Apotex, Inc. v. Thompson
Oral Argument — 02/04/2003 · Case 02-1295 · 87:35
0:00
Judge Newman
Next case is number 02-1295, Apotex Incorporated, against the Secretary of Health and Human Services, the Food and Drug Administration, and SmithKline Beach. Mr. Moore.
0:12
Appellant Attorney (Moore)
If it pleases the court, I will start with the question that we started with before Judge Jackson quite some time ago. The question in this case is whether, and certainly if at some point in time, when, there will ever be a generic for SmithKline's new drug tax. That's the court question.
0:41
Judge Newman
But you're really asking us to decide, to give an advisory opinion? Can we, it would be helpful to concentrate on the issues.
0:50
Appellant Attorney (Moore)
Yes, ma'am. First of all, the question is truly whether there will be a judicial remedy. This court has said in the Milan case that there, that an NDA has no claim against the NDA holder slash patentee for removal of illegally listed patents from the orange.
1:16
Now, that leaves us with whether there is an action.
1:21
Against the NDA. And as we've said before, that has to be the case. But in the alternative, there is a more fundamental question here. And that is whether there is any gatekeeper anywhere in the federal government, be it the executive branch or the judiciary, who will release the clear and unambiguous requirements of the statute regarding the listing of patents in the orange.
1:57
The statute 355C2, 355B1 is crystal clear. The NDA applicant or NDA holder shall file patents which claim for which the application was submitted.
2:19
And FDA has refused to release this mandatory requirement statute.
2:27
And now we are left with a...
2:31
separate question.
2:32
There is a right to judicial review.
2:36
Judge Newman
Isn't the question, as Judge Jackson found, that the remedy of the statute, which is the infringement suit, is the statutory remedy?
2:48
You're saying that there is no remedy, but in that, in such an action, the validity, infringement, and every other aspect of the patent is subject to challenge.
2:59
Now, I appreciate that.
3:02
There is a question as to the adequacy of, or at least the expeditiousness of such a remedy, but where did Judge Jackson go wrong in stating that this was a legislative issue rather than a judicial one?
3:21
Appellant Attorney (Moore)
The APA, Section 704, says there shall be a right of review for any final agency action for which there is no other remedy.
3:32
in a court. Now, the relief that we have sought here is injunctive relief requiring FDA to grant final approval of Amputex's
3:45
abbreviated new drug application for AMDM. Amputex has completed, the FDA has completed every subsequent aspect of this review of that
3:57
application, and the only thing holding up, holding up final approval, are these additional patents listed in the Orange
4:07
Book on which SmithKline has filed actions and on which SmithKline has obtained multiple 31 states.
4:15
Judge Mayer
Well, Mr. Moore, I think we all understand the factual background. I take it, though, that your answer to Judge Newman about the
4:27
adequacy of the...
4:29
...subsequent litigation that the statute provides for would be that the subsequent litigation doesn't deal with the problem of the
4:39
temporary injunction that's ordered by statute, the automatic 30-month temporary injunction, and that given the decision of this court in
4:51
Dandrack, there's no way to shorten that, except in the narrow current circumstances.
5:00
...that Dandrack says it can be shortened within the context of the subsequent litigation. But in terms of the repetitiousness of filing of perhaps improper patents, your argument is, if I understand it, that the listing creates this temporary injunction for which there is no judicial remedy.
5:29
Is that, do I understand your brief correctly?
5:32
Appellant Attorney (Moore)
Precisely so. These cases should never have been filed under the statutory patent infringement mechanism established by Hatch-Laxman.
5:47
Judge Mayer
But look at the implications of your argument, Mr. Moore. The implications of your argument would appear to be that the FDA would have to set up a system of some kind involving the...
6:04
and I suppose this would not come as a total blow to the patent lawyers in the country,
6:10
a system of some kind equipped with proper patent lawyers and analysts
6:18
to determine whether a particular patent that the patentee proposes to list in the Orange Book
6:26
meets the criteria of the statute.
6:29
And then the subsequent result would be that you'd be right back up here
6:33
challenging the decision of the FDA under an APA theory,
6:39
and we'd have just another set of litigation before we ever got to the patent suit.
6:47
Am I missing something? Is that not the implication of your position?
6:53
Appellant Attorney (Moore)
No, Your Honor. With all due respect, I will say that we regard one remedy here,
7:01
one easy remedy, as FDA, a patent lawyer,
7:06
Judge Mayer
or two, or 10, or 12, or 20, whatever it may take.
7:10
Appellant Attorney (Moore)
Well, in our appendix, it is interesting, Your Honor, in our appendix,
7:14
at one point early on in the case of this report,
7:18
we undertook a little survey to see how many patents were actually listed in the Orange Book in a year,
7:26
and the number was under 40.
7:29
I was surprised, and I think everyone else was surprised.
7:33
So we are not looking at a massive administrative task.
7:38
Judge Mayer
Even assuming you're not looking at a massive administrative task,
7:42
are we looking at yet another basis for more litigation now,
7:48
the listing question, before we even get to the hypothetical infringement suit that Hatch-Waxman creates for us?
7:59
Appellant Attorney (Moore)
I have two responses.
8:01
First of all, I think it is likely that if there were an administrative enforcement scheme in place,
8:09
we would not see the sorts of patents that we see in this case.
8:14
It is a self-generating system.
8:19
You go to the patent office to get any kind of a patent that you can.
8:25
You get it into the Orange.
8:29
You, you know, provoke the draft war certification, the resulting lawsuit,
8:37
Appellee Attorney (Daniel E. Troy)
and you've got your automatic 30-month stay.
8:40
Appellant Attorney (Moore)
And district courts are busy, very busy.
8:45
And even if it's a clear case of non-infringement or invalidity,
8:49
it can take a long time to get a decision,
8:55
get the patent issues resolved,
8:57
and in the meantime, the innovator has continued with its monopoly.
9:04
Judge Newman
Why is this different from what you've asked now?
9:07
You took this case to the district court.
9:09
You've asked that court to construe the claims,
9:13
which we know generally have...
9:18
...embraces all of the major issues in patent litigation,
9:22
involves the prosecution history and prior art and all sorts of things.
9:27
So, and here we are, although we're here reviewing the threshold question,
9:33
had the district court actually undertaken the review that you say is appropriate
9:40
with respect to the listing, wouldn't you have it as elaborate a litigation
9:46
and a...
9:47
...a direct appeal from the FDA rather than an appeal under a Hatch Waxman?
9:53
Appellant Attorney (Moore)
Your Honor, first of all, I am unwilling, for the purpose of this case,
10:01
to accept the premise that claim construction will frequently be a difficult process.
10:08
It most assuredly is not in this case.
10:11
Judge Newman
Well, if it's not difficult, then it should go expeditiously under a Hatch Waxman as well.
10:16
After all, those 30 months...
10:18
...are a maximum, and any delays in the dockets of the district courts
10:23
and the appellate courts would apply just as well,
10:27
whether it comes through Hatch Waxman, would it not,
10:29
or whether it's an administrative appeal,
10:31
plus undoubtedly having an extra tribunal in the administrative agency.
10:36
Appellant Attorney (Moore)
Your Honor, there has...
10:39
I think it's necessary to make one clear distinction between underlying patent litigation,
10:44
which is currently ongoing,
10:46
and the case that we brought to the district court and that we brought here.
10:50
The issue in the underlying patent infringement litigation
10:55
is whether the relevant claim or claims of the patent consumed read on the accused front.
11:04
What is not at issue in the underlying patent litigation
11:07
is whether the claim or claims of the relevant patent read on...
11:16
...the innovator's product, the enabler's product.
11:20
That is a question that is never addressed in the underlying Hatch Waxman litigation.
11:28
So, in the patent litigation, the district court never gets to that issue.
11:36
Now, would the district court have gotten there
11:39
if the district court had answered...
11:42
...had ruled the other way in my land?
11:44
Yes.
11:45
But my land blocks us.
11:48
From pursuing that relief in the patent court.
11:57
Judge Mayer
My land blocks you because you're saying that is not a litigable issue under my land
12:04
as between the private parties.
12:07
Precisely. Precisely.
12:09
Appellant Attorney (Moore)
This court held in my land quite clearly
12:11
that there is no right of action under either the Food, Drug, and Consumption Act
12:17
or the patent statutes
12:20
to force the delisting of an illegally listed patent.
