[00:00:05] Speaker ?:
Okay.

[00:00:38] Speaker 02:
Okay, the next argued case is number 16-2475, AIDS Healthcare Foundation against Gilead Sciences, Incorporated.

[00:00:47] Speaker 02:
Mr. Hipskind.

[00:00:50] Speaker 00:
Thank you, Your Honors, and may it please the Court?

[00:00:53] Speaker 00:
The AIDS Healthcare Foundation is the largest non-profit provider of HIV and AIDS.

[00:00:58] Speaker 04:
I take it that the problem here is that you'd like to get some generic drug manufacturer to file an

[00:01:08] Speaker 04:
And you'd like to have the issue of patent validity determined before that happens so that it can move forward quickly without delay, right?

[00:01:20] Speaker 00:
That's correct, Your Honor.

[00:01:21] Speaker 04:
So the problem I'm having is under 28 U.S.C.

[00:01:26] Speaker 04:
955, the antefiler is precluded from requesting a declaratory judgment, as I read the section.

[00:01:37] Speaker 04:
until after 45 days after the andafiling.

[00:01:43] Speaker 04:
So why shouldn't that same limitation apply to your client?

[00:01:49] Speaker 04:
In other words, why shouldn't your client be treated the same as the andafiler insofar as the ability to request declaratory judgment is concerned?

[00:01:59] Speaker 00:
That specific provision is actually talking about

[00:02:06] Speaker 00:
So after a generic files an ANDA, it gives the branded manufacturer an opportunity to file suit or to allow the ANDA application to go through.

[00:02:17] Speaker 00:
But here, that shouldn't apply because our client, AHF, is not filing an ANDA.

[00:02:24] Speaker 00:
It is not a generic manufacturer.

[00:02:26] Speaker 04:
Well, do you agree that if this were an ANDA filer who were doing this, that a declaratory judgment action by the ANDA filer would be barred

[00:02:35] Speaker 04:
by Section 955?

[00:02:37] Speaker 04:
Yes, Your Honor, I would.

[00:02:39] Speaker 04:
So why should your client be able to circumvent that time limitation by suing on behalf of the end of filers?

[00:02:49] Speaker 00:
Because our client is currently engaging in activities that give rise to a potential induced infringement liability.

[00:02:57] Speaker 00:
So under the Hatch-Waxman provisions, you're pointing to a particular provision that

[00:03:03] Speaker 00:
bars an ANDA filer from filing a declaratory judgment action until 45 days after filing the ANDA, but the Hatch Raxon also provides safe harbors for the activities that ANDA filers engage in.

[00:03:18] Speaker 00:
Our client is not protected by any of these safe harbors, and it's this present liability that's giving rise to, or these present activities that are giving rise to a future liability

[00:03:30] Speaker 00:
once an ANDA is filed.

[00:03:32] Speaker 02:
But you couldn't make the filing in your name, right?

[00:03:35] Speaker 02:
There would have to be an ANDA filing for you to achieve the purpose that you're seeking.

[00:03:42] Speaker 00:
That's correct, Your Honor.

[00:03:43] Speaker 00:
So that's prohibited.

[00:03:45] Speaker 00:
That is prohibited by an ANDA filer.

[00:03:47] Speaker 00:
However, the activities that our client is engaged in presently give rise to an induced intervention.

[00:03:52] Speaker 02:
But what difference would it make?

[00:03:54] Speaker 02:
It couldn't be performed, could it, if you succeed?

[00:04:00] Speaker 00:
It cannot be performed until... I guess I'm not sure I understand your question.

[00:04:05] Speaker 02:
I'm trying to understand your purpose.

[00:04:07] Speaker 02:
You're seeking a consequence.

[00:04:11] Speaker 02:
Yes.

[00:04:11] Speaker 02:
Which is barred by law.

[00:04:15] Speaker 00:
I don't believe that it is, Your Honor.

[00:04:18] Speaker 02:
The antifiling would not be available, would it, to a generic?

[00:04:22] Speaker 00:
An antifiling is not available to a generic president.

