[00:00:05] Speaker 04:
Good morning, Your Honor, and may it please the Court.

[00:00:13] Speaker 01:
The FDCA directs innovators to include two kinds of patents for listing in the Orange Book, those that claim a drug and those that claim a method of using a drug.

[00:00:22] Speaker 01:
Now what counts as a drug or a method of using a drug is the subject of controlling FDA regulations.

[00:00:29] Speaker 01:
And what those regulations say about method patents is that innovators need to list those patents that claim indications or other conditions of use for which approval is sought or has been granted.

[00:00:40] Speaker 01:
Now in this case, there's no dispute that the 963 patent claims elements of the FDA-required risk evaluation and mitigation strategy are REMs for Xyra.

[00:00:51] Speaker 04:
The relevant claims here are to a system consisting of computer memories and a data processor.

[00:01:01] Speaker 04:
These don't sound like methods of

[00:01:04] Speaker 04:
treatment method of use claims.

[00:01:07] Speaker 01:
So two points on that, Your Honor.

[00:01:08] Speaker 01:
The first is that with respect to the claim construction question, which I'd like to put off for just a moment, the question isn't is this a system type claim or a method type claim, but what is the scope such that there would be infringement as in does it with a method a claim to a system a computer implemented system read on or be infringed by a

[00:01:28] Speaker 01:
Avidel using what they would call, say, a method or a plan of procedure instead of a system, as they would call it.

[00:01:34] Speaker 01:
But you don't have to get to the claim construction question, because the FDA has interpreted method of using to encompass those conditions of use for which approval is sought or has been granted.

[00:01:45] Speaker 01:
And there is no question that the REMS

[00:01:48] Speaker 01:
covers, excuse me, that the patent covers the REMS and that the REMS is a condition of use for which approval is granted.

[00:01:55] Speaker 00:
The words of the claims themselves are directed to, it makes clear that it's directed to a system.

[00:02:01] Speaker 00:
I mean, I hear what you're saying, but you seem to be really making a simple issue already complex.

[00:02:10] Speaker 01:
Even if you accept that the claim should be construed as meaning system and not method, there's still the question under FDCA law whether the claimed computer-implemented system constitutes a method of using the drug within the meaning of the statute.

[00:02:28] Speaker 00:
We don't apply the FDCA law here, do we?

[00:02:33] Speaker 00:
This is the Federal Circuit.

[00:02:34] Speaker 00:
We apply patent law, the US patent law.

[00:02:36] Speaker 01:
Well, the question is the interpretation of the FDCA.

[00:02:39] Speaker 01:
These are terms codified in the FDCA.

[00:02:41] Speaker 01:
So for example, an evidence position is that this is all patent law.

[00:02:44] Speaker 01:
What counts as a drug?

[00:02:46] Speaker 01:
What counts as a method of using a drug?

[00:02:48] Speaker 01:
But the FDA has issued regulations.

[00:02:49] Speaker 01:
For example, it's not a question of patent law whether claiming a drug encompasses claiming a polymer.

[00:02:55] Speaker 01:
FDA has regulation on that.

[00:02:56] Speaker 01:
The answer is sometimes it is and sometimes it isn't, depending on certain scientific evidence.

[00:03:01] Speaker 01:
As to the method of use question, under the statute it just says method of using the drug at the relevant time.

[00:03:06] Speaker 01:
Does that include off-label uses?

[00:03:09] Speaker 01:
FDA has a regulation on that too.

[00:03:10] Speaker 01:
The answer is no.

[00:03:11] Speaker 01:
It has to be a condition of use for which approval is sought or has been granted.

[00:03:16] Speaker 01:
These are FDCA terms.

[00:03:17] Speaker 01:
that Congress has charged FDA with interpreting.

[00:03:20] Speaker 01:
And its controlling regulation says that a method of use encompasses indications, such as how to treat a given condition, but also conditions of use.

[00:03:31] Speaker 01:
And there is no serious question that the remedy.

[00:03:34] Speaker 04:
FDA considers that its role is ministerial in dealing with

[00:03:43] Speaker 04:
the patents and patent law.

[00:03:48] Speaker 01:
So absolutely, Your Honor.

[00:03:49] Speaker 01:
FDA considers its role ministerial in the question of whether a given patent should be listed.

