, it was approving the fact that the president later modified the plan when it was both consistent with the initial plan and the initial plan contemplated modification.

[00:09:22] Speaker 02:
They're not really answering my question.

[00:09:24] Speaker 02:
My question is what makes the legislative history and the statutory scheme here so special that notwithstanding the fact that Congress did not explicitly include

[00:09:34] Speaker 02:
any sort of consequences for failure to meet the timeline that this is different and deserves different treatment than a case like the statutory scheme we see in BRAH or Trans-Pacific?

[00:09:45] Speaker 00:
Yes, Your Honor.

[00:09:46] Speaker 00:
So here we have

[00:09:48] Speaker 00:
Congress creating schemes where it is in the legislative history emphatic about the deadline.

[00:09:53] Speaker 00:
It is saying that these must be completed within the statutory period.

[00:09:58] Speaker 05:
But there are other remedies for failure to comply with the deadline, right?

[00:10:03] Speaker 05:
There could be a mandamus petition to force the agency to act within the timeline.

[00:10:09] Speaker 05:
It doesn't have to be that action later becomes ineffective.

[00:10:15] Speaker 00:
Your Honor, thank you for bringing up Mandamus, because that would not be a remedy that could at all be reconciled with Congress's intent here.

[00:10:23] Speaker 00:
Mandamus and APA, because those were obviously available for inter-parties reexaminations that lingered and lingered, and that simply added months or years of delay.

[00:10:34] Speaker 05:
But with the inter-parties reexamination, there wasn't a specific standard.

[00:10:39] Speaker 05:
I forget what the language was, but expeditious or something like that, right?

[00:10:43] Speaker 00:
That's absolutely right, Your Honor.

[00:10:45] Speaker 00:
In this court's decision in Ethicon, the standard is special dispatch.

[00:10:49] Speaker 00:
And this court described it as a very heightened standard.

[00:10:52] Speaker 00:
It had to be extraordinary or accelerated movement.

[00:10:55] Speaker 00:
And that was not getting the agency to act.

[00:10:58] Speaker 05:
And if mandamus for... But if you have a specific time frame, which this statute has, why can't that be enforced by mandamus?

[00:11:07] Speaker 00:
Because the mandamus period, Your Honor, would add significantly more time to the time period that Congress envisioned.

[00:11:15] Speaker 00:
Because remember, in the statute itself, Congress not only set a one-year time period, but Congress said it was going to grant two and only two exceptions.

[00:11:29] Speaker 00:
Congress did give an open-ended exception, which would be akin to this mandamus

[00:11:34] Speaker 00:
a procedure that would take months or years on top of the one-year time period.

[00:11:39] Speaker 00:
But that was very limited by Congress.

[00:11:42] Speaker 00:
The only open-ended discretion it gave to the board was in the very specific scenario of Joinder.

[00:11:50] Speaker 00:
For other extensions, there has to be good cause.

[00:11:53] Speaker 00:
And Congress itself limited that to six months.

[00:11:56] Speaker 05:
How is that a response to my suggestion that endemas is an available remedy for the time

[00:12:03] Speaker 00:
Your Honor, I believe that mandamus petitions would ordinarily take longer than the six months that Congress itself contemplated as the outside maximum for an IPR.

[00:12:13] Speaker 00:
And the reason that Congress did that, the reason Congress both put in the one-year time period and the six-month extension and capped it, is because we know from the legislative history that Congress was very dissatisfied that these proceedings were not working.

[00:12:28] Speaker 00:
Inter-parties re-exams, just like IPRs and PGRs, are intended to have a stop-all effect.

[00:12:36] Speaker 00:
They are intended to have an effect on pending district court litigation.

[00:12:41] Speaker 00:
District courts routinely stay their cases so that they can see what the outcome is of an IPR or PGR

[00:12:50] Speaker 00:
But just like in inter-party re-exams, when those lingered, we weren't having the effect of actually improving district-wide education.