[00:04:25] Speaker 02:
So how could you obtain the product?

[00:04:28] Speaker 00:
Well, Your Honor, what we're trying to do is expedite generic entry.

[00:04:32] Speaker 01:
The problem is, Judge Newman is asking a great question, which is, how can you possibly have induced infringement when there's no direct infringement?

[00:04:40] Speaker 01:
Induced infringement requires an act of direct infringement.

[00:04:44] Speaker 01:
So there is no direct infringement.

[00:04:46] Speaker 00:
I agree.

[00:04:47] Speaker 00:
There is presently no direct infringement.

[00:04:49] Speaker 00:
There will be a direct infringement.

[00:04:50] Speaker 01:
But you're putting your direct infringement is based on what the antifiler will do, right?

[00:04:56] Speaker 00:
Correct.

[00:04:57] Speaker 00:
So our client is currently engaging in activities that are going to induce an ANDA filer to file an ANDA.

[00:05:04] Speaker 00:
It's the activities of our client that will give rise to an inducement claim that they are seeking a declaratory judgment action to clear the air of that uncertainty of the inducement claim.

[00:05:15] Speaker 00:
I admit that the inducement claim will not be perfected.

[00:05:20] Speaker 00:
Gilead would not be able to file such a claim against our client until the ANDA is filed.

[00:05:25] Speaker 00:
But it's the activities that are presently occurring that give rise to our client's liability.

[00:05:30] Speaker 01:
There are no activities occurring that relate to direct infringement, right?

[00:05:36] Speaker 00:
Well, no.

[00:05:37] Speaker 01:
There are activities that are encouraging generics to... There might be encouragement, but there's no activities occurring that relate to direct infringement, which is a prerequisite for inducement, right?

[00:05:48] Speaker 00:
Yes, Your Honor.

[00:05:48] Speaker 00:
Direct infringement is a prerequisite.

[00:05:51] Speaker 01:
So are there activities that relate to direct infringement?

[00:05:54] Speaker 00:
Not presently.

[00:05:55] Speaker 00:
There won't be a direct infringement until Ananda is filed.

[00:05:58] Speaker 01:
At least until like November 2019 or a year later.

[00:06:00] Speaker 01:
That's correct.

[00:06:01] Speaker 04:
Yeah.

[00:06:02] Speaker 04:
Yeah, but I mean, if there were no statutory bar here, the whole purpose of the Declaratory Judgment Act is to permit people to resolve future uncertainties, even though the future activity doesn't bite at this time.

[00:06:19] Speaker 04:
I'm not unsympathetic to that argument, but I'm still troubled

[00:06:23] Speaker 04:
by how you can evade 21 U.S.C.

[00:06:26] Speaker 04:
955 by saying that you're trying to get somebody to file an ANDA and the person who filed the ANDA couldn't sue now because of the statutory limitation and how could it be that Congress would allow you to sue?

[00:06:44] Speaker 00:
There's no statutory bar for purchasers such as AHF who is

[00:06:52] Speaker 00:
attempting to induce liability or excuse me.

[00:06:56] Speaker 04:
Why would Congress want to bar the antefiler from suing but permit someone who deals with the antefiler to sue?

[00:07:04] Speaker 04:
I'm puzzled by that.

[00:07:06] Speaker 04:
It looks as though the legislative history of this suggests that the purpose of 955 and the limitation on declaratory judgment actions was to create a period where

[00:07:19] Speaker 04:
the original drug NDA filer didn't have to worry about litigation, right?

[00:07:29] Speaker 04:
I mean, that seems to be the purpose of this.

[00:07:32] Speaker 04:
So why would Congress have wanted someone who is trying to get someone to file an ANDA to be treated better than someone who is planning to file the ANDA itself?

[00:07:45] Speaker 04:
I'm just puzzled.

[00:07:47] Speaker 00:
Well, I don't see that they're treated better.

[00:07:50] Speaker 00:
Our client is engaging in activities that expose it to liability and expose it to a claim years from now.

[00:07:57] Speaker 04:
The provision that you're talking about... You can't be liable until there's direct infringement, right?