12:25
Judge Mayer
But by the time you get to that litigation,
12:27
isn't the question of listing sort of historical?
12:32
I mean, who cares at that point?
12:35
Appellant Attorney (Moore)
Well, I will tell you in answer to that,
12:37
we care a great deal for two reasons.
12:41
Appellee Attorney (Daniel E. Troy)
First of all, the multiple 30-month stays
12:44
that can go on ad infinitum
12:47
if an NDA holder patentee is able to control the prosecution
12:52
of applications through the patent office at an appropriate pace.
12:57
Then this can go on forever.
13:00
Appellant Attorney (Moore)
Patents issue yearly.
13:01
They get listed in the Orange Book yearly.
13:05
Judge Newman
You know, I might have thought that was a problem,
13:08
but you tell us there are only 40 patents listed
13:11
for the entire massive pharmaceutical industry in this nation?
13:16
Appellant Attorney (Moore)
That was...
13:17
That was the interesting thing about this.
13:19
It is interesting.
13:20
That was an interesting and surprising finding for us.
13:23
Judge Newman
Perhaps it's not an issue?
13:25
Appellant Attorney (Moore)
Is this abuse widespread?
13:27
I don't know.
13:29
I'm in two or three cases where, in our view,
13:32
there is abuse.
13:34
And one case like this is one too many.
13:38
We're dealing with a $2 billion market.
13:40
Smith & Klein has continued to file patent applications.
13:44
We've counted them all up.
13:46
Time for a reply brief.
13:48
And here I see on January 2, 2003,
13:53
U.S. patent application 2003-0004188.
13:59
Invented is peroxyde nitrochloride anhydride in 4B
14:02
and anthroxyde nitrochloride in 4B.
14:06
Judge Newman
Are you asking us to presume
14:07
that there's something fraudulent about that activity?
14:11
I'm not sure I understand the issue.
14:14
Appellant Attorney (Moore)
Your Honor,
14:15
I am not asking the court to presume fraud.
14:18
I am absolutely not doing this.
14:22
However, I can tell you that it's a matter of public record
14:25
that the Federal Trade Commission is investigating Smith & Klein
14:29
for potential violation of the antitrust laws
14:33
in connection with this patent listing.
14:34
Judge Newman
Well, then perhaps your issues will be resolved in that forum.
14:40
Appellant Attorney (Moore)
Perhaps it would.
14:41
But the congressional purpose of this statute is twofold.
14:45
One, to protect legitimate intellectual property rights of NBA owners.
14:50
And second, to encourage the introduction of generic competition.
14:57
The scheme as it currently exists today,
15:02
in our case, certainly,
15:05
and in another case involving a drug by the name of gabapentin
15:09
in an appeal which this court just signed about two weeks ago.
15:14
Judge Newman
Is that before us in this case?
15:15
Appellant Attorney (Moore)
No, Your Honor, it is not.
15:18
Judge Newman
Okay.
15:19
All right, thank you, Mr. Morgan.
15:20
Appellant Attorney (Moore)
I see I'm into my reply time.
15:23
Judge Newman
You've exceeded your time, but Judge Bryson has a question.
15:25
Could I ask a question?
15:26
Appellee Attorney (Daniel E. Troy)
Because jurisdiction has been raised,
15:28
and I didn't want to chew into your argument on the merits.
15:34
But it's an important question,
15:36
and I would like you to comment on it.
15:39
And in particular, I would like you to comment on whether,
15:42
given the exclusive jurisdiction that this court has,
15:46
over cases that arise in part under 1338,
15:50
which would be the premise for our having jurisdiction in this case at all,
15:54
whether that would mean that in cases such as the AAI Pharma case,
16:00
which went to the Fourth Circuit,
16:01
and some of the Hatch-Waxman cases that have been decided by the D.C. Circuit,
16:05
those courts would not have jurisdiction,
16:08
and we would have exclusive jurisdiction over this kind of appeal,
16:12
and the kind of appeal that was taken in AAI Pharma.
16:14
Appellant Attorney (Moore)
I think there are two answers to that question,
16:20
and I have thought about this a good bit.
16:24
The first answer is 355 and C2 clearly represent statutes relating to patent law under 1338,
16:51
and this court,
16:55
ought to be dealing with,
16:57
to the extent we do,
17:00
ought to be dealing with this,
17:02
with these issues.
17:04
The question of whether a given patent claims a drug
17:12
is quintessally a patent law.
17:17
Appellee Attorney (Daniel E. Troy)
And the very,
17:19
this is the very threshold point in this statutory scheme,
17:24
and my second point is,
17:33
we are here asking for judicial relief
17:38
Appellant Attorney (Moore)
in the form of final approval of Amphitex's AMDA.
17:44
An essential element of our right to the court
17:49
is establishing that the patents in question do not claim the approved drug.
17:58
Appellee Attorney (Daniel E. Troy)
And only that determination,
18:02
that claim construction determination,
18:05
gets the job done.
18:07
It is an essential element of our right to relief
18:10
Appellee Attorney (Daniel E. Troy)
under Christensen versus Cole,
18:12
and this court's authority.
18:14
And would you,
18:15
well, if I could just,
18:16
the second half of my question was,
18:18
would the Fourth Circuit be incorrect
18:21
in having assumed jurisdiction in that case?
18:24
Yes.
18:25
Yes.
18:25
And the DC Circuit,
18:26
ditto?
18:27
Yes.
18:28
Yeah, so,
18:29
we'd be going into conflict with both of those circuits
18:32
on the jurisdictional issue,
18:33
to the extent that they
18:34
can be deemed to have addressed and ruled on, though,
18:38
the jurisdictional question.
18:40
Appellant Attorney (Moore)
The DC Circuit,
18:42
I do not believe,
18:44
there's plenty of case law out there,
18:46
the DC Circuit,
18:47
I do not believe,
18:48
has ever ruled on a case like this.
18:51
Okay.
18:51
The Fourth Circuit sits out there by itself.
18:54
Appellee Attorney (Daniel E. Troy)
But the DC Circuit rulings on Hatch-Waxman issues,
18:56
you say,
18:57
would be,
18:58
the DC Circuit would be deprived of jurisdiction
19:00
over the kinds of cases they have addressed?
19:02
No, Your Honor.
19:04
No.
19:04
Absolutely not.
19:04
Oh, I thought you said the answer was yes.
19:06
Okay.
19:07
Appellant Attorney (Moore)
My focus here,
19:08
I haven't tried to draw a line.
19:12
Appellee Attorney (Daniel E. Troy)
That's sort of the challenge here, isn't it?
19:15
Appellant Attorney (Moore)
Yes.
19:15
Yes, it is.
19:16
My focus here is 355 and .
19:20
Appellee Attorney (Daniel E. Troy)
Right.
19:21
Appellee Attorney (Daniel E. Troy)
Now,
19:21
Appellant Attorney (Moore)
when we turn to questions of exclusivity,
19:27
when we turn to a question of whether under Hatch-Waxman
19:30
there is,
19:32
as we have argued,
19:33
only one 30-month stay available.
19:36
Okay.
19:36
All right.
19:37
Those questions answered the patent law question
19:41
Appellee Attorney (Daniel E. Troy)
would clearly belong in the DC Circuit.
19:44
They are here before this Court
19:46
only as a matter of dependent jurisdiction.
19:49
Quite clearly,
19:50
the majority of the issues that arise under this statute
19:55
Appellant Attorney (Moore)
belong in the DC Circuit or another regional circuit.
19:58
Appellee Attorney (Daniel E. Troy)
So you're saying that the patent laws referred to
20:01
in this,
20:02
in 1338,
20:03
for present purposes,
20:05
include not all of Hatch-Waxman,
20:07
but only 355 and .
20:10
Appellant Attorney (Moore)
I think that's clearly correct.
20:12
Appellee Attorney (Daniel E. Troy)
And there's nothing else in Hatch-Waxman
20:14
that you think would fall within the patent law's requirement,
20:20
provision of 1338?
20:20
Well, there is this Court's own precedent
20:22
Appellant Attorney (Moore)
in at least two cases involving patent term extension
20:28
where the Court,
20:30
what about the exercise of
20:33
construing provisions of Hatch-Waxman
20:36
and Uruguay Rounds Agreement Act
20:42
in order to correlate those two people,
20:47
separate pieces of legislation?