[00:12:57] Speaker 04:
So I understand all of this.

[00:12:58] Speaker 04:
And even if we agree with you that Congress was very worried about the timing here, and that's why it was enacting this one-year deadline.

[00:13:07] Speaker 04:
The case law still says that Congress has to impose some kind of consequence for failing to meet that.

[00:13:16] Speaker 04:
And even if we say that consequence doesn't have to be in the statute, and we can look to the legislative history, have you cited anything in the legislative history that suggests that PTAB would lack authority after one year, rather than they should just comply with them one year?

[00:13:35] Speaker 00:
To effectuate Congress's intent.

[00:13:36] Speaker 04:
No, no, no.

[00:13:37] Speaker 04:
I'm not going there.

[00:13:39] Speaker 04:
I understand what you think Congress's intent is.

[00:13:41] Speaker 04:
Even if I agree with you, I think the case law doesn't help you because it says even if Congress's intent is to speed things up,

[00:13:52] Speaker 04:
If they really want the agency to lose authority, they have to say so in fairly explicit language.

[00:13:59] Speaker 04:
And luckily for you, I'm a judge that believes in legislative history, so I'm allowing you to look at legislative history and tell me where Congress said the agency lacked authority after one year.

[00:14:18] Speaker 00:
Your Honor, the way I would answer the question

[00:14:21] Speaker 00:
is that the case law is clear.

[00:14:24] Speaker 00:
I understand what you're going to say.

[00:14:26] Speaker 04:
I'm going to take this answer as there is no explicit place in the legislative history that Congress said the agency would lack authority after a year.

[00:14:35] Speaker 00:
We have to agree with that, Your Honor.

[00:14:36] Speaker 00:
I'm not disputing that.

[00:14:38] Speaker 00:
But I respectfully would urge the court that the test here is always to evaluate the text and the context of the statute and the legislative purpose and the goal.

[00:14:49] Speaker 00:
The goal here

[00:14:50] Speaker 00:
was to have effective IPRs and PGRs that will actually end with a reliable end date so that district courts can rely on them and Article 3 jurisdiction in those cases is not tied up so that there can actually be an estoppel effect which only happens once there is a final written decision and there is no indication in the legislative history that Congress contemplated

[00:15:13] Speaker 00:
it going back to what we already had, which was a real strong message to act quickly and the only recourse being a mandamus petitions or APA review.

[00:15:23] Speaker 00:
That is the reading that the board adopted.

[00:15:25] Speaker 00:
And if this court were to adopt it here, we can see what would happen because it happened in this case.

[00:15:32] Speaker 00:
Once the board decided that it had discretion, this case took 19 and a half more months.

[00:15:39] Speaker 00:
well beyond the initial period that Congress contemplated, again, putting it squarely in that time period that Congress said we're not satisfied with and we are changing.

[00:15:48] Speaker 00:
And on these facts, with this legislative history, with the prior scheme that Congress was replacing, it is clear that Congress wanted these proceedings to end.

[00:15:57] Speaker 00:
Otherwise, this entire scheme wouldn't work and we're back to where we started.

[00:16:02] Speaker 00:
And we always take into account when Congress replaces statutory language with other language.

[00:16:07] Speaker 00:
I see my time is just about up, but if I could just very briefly touch on written description.

[00:16:12] Speaker 05:
It'll give me a minute or so.

[00:16:15] Speaker 00:
That's all I need, Your Honor, because while we think that final written decision is invalid and not before the court, the patent is valid.

[00:16:24] Speaker 00:
The board here measured written description by the distance between disclosures, and that is not a valid way to evaluate a patent specification.

[00:16:33] Speaker 00:
Our patent is well-organized, coherent, broken down into sections,

[00:16:37] Speaker 00:
and it goes through aversive agents, specifying that gelling agents are aversive agents, then specifying surfactants as one of three categories in that list that the patent, that's in columns six and seven, and then in column 28, repeats those same three categories and lists PGGs as the third listed type.