[00:08:03] Speaker 04:
You agree with that.

[00:08:04] Speaker 00:
I do, but it's the activities that AHF are engaged in today that would give rise to that liability.

[00:08:10] Speaker 00:
So, but for the filing of an ANDA,

[00:08:13] Speaker 00:
a 271b inducement claim against our client would be based on the activities today.

[00:08:19] Speaker 00:
And that's why a declaratory judgment action is necessary in order to get rid of that threat of this future liability.

[00:08:28] Speaker 00:
And addressing your question about the 45-day, that is a modest period where the branded pharmaceutical can decide whether it is going to file suit against the andafiler

[00:08:42] Speaker 00:
But what we have here is actually the interplay of NCE exclusivity that prohibits, new chemical entity exclusivity that prohibits the filing of an ANDA until November 2019.

[00:08:54] Speaker 02:
So what relief are you requesting?

[00:08:57] Speaker 02:
And order that a specified generic producer will file an ANDA application when permitted to do so?

[00:09:10] Speaker 00:
No, Your Honor, we're requesting that the district court's order be reversed and that our client, HF, has standing to challenge the patents at suit that give rise to its potential liability, which are the five patents in suit in the declaratory judgment action.

[00:09:27] Speaker 02:
That your client would be in the position of an antifiling, of an antifiler, but not restrained by the time restraints of hypothetical infringement.

[00:09:40] Speaker 00:
Well, not that our client would be in the position of an antifiler, just that our client would be in the position of a party seeking to eliminate the uncertainty of its legal liability.

[00:09:52] Speaker 02:
Even though there is neither present nor induced infringement?

[00:09:58] Speaker 00:
There is only not a claim for induced infringement because there's no direct infringement, but the activities that would give rise to that claim are present.

[00:10:07] Speaker 00:
And I think that that's similar to the FINA research case that we cite in our briefing, where the future direct infringement has not yet occurred, but there is substantial questions as to the activities that would give rise to an induced infringement allegation once that direct infringement were to occur in the future.

[00:10:30] Speaker 00:
And that's the same thing here.

[00:10:32] Speaker 00:
In the future, there will be an ANDA that's filed.

[00:10:35] Speaker 00:
Gilead will have the opportunity to file an induced infringement claim against AHF based on its activities today, unless AHF can say that claim would be baseless, there is no claim, because the patents that you would be suing for induced infringement on are invalid.

[00:10:51] Speaker 00:
And so that dispute is real and immediate today, even though the direct infringement comes in the future.

[00:10:58] Speaker 00:
Why is it that the safe harbor doesn't protect you?

[00:11:06] Speaker 00:
You believe that you're referring to the safe harbor from Section 271E?

[00:11:09] Speaker 00:
Yeah.

[00:11:11] Speaker 00:
Which safe harbor?

[00:11:13] Speaker 04:
Yeah, the safe harbor of 271E.

[00:11:17] Speaker 00:
Because AHF is not preparing materials for submission to the FDA.

[00:11:24] Speaker 00:
Well, it's asking somebody to do that.

[00:11:26] Speaker 00:
That's correct.

[00:11:28] Speaker 00:
But that is separate from preparing the materials.

[00:11:32] Speaker 04:
In fact, we point to... So you're saying that somebody could induce infringement and incur liability even though the infringement itself is protected by the safe harbor?

[00:11:47] Speaker 00:
Yes, because the infringement isn't protected by the safe harbor.

[00:11:50] Speaker 00:
It's the activities of the generic manufacturer in preparing the end of filing that are protected.

[00:11:56] Speaker 00:
I take it there's no case law on this, right?

[00:12:00] Speaker 00:
There is.

[00:12:01] Speaker 00:
In this circuit, there's Forest Labs versus IVACs Pharmaceuticals.

[00:12:12] Speaker 00:
There was a 271E2.

[00:12:13] Speaker 00:
The act of filing an ANDA could support an action for induced infringement.

[00:12:19] Speaker 00:
And in this case, in our briefing, we cite to a number of ANDAs.