[00:03:54] Speaker 01:
It does not look at the patent claims.

[00:03:56] Speaker 01:
It simply accepts the submission.

[00:03:57] Speaker 04:
And that's the question here, whether it should be delisted.

[00:03:59] Speaker 01:
So the question is whether it should be delisted under the FDCA question of whether it's claiming a method of using a drug.

[00:04:07] Speaker 01:
Now, that question, the FDA does not say it has only a ministerial role in.

[00:04:11] Speaker 01:
In fact, it has repeatedly issued rulemaking following notice and comment, and it's told the world exactly what counts as a method of using a drug.

[00:04:19] Speaker 01:
And it has said, actually, in this particular case, with respect to Jazz and Avidel,

[00:04:24] Speaker 01:
that the REMS is a condition of using the drug.

[00:04:27] Speaker 00:
So in the dispute over whether Avedale needed it... Counsel, isn't it the case that we've already decided that the delisting statute, it specifically evokes U.S.

[00:04:37] Speaker 00:
patent law?

[00:04:38] Speaker 00:
That's in the Apotex case.

[00:04:39] Speaker 01:
In Apotex, this court held correctly that it involves a substantial question of patent law, and it described the nature of that substantial question of patent law as essentially an infringement inquiry, i.e.

[00:04:51] Speaker 01:
does the drug or method of using the drug, whatever that might be, does it fall within the scope of a patent claim?

[00:04:58] Speaker 01:
That's the infringement inquiry.

[00:05:00] Speaker 01:
And again, it's not actually disputed.

[00:05:02] Speaker 01:
The district court in the opinion below at appendix page two said,

[00:05:05] Speaker 01:
that this patent claims the FDA required REMS conditions of using XIREN.

[00:05:12] Speaker 01:
In other words, it said that the patent claims exactly what we say it claims, and it said that that's a condition of use.

[00:05:18] Speaker 01:
On top of that, when the FDA was asked the question in the context of the certification dispute, what it said was that Avedale was seeking approval of a condition of use claimed by the patent.

[00:05:28] Speaker 03:
Now, Judge Laurie?

[00:05:29] Speaker 03:
I think I should ask you this question.

[00:05:31] Speaker 03:
How do you make the connection from method of using drug to condition of use?

[00:05:39] Speaker 03:
So obviously, method and condition are two different words.

[00:05:43] Speaker 01:
They are two different words, as is indication.

[00:05:45] Speaker 01:
So the question I think is really, how did FDA make that connection?

[00:05:49] Speaker 01:
I think the reason that FDA made that connection has to do with the structure of the Hatch-Watzman Act.

[00:05:54] Speaker 03:
And in particular, in what regulation did FDA make the connection saying that compliance with a REMS while a condition of use is also

[00:06:08] Speaker 03:
method of use.

[00:06:09] Speaker 01:
There isn't an FDA regulation about whether REMS is a condition of use.

[00:06:14] Speaker 01:
So there's two steps here.

[00:06:15] Speaker 01:
Whether method of use constitutes condition of use, that's a regulation.

[00:06:19] Speaker 01:
That's 21 CFR 314.53B1.

[00:06:22] Speaker 01:
It's also in the original rulemaking on the subject in October of 1994, the Federal Register notice that both sides cite.

[00:06:31] Speaker 01:
On the question of whether a REMS is a condition of use,

[00:06:36] Speaker 01:
That is a question that, as I said, the district court actually answered in our favor in the opinion granting the delisting.

[00:06:43] Speaker 01:
So what a condition of use is in the FDCA context is generally those conditions that bear on approvability, that are material to approvability.

[00:06:51] Speaker 01:
The FDA doesn't just say a drug is safe.

[00:06:53] Speaker 01:
The FDA says the drug is safe under the conditions under which it's going to be deployed in the marketplace.

[00:06:58] Speaker 01:
The classic example is the FDA has to approve based on whether it's over the counter or prescription only.

[00:07:05] Speaker 01:
Those are conditions of use for the drug for its approvability.

[00:07:08] Speaker 01:
In the context of this particular issue, the REMS, it is absolutely a critical condition of use.

[00:07:13] Speaker 01:
We're talking about a drug whose active ingredient is the salt form of gamma hydroxybutyrate, a schedule one controlled substance that has no medicinal use.