20:49
Appellee Attorney (Daniel E. Troy)
But those would have been in the context
20:51
of a private suit for patent infringement,
20:53
wouldn't they not?
20:54
Appellant Attorney (Moore)
No, these were,
20:56
and I hope I have the procedural posture right,
20:59
I have it right on at least one.
21:01
One of them was clearly a suit against FDA
21:03
and the head of the patent laws.
21:10
That goes back to about 1989.
21:13
The case is cited and discussed in our briefs.
21:17
These cases are cited and discussed in our briefs.
21:19
Well, that's all right.
21:20
I'll find it.
21:21
Judge Mayer
All right.
21:22
Let me add a little bit on this
21:25
because we need jurisdiction.
21:27
Of course, we have to attend to even if you didn't,
21:30
but you did.
21:32
Let me...
21:35
Your suggestion in your colloquy with Judge Bryson
21:39
is that a question like the sequential 30-month
21:44
temporary injunction issue
21:47
could go to the DC Circuit
21:52
as a purely APA issue
21:55
if there were no patent issue
21:58
raised in that same suit.
22:00
But I think that you would say
22:03
that we could decide the question here,
22:08
since it's been raised in this case,
22:11
because it is either,
22:14
well, perhaps because it is pendent,
22:17
it's a pendent issue to the patent issue
22:21
that you're alleging is raised
22:24
by your view of Pat Waxman.
22:27
Is that right?
22:28
Appellant Attorney (Moore)
That's correct.
22:28
I agree.
22:29
Judge Mayer
Now, add to that,
22:30
OK.
22:31
So, basically...
22:33
All right.
22:34
Now, I assume that
22:35
if we disagreed with your view
22:39
of whether your reading of it
22:44
of those two statutory sections
22:47
Appellee Attorney (Daniel E. Troy)
could raise a patent issue,
22:50
Judge Mayer
I suppose if you had also
22:53
a count in your claim,
22:55
in your original complaint,
22:59
that was a clear patent.
23:01
Yes.
23:02
So, in that case issue,
23:03
we would have jurisdiction
23:05
over the whole mess.
23:07
Appellee Attorney (Daniel E. Troy)
Yes.
23:07
Judge Mayer
And in that regard,
23:09
you mentioned several times
23:12
in your brief
23:12
that no matter what else happens,
23:15
count four of our complaint
23:17
does the job of jurisdiction.
23:19
Can you help me?
23:20
I've read and reread
23:22
count four,
23:23
and I'm trying to understand
23:24
exactly why you singled
23:27
count four out
23:28
Appellee Attorney (Daniel E. Troy)
as getting you in the door
23:30
Judge Mayer
regardless of what we thought
23:31
about any of the points
23:32
or any part of your issues.
23:33
I went back over
23:35
the amended complaint,
23:36
Appellant Attorney (Moore)
Your Honor,
23:37
and I will give you,
23:39
first of all,
23:40
first paragraph,
23:41
count four,
23:42
for Chris Lara,
23:42
all previous allegations.
23:44
All 187 paragraphs.
23:46
Appellee Attorney (Daniel E. Troy)
Yes.
23:46
.
23:48
Judge Mayer
.
23:48
.
23:49
.
23:49
.
23:49
.
23:49
.
23:49
.
23:49
.
23:51
.
23:52
.
23:52
.
23:52
.
23:55
Appellant Attorney (Moore)
.
24:02
Appellee Attorney (Daniel E. Troy)
.
24:05
Appellant Attorney (Moore)
.
24:06
.
24:06
.
24:06
.
24:07
.
24:10
.
24:10
.
24:10
.
24:19
.
24:19
.
24:19
.
24:19
.
24:19
.
24:19
.
24:20
.
24:41
1-3-9 and the paragraphs that I have received rank of the attention report in particular are paragraphs 3, 118, and 139.
25:06
Judge Mayer
Not anything on 02739?
25:10
Just for my memory, sir.
25:14
Appellee Attorney (Daniel E. Troy)
Okay.
25:15
In which we request an injunction given this final date.
25:24
Judge Newman
Is that okay, at least for the moment?
25:26
Mm-hmm.
25:26
Okay, at least for the moment.
25:28
Okay, thank you, Mr. Moore.
25:29
We'll save you a rebuttal time.
25:34
Now you've divided up the argument, Mr. Troy.
25:38
Amicus Attorney
Thank you, Your Honor.
25:39
Thank you.
25:39
I'm here on behalf of the government athletes.
25:43
I agree with Mr. Bruce to divide up my 2-3-1-9-0-3.
25:48
I went about 25 minutes, so I don't want to be too much of a risk.
25:54
Appellee Attorney (Daniel E. Troy)
Mr. Bruce, with all due respect, the threshold jurisdiction question here is when you got the program.
26:04
Appellee Attorney (Daniel E. Troy)
And I think the whole tenor of the discussion before the discussion of jurisdiction really illustrates the degree to which, again, with all due respect to this court, that right now this case does not belong in this court because what we're talking about is construction of the statute, essentially the Administrative Procedure Act case.
26:25
Appellee Attorney (Daniel E. Troy)
Let me ask you... I'm sorry.
26:29
We let you get one sentence out.
26:31
Thank you.
26:34
If I could just ask one quick question.
26:37
I think I know where you're going, and maybe I can short-circuit this.
26:40
Suppose that we say, okay, no jurisdiction.
26:44
The only question here has to do with an APA challenge to the FDA's declining to take particular procedural steps, i.e., look at the patent for its merits.
26:54
That goes to the D.C. Circuit.
26:56
They say you're wrong.
26:57
FDA has to look at these things.
26:59
Now, does the next case come to us, or does the next case still come to us?
27:03
Does the next case still go to the D.C. Circuit?
27:04
Once it has been decided, let's suppose, make it easy, the Supreme Court affirms the D.C. Circuit.
27:10
Henceforth, the question is whether the FDA, which is dutifully going through these reviews,
27:18
the question then is when a review of the FDA's decision, either to kick a case off the Orange Book or to kick a patent off or keep it on,
27:28
when that comes up under APA review, does that go to the D.C. Circuit or to us?
27:32
Appellee Attorney (Daniel E. Troy)
That would come.
27:33
It is, obviously, that question is not here, but it might well come here, and let me explain why.
27:38
That case would still arise under the APA, and that is the first problem of your jurisdiction.
27:44
This court knows more about its jurisdiction than I do, but arising under and whether a patent was a necessary element in one of that.
27:51
Judge Mayer
Well, if that case would arise under our statute, then the decision as to whether that case exists must arise under our statute.
28:02
Well.
28:03
Appellee Attorney (Daniel E. Troy)
To respect your honor, I was just going to make the point that it still would not arise under the APA.
28:07
Judge Mayer
It doesn't arise under the APA, it arises under the patent statute.
28:11
Appellee Attorney (Daniel E. Troy)
Well, no, it arises under the issue that we're discussing here, the Food Drug and Cosmetic Act,
28:15
the interpretation of the Food Drug and Cosmetic Act, and it would arise under the Food Drug and Cosmetic Act,
28:21
and I don't believe this court wants to take jurisdiction over all the bills relating to the Food Drug and Cosmetic Act.
28:24
Judge Newman
But the other half says war requires decision of, depends on decision of, so you don't really have to decide.
28:32
Right.
28:33
Right.
28:35
Appellee Attorney (Daniel E. Troy)
Yes, so that we're on the second prong of your jurisdiction, which is nor is a patent law determination a necessary element in one of the APA Texas claims.
28:44
And at this point, what is before this court is the question that I guess I should have started,
28:50
which is whether or not FDA properly decides not to undertake a substantive review of patents when they're listed in the Orange Book.
29:00
That's the question before the court right now.
29:03
That's the state of the question that does not turn on any kind of element of patent law.
29:09
It's a straight Chevron question of statutory interpretation.
29:16
And rather than a barbary, the statute says, C2 says, upon submission of the patent information, the secretary shall publish.
29:27
Appellee Attorney (Daniel E. Troy)
That's the 84A of the statutory appendix.
29:30
Appellee Attorney (Daniel E. Troy)
FDA is given virtually no time to evaluate the patent.
29:34
Okay.
29:34
The Orange Book is meant to be updated every 30 days, which means the patent comes in a few days before we have to update the Orange Book.