[00:12:25] Speaker 04:
Does that case talk about the safe harbor?

[00:12:29] Speaker 00:
I believe that it does.

[00:12:32] Speaker 00:
Yes.

[00:12:34] Speaker 01:
But in this case... I think it was the act of filing an ANDA.

[00:12:38] Speaker 00:
The infringement?

[00:12:39] Speaker 00:
Yes.

[00:12:40] Speaker 00:
That's right.

[00:12:41] Speaker 00:
So the act of filing is the infringement and the activities that induce a generic, for example by our client, AHF, that induce a generic to file the ANDA

[00:12:51] Speaker 00:
are not protected by the safe harbor, and those are the inducement activities that have induced the direct infringement.

[00:12:58] Speaker 00:
The direct infringement being the filing.

[00:12:59] Speaker 01:
But the direct infringement is the filing of the NDA.

[00:13:03] Speaker 01:
It's not the activities under the safe harbor.

[00:13:06] Speaker 01:
Correct.

[00:13:06] Speaker 02:
It is a hypothetical, statutorily declared act of infringement under Hatch-Waxman.

[00:13:14] Speaker 02:
There is no direct infringement otherwise.

[00:13:16] Speaker 02:
Right.

[00:13:17] Speaker 02:
That's correct, Your Honor.

[00:13:19] Speaker 02:
All right.

[00:13:19] Speaker 02:
Let's hear from the other side.

[00:13:29] Speaker 02:
Mr. Frischman.

[00:13:31] Speaker 03:
Good morning, and may it please the court.

[00:13:33] Speaker 03:
What AAHF wants relief for is a quintessentially constitutionally impermissible advisory opinion.

[00:13:41] Speaker 04:
That's a comment that could apply to the Declaratory Judgment Act as a whole.

[00:13:46] Speaker 04:
And the Declaratory Judgment Act does not violate Article 3.

[00:13:49] Speaker 04:
That's quite true, Your Honor.

[00:13:51] Speaker 04:
So the question is, you know, whether this satisfies the Med Immune standard for a declaratory judgment act.

[00:13:58] Speaker 04:
It's not as though they're seeking an advisory opinion.

[00:14:01] Speaker 04:
Anyone who files a declaratory judgment act in that sense is asking for an advisory opinion about something.

[00:14:08] Speaker 03:
I would agree, Your Honor.

[00:14:08] Speaker 03:
I'm speaking of it in the Med Immune sense.

[00:14:11] Speaker 03:
This is far short of what Med Immune requires.

[00:14:14] Speaker 03:
Because here, who the endophiler is going to be, what the product is going to be,

[00:14:19] Speaker 03:
when the and is going to be filed, when it might be approved, are all hypothetical, are all speculative and unknown at this stage.

[00:14:28] Speaker 03:
I want to address for a moment the issue of induced infringement.

[00:14:32] Speaker 04:
There's no current liability for induced infringement, number one, because there's no... But that doesn't mean that you can't worry about it, because activities that occur today could lead to liability in the future once an and is filed.

[00:14:45] Speaker 04:
I mean, you could imagine

[00:14:47] Speaker 04:
a situation in which a month away from the ANDA filing, the foundation here is encouraging somebody to file an ANDA.

[00:14:56] Speaker 04:
That could lead to inducement liability, right?

[00:15:00] Speaker 03:
I don't know that it could, Your Honor, and in this case... Why not?

[00:15:05] Speaker 03:
First of all, because until an ANDA is filed, there is no act of infringement, and so it's premature to assume it will get filed.

[00:15:11] Speaker 03:
I can't know that.

[00:15:12] Speaker 04:
Well, what case says that if you induce

[00:15:15] Speaker 04:
before direct infringement and the direct infringement ultimately occurs, you're not liable for inducement.

[00:15:20] Speaker 04:
I don't think there's a case like that, is there?

[00:15:23] Speaker 03:
That's not the case, Your Honor.

[00:15:24] Speaker 03:
The issue is whether or not there's any certainty.