[00:07:22] Speaker 01:
The only way this drug got on the market and treated a historically untreated set of patients is by virtue of the rings, by virtue of the post-marketing restrictions, to assure its safe use.

[00:07:32] Speaker 01:
It is absolutely a critical reason why FDA was able to approve it, and it's part of the conditions of use that led to the FDA's decision that it was safe.

[00:07:41] Speaker 03:
So I think you were going to, can you get to the point that I think you were deferring about how even if we want to and think we should use the patent law terms method as a relevant category why you think that these claims, these

[00:08:00] Speaker 03:
facially system claims might qualify.

[00:08:04] Speaker 03:
Do I understand that that is one of your positions?

[00:08:10] Speaker 01:
Roughly, yes.

[00:08:10] Speaker 01:
I would say it slightly differently.

[00:08:12] Speaker 01:
I would say that even if you think that claim construction is required, and in particular even if you think the question whether you should construe system to encompass methods in this context is required, I think you should answer that question in our favor, and I can get to that.

[00:08:24] Speaker 01:
So I think the basic confusion with respect to claim construction here is that there are two separate types of inquiries.

[00:08:31] Speaker 01:
One is, what category of claim is this?

[00:08:34] Speaker 01:
Does this call into question things like divided infringement for method claims?

[00:08:38] Speaker 01:
Or is this a system type claim?

[00:08:40] Speaker 01:
That's one type of question.

[00:08:41] Speaker 01:
That's actually not the question before the court.

[00:08:44] Speaker 01:
The question before the court has made clear in Apotex is an infringement type question.

[00:08:48] Speaker 01:
What does the claim cover?

[00:08:49] Speaker 01:
What does it encompass?

[00:08:50] Speaker 01:
So to give an example.

[00:08:52] Speaker 01:
If we had absolutely conclusive testimony with Avidel admitting, they do every single thing in these claims.

[00:08:57] Speaker 01:
They use a computer to implement something.

[00:08:59] Speaker 01:
And they do everything in the claims.

[00:09:01] Speaker 01:
But they don't admit that it's a system.

[00:09:03] Speaker 01:
They actually call it their computer-implemented method or plan of procedure for having each of the elements of the claim.

[00:09:11] Speaker 01:
Go to the finder of fact and say, we think that you should find it in our favor.

[00:09:14] Speaker 01:
They're practicing the claim.

[00:09:15] Speaker 01:
They say, it's a system.

[00:09:17] Speaker 01:
We say, it's got the word system, but the plain and ordinary meaning of the word system encompasses plans of procedure and methods.

[00:09:25] Speaker 01:
And the fact that you're just calling it a method rather than a system doesn't change the scope of the claim.

[00:09:31] Speaker 01:
So that's the sense in which claim can turn.

[00:09:32] Speaker 00:
Would it be better off just looking at the plain meaning of the terms of the claim?

[00:09:37] Speaker 00:
And here, the claim is directed to a system.

[00:09:42] Speaker 00:
It's directed to computer memories, prescription fields, patient fields, the doctor fields, the pharmacy fields.

[00:09:52] Speaker 00:
Isn't that a system?

[00:09:56] Speaker 01:
So there are other patents in this family that have all of these fields as well.

[00:10:00] Speaker 01:
the preamble language says method instead of system.

[00:10:04] Speaker 00:
So it's not that those fields necessary.

[00:10:06] Speaker 00:
Wouldn't this be a system?

[00:10:09] Speaker 00:
Why would I claim that this is a method claim and not a systems claim?

[00:10:13] Speaker 01:
Again, Judge Raina, I agree with you that this is a system claim as opposed to a method claim for purposes of categorizing what body of law bears on it, such as for divided infringement problems.

[00:10:24] Speaker 00:
But that's not the construction.

[00:10:25] Speaker 00:
Why do we need to go any further?

[00:10:26] Speaker 01:
Because the question for purposes of claim construction, as this court made clear in Apotex, is what does the claim cover?

[00:10:33] Speaker 01:
What does it read on?

[00:10:34] Speaker 01:
What would it be infringed by?

[00:10:35] Speaker 01:
And so the question for purposes of, is this a computer-implemented system?

[00:10:40] Speaker 01:
Does it encompass?

[00:10:41] Speaker 01:
Does it read on a method of using a drug?

[00:10:43] Speaker 01:
The answer is yes.