29:43
We've got to list it.
29:45
Again, upon submission, the secretary shall publish.
29:48
We have 30 days to update the Orange Book, which could mean much less time to list.
29:54
That certainly does not give time for the kind of administrative mechanism that Judge Clay would properly identify.
30:03
Right.
30:04
Right.
30:04
That's the kind of thing that we would have to undertake if we were to undertake the analysis that Mr. Moore would like us to undertake.
30:11
Judge Mayer
Well, let me challenge you on that a little bit, because you're suggesting that what you would have to do is a full-scale patent analysis as to whether there's, as to whether, as to the nature, well, you'd have to do a Markman hearing, I suppose, on claim construction, and then you'd have to determine whether there's a patent.
30:34
You'd have to determine whether there was infringement, literally, or under the doctrine of equivalence, and then you'd have to go through all the defenses.
30:42
And I suggest to you I don't think that's at all true, because the statutory criteria for listing isn't whether there is, in fact, an infringement of the claim.
30:58
Fact.
30:59
Appellee Attorney (Daniel E. Troy)
Fact.
30:59
Judge Mayer
Fact.
31:00
Fact.
31:00
Fact.
31:04
that the patent claim, the drug for which the applicant submitted the application,
31:12
I'll leave out the subclause on method because it's the same thing,
31:16
and that's one thing, that's a fairly straightforward call in many cases,
31:22
although it could be complicated in a few,
31:25
and with respect to which a claim of patent infringement could reasonably be asserted.
31:31
That's a pretty low standard.
31:36
That's not a full-blown patent litigation.
31:40
I mean, we're familiar with the details of the full-blown patent world,
31:44
and we wouldn't wish that on anybody.
31:49
And I've always felt sympathy for the district court.
31:53
But that's not what this statute asks you to do.
31:56
This statute asks you to do a much more limited analysis.
32:02
So I'm not sure I'm willing to accept your proposition
32:04
that you need to hire Lord Bissell and all the rest of those folks
32:09
to come over and be FDA employees in order to make this thing work.
32:14
They'd volunteer.
32:15
Appellee Attorney (Daniel E. Troy)
Well, let me read you what Lord Bissell said, Your Honor.
32:20
On page 32 of their brief, they wrote,
32:23
The analysis for determining the legality of arms publicity is identical
32:27
to the analysis used in any patent case,
32:31
except one thing.
32:32
Once the claims of the relevant patent are properly construed,
32:34
they are applied to the product that is the subject of the approved NEA
32:38
rather than to an alleged infringer's rights.
32:40
Judge Mayer
You're not suggesting we should accept everything that Lord Bissell said, are you?
32:44
Appellee Attorney (Daniel E. Troy)
Not everything, but I think that that is a major concession on their part.
32:50
Judge Mayer
Well, it may be a major concession on their part,
32:52
but it's an erroneous assumption about what the statute requires.
32:56
So let's deal with what the statute seems to call.
33:02
What's the problem?
33:03
The problem is,
33:04
Appellee Attorney (Daniel E. Troy)
the Congress seems to have,
33:07
and we believe Congress unambiguously,
33:09
took these kinds of inquiries
33:11
and directed them to the courts
33:13
where patent expertise resides.
33:20
Judge Mayer
I'm sorry to say,
33:21
we've just said in two cases,
33:23
the courts can't deal with it.
33:24
Appellee Attorney (Daniel E. Troy)
Somebody has to deal with it, don't they?
33:26
At least with respect to the 30 months.
33:29
I mean, that's where the rubber hits the road here, let's face it.
33:32
What we're really talking about is this mandatory thing.
33:35
We can't get out of it.
33:36
We can't get out of it.
33:37
We can't get out of it.
33:37
Which we've managed to say in two different cases,
33:40
go over there.
33:42
And this, now we've arrived over there,
33:45
and the question is, are we now to say,
33:47
once you've arrived at the only remaining spot,
33:50
you have no remedy?
33:52
Appellee Attorney (Daniel E. Troy)
There's no spot there.
33:53
With respect, I think that there is a spot there.
33:56
Okay.
33:56
And that is, if you're listening,
33:58
can be a remedy in the district court
34:00
from the infringement court.
34:01
The infringement court can, under the Abbott case,
34:03
be listening at the end of the day.
34:05
The whole...
34:06
Appellee Attorney (Daniel E. Troy)
At the end of the day.
34:07
But that, as a practical matter,
34:10
the end of that day is after, potentially,
34:12
a long string of 30-month stays,
34:16
at least if the appellees are correct
34:20
on the multiple 30-month stay issue,
34:23
which stretch out as far as the eye can see,
34:26
or the imagination of the patent drafters can permit, right?
34:30
I mean, there's nothing the district court can do about that
34:32
if we are right about Andrix.
34:34
Appellee Attorney (Daniel E. Troy)
That's...
34:35
Yes, the choice that Congress made
34:38
was to have these issues resolved
34:40
in patent litigation in the courts.
34:43
And part of the...
34:44
Judge Mayer
Which issues resolved, Chancellor?
34:48
Appellee Attorney (Daniel E. Troy)
I would suggest that all of the issues
34:51
relating to the vindication
34:54
of the intellectual property rights
34:56
of the innovator vis-a-vis the generic...
34:59
Judge Mayer
Does that include the criteria for listing?
35:04
I mean, that's what we're talking about.
35:06
Yes, look.
35:07
There's a statute here that has two criteria in it.
35:10
Yes, for listing.
35:11
The implication of listing
35:13
is that there is going to be
35:15
an automatic 30-month temporary injunction,
35:19
whether you like it or not,
35:21
and we've even told the district courts
35:23
you can't do a lot about it
35:25
in one of our cases, all right?
35:28
Yes.
35:29
That listing concept has a tremendous impact,
35:33
particularly when you have a clever,
35:37
innovative innovator such as this one
35:39
who likes to string listings on for hot infinitum.
35:43
Now, you've got a problem.
35:45
Can you help me?
35:46
I've got a delegation problem
35:48
with the denial by the agency
35:52
of any willingness to look at
35:55
its responsibility under this statute.
35:58
Here's my delegation problem.
36:00
As a general rule,
36:02
Congress cannot delegate legislative power
36:06
to...
36:07
to an executive branch agency.
36:10
You would agree with that.
36:11
Absolutely.
36:12
And there is a principle, a standard,
36:14
that the Supreme Courts have said exists.
36:17
Do you happen to remember offhand
36:19
what the phrase is?
36:21
There's a...
36:25
You're close.
36:26
It's the pound.
36:27
An intelligible principle.
36:29
Right.
36:30
Congress set out an intelligible principle
36:33
with two criteria in it,
36:35
and that probably is sufficient
36:37
for a delegation.
36:39
A delegation of power to the agency
36:41
to make that determination.
36:44
As I read the evidence in this case,
36:46
the agency has sub-delegated that responsibility
36:51
to the private sector.
36:53
And what the agency says is,
36:55
if there's a challenge to the listing,
36:59
we, the agency, will call up and say,
37:02
hey, guys, did you really mean this listing?
37:05
And if the guys say, oh, yeah, that's the end of the case.
37:09
I believe that's the ministerial concept
37:12
that you're bringing us.
37:13
That is correct.
37:14
Now, I'm having a little problem
37:16
with the principle of delegation involved here.
37:21
In fact, I've gone to the trouble
37:22
of even looking at some of the cases
37:25
on delegation and sub-delegation.
37:27
And I think they put you at risk here
37:31
because you have a statute
37:34
which has significant legal impact
37:37
on the...
37:39
private sector parties.
37:41
But nobody's policing it
37:43
except the company that has a conflict of interest
37:47
with regard to whether that listing is or is not valid.
37:50
Help me understand
37:53
how we're to sort of sweep that
37:55
into the delegation doctrine.
37:58
Appellee Attorney (Daniel E. Troy)
Well, the delegation presupposes
38:00
that we have an obligation to police again.
38:02
Somebody has to.
38:03
Judge Mayer
Who is going to police?
38:05
Look, you would agree that we have to have
38:08
an intelligible principle,
38:09
or the whole thing goes out.
38:10
We have to hold Hatch-Waxman unconstitutional
38:13
as an improper delegation.
38:15
I don't want to do that.