[00:16:57] Speaker 05:
PGG is a surfactant, but not all surfactants are gelling agents, right?

[00:17:03] Speaker 00:
Yes, Your Honor.

[00:17:06] Speaker 00:
specification here in the four corners of the patent by tracing through a person of ordinary skill in the art.

[00:17:11] Speaker 00:
Frankly, any reader would appreciate that the patent is expressly disclosing PGGs as surfactants to be used, and this is important in column 28.

[00:17:20] Speaker 00:
It specifically says that these surfactants, including PGGs, are useful in accordance with the present invention.

[00:17:28] Speaker 00:
And with the logical sequential disclosures from columns 6 and 7 to 28,

[00:17:33] Speaker 00:
And the way the patent is organized, that is how a person of ordinary skill and the art would read it.

[00:17:38] Speaker 00:
They would not simply look at 20 or so columns in between and think this somehow can't be related.

[00:17:43] Speaker 00:
And respectfully, the board just applied a legally erroneous, overly superficial analysis of the patent document.

[00:17:51] Speaker 05:
OK.

[00:17:52] Speaker 05:
All right.

[00:17:52] Speaker 05:
We'll give you two minutes for rebuttal.

[00:17:54] Speaker 00:
Thank you, Your Honor.

[00:17:55] Speaker 05:
Ms.

[00:17:55] Speaker 05:
Rashid.

[00:18:01] Speaker 01:
May I please the court?

[00:18:03] Speaker 01:
Let's start with the availability.

[00:18:06] Speaker 05:
I look at this record and I scratch my head why it took so long to get this decision out because if I recall correctly the bankruptcy was initiated only like ten days before the end of the one year period and then after it was permissible for the

[00:18:31] Speaker 05:
were to go ahead and address this, it took another 19 months to get the decision out.

[00:18:37] Speaker 05:
What?

[00:18:38] Speaker 05:
Why did this happen?

[00:18:41] Speaker 01:
Part of the reason is because, Your Honor, the stay was still in place after the deadline passed.

[00:18:46] Speaker 01:
The stay wasn't lifted until four months later.

[00:18:49] Speaker 01:
And at that point, Purdue had introduced its brand new argument that somehow the entire proceeding just disappeared.

[00:18:56] Speaker 05:
It was 19 months after the stay was lifted, right, that the decision came out?

[00:18:59] Speaker 01:
This was an issue of first impression for the board.

[00:19:02] Speaker 01:
It involved very important issues about the application of the automatic stay.

[00:19:06] Speaker 01:
These aren't issues that are necessarily in the wheelhouse of PTAB judges.

[00:19:10] Speaker 01:
And it involves very complicated issues about whether or not this is a governmental action or not, whether the agency is exercising its regulatory powers or its police powers.

[00:19:22] Speaker 01:
There are a lot of unanswered questions for those oil states.

[00:19:24] Speaker 01:
So this is not something that the agency could have resolved on its own.

[00:19:28] Speaker 01:
It wanted some briefing.

[00:19:29] Speaker 05:
I mean, really, I don't think the agency looks great.

[00:19:32] Speaker 05:
That doesn't mean that under the case law that it loses the authority, but it doesn't look good.

[00:19:38] Speaker 01:
You know, the other thing here is because this thing was pending for so long, the panels were changed twice because APJs had left the agency.

[00:19:47] Speaker 01:
And so that also required those APJs to then come on board and familiarize themselves with this case and to make sure that they're on board with the decision that was going to go out.

[00:19:59] Speaker 01:
That's another explanation.

[00:20:00] Speaker 02:
That actually had to be undertaken to lift the stay.

[00:20:03] Speaker 02:
I mean, was it, what action had to be undertaken to lift the stay?