[00:10:44] Speaker 01:
Under the plain meaning of system, just look in a dictionary for the definition of system.

[00:10:47] Speaker 01:
We provided one at, I think it's 2884 of the joint appendix.

[00:10:51] Speaker 03:
Maybe just another way, I think, of saying what I think Judge Raina is saying.

[00:10:57] Speaker 03:
For there to be a method, a client has to read on a set of actions taken over time.

[00:11:06] Speaker 03:
This isn't that.

[00:11:07] Speaker 01:
It does read on a set of actions taken over time, because under 271A, you can improve... This reads on a collection of units with certain action capabilities.

[00:11:18] Speaker 01:
It does recite those, but my point is that under 271A, what counts as infringement would include the use.

[00:11:24] Speaker 01:
So if someone were to use these components and with these capabilities, it would read on the method of them having done that.

[00:11:33] Speaker 03:
Do I understand right?

[00:11:34] Speaker 03:
You all have, or have, I guess, actual technical method claims that read on steps that those are not part of this patent and therefore not listed, or at least not in front of us?

[00:11:49] Speaker 01:
That is correct.

[00:11:51] Speaker 03:
Getting back to something I think that was said very much earlier in this argument.

[00:11:58] Speaker 03:
unduly complicating something that it makes all the sense in the world to remain very simple.

[00:12:05] Speaker 01:
So the very simple point is that the FDA has regulations for what you should list.

[00:12:11] Speaker 01:
And it includes conditions of use.

[00:12:12] Speaker 01:
And it is important for advancing a key policy of the Hatch-Waxman Act.

[00:12:16] Speaker 01:
which is that you want disputes over those patents that cover the features of the drug and its conditions of use that the generics are going to have to copy.

[00:12:24] Speaker 01:
In this context, there's absolutely no question, if you want to make a generic version of Xyron, or if you want to submit a 505b2 with sodium oxidate as your active ingredient, you're going to need the restrictions to assure safe use that are recited in this patent.

[00:12:37] Speaker 01:
And under the Hatch-Waxman Act, the whole point is to accelerate that patent dispute and allow it to be resolved before the product is launched, and the public doesn't suffer the harm of withdrawing a product from the market.

[00:12:48] Speaker 01:
You want the system next to the method both there.

[00:12:50] Speaker 04:
You are well into your rebuttal time.

[00:12:52] Speaker 04:
You can continue or save it.

[00:12:54] Speaker 01:
No, I'll reserve the balance, Judge Larry.

[00:12:56] Speaker 01:
Thanks so much.

[00:12:57] Speaker 04:
Mr. Bill.

[00:13:04] Speaker 02:
Good morning, Rob.

[00:13:05] Speaker 02:
May it please the court.

[00:13:07] Speaker 02:
I agree with the sentiments that this is overly complicating something that I think is very straightforward and that the district court got correct.

[00:13:15] Speaker 02:
And I think the route to affirmance can go through one of two ways.

[00:13:19] Speaker 02:
One, these are indeed computer system claims with two components each, every single claim.

[00:13:26] Speaker 02:
has computer memories of certain fields and a data processor that is empowered to enable to do certain things.

[00:13:35] Speaker 02:
Those are classic patent law system claims.

[00:13:39] Speaker 02:
And the statute directs the courts to apply those principles in the delisting statute when it looks at whether a patent claims a method.

[00:13:51] Speaker 02:
Those are three terms that indicate patent law applies.

[00:13:56] Speaker 02:
But elsewhere in the statute, it's perfectly consistent.

[00:13:59] Speaker 02:
The statute elsewhere refers to method of use patent.

[00:14:04] Speaker 02:
That's in subsection B to B. It also refers to patents that claim a method of using such drugs.

[00:14:13] Speaker 02:
Those require looking at what the patent claims.

[00:14:17] Speaker 02:
And the district court did that here and reached that very straightforward conclusion before you even get to any other things that you might have to look at.

[00:14:26] Speaker 04:
What about your opponent's conditions of use argument?

[00:14:30] Speaker 04:
And first, was that waived?

[00:14:34] Speaker 02:
So here's what I'll say.

[00:14:37] Speaker 02:
Maybe.

[00:14:38] Speaker 02:
We think it was, and we've made that argument, but we could see how the court would want to address it anyway.