[00:15:26] Speaker 03:
So in this hypothetical... Okay, but that's a different question.

[00:15:29] Speaker 04:
So my hypothetical is a month before the ANDA filing, the AIDS Foundation says, please file this ANDA here.

[00:15:38] Speaker 04:
We'll help you file the ANDA.

[00:15:40] Speaker 04:
They could incur

[00:15:42] Speaker 04:
liability for doing that, even though the direct infringement is a month in the future, right?

[00:15:48] Speaker 04:
I'm aware of no case in which... No, no, no, answer my question.

[00:15:51] Speaker 04:
Is that true?

[00:15:53] Speaker 03:
It would depend on the facts, if there's enough certainty.

[00:15:57] Speaker 03:
If there's enough certainty and there's a defined product.

[00:15:59] Speaker 03:
I still question under this court's Sandoz decision and Benetech decisions whether the infringement liability, induced or otherwise, can ever attach until the ANDA is filed.

[00:16:10] Speaker 03:
That's not this case by a long shot because here there are no concrete allegations as, for example, who have they induced?

[00:16:17] Speaker 03:
The only allegations in the complaint concerning inducement, which I think it's important because otherwise their liability is only when the product is launched one day, their hypothetical liability.

[00:16:28] Speaker 03:
As far as inducement goes, the only allegations in the complaint about communications with generics is that they sent unsolicited letters and they were ignored and they acknowledged

[00:16:37] Speaker 03:
in questioning by the district court that there had been no response to those communications.

[00:16:42] Speaker 03:
That's Appendix 1666 and 67 in oral argument.

[00:16:47] Speaker 03:
So on that record, there's no objective concern about inducement liability, even if hypothetically it would be possible to induce, to have inducement liability for an ANDA filing.

[00:16:58] Speaker 03:
That's not this case.

[00:17:00] Speaker 01:
Your position is that under Benetech and Sandoz, the fact that

[00:17:04] Speaker 01:
in ANDA might be filed in a few years, that just doesn't give rise to the kind of immediacy and reality required for a DJ action.

[00:17:15] Speaker 01:
That's correct, Your Honor.

[00:17:16] Speaker 04:
And the reason is that... Well, except that Sandoz says that the lapse of time in and of itself is not determinative.

[00:17:23] Speaker 04:
And your argument has to rest not on the lapse of time.

[00:17:27] Speaker 04:
If there were certainty as to

[00:17:29] Speaker 04:
the identity of the ANDA filer and the ANDA that was going to be filed, the fact that that might be years away under Sandoz wouldn't prevent a declaratory judgment action, right?

[00:17:39] Speaker 03:
To the extent that there was no prospect of change in the intervening years, but that's again not this case.

[00:17:44] Speaker 03:
We don't know anything from the allegations about what ANDA will be filed.

[00:17:49] Speaker 03:
And it's a concrete issue.

[00:17:51] Speaker 03:
If you look at the patents in suit, there's five patents and 70 claims.

[00:17:55] Speaker 03:
So let me pick one example, the 219 patent owned by Japan Tobacco.

[00:17:59] Speaker 03:
it claims a drug called albitegravir in combination with certain other drugs, one of which, one of the triple combinations can be with TAF.

[00:18:08] Speaker 03:
Of the four products that are at issue, an individual standalone product and then a single, double, and triple combination, only one of them has albitegravir.

[00:18:17] Speaker 03:
So there's no way to know when meanda comes, will it even include that particular drug and thus implicate that patent.

[00:18:25] Speaker 03:
The same holds true for

[00:18:27] Speaker 03:
The 374 patent, which claims a drug called cobicistate.

[00:18:31] Speaker 03:
The same holds true, arguably, for the 3791 patent, which claims TAF at a certain purity level without certain undesirable diastereomers.

[00:18:40] Speaker 03:
So some claims say less than 40%, 20%, or 5%.

[00:18:44] Speaker 03:
No way to know which of those claims might be implicated, if any of them or all of them.

[00:18:50] Speaker 03:
We just have no idea at this stage what liability could possibly rise in the future.