[00:20:07] Speaker 02:
Was it that there was a stay and then the agency, you know, was not keeping track of what was happening with the bankruptcy proceeding?

[00:20:16] Speaker 02:
And so it was incumbent upon the parties to bring this to the attention of the agency?

[00:20:20] Speaker 01:
The APJs here were keeping track.

[00:20:23] Speaker 01:
They were keeping in touch with the parties.

[00:20:25] Speaker 01:
They asked the parties to approach the bankruptcy court to get resolution on either lifting the stay or getting a decision on whether or not the stay applied.

[00:20:35] Speaker 01:
They asked the parties to approach the bankruptcy court with those questions.

[00:20:40] Speaker 01:
They asked them to check in with the APJs.

[00:20:42] Speaker 01:
They had a hearing before the deadline expired.

[00:20:44] Speaker 01:
the 18-month deadline expired.

[00:20:46] Speaker 02:
And the parties didn't do that?

[00:20:48] Speaker 01:
And the parties didn't do that until after the expiration of the deadline, unfortunately in this case.

[00:20:57] Speaker 01:
Going to whether or not there are less drastic measures available, I'm surprised to hear... I'm not sure that I understand that.

[00:21:04] Speaker 05:
Surely the PTL was aware when the state was lifted, right?

[00:21:09] Speaker 01:
They were aware when the stay was lifted, but what they were facing was an argument that the agency didn't even have jurisdiction to do anything at that point, that the agency was stripped of its authority to issue a final written decision.

[00:21:28] Speaker 01:
So they needed to resolve that predicate question before they could issue the final written decision.

[00:21:34] Speaker 01:
I think that is really what the holdup here was.

[00:21:37] Speaker 01:
During that time, Purdue could have sought mandamus relief from this court.

[00:21:43] Speaker 01:
Brock points to the availability of APA review under section 706.

[00:21:46] Speaker 01:
One, this court's decision in rape paralyzed veteran provides for the same relief.

[00:21:53] Speaker 01:
And I don't understand why it would have taken so long.

[00:21:56] Speaker 01:
The relief requested is simply to

[00:21:59] Speaker 01:
to issue a decision that's been unreasonably delayed, not a decision on the merits, nothing else that would take an extremely long time for this court to decide.

[00:22:11] Speaker 01:
So I do think that that is relevant here.

[00:22:14] Speaker 04:
But if we read this statute as not taking away your authority after 12 months, and mandamus has to be based upon unreasonable delay,

[00:22:26] Speaker 04:
Wouldn't that allow the board to routinely blow by the 12 months time period?

[00:22:32] Speaker 04:
Because unreasonable delay, I assume, is not going to be 13 months.

[00:22:37] Speaker 04:
for 14 months, even.

[00:22:38] Speaker 04:
And so then it gives the agency the authority to kind of just ignore what Congress said about the 12 months.

[00:22:46] Speaker 04:
Now, I know your answer is you're not going to do that, and you have a history of not doing that.

[00:22:49] Speaker 04:
But I worry if we give you that explicit authority to say you can go past 12 months, that it's going to be abused.

[00:22:59] Speaker 04:
And how would that be remedied?

[00:23:03] Speaker 01:
We already treat this deadline as mandatory.

[00:23:07] Speaker 01:
This is a mandatory deadline.

[00:23:09] Speaker 05:
You're not asking in a mandamus proceeding to say that you get more than 12 months subject to the statutory exceptions, right?

[00:23:17] Speaker 01:
It depends on the circumstances as to why it was delayed.

[00:23:20] Speaker 05:
I mean, look, they viewed the deadline as important.

[00:23:24] Speaker 05:
They said 12 months, a couple of exceptions.

[00:23:26] Speaker 05:
If you don't comply with it, you know.

[00:23:28] Speaker 01:
We don't disagree.

[00:23:30] Speaker 01:
We don't disagree that the deadlines are important.

[00:23:31] Speaker 01:
We don't disagree that that was the reason why.