[00:14:43] Speaker 02:
So in response to the first motion for judgment on the pleadings, they referenced conditions of use but never suggested that patent law shouldn't apply.

[00:14:52] Speaker 02:
And so that's the part, patent law applying or not, that we suggested was waived.

[00:14:57] Speaker 03:
I'm sorry.

[00:14:58] Speaker 03:
I thought in the first round, they said, we have a whole separate little section of their, it's a motion to, whatever the motion was, where the filing was.

[00:15:06] Speaker 03:
And it says, that by enough is enough.

[00:15:09] Speaker 03:
That by itself is enough.

[00:15:10] Speaker 03:
We don't need to get into anything else.

[00:15:12] Speaker 03:
And I thought that piece was actually not dependent on patent.

[00:15:16] Speaker 03:
But when the motion was redone, they didn't say the same thing.

[00:15:20] Speaker 02:
Exactly.

[00:15:21] Speaker 02:
So that's why I say it's a little unclear.

[00:15:22] Speaker 02:
You could read the first one in that way.

[00:15:24] Speaker 02:
But in any event, the second one very clearly doesn't raise it.

[00:15:28] Speaker 02:
But we think the merits are straightforward in any event.

[00:15:31] Speaker 02:
And turning to your honest question, let's look at the regulation that JAAS relies heavily on.

[00:15:36] Speaker 02:
And that is at 314.53b1.

[00:15:40] Speaker 02:
What it says is this.

[00:15:42] Speaker 02:
Quote, for patents that claim a method of use,

[00:15:45] Speaker 02:
That's how it starts the sentence that they're relying on, for patents that claim a method of use.

[00:15:51] Speaker 02:
So we're already confining the world that that can include as patents that claim a method of use.

[00:15:57] Speaker 02:
This court knows what those are.

[00:15:58] Speaker 02:
And then it goes on to say, here's what you must submit.

[00:16:00] Speaker 02:
You must submit information only on those patents that claim

[00:16:05] Speaker 02:
indication or other conditions of use.

[00:16:07] Speaker 02:
So whatever that other part means, it doesn't purport to expand on the statutory language.

[00:16:14] Speaker 02:
That's the preamble of that very sentence, patents that claim a method of use.

[00:16:19] Speaker 02:
So we don't think you should read, and consistent with the statute, I don't think FDA would read those to include things that aren't methods of use.

[00:16:28] Speaker 02:
And in fact, when FDA defined

[00:16:30] Speaker 02:
elsewhere in its regulations, what it meant by conditions of use.

[00:16:34] Speaker 02:
And this is at section 310.3, subsection H5.

[00:16:41] Speaker 02:
It talks there about what might a new thing be, what might a new method or condition of use be.

[00:16:48] Speaker 02:
And what it says there is it's things like dosage, method or duration of administration or application, or other conditions of use.

[00:16:57] Speaker 02:
That accords with the common sense

[00:17:00] Speaker 02:
understanding of what it means to use a drug.

[00:17:02] Speaker 02:
And that, I reference two ways that would be easy to affirm on.

[00:17:05] Speaker 02:
That's the second way, taking a step back.

[00:17:08] Speaker 02:
Under no ordinary meaning of method of using a drug, even if you're willing to put aside patent law principles, and we don't think you should, but method of using a drug has a common sense meaning.

[00:17:19] Speaker 02:
It's taking it or administering it to have some effect on the body.

[00:17:30] Speaker 04:
the sedative or treat diabetes?

[00:17:35] Speaker 02:
Precisely, Your Honor.

[00:17:36] Speaker 02:
Very familiar with that.

[00:17:38] Speaker 02:
And in the section that I referenced, subsection five, it reflects that.

[00:17:42] Speaker 02:
The immediate preceding subsection, subsection four, also reflects where FDA has described what a new use of a drug would be.

[00:17:49] Speaker 02:
And it says it's things like treating diseases, indications, administering it.

[00:17:57] Speaker 03:
Say again what the point is here, making out of that paragraph 5 and 3010.3.

[00:18:03] Speaker 03:
Sure.

[00:18:04] Speaker 02:
The question was about the conditions of use.

[00:18:09] Speaker 02:
And so addressing what FDA itself considers those conditions of use to be.

[00:18:13] Speaker 02:
So in 314.53b, we know that it doesn't consider conditions of use to be broader than

[00:18:22] Speaker 02:
methods of use patents.