[00:18:55] Speaker 03:
So from the perspective of

[00:18:57] Speaker 03:
declaratory judgment, this is far, far short of anything the court has previously held is sufficiently immediate, real, and definite to give rise to declaratory judgment concern.

[00:19:10] Speaker 01:
Has AHF filed any proceedings in the PTAB, for example, IPRs or anything like that?

[00:19:19] Speaker 03:
No, they have not.

[00:19:20] Speaker 03:
And certainly that was an option open to them if they wished to challenge

[00:19:24] Speaker 03:
the patent in the patent office.

[00:19:26] Speaker 03:
And of course, the IPR does not require a showing of Article 3 standing as does proceeding in federal court.

[00:19:33] Speaker 03:
So that is an option they simply chose not to avail themselves of for whatever reason.

[00:19:40] Speaker 03:
Separate and apart from the question of immediacy and realities, also the question of whether or not there is adversity in the sense of any action taken by the declaratory judgment defendants, in this case, Japan Tobacco and Gilead,

[00:19:54] Speaker 03:
adverse to AHF.

[00:19:56] Speaker 03:
And in this case, there's none.

[00:19:57] Speaker 03:
So with regard to JT, there's no communication of any kind alleged between AHF and Japan Tobacco.

[00:20:03] Speaker 03:
With regard to Gilead, there's no affirmative act by Gilead that AHF can point to.

[00:20:08] Speaker 03:
So they're attempting to initiate the declaratory judgment claim by trying to manufacture their own dispute.

[00:20:15] Speaker 03:
So they write a letter and say, if you won't give us a covenant not to sue, then we think that gives us jurisdiction.

[00:20:21] Speaker 03:
But they cite no case.

[00:20:23] Speaker 03:
in which the court has found that that is sufficient in the absence of some other acts adverse to the declaratory judgment plaintiff.

[00:20:33] Speaker 03:
They point to prior litigation, but of course I think it proves exactly the opposite point.

[00:20:38] Speaker 03:
All the prior litigation was directed against the antifilers or their corporate affiliates.

[00:20:45] Speaker 03:
Gilead hasn't sued end customers or clinics or nonprofits like AHF.

[00:20:51] Speaker 03:
This issue will be resolved in due course in the course of ordinary Hatch-Wax litigation.

[00:20:57] Speaker 03:
And in fact, Your Honor, notable here is the fact that there are five patents in suit, but there are 12 in the Orange Book.

[00:21:06] Speaker 03:
And the Orange Book for the Genvoia, the four-drug product, is reproduced in the complaint.

[00:21:13] Speaker 03:
There are 12 patents listed therein, one of which is expired.

[00:21:18] Speaker 03:
So there are at least six unexpired patents

[00:21:20] Speaker 03:
for which a generic manufacturer, if that's the product they choose to make, is going to have to do a paragraph four certification, go through the Hatch-Waxon litigation, and this will all be resolved as Congress had contemplated before those patents expired.

[00:21:35] Speaker 03:
One of them, for example, expires, or two of them in 2026.

[00:21:37] Speaker 03:
So there's no urgency here, and nothing will be accomplished since not even all the patents at issue are the subject of this declaratory judgment case.

[00:21:48] Speaker 03:
And that same holds true for the other

[00:21:50] Speaker 03:
three products.

[00:21:51] Speaker 04:
Yeah, but we've said that if there are a couple of patents, that you don't have to sue on both of them to have a declaratory judgment action to strike down one of them.

[00:22:04] Speaker 03:
I don't disagree with that, Your Honor.

[00:22:06] Speaker 03:
My point here is rather that because there are other patents that will have to be litigated as part of the paragraph four, the acceleration here really accomplishes nothing, even if it were constitutionally permissible, even if it didn't violate section 955,

[00:22:20] Speaker 03:
There's nothing to be accomplished that won't get accomplished when and if there is paragraph four litigation.

[00:22:27] Speaker 03:
And at least at that point, there will have been an action to find infringement.

[00:22:31] Speaker 03:
One will know which patents there are actually disputes concerning and which ones.