38:16
So, if we assume Hatch-Waxman
38:19
is a valid delegation to the agency,
38:22
what I have to understand from you is
38:25
how does the agency implement its responsibilities
38:29
under this delegation?
38:32
Appellee Attorney (Daniel E. Troy)
Again, I think we use it consistently
38:34
with the choices that Congress made.
38:35
Again, Congress sets this up as a complex signal
38:39
mechanism between the innovators and the generics
38:42
with listing as a means actually to speed
38:45
the generics to the market
38:46
and to give the generics a sense
38:49
of what the full tax portfolio was
38:52
that they would base on as part of the innovators.
38:56
At the same time, the innovators got the right
38:58
to be able to vindicate those tax rights in court.
39:02
Appellee Attorney (Daniel E. Troy)
And Congress clearly had made the choice
39:06
that the decision as to
39:09
listing, if you will,
39:10
but more importantly,
39:12
Appellee Attorney (Daniel E. Troy)
the vindication of the intellectual property rights
39:16
are to be made where the expertise
39:18
resides in the courts.
39:20
Judge Mayer
No question.
39:20
What we're talking about is
39:21
the 30-month temporary injunction trigger.
39:24
That's all we're talking about.
39:25
Appellee Attorney (Daniel E. Troy)
Exactly.
39:26
But what's being attempted here is,
39:28
I think, an end run around the 30-month trigger
39:31
because Congress basically said,
39:33
we're going to send these things to the courts
39:36
and let the courts work them out
39:37
and in the interim,
39:38
we're going to put in this 30-month stay.
39:40
Now, we certainly take your point at the FDA
39:42
that there have been some problems.
39:45
Some problems.
39:46
And we should not overstate the problems.
39:47
Courts like...
39:48
Well, we need one problem and we're up here.
39:52
That's correct.
39:52
And so we tend to see the problems.
39:54
But overall, that question is working pretty well.
39:56
The number of cases where there have been these evergreen
39:59
and multiple 30-month stays is not that large.
40:03
We do not denigrate them.
40:05
And as you know,
40:05
we propose a rule to try and get rid
40:07
of multiple 30-month stays.
40:08
Judge Mayer
99,999 people don't commit crimes.
40:13
It's that one-tenth of one percent
40:15
that fog up the courts.
40:17
We got that one problem right here, counsel.
40:19
Deal with it.
40:21
Appellee Attorney (Daniel E. Troy)
The question is, first of all,
40:23
whether Congress made the choice to give us,
40:26
given that we have to list the patents,
40:27
again, within less than 30 days,
40:30
to have us do that,
40:32
and to a certain extent,
40:33
whether it will again be handled.
40:35
Because to set up the kind of administrative structure
40:37
that you were talking about would divert us
40:40
from our other public health mission,
40:42
our primary public health mission,
40:44
who didn't pay NDAs?
40:45
Judge Mayer
I understand all that.
40:46
But we have a legal problem,
40:48
not a practical problem.
40:49
The legal problem is,
40:51
can you turn your back on your statute?
40:54
I understand that you don't want to have to be bothered
40:57
with all of this,
40:58
and I don't blame you.
40:59
I truly don't.
41:01
But I don't know that that helps.
41:03
Could we decide,
41:05
the law requires that somebody look at this,
41:09
somebody who is within the ambit of proper delegation,
41:13
but since the agency really doesn't want to be bothered,
41:17
and it's a lot of hassle,
41:19
we're not going to impose the delegation document.
41:22
Can we do that?
41:23
Appellee Attorney (Daniel E. Troy)
We can put it that way, Your Honor, obviously.
41:26
Judge Mayer
But that's your argument.
41:28
Appellee Attorney (Daniel E. Troy)
I don't think I'm walking away from the statute.
41:30
I think I'm relying on Congress' words,
41:32
on a text in the statute which says,
41:34
upon submission of the information,
41:37
the Secretary shall publish.
41:39
That's 355 .
41:40
And also says, upon approval,
41:42
we shall publish,
41:43
and we are obligated by the statute,
41:46
by the statute,
41:47
to update the Orange Book every 30 days.
41:50
That strongly implies it's not actually decided,
41:53
a purely ministerial function.
41:55
Appellee Attorney (Daniel E. Troy)
If I understand your argument,
41:57
it really is,
41:57
your response to Judge Plager,
41:58
I take it, on delegation is really,
42:00
this isn't a delegation problem,
42:02
because Congress didn't set up something
42:04
that was to be decided.
42:05
It simply said,
42:06
as soon as you submit something
42:08
that has the following things on the piece of paper,
42:11
the FDA is to publish it.
42:13
And they didn't anticipate that.
42:15
There was no decision-making to be done,
42:17
at least in the course of the administrative process.
42:19
So, ergo, no delegation.
42:21
Absolutely.
42:22
No act, therefore, no act was delegated.
42:25
Appellee Attorney (Daniel E. Troy)
There's no mechanism for appeal,
42:27
there's no delisting remedy,
42:29
there's nothing in the statute
42:31
that suggests that we are to undertake
42:34
anything other than the ministerial conduit
42:37
by which the two parties are committed.
42:39
Appellee Attorney (Daniel E. Troy)
But then the question is,
42:42
you may be right about that,
42:44
and indeed,
42:45
each of these various cases that we have decided,
42:48
we've seen various parts of this animal bit by bit,
42:52
may be defensible,
42:53
but is it fair to assume that Congress
42:56
intended to create a mechanism
42:58
that would operate as we now,
43:01
if we rule in your favor on this,
43:04
issue and sort of close the last door
43:06
to review here of the 30-month stay issue,
43:10
is it fair to assume that Congress
43:12
would have created such an animal?
43:14
Appellee Attorney (Daniel E. Troy)
I think it is fair to assume that Congress
43:16
did not intend to get into the business
43:18
of claim construction and marketing...
43:20
Appellee Attorney (Daniel E. Troy)
Right, now that's the answer to this particular case.
43:23
But then the broader question,
43:24
you're here representing the public interest,
43:27
and is it in the public interest
43:29
to have a system that does not permit any review
43:34
of a chain of 30-month stays?
43:37
I mean, this may be an invitation for you
43:39
to talk about the new regulations, but...
43:42
Appellee Attorney (Daniel E. Troy)
Well, we have recognized the problem,
43:45
and in the proper mode of administrative law,
43:50
prospectively, contextually rule-making,
43:51
and transparently,
43:52
we propose to try and solve
43:54
the problems that there are with cash wax.
43:56
I want to understate, overstate,
43:58
yes, we have tried to deal with the problem
44:01
in the proper way,
44:02
but to impose upon it,
44:04
contrary to the statute,
44:06
this obligation to engage in claim construction
44:08
at this point,
44:09
would, I think, end up speeding things,
44:12
because, as you said, Your Honor,
44:13
we would have to make a decision,
44:17
and then it would be challenged,
44:18
and then it would come back to this court,
44:19
and I'm not sure
44:20
we would bring generic drugs to market anywhere.
44:22
Judge Mayer
Are you suggesting that the solution to this problem
44:26
would be for us to hold
44:28
that your proposed regulations,
44:31
in fact, have been the law all along?
44:33
Absolutely not.
44:34
That there were no sequential
44:36
30-month periods allowed,
44:39
and therefore we adopt your position?
44:43
Appellee Attorney (Daniel E. Troy)
I believe that the reason why we didn't propose that
44:46
is because we thought if we had,
44:47
we would be in violation of laws
44:49
of cases like George Counter's,
44:51
which suggest that agencies may not act retroactively.
44:55
Judge Mayer
But we can act retroactively.
44:58
Appellee Attorney (Daniel E. Troy)
You can act retroactively,
44:59
although you would have to invalidate
45:01
a prior, a pre-existing legal regime
45:03
embodied in regulation
45:05
based upon a reasonable construction of the statute,
45:08
and...
45:08
Judge Mayer
Unless, of course,
45:09
we found the statute to be plain on its face
45:11
in which, in that Chevron Step 1.
45:13
Appellee Attorney (Daniel E. Troy)
Yes, if you found it under Chevron Step 1
45:15
that our interpretation
45:18
Appellee Attorney (Daniel E. Troy)
that there could be multiple 30-month,
45:20
that there could be multiple 30-month days
45:22
was inconsistent
45:23
Appellee Attorney (Daniel E. Troy)
because Congress had directly spoken
45:25
to the precise question and issue,
45:26
if you found that,
45:27
then, of course,
45:28
we would be in the world
45:30
where our new regulation proposes
45:32
to be a reasonable...