[00:18:23] Speaker 02:
It, in fact, starts that sentence with saying four methods of use claims.

[00:18:28] Speaker 02:
Here's the ones you must submit, and only those.

[00:18:31] Speaker 02:
And then that's also reflected in the subsection H5 that I referenced, the definitional section, 310.3 H5.

[00:18:39] Speaker 03:
Which doesn't use the phrase method of use.

[00:18:41] Speaker 02:
Correct.

[00:18:42] Speaker 02:
But if we're looking at what FDA considers conditions of use to be, it illustrates that it doesn't consider it to be more than things like treating diseases or indications or dosages or things like that.

[00:18:57] Speaker 02:
So it just sheds light on conditions of use.

[00:18:59] Speaker 02:
But we don't think you even need to get to what conditions.

[00:19:02] Speaker 03:
I thought your point about the point 43 regulation was that there might be lots of conditions of use, some of which don't in fact involve what the patient is specifically doing.

[00:19:15] Speaker 03:
But that sentence says the only ones that we care about for purposes of that sentence are one that fall under a method of use.

[00:19:24] Speaker 02:
That would be exactly another way of thinking about it, that if you consider conditions of use to be broader than methods of use, and I don't think you should, and I think FDA regulations- Even though the district court thought that compliance with this, coming within this, having this system is a condition of use.

[00:19:43] Speaker 03:
I think- So are you disagreeing with the district court on this point?

[00:19:46] Speaker 02:
I think you can take that as a given.

[00:19:48] Speaker 02:
I will say it was a passing comment on page two in route to deciding that these were system claims, not method claims.

[00:19:55] Speaker 02:
But if you want to consider rounds to be quote unquote conditions of use, then I think to your honor's other question, that sentence that we are focusing on clearly limits the realm of patents that claim a method of use to not include all conditions of use.

[00:20:12] Speaker 02:
So either it's included within methods of use or

[00:20:16] Speaker 02:
It doesn't include others.

[00:20:17] Speaker 04:
What if the claim read, a method for treatment of a narcoleptic patient with a prescription drug that has a potential for misuse by employing this REM system?

[00:20:30] Speaker 02:
If it ultimately described a method, then it would at least get through the first gate that these must be method claims.

[00:20:38] Speaker 02:
If it further provided for using that drug at the end of the day, so steps that ended with, for example, and then go treat the patient, then we're certainly more in the realm of a method of using a drug, because you have a step that uses a drug.

[00:20:53] Speaker 02:
And that stands in sharp contrast to what we have here, where it's all about distribution.

[00:20:59] Speaker 02:
It's about controlling distribution of these drugs, not use of the drugs.

[00:21:04] Speaker 02:
And the FTC spoke to this in its amicus brief in the district court.

[00:21:09] Speaker 02:
It explains that under any common understanding of the statute, whether, frankly, whether system or method, these are all about distribution.

[00:21:17] Speaker 02:
It used the example of carting drugs in an airplane.

[00:21:21] Speaker 02:
So that may be the way you get drugs from point A to point B, or a restriction on, or a precondition for, or prerequisite for using a drug.

[00:21:30] Speaker 02:
But certainly, a patent on an airplane with drugs in it isn't a use of the drugs in the way we commonly think about it.

[00:21:37] Speaker 00:
Doesn't the fact that this is a dangerous drug that we're talking about, and it's subject to a REM,

[00:21:48] Speaker 00:
Doesn't that put it into a different context than a drug that's not as addictive or as deadly as this particular drug is?

[00:22:00] Speaker 00:
Wouldn't the fact that this is so dangerous that Congress has recognized that by putting it as a schedule two drug, doesn't that change the definition of a method of use?

[00:22:15] Speaker 00:
Isn't part of the method of a patient's use of the drug connected, intertwined so closely with how you get the drug that we should look at this as a method of use?

[00:22:29] Speaker 02:
Not at all, Your Honor.

[00:22:30] Speaker 02:
And the reason we know that is when Congress enshrined the REMS systems as prerequisites for certain drugs in 2007, it didn't change the listing statute one whit.

[00:22:41] Speaker 02:
The listing statute has been in place here since 2003.

[00:22:45] Speaker 02:
And it very clearly provides that patents shall not be listed unless they meet one of two conditions.