[00:22:35] Speaker 02:
The urgency would be to permit an immediate challenge to validity.

[00:22:40] Speaker 02:
Isn't that right?

[00:22:41] Speaker 02:
Never mind the end.

[00:22:44] Speaker 03:
The immediate challenge to validity would only challenge

[00:22:47] Speaker 03:
five of the 12 patents in the Orange Book.

[00:22:49] Speaker 02:
Maybe, but if it challenges the broadest one to the foundation product, perhaps that would be useful to the public, represented by this complainant.

[00:23:06] Speaker 03:
Your Honor, I think it would be speculative as to whether it would have any utility at all, because for example, depending on what drug the generic file's on, what combination

[00:23:16] Speaker 03:
Some of these patents may never be asserted at all.

[00:23:20] Speaker 02:
But that's their problem.

[00:23:22] Speaker 02:
If they're allowed to challenge validity, then these other issues might be on the table.

[00:23:28] Speaker 02:
The question is whether they can come into court at all on their own initiative and challenge validity.

[00:23:34] Speaker 02:
That's what they're asking for.

[00:23:36] Speaker 03:
That is absolutely the fundamental question.

[00:23:39] Speaker 03:
What we would submit is that on this record, where there's no product in development that we're aware of,

[00:23:47] Speaker 03:
We don't even know who will develop it.

[00:23:48] Speaker 03:
We know it's not AHF.

[00:23:50] Speaker 03:
We don't know when they will develop it.

[00:23:52] Speaker 02:
You're saying that it's impractical, but that isn't what they're asking for.

[00:23:55] Speaker 02:
They're just asking for the right to come into court and fight.

[00:24:00] Speaker 03:
It's more than impractical, Your Honor.

[00:24:01] Speaker 03:
It's so indeterminate that it doesn't meet the immediacy or the reality requirements of MedImmune.

[00:24:09] Speaker 03:
This dispute is absolutely and completely hypothetical because there's no idea what product is going to be made.

[00:24:17] Speaker 03:
and thus what issues need to be litigated.

[00:24:19] Speaker 03:
And so it's a hypothetical dispute in which the court is potentially going to be asked to address claims that will never be of practical relevance because for example, the generic will file on a different combination of products and those claims would never even be asserted.

[00:24:37] Speaker 03:
So it's that kind of practical requirement in MedImmune of immediacy and reality that there'd be a concrete product and that there'd be actual current harm

[00:24:48] Speaker 03:
that drives the fact that there's no... No, it doesn't have to be current harm.

[00:24:52] Speaker 04:
The whole purpose of the Declaratory Judgment Act is somebody says, I'm going to do something in the future which may create liability.

[00:24:59] Speaker 04:
I'd like to know whether that's permissible or not.

[00:25:02] Speaker 04:
It does not have to be current harm.

[00:25:05] Speaker 03:
I would agree with Your Honor.

[00:25:06] Speaker 03:
It has to be either current or imminent.

[00:25:08] Speaker 03:
And to the extent I suggested one and not the other, that would have been... I misspoke.

[00:25:12] Speaker 03:
But imminency is very much a requirement.

[00:25:15] Speaker 03:
of Med Immune and the Declaratory Judgment Act.

[00:25:17] Speaker 03:
And there's no imminent harm here.

[00:25:19] Speaker 03:
AHF, to the extent it's ever going to be exposed to infringement liability, it'll happen after a generic files goes through the FDA process.

[00:25:29] Speaker 03:
If it's successful, gets a product approved, chooses to launch that product.

[00:25:34] Speaker 03:
And at that point, AHF will be in a position to purchase the product and presumably use it and thereby have liability.

[00:25:41] Speaker 03:
But there's no allegation here.

[00:25:44] Speaker 03:
that would suggest that they face any plausible liability before that time.

[00:25:51] Speaker 03:
Is there no further questions?

[00:25:52] Speaker 03:
Any more questions?

[00:25:54] Speaker 02:
More questions?

[00:25:55] Speaker 02:
OK.