45:54
You know,
45:56
Judge Newman
I don't want to prolong this,
45:58
but I just wonder
46:00
Judge Mayer
whether I've misunderstood.
46:04
Judge Newman
I always thought the purpose of Hatch-Waxman
46:07
was not to add an automatic
46:08
30 months to the life of a patent,
46:11
but to permit a generic manufacturer
46:15
to challenge the validity of the patent
46:20
long before the patent had expired.
46:22
So that that is at any time,
46:24
which, of course,
46:25
can be done by just going out
46:27
with an infringing product,
46:28
but instead of doing that
46:30
with all of the risks
46:31
to create this artificial infringement
46:34
by statute,
46:36
which then permits the litigation,
46:38
and then the 30 months
46:39
is the maximum period
46:41
that one's allowed
46:42
to drag out the litigation.
46:44
So if that's...
46:46
That is, I guess,
46:48
the purpose and the intent
46:50
and the working
46:51
of Hatch-Waxman.
46:53
So can't a would-be competitor,
46:58
a generic manufacturer,
47:00
avoid the...
47:01
A generic manufacturer
47:03
to challenge the validity
47:06
of the patent
47:07
long before the patent had expired
47:10
so that that is at any time,
47:12
which, of course,
47:13
can be done by just going out
47:15
with an infringing product,
47:17
but instead of doing that
47:18
with all of the risks
47:19
to create this artificial
47:22
infringement by statute,
47:24
which then permits the litigation,
47:26
and then the 30 months
47:27
is the maximum period
47:29
that one's allowed
47:30
to drag out the litigation.
47:32
So if that's...
47:34
That is, I guess,
47:36
the purpose and the intent
47:38
and the working of Hatch-Waxman.
47:41
So can't a would-be competitor,
47:46
a generic manufacturer,
47:48
avoid the entire operation
47:50
just by going out
47:51
with the infringing product
47:53
and let the course
47:56
of litigation occur
47:57
without the benefits
47:59
of the artificial infringement
48:03
that Hatch-Waxman creates?
48:05
Appellee Attorney (Daniel E. Troy)
Well, I don't believe so,
48:07
Your Honor,
48:07
because what Hatch-Waxman does
48:09
is it says to the FDA...
48:10
Judge Newman
It has to be approved.
48:11
Is that it?
48:12
That the ANDA has to be approved.
48:13
Appellee Attorney (Daniel E. Troy)
And it can't be approved
48:14
Judge Mayer
until these issues are resolved.
48:16
They could go out,
48:17
but then they'd go to jail
48:19
because they have to have
48:20
the FDA act.
48:21
Yes.
48:22
Judge Newman
But is the FDA,
48:23
then, is prohibited
48:25
from approving an ANDA
48:27
during the course
48:29
of this litigation?
48:32
Appellee Attorney (Daniel E. Troy)
That's correct, Your Honor.
48:33
Judge Newman
Whether or not
48:34
the patent is expired?
48:37
Appellee Attorney (Daniel E. Troy)
If the patent is expired,
48:40
then, presumably,
48:42
a patent holder,
48:43
the ANDA holder says
48:46
it's a section,
48:47
paragraph three...
48:48
Appellee Attorney (Daniel E. Troy)
No, there wouldn't be...
48:49
Appellee Attorney (Daniel E. Troy)
And then it doesn't apply.
48:50
Paragraph four only applies...
48:52
The thirty percent
48:53
three-month stay
48:53
only kicks in,
48:54
not with a paragraph three,
48:55
but a paragraph four,
48:56
which is an infringement
48:58
or a claim of invalidity.
48:59
Judge Newman
So if the patent expires
49:00
in the middle of that...
49:01
Appellee Attorney (Daniel E. Troy)
then game over
49:02
and we approve the drug.
49:04
Okay.
49:04
You're right, Your Honor,
49:05
that Hatch-Waxman
49:06
was a complicated deal
49:07
where the generics
49:08
got certain things
49:09
and the innovators
49:10
got certain things.
49:11
They got extensions
49:12
of their exclusivities.
49:13
The generics got the right
49:14
to provide on studies
49:17
done by the innovators.
49:18
But the mechanism
49:19
for the vindication
49:20
of the intellectual property rights
49:22
was the thirty-month stay.
49:24
And it was meant
49:25
to be decided...
49:25
These issues were meant
49:26
to be decided
49:26
by the courts,
49:28
by the infringement court,
49:29
which has, we believe,
49:31
the full panoply
49:32
Appellee Attorney (Daniel E. Troy)
of remedies,
49:32
including ordering
49:33
the innovator
49:37
to delist
49:38
Appellee Attorney (Daniel E. Troy)
in the appropriate case
49:39
at the end
49:40
of the patent infringement
49:42
litigation.
49:42
That's the way
49:44
the system
49:44
was set up
49:45
by Congress
49:45
and they did not
49:47
intend for us
49:48
to get into
49:48
the business
49:49
that, frankly,
49:50
this court
49:50
is much better suited
49:51
to be doing.
49:54
Okay.
49:54
Judge Mayer
Can we let
49:55
Mr. Troy
49:55
off the hook?
49:56
No, I don't want
49:57
to let Mr. Troy
49:58
off the hook
49:58
but I don't have
49:59
any more questions.
50:03
Appellee Attorney (Daniel E. Troy)
Well, I do have
50:04
one further question
50:05
I think you've answered
50:06
but I'll just take
50:06
two seconds
50:07
and that is that
50:08
you don't...
50:10
The new regulated...
50:12
proposed regulations
50:12
do not affect,
50:14
I take it,
50:14
in any respect
50:15
the position
50:15
you've argued to us
50:16
in the thirty-month stay
50:18
portion of your brief.
50:19
No, they do not.
50:20
They don't.
50:21
Okay, that's what
50:22
you're saying.
50:23
Judge Newman
Let's give
50:23
Mr. Bruce
50:24
his full
50:25
five minutes.
50:27
Appellee Attorney (Daniel E. Troy)
I calculated
50:28
eight, Your Honor,
50:29
but I'll take
50:30
whatever you can
50:30
give you
50:32
very much.
50:33
Time's up.
50:37
I'd like to start
50:38
with an observation
50:39
that you made
50:40
Appellee Attorney (Daniel E. Troy)
or a question
50:41
that you mentioned
50:41
later.
50:42
You said
50:43
Appellee Attorney (Daniel E. Troy)
that's the end
50:44
of the case
50:44
at FDA
50:45
when you go
50:46
through this process
50:47
and the idea
50:48
of drug
50:48
reaffirmed
50:52
what the listing...
50:54
Well, actually,
50:54
it's not the end
50:55
of the case.
50:56
It wasn't the end
50:56
of the case here.
50:59
As it was required
51:00
to do
51:01
by the FDA's
51:03
regulation
51:03
specifically
51:06
10.25 feet
51:08
of 21 CFR,
51:11
Avotex filed
51:12
a citizen's
51:13
petition
51:14
as a requirement
51:15
under those regs
51:16
to seek
51:16
judicial review
51:17
ultimately
51:18
of what
51:18
the agency
51:19
has done.
51:20
And in
51:21
the answer
51:23
that the agency
51:24
gave
51:24
to the citizen
51:25
the citizen's
51:25
petition,
51:26
it addressed
51:26
the merits
51:27
of the only argument
51:29
that was put
51:30
before it
51:30
with respect
51:31
to whether or not
51:32
it was proper
51:33
to claim
51:35
a different
51:35
polymer form
51:36
of the active ingredient.
51:38
I don't want
51:39
to get into
51:39
the details here
51:40
because I don't
51:40
understand
51:41
the technology
51:41
very well,
51:42
but the agency
51:43
was crystal clear
51:45
on this point
51:45
in its decisions
51:46
as of page
51:47
1559 of the record
51:48
that these
51:50
anhydrite patents
51:51
which were
51:55
listed
51:56
in the
51:57
citizen's
51:57
complies
51:58
with the
51:59
statute
51:59
and FDA
52:00
regulations.
52:02
That was
52:03
the decision
52:04
really that's
52:05
brought up here.