[00:22:51] Speaker 02:
They must claim a drug or a method of using a drug.

[00:22:55] Speaker 02:
And so while certainly Congress has acknowledged that those are important,

[00:22:59] Speaker 02:
rems, patents on rems that are just about distribution do not fall within the clear terms of the statute.

[00:23:08] Speaker 03:
Can I ask you a question?

[00:23:10] Speaker 03:
I think it's the blue brief.

[00:23:13] Speaker 03:
Anyway, the other side's brief says that Avedale has filed counterclaims that seek to impose antitrust liability premised on the allegedly improper listing of the 963 in the orange book.

[00:23:25] Speaker 03:
Is that true?

[00:23:26] Speaker 02:
That is accurate, yes.

[00:23:27] Speaker 02:
In this case?

[00:23:28] Speaker 02:
in the litigation below.

[00:23:31] Speaker 02:
It's in the parallel case, technically, to this one.

[00:23:35] Speaker 02:
But they're all being litigated around the same.

[00:23:39] Speaker 02:
Yes.

[00:23:39] Speaker 02:
And we think that's absolutely appropriate.

[00:23:41] Speaker 02:
We don't need to get into that.

[00:23:42] Speaker 02:
Here, we think the court need not even go to whether the patents were properly listed at the outset, which we think they clearly were not.

[00:23:50] Speaker 02:
They were listed in 2014, 11 years after the delisting statute came into being.

[00:23:55] Speaker 02:
Congress passed that in response to the FDA saying, we just have a ministerial role, and we won't police the delisting of patents.

[00:24:03] Speaker 02:
That was in early 2003.

[00:24:05] Speaker 02:
Later in 2003, this court came and recognized that the courts didn't have authority at that time to police delisting or provide a delisting remedy.

[00:24:13] Speaker 02:
So Congress acted swiftly and decisively and said, here is a counterclaim.

[00:24:19] Speaker 02:
that is effective for delisting patents that neither claim a drug nor a method of using a drug.

[00:24:26] Speaker 03:
Can I ask you one other thing?

[00:24:28] Speaker 03:
So in at least a couple of areas of patent law that have come to my mind, one is exhaustion, another is 101 analysis.

[00:24:37] Speaker 03:
The Supreme Court has had occasion to say method claims, non-method claims, you can write that's fundamentally the same thing either way, and we shouldn't make something significant turn on that distinction for at least those two kinds of examples.

[00:24:53] Speaker 03:
Why should we not do something similar here?

[00:24:57] Speaker 03:
Here, this is an FDCA provision.

[00:25:02] Speaker 03:
Should it really make a difference for purposes of delisting and listing all the consequences that that entails, whether a particular claim is written one way or the other?

[00:25:18] Speaker 03:
Even in patent law, sometimes it doesn't make a difference.

[00:25:21] Speaker 02:
So a couple of thoughts on that, Your Honor.

[00:25:22] Speaker 02:
First, I think you're referring, for example, to the Alice decision, where it said the methods and systems are not meaningfully different.

[00:25:29] Speaker 03:
An LG on the exhaustion side, right?

[00:25:31] Speaker 02:
Exactly.

[00:25:31] Speaker 02:
And so what the courts did there was look underneath and see what the invention was really trying to get at.

[00:25:37] Speaker 02:
But in that case, there wasn't a clear statutory provision that says, you shall not list, or you shall be entitled to delist however you want to think about it.

[00:25:47] Speaker 02:
other than two separate categories.

[00:25:49] Speaker 02:
And so Congress came in responding to abuses of the Orange Book, where patents were improperly listed and therefore triggered 30-month stays that should never have been triggered.

[00:25:59] Speaker 02:
Congress came in and said, no, we're going to allow you to delist two specific things.

[00:26:05] Speaker 02:
And it, respectfully, did not include systems.

[00:26:08] Speaker 02:
It could have.

[00:26:09] Speaker 02:
Congress knew about patent law.

[00:26:10] Speaker 02:
It could have said, or systems that are somehow related to the distribution of drugs, which is effectively what it is.

[00:26:16] Speaker 04:
Isn't your answer to Judge Connell also that this isn't a 101 case?

[00:26:22] Speaker 02:
Certainly.

[00:26:23] Speaker 02:
It isn't a 101 case.