[00:25:55] Speaker 02:
Thank you, counsel.

[00:26:02] Speaker 02:
Mr. Hipskate.

[00:26:04] Speaker 04:
Just a couple of brief points.

[00:26:07] Speaker 04:
Address the concreteness issue, would you?

[00:26:09] Speaker 04:
Because that seems to be their main argument, is that we don't know what the end would look like.

[00:26:16] Speaker 04:
We don't know exactly what you're trying to do.

[00:26:19] Speaker 04:
And you haven't made it clear in the complaint.

[00:26:24] Speaker 00:
Yes.

[00:26:24] Speaker 00:
So the concreteness argument is largely a red herring.

[00:26:28] Speaker 00:
Where this comes up in this court's cases are largely in the context of declaratory judgments

[00:26:34] Speaker 00:
involving non-infringement.

[00:26:36] Speaker 00:
Here, AHF is only seeking a declaratory judgment of invalidity of the patents in suit.

[00:26:44] Speaker 04:
And as we were discussing earlier, the problem that they say is there are several different patents here, several different claims.

[00:26:52] Speaker 04:
We don't know which ones would be implicated by the conduct that you're encouraging.

[00:26:59] Speaker 00:
Well, it's the artificial act of infringing

[00:27:02] Speaker 00:
of the and defiling that would be the infringement that AHF is inducing.

[00:27:07] Speaker 00:
So what the exact product would look like or what the details of the and defiling are really don't apply to a declaratory judgment claim of invalidity of the patent because it's not measuring infringement.

[00:27:21] Speaker 01:
Aren't you basing your claim of a dispute based on some induced infringement of a specific product?

[00:27:28] Speaker 00:
No, Your Honor.

[00:27:29] Speaker 01:
I mean, of a product though.

[00:27:32] Speaker 00:
No, as you're talking about, the infringement is a hypothetical, artificial, statutory infringement of the ANDA filing.

[00:27:39] Speaker 00:
It's not the future sales of the actual generic product.

[00:27:44] Speaker 01:
So it's based on the assumption that somebody's going to have an ANDA filing.

[00:27:48] Speaker 00:
Yes.

[00:27:49] Speaker 02:
But you never represented that your client would file the ANDA.

[00:27:54] Speaker 02:
Isn't that right?

[00:27:54] Speaker 00:
That's correct.

[00:27:56] Speaker 02:
You just hope somebody else will.

[00:28:00] Speaker 00:
Killian tries to inject a certain amount of uncertainty, but if you look at the facts that are pled and that we cite in our briefing, TDF, which is the tenofovia predecessor of TAF, there were three ANDAs that were filed, and this is just a minor change in the product.

[00:28:21] Speaker 00:
This uncertainty that Gilead's trying to inject in the inevitability of an anda is really red herring because we know from past experience that there's great interest on the part of generics in this particular drug.

[00:28:35] Speaker 04:
Yeah, but so why didn't you file something which said we want somebody to produce this specific product that looks this way and we think

[00:28:44] Speaker 04:
that potentially would infringe X, Y, and Z claims of these patents.

[00:28:49] Speaker 04:
And we'd like a declaratory judgment that those claims are invalid.

[00:28:53] Speaker 04:
But you didn't do that.

[00:28:56] Speaker 04:
I see my time's up.

[00:28:57] Speaker 00:
May I respond?

[00:28:58] Speaker 00:
Yeah, you don't have the right to sit down yet.

[00:29:00] Speaker 00:
Yeah.

[00:29:02] Speaker 00:
I believe that we did.

[00:29:04] Speaker 00:
We specifically asked for generic versions of GenVoya, which was the first TAF-containing product Gilead released.

[00:29:11] Speaker 00:
So that is a specific copy of a specific concrete product that we are requesting generic manufacturers to undertake the ANDA process for.

[00:29:23] Speaker 02:
Any more questions?

[00:29:29] Speaker 02:
Thank you.

[00:29:30] Speaker 02:
Thank you both.

[00:29:31] Speaker 02:
The case is taken under submission.