[00:23:33] Speaker 05:
If you don't comply with the deadlines, you could be mandamus, right?

[00:23:37] Speaker 05:
It's not a question of unreasonable delay.

[00:23:39] Speaker 05:
It's a question of you didn't comply with the statute.

[00:23:44] Speaker 01:
That's right.

[00:23:45] Speaker 01:
The statute is mandatory.

[00:23:47] Speaker 01:
We believe the deadline is to be mandatory.

[00:23:49] Speaker 01:
So there is a legal consequence.

[00:23:50] Speaker 05:
We could issue an order telling you to decide it, right?

[00:23:55] Speaker 01:
I'm sorry, say that again.

[00:23:56] Speaker 05:
In a mandamus proceeding, if you go beyond 12 months and exceptions don't apply, the court should issue an order telling you to decide it right away, right?

[00:24:04] Speaker 01:
I think it would depend on the circumstances, whether the delay was unreasonable or not.

[00:24:09] Speaker 05:
No.

[00:24:10] Speaker 05:
It hurts your argument.

[00:24:13] Speaker 01:
I don't know if one day post the 12-month deadline, that that would be considered a reasonable delay.

[00:24:19] Speaker 01:
Why not?

[00:24:19] Speaker 05:
Congress thought the one-year deadline was important.

[00:24:22] Speaker 05:
If you go beyond the one-year deadline, why are you not subject to an order of mandamus to go ahead and decide it right away?

[00:24:28] Speaker 01:
If Congress thought the deadline took precedence over the ability to issue the decision, they should have said so in the statute.

[00:24:36] Speaker 01:
But they did not provide for the agency to lose jurisdiction.

[00:24:39] Speaker 05:
No, no, you're mixing up two things.

[00:24:41] Speaker 05:
You're mixing up two things.

[00:24:42] Speaker 05:
The question is, what consequences flow from the failure to achieve the deadline?

[00:24:50] Speaker 05:
And the cases seem to suggest, no, you don't lose the authority.

[00:24:53] Speaker 05:
But that has nothing to do with your authority to exceed the deadline in a mandamus proceeding.

[00:25:00] Speaker 05:
I simply do not understand your argument that you can only get mandamus if there's an unreasonable delay beyond the one-year period.

[00:25:09] Speaker 05:
That to me makes no sense.

[00:25:14] Speaker 01:
Well, under 7061, it's either if the decision is unlawfully withheld, and it wouldn't be unlawful here, but... Unlawfully withheld once you go past the one-year deadline, save for the exception.

[00:25:30] Speaker 01:
It's a mandatory deadline.

[00:25:32] Speaker 01:
We don't disagree with you on that, just like the question is, what is the consequence of missing the deadline?

[00:25:38] Speaker 01:
Does that mean that the agency no longer has the authority to issue that decision?

[00:25:42] Speaker 05:
That's not what we've been talking about.

[00:25:44] Speaker 05:
I've been talking about a mandamus proceeding.

[00:25:46] Speaker 05:
And I'm suggesting to you that if you go one day past the one-year deadline, that mandamus is available.

[00:25:54] Speaker 05:
And you're somehow suggesting, oh, no, the delay has to be unreasonable or depends on the circumstances.

[00:25:59] Speaker 05:
Doesn't depend on the circumstances.

[00:26:01] Speaker 05:
The statute says a year.

[00:26:02] Speaker 05:
If you don't do it in a year, you get mandamus.

[00:26:05] Speaker 01:
What's the problem with that?

[00:26:06] Speaker 01:
The history of the precedent both before the Supreme Court and this court takes into consideration the reasons, the circumstances surrounding the delay.

[00:26:14] Speaker 01:
And that's important.

[00:26:16] Speaker 05:
Not if it's a mandatory requirement that you do it in a year.

[00:26:20] Speaker 01:
In those cases, the rules were also mandatory.