[00:26:24] Speaker 02:
Although, frankly, these claims are very susceptible, but this is absolutely not a 101 case.

[00:26:29] Speaker 02:
and under basic principles of Apotex, which recognized that it was a patent law question.

[00:26:34] Speaker 02:
And the delisting statute that came along shortly thereafter provided two very specific categories.

[00:26:40] Speaker 02:
And so this is not a method, it's a system.

[00:26:43] Speaker 02:
But even if you back up and decide to look under the hood, as it were, there's nothing about these claims that relates to methods of, or even systems of, using a drug in the common sense understanding that the FDA statute applies and the FDA regs reflect.

[00:27:00] Speaker 02:
So unless there are further questions, we would respectfully request that the court affirm the district court's delisting order.

[00:27:07] Speaker 02:
We thank the court very much for expediting the hearing on this appeal.

[00:27:11] Speaker 02:
I'd be remiss if I didn't note that every day that goes by is a win for Jazz and a loss for those who would desperately love to use Avedale's superior product.

[00:27:22] Speaker 02:
So with respect, if the court sees fit to affirm, and we hope that it does, we would respectfully ask that it lifts the stay as expeditiously as possible, perhaps even in advance of a formal opinion.

[00:27:35] Speaker 02:
And I don't want to get out of my lane here, but I just wanted to impress that on the court so that delisting can proceed as Congress intended as quickly as possible.

[00:27:44] Speaker 04:
Thank you.

[00:27:52] Speaker 01:
Thank you, your honor.

[00:27:54] Speaker 01:
Apart from just noting that there's been no finding of superiority over Jazz's transformational product here, I'd just like to make three quick points.

[00:28:02] Speaker 01:
Number one, with respect to waiver, we just heard counsel say

[00:28:06] Speaker 01:
that the first brief might have made the point that the second brief didn't say the same thing.

[00:28:10] Speaker 01:
At page 22 of the red brief, they said we made the same arguments both times.

[00:28:13] Speaker 01:
And the FTC responded to our conditions of use argument 5669 in the joint appendix based on our renewed briefing response, not the original one.

[00:28:21] Speaker 01:
That's waiver.

[00:28:22] Speaker 01:
As to the definitional regulation 310.3 H5 that counsel referred to, just to be clear, the definition in that regulation is a definition of newness, not conditions of use.

[00:28:32] Speaker 01:
But if you look at what it says about conditions of use, it says,

[00:28:35] Speaker 01:
dosage methods or other conditions of use.

[00:28:39] Speaker 01:
So first of all, it's not limited to the methods.

[00:28:41] Speaker 01:
And second of all, it clearly encompasses dosage, which no one says is a method.

[00:28:45] Speaker 01:
So the definition they're talking about isn't the right kind of definition, and it actually supports our position, not theirs.

[00:28:51] Speaker 01:
But the last point I'd like to make is the following.

[00:28:54] Speaker 01:
The key question here is whether it's a condition of use, not whether it's a method.

[00:28:59] Speaker 01:
We know that method doesn't mean the same thing in this context as in patent law because process patents are expressly excluded from methods for purposes of the regulation, but process patents are method patents for purposes of patent law under Section 100 of the Patent Act.

[00:29:14] Speaker 01:
In this context, we also know that the RIMS is a condition of use.

[00:29:17] Speaker 04:
Process patents aren't methods of use.

[00:29:19] Speaker 04:
They're methods of preparation.

[00:29:23] Speaker 01:
There are method patents, though.

[00:29:24] Speaker 01:
The point is that process and method.

[00:29:27] Speaker 01:
Process is excluded.

[00:29:29] Speaker 01:
Method is included.

[00:29:29] Speaker 01:
But under patent law, every single method patent is a process patent.

[00:29:36] Speaker 01:
The last point I'll make is this.

[00:29:37] Speaker 01:
The district court said that this was a condition of use.

[00:29:40] Speaker 01:
The FDA said it was a condition of use.

[00:29:42] Speaker 01:
And the FDA said its policy is to allow listing of REMS patents because they are conditions of use.

[00:29:47] Speaker 01:
Accordingly, we'd ask that the court vacate the order below and hold that listing was appropriate in this case.

[00:29:54] Speaker 01:
Thank you.

[00:29:55] Speaker 04:
Thank you.