52:05
And by the way,
52:06
they did not
52:08
raise in the
52:09
citizen's
52:09
petition
52:09
then or
52:10
later
52:11
the other
52:12
arguments
52:12
that they're
52:12
advancing now
52:13
with respect
52:14
to compression
52:14
patents
52:15
and product
52:16
by process
52:17
patents.
52:25
So,
52:25
on the
52:26
one question
52:26
that they
52:27
properly
52:27
preserved
52:28
to have
52:29
the finale
52:30
that Mr. Moore
52:31
concedes
52:31
under 704
52:32
they must
52:33
have,
52:34
they cannot
52:34
show that
52:36
that decision
52:36
was arbitrary
52:37
and precious.
52:38
They haven't even
52:38
mentioned it today
52:39
in their argument.
52:40
Among the reasons
52:41
they can't show
52:41
that is that
52:42
there are two
52:43
courts,
52:45
the Zenith
52:46
decision
52:47
and the
52:48
venue decision
52:49
both discussed
52:50
in the briefs
52:50
that reached
52:51
the same conclusion
52:51
that when you claim
52:53
a different
52:54
form of
52:55
an active ingredient
52:55
it's listable.
52:57
And while
52:58
Andrews,
52:58
that Judge Bryson
53:00
was on,
53:00
didn't decide
53:02
that question
53:02
in footnote
53:03
five
53:04
of the
53:05
decision
53:07
you acknowledged,
53:09
the court
53:09
acknowledged
53:10
those district
53:11
court decisions
53:11
without suggesting
53:12
in any way
53:12
they were wrong.
53:13
So,
53:14
that's an important
53:15
thing to understand.
53:16
Did he suggest
53:16
they were right?
53:18
Well,
53:19
I read it
53:20
that way
53:21
when Judge Bryson
53:22
Well,
53:23
it was,
53:23
Judge Dyck wrote
53:24
Appellee Attorney (Daniel E. Troy)
the opinion
53:24
and I won't
53:26
speak for him.
53:27
Appellee Attorney (Daniel E. Troy)
That's right.
53:27
In any event,
53:28
that's important.
53:30
Another thing
53:31
important about
53:31
the alternative
53:33
during the
53:33
state issue,
53:34
we talked about
53:35
Chevron
53:36
and that's what
53:36
dominates
53:37
the legal
53:37
landscape today
53:38
but there are other
53:39
principles out there
53:39
that are important
53:40
that remain
53:41
by the principles
53:42
of statutory
53:42
construction
53:44
and one of them
53:45
Appellee Attorney (Daniel E. Troy)
is under
53:47
Udall versus
53:48
Tallman
53:49
the decision
53:49
from the
53:50
80s,
53:55
Appellee Attorney (Daniel E. Troy)
the construction
53:55
of the
53:55
statute
53:55
by the people,
53:57
he said men then
53:58
but the people
53:59
charged with
53:59
responsibility
54:00
for setting
54:01
its machinery
54:02
in motion
54:02
and making
54:03
the parts work
54:04
efficiently
54:05
and smoothly
54:05
is entitled
54:06
to particular
54:07
deference.
54:08
As the agency
54:08
made clear
54:09
in the notice
54:10
of proposed
54:11
rule making
54:11
that you referred
54:12
to Judge Bryson
54:13
they have
54:13
always,
54:15
always interpreted
54:17
Pats Waxman
54:18
until this
54:18
suggested change
54:19
which they say
54:20
is a different
54:21
reading of ambiguous
54:22
language.
54:24
They have always
54:25
appeared for
54:26
Do you disagree
54:26
Judge Mayer
with their
54:27
position that
54:29
they could go
54:30
from sequential
54:31
30 months
54:32
to one
54:33
In fact
54:34
Appellee Attorney (Daniel E. Troy)
we have
54:35
not challenged
54:36
that.
54:37
There has been
54:37
notice and comment
54:38
on that rule
54:39
of course.
54:40
It has not been
54:41
challenged either
54:42
by my client
54:43
or by Pharma
54:44
General.
54:45
Appellee Attorney (Daniel E. Troy)
When you say
54:45
it hasn't been
54:45
challenged,
54:46
it hasn't been
54:46
challenged in court.
54:47
Appellee Attorney (Daniel E. Troy)
What I'm saying
54:48
in the comments
54:49
In the comments
54:50
Appellee Attorney (Daniel E. Troy)
Has the comment
54:52
period closed?
54:53
Appellee Attorney (Daniel E. Troy)
We have filed
54:54
our comments.
54:55
Appellee Attorney (Daniel E. Troy)
You have no
54:56
objection to that?
54:57
Appellee Attorney (Daniel E. Troy)
That is correct
54:57
as a prospective
54:59
matter
54:59
as it must be
55:00
because what
55:01
they are doing
55:02
is changing
55:02
a legislative
55:03
rule.
55:04
They are changing
55:06
314.107
55:07
which very
55:09
clearly
55:10
contemplates
55:11
multiple
55:13
certifications
55:13
with
55:15
different
55:15
expiration dates.
55:16
When you change
55:17
a legislative
55:18
Judge Mayer
rule,
55:18
you can only
55:19
do it
55:19
prospectively.
55:20
So you haven't
55:21
challenged their
55:22
proposed rule
55:24
making to go
55:24
to one
55:25
30 month
55:26
rule?
55:27
That's correct.
55:28
Alright.
55:31
Then that
55:32
raises
55:32
in my mind
55:34
the question
55:36
do you
55:37
think
55:38
Congress
55:40
anticipated
55:41
or
55:42
foresaw
55:43
the
55:43
possibility
55:45
that
55:46
conservators
55:46
would try
55:47
to string
55:48
together
55:49
multiple
55:50
30
55:51
month
55:52
periods
55:53
by filing
55:54
multiple
55:55
variations
55:56
on the
55:57
basic
55:57
patent
55:59
for
56:00
an extended
56:01
period of
56:02
time?
56:03
Do you think
56:03
Congress saw
56:04
that
56:04
and decided
56:05
that
56:06
that was
56:08
okay?
56:10
Or
56:11
do you
56:12
think
56:12
Congress
56:12
never even
56:13
looked at
56:14
the problem?
56:15
The government
56:17
takes the
56:17
position that
56:18
either
56:19
the one
56:21
30 month
56:21
or multiple
56:22
30 months
56:23
are within
56:24
the contemplation
56:25
or the
56:26
non-contemplation
56:27
of Congress.
56:29
Do you agree
56:29
that that's
56:30
so?
56:31
Appellee Attorney (Daniel E. Troy)
That's
56:32
the government's
56:33
reading of
56:33
the statutory
56:34
language.
56:35
Judge Mayer
What is
56:36
Appellee Attorney (Daniel E. Troy)
my view
56:38
speaking
56:38
for my
56:39
client,
56:41
my view
56:42
at least
56:42
is,
56:43
which is
56:43
not informed
56:44
by being
56:44
present at
56:45
the creation
56:45
of
56:45
is that
56:48
Congress
56:48
didn't think
56:49
about that
56:50
issue
56:50
at all.
56:52
It didn't
56:52
address it
56:53
one way
56:53
or the
56:53
other,
56:54
which is
56:54
an absolutely
56:56
textbook
56:56
case
56:58
for
56:58
deference
56:59
to the
57:00
agency,
57:00
especially
57:01
in a now
57:02
necessarily
57:03
under the
57:03
Meade case
57:04
decided in
57:05
2001,
57:06
when the
57:06
agency then
57:09
defines,
57:10
if you will,
57:10
the meaning
57:11
of the
57:11
statute
57:11
through a
57:12
legislative
57:13
regulation.
57:14
If there was
57:15
anything in
57:16
the legislative
57:16
history of
57:17
Hatch-Waxman
57:18
or anything
57:18
else that
57:19
supported the
57:20
argument
57:20
that
57:21
Apotex
57:22
has advanced
57:22
here about
57:23
only one
57:24
multiple,
57:25
one 30-month
57:26
stay,
57:26
you would have
57:27
heard of it.
57:28
There isn't.
57:29
Congress was silent.
57:30
It's a gap.
57:31
The agency is
57:33
entitled to
57:33
fill that gap.
57:34
And again,
57:34
it's important
57:35
that they did
57:36
it immediately.