[00:26:23] Speaker 02:
This is kind of a hypothetical that's being asked right now about the procedure to mandamus.

[00:26:28] Speaker 02:
The argument is this, is that one thing that supports the idea that this is not a statute that removes the PTO's power to issue a decision outside the year time period is that

[00:26:44] Speaker 02:
somebody who was in a circumstance where they hadn't received a decision within so much time could come to this court and seek a petition forbidding mandamus.

[00:26:56] Speaker 02:
And so if they could seek a petition for mandamus, that means the statute isn't without teeth, if you will, that there is some consequence.

[00:27:04] Speaker 02:
So that's what these questions are going to.

[00:27:06] Speaker 02:
And so what is the PTO's view on whether a party

[00:27:11] Speaker 02:
could seek a petition for iridium mandamus if they hadn't received a decision from the PTO within the year timeline and hadn't sought an extension.

[00:27:21] Speaker 02:
No extension has been sought.

[00:27:26] Speaker 01:
I believe that they could seek a writ of mandamus, but I think the only relief that they can get is an order from this court asking the agency to act.

[00:27:36] Speaker 01:
That's the only thing that's available to them.

[00:27:37] Speaker 02:
That's the only thing iridium mandamus can give anybody.

[00:27:39] Speaker 02:
That's right.

[00:27:43] Speaker 01:
Let's talk about the exceptions.

[00:27:45] Speaker 01:
This case is exactly like Barnhart.

[00:27:47] Speaker 01:
Barnhart that produced reasoning here suffers from the same fallacy that Justice Scalia's reasoning suffered from in footnote seven of Barnhart.

[00:27:59] Speaker 01:
The exceptions don't create the rule.

[00:28:02] Speaker 01:
Yes, to the extent that these are exceptions, they don't suggest that what Congress was intending to do was to strip the agency of the authority to issue that decision.

[00:28:11] Speaker 01:
And so I think these exceptions should really just be understood as a series of deadlines based on certain circumstances.

[00:28:20] Speaker 01:
Even if there is an inference from these exceptions that Congress intended to do something like that, you still have to take it into consideration.

[00:28:30] Speaker 01:
It's still just an inference.

[00:28:31] Speaker 01:
You still have to take it into consideration the entire context of the statute and other provisions in the statute.

[00:28:38] Speaker 01:
And here, you've got 328A, which requires the agency to issue a final written decision if the proceeding has been instituted and it has not been dismissed.

[00:28:49] Speaker 01:
That is relevant here, and it's been relevant in some of these other Supreme Court cases where there is another provision that requires the agency to act, and we have that here.

[00:29:02] Speaker 01:
I see I'm out of my time, but I just wanted to make a couple of more points if that's okay.

[00:29:09] Speaker 01:
It doesn't seem like produced relying on a not later than language anymore.

[00:29:13] Speaker 01:
And I don't think that's persuasive at all, because a lot of these cases use the same language.

[00:29:17] Speaker 01:
The AIA is replete with not later than language.

[00:29:20] Speaker 01:
And that's just not sufficient to create a jurisdictional bar.

[00:29:25] Speaker 01:
And finally, I think the reason for the delay is important because in every single one of these cases, it doesn't justify the delay necessarily, but it helps explain what the most natural reading of the statute should be.

[00:29:42] Speaker 01:
In Barnhart, the Supreme Court said that the goal of the statute was to allocate the greatest number of beneficiaries.

[00:29:49] Speaker 05:
I think we're pretty familiar with Barnhart.

[00:29:51] Speaker 05:
I think we're out of time.

[00:29:53] Speaker 01:
OK, thank you, Your Honor.

[00:30:01] Speaker 05:
Mr. Pinnas.

[00:30:09] Speaker 03:
May it please the court, Chris Pinos from the Robbins Kaplan Law Firm on behalf of the Appellee Collegium Pharmaceutical.

[00:30:15] Speaker 03:
I want to pick up where my colleague from the Solicitor's Office left off, which is on the issue of why the board had set up an authority issue.

[00:30:24] Speaker 04:
We've heard a lot about the authority issue, and we've heard almost nothing about the written description issue.

[00:30:29] Speaker 04:
And since you're representing

[00:30:31] Speaker 04:
you know, the private party, can you tell us what's the substantial evidence for a lack of written description here?

[00:30:37] Speaker 04:
Because I see your friend's argument that this is a big patent that's organized and a skilled artisan might look and pick one thing from here, one thing from here, one thing from here.

[00:30:47] Speaker 04:
The board disagreed.

[00:30:49] Speaker 04:
and found lack of written description, I always struggle with what's substantial evidence for a finding of lack of written description.

[00:30:56] Speaker 04:
What is it here?

[00:30:57] Speaker 03:
Yes, judges.

[00:30:58] Speaker 03:
I will walk through two of them in particular that will get you to why the substantial evidence supports the lack of written description finding.

[00:31:05] Speaker 03:
The first is that the substantial evidence supports the board's conclusion that PGGs are not gelling agents.

[00:31:12] Speaker 03:
And now that's important because if PGs aren't gelling agents, Purdue's entire written description argument falls apart.

[00:31:17] Speaker 03:
And the board's conclusion, I'll give you the conclusion and then the evidence that supports that.

[00:31:22] Speaker 03:
The board's conclusion was that they, quote, do not agree with the patent owner, that the specification contemplates or adequately discloses that PGGs can be used as a gelling agent in the claim dosage form.

[00:31:33] Speaker 03:
Now, that was an appendix number 37.

[00:31:35] Speaker 03:
The substantial evidence that supports that, there's several.

[00:31:39] Speaker 03:
It is from Collegian's expert who said the 961 patent described nowhere that PGGs are gelling agents.

[00:31:47] Speaker 03:
That's an appendix

[00:31:48] Speaker 03:
3352, paragraph 22.

[00:31:51] Speaker 03:
Cleagin's expert saying that he is unaware of any literature outside of the patent that describes PGGs as Chilean agents.

[00:31:59] Speaker 03:
That is the same appendix number, paragraph 24.

[00:32:03] Speaker 03:
Contrast that with Purdue's expert, Dr. Constantinides, who said

[00:32:08] Speaker 03:
He agreed the 961 patent does not describe PGGs as gelling agents.

[00:32:12] Speaker 03:
That's at appendix 3184, deposition site 87 through 15.

[00:32:18] Speaker 03:
And that their expert, this is Dr. Con Santanedes, Purdue's expert, cite no literature anywhere on the record for his conclusion that PGGs can be gelling agents.

[00:32:28] Speaker 03:
And that is at appendix 3183, deposition sites 75, 8 through 15.

[00:32:35] Speaker 03:
So the substantial evidence is replete throughout the record.

[00:32:40] Speaker 03:
And Purdue just asked this board to reweigh the evidence, or excuse me, this panel to reweigh the evidence.

[00:32:46] Speaker 03:
There is substantial evidence.

[00:32:47] Speaker 03:
And in fact, the board said, in reference to Purdue's expert, Dr. Constantinides' testimony on this point, that beam PGGs is gelling agents.

[00:32:58] Speaker 03:
is unsupported and entitled to little weight.

[00:33:00] Speaker 03:
And that's at Appendix Number 38.

[00:33:03] Speaker 03:
So we think there's plenty of substantial evidence for this panel to find that PGGs are not gelinators.

[00:33:07] Speaker 03:
And that can end the board's inquiry.

[00:33:09] Speaker 03:
And you can just affirm the PTAPS finding.

[00:33:12] Speaker 03:
There's a separate and independent reason, though, why you can affirm the board's lack of written description finding.

[00:33:21] Speaker 03:
Even if you were to find that PGGs are gelinators, and again,

[00:33:24] Speaker 03:
Substantial evidence that I just went through supports that they're not.

[00:33:26] Speaker 03:
Even if you were to find PGGs are gelling ages.

[00:33:30] Speaker 03:
There's also substantial evidence in the record to support the board's finding that Purdue was not in possession of an abuse deterrent dosage form with the recited combination of pharmaceutical ingredients with the claimed functionality.

[00:33:43] Speaker 03:
And that's at appendix number 32 from the board.

[00:33:47] Speaker 03:
It's only with the benefit of hindsight that Purdue asks you to sort of jump through the specification, use it like a hopscotch grid,

[00:33:54] Speaker 03:
to arrive at what they recite as the claimed invention.

[00:33:58] Speaker 03:
But, Your Honors, respectfully, this is, in our opinion, a Russian nobozine case.

[00:34:03] Speaker 03:
Purdue improperly disclosed a forest in its specification, but provided no blaze marks for opposed to identify what would later become the claimed combination.

[00:34:16] Speaker 03:
Now, Your Honors, I see I still have time.

[00:34:18] Speaker 03:
would like me to address the statutory question I will otherwise I will sit down if you don't have any other questions.

[00:34:26] Speaker 03:
I think we're done.

[00:34:28] Speaker 03:
Thank you.

[00:34:35] Speaker 05:
Thank you for the additional time.

[00:34:38] Speaker 00:
On the

[00:34:40] Speaker 00:
timing of the final written decision, the PTO's arguments prove our point.

[00:34:45] Speaker 00:
The PTO is offering to this court that things like additional briefing or panel change orders are going to be enough to blow past Congress's deadline.

[00:34:53] Speaker 00:
If that's enough, if that meets the PTO's view of what is an unusual circumstance to go beyond the date, we're looking at any situation that would satisfy that and tie up this court with mandamus petitions or district courts with APA review.

[00:35:07] Speaker 00:
That, again, is not reconcilable.

[00:35:10] Speaker 00:
with the path that Congress took here, which was not the ordinary course, but setting up a scheme that had to work effectively and expeditiously so that it could work concurrently with district court litigation.

[00:35:21] Speaker 00:
And that is the consequence here.

[00:35:23] Speaker 00:
It's not that we come up with a super valid patent or we somehow, Collegium can't raise its arguments, we just go back to the pending district court case that we've been trying to litigate since 2017.

[00:35:35] Speaker 00:
Second, the real reason we're here, and this was touched on, the bankruptcy stay.

[00:35:40] Speaker 00:
When we told the board about that, Collegium disputed it, and the board was very clear, and this is at Appendix 868, that Collegium should go seek relief.

[00:35:48] Speaker 00:
That was the entire purpose of the six-month stay.

[00:35:51] Speaker 00:
It has nothing to do with Congress's intent that we're here.

[00:35:54] Speaker 00:
It has nothing to do with the bankruptcy laws.

[00:35:56] Speaker 00:
But Collegium did not act.

[00:35:58] Speaker 00:
And it was specifically told by the board that it could take steps.

[00:36:01] Speaker 00:
It didn't need our agreement.

[00:36:02] Speaker 00:
It ultimately got the stay lifted without our agreement.

[00:36:05] Speaker 00:
And then finally, with respect to written description, Collegium's arguments there were rejected by the board in terms of PGGs as gelling agents.

[00:36:14] Speaker 00:
The board in the enablement analysis at appendix 48 to 53 clearly credited our expert as testifying that a person of ordinary skill in the art would recognize PGGs as gelling agents.

[00:36:27] Speaker 00:
If the court has no further questions, we would ask the court to act.

[00:36:30] Speaker 05:
Thank you, Ms.

[00:36:30] Speaker 05:
Ritchie.

[00:36:31] Speaker 05:
Thank you all, counsel.

[00:36:32] Speaker 05:
The case is submitted.