57:37
It's also important
57:38
that to my
57:38
knowledge,
57:39
which is not
57:40
complete,
57:40
but to my
57:41
knowledge,
57:41
until this argument
57:42
advanced by
57:43
Apotex in
57:44
this case,
57:44
no one had
57:45
even advanced
57:45
the theory of
57:46
the statute of
57:47
construction
57:48
they had.
57:48
And by the way,
57:49
that's not one the
57:50
agency has adopted
57:51
in its rule.
57:52
They have
57:52
rejected
57:54
Apotex's
57:55
Appellee Attorney (Daniel E. Troy)
rule.
57:55
Their theory,
57:56
I guess,
57:56
gets them to
57:56
the same
57:57
place,
57:57
but it's
57:57
a different
57:58
theory.
57:59
Appellee Attorney (Daniel E. Troy)
One final
58:00
word.
58:02
We have
58:02
consistently
58:03
taken the
58:04
position in
58:05
this case
58:05
that these
58:06
issues of
58:07
what court
58:09
do you go
58:09
to should
58:10
be in the
58:10
infringement
58:11
court.
58:11
There are obvious
58:12
policy reasons
58:13
for that.
58:14
First,
58:15
it recognizes
58:16
that Hatch-Waxman
58:17
protects,
58:18
it protects
58:19
the pioneer
58:20
drug manufacturer's
58:21
choice of
58:22
form,
58:22
45-day
58:23
war
58:23
trial
58:24
ensures that.
58:24
Secondly,
58:25
the judge there
58:26
knows what
58:26
the patents
58:27
are all
58:27
about.
58:27
This judge is adjudicating
58:29
right now
58:29
the litigant
58:30
of those
58:30
patents.
58:31
Third,
58:32
he has
58:32
or she has
58:33
the authority
58:34
to issue
58:34
orders
58:34
advising
58:34
all parties
58:35
unlike the
58:36
situation
58:37
where we
58:37
have here
58:37
where Apotex
58:38
goes off
58:38
by itself
58:39
to litigate
58:39
the DC
58:40
Circuit
58:40
and then
58:41
the others
58:42
are free
58:42
to ignore
58:42
that judgment
58:43
when Apotex
58:44
loses.
58:45
And finally,
58:45
and this might
58:46
be important,
58:47
if those
58:48
matters are
58:49
adjudicated
58:49
in that court,
58:51
this court
58:52
unquestionably
58:53
has jurisdiction.
58:54
There's no doubt
58:55
about that.
58:56
Now,
58:56
to be sure
58:57
of my
58:57
Judge Mayer
I understand
58:58
what you're
58:59
saying.
58:59
You're saying
59:00
that we should
59:00
take jurisdiction
59:01
over this
59:01
whole mess.
59:02
Appellee Attorney (Daniel E. Troy)
No,
59:03
no,
59:03
what I'm
59:03
saying is
59:04
when these
59:04
issues
59:05
of listing
59:07
are decided
59:08
by the
59:09
Patent
59:09
Infringement
59:10
Court,
59:10
in the course
59:11
of a patent
59:11
case,
59:12
you clearly
59:12
have jurisdiction
59:13
over them.
59:14
Mylon,
59:14
of course,
59:16
Mylon,
59:16
Judge Mayer
Why would
59:17
a patent
59:19
litigation
59:20
court ever
59:21
decide
59:21
the listing
59:22
issue?
59:22
Appellee Attorney (Daniel E. Troy)
Well,
59:23
there's
59:23
an answer
59:25
to that
59:25
in two cases
59:26
that will
59:26
bring to
59:35
Appellee Attorney (Daniel E. Troy)
light
59:35
just this
59:35
last month.
59:36
Appellee Attorney (Daniel E. Troy)
KOS versus
59:38
Barr Laboratories,
59:40
203 West
59:41
Wall,
59:42
145578.
59:43
Both cases
59:44
held,
59:45
both cases
59:46
held that
59:47
listing
59:48
questions
59:49
could be
59:50
questions
59:50
of defense
59:51
of a
59:52
271E2
59:53
infringement
59:54
claim.
59:55
Now,
59:56
Mylon said
59:57
otherwise.
59:58
My,
59:59
but,
60:00
but,
60:01
but,
60:01
Why should
60:02
we care
60:02
what Mylon said?
60:03
Well,
60:04
let me
60:05
finish.
60:06
Mylon,
60:07
Mylon said otherwise
60:08
in this context,
60:09
and the same
60:10
context was
60:11
true in
60:11
Andrews.
60:12
In those cases,
60:13
the generic
60:14
went off
60:14
by itself,
60:15
you know,
60:16
which itself
60:18
is infamous.
60:19
My,
60:20
Mylon said
60:23
that
60:24
these issues,
60:25
uh,
60:26
that,
60:26
uh,
60:27
what condemned
60:28
an independent
60:28
court of
60:29
action seeking
60:29
to be
60:30
listed outside
60:30
the properties
60:31
of that case.
60:32
It did say
60:34
without examining
60:36
271E2
60:37
Appellee Attorney (Daniel E. Troy)
at all,
60:38
Appellee Attorney (Daniel E. Troy)
referring only
60:39
to 282,
60:40
Appellee Attorney (Daniel E. Troy)
and the plain,
60:41
you know,
60:41
Appellee Attorney (Daniel E. Troy)
general language
60:42
of that section,
60:43
that these
60:44
listing issues
60:44
weren't a defense.
60:46
Uh,
60:47
that's,
60:47
that,
60:49
it's up to you
60:50
to decide
60:51
if there's a way
60:52
out of this.
60:53
I think it was you,
60:54
Judge Bryson,
60:54
asked where lies
60:55
the public interest
60:56
in all of this.
60:59
I think it's
61:00
court has committed
61:00
itself to
61:00
recognizing that
61:02
these,
61:02
these kind of
61:03
listing issues
61:03
can be raised
61:04
in Philadelphia.
61:05
They have pled
61:06
them,
61:06
Appellee Attorney (Daniel E. Troy)
they have pled
61:07
them as answers
61:08
Appellee Attorney (Daniel E. Troy)
to infringement
61:09
in the Philadelphia
61:11
case.
61:12
Um,
61:12
I'm just offering
61:14
that as a
61:14
final
61:15
Judge Mayer
I don't understand
61:16
what,
61:16
what would
61:17
the,
61:17
uh,
61:18
the argument
61:19
would be,
61:20
it shouldn't,
61:21
dear court,
61:30
the argument,
61:31
Appellee Attorney (Daniel E. Troy)
well,
61:31
let me tell you
61:32
Judge Mayer
And how does that
61:33
differ from saying,
61:34
I,
61:34
the only way
61:36
you could get there
61:36
is by saying
61:37
that patent
61:38
doesn't have anything
61:39
to do with
61:40
the drug
61:41
for which
61:42
I've filed
61:43
my hand.
61:44
How is that
61:45
any different
61:45
from the basic
61:46
patent litigation
61:47
that's supposed
61:48
to take place?
61:49
Appellee Attorney (Daniel E. Troy)
It's very different.
61:50
What we're talking
61:50
about here
61:51
is the artificial,
61:53
very special,
61:54
uh,
61:56
infringement
61:56
that was created
61:57
by Hatch Waxman.
61:59
Judge Mayer
Yeah,
61:59
but we've said,
62:00
we've said the creation
62:01
is artificial
62:02
but the litigable
62:04
issues are
62:04
traditional.
62:06
Appellee Attorney (Daniel E. Troy)
Well,
62:06
all I'm saying
62:07
is that there are
62:08
two district courts
62:09
out there,
62:10
one of which
62:10
held,
62:11
for example,
62:12
Well,
62:12
Judge Mayer
I don't care
62:13
what the district court
62:14
said.
62:14
I want you to help
62:15
me understand
62:16
why,
62:17
why would
62:18
challenging,
62:19
I mean,
62:19
I'm just curious,
62:20
why would challenging
62:21
the listing
62:23
be any different
62:24
from litigating
62:25
the question
62:26
of infringement?
62:28
Well,
62:28
Appellee Attorney (Daniel E. Troy)
there's infringement
62:32
under 271A,
62:34
classic infringement,
62:36
that would be available
62:37
irrespective of
62:38
all the listing.
62:39
I'm talking about
62:40
the special cause
62:41
of action created
62:42
in 271A2
62:43
that has to do
62:45
with the interplay
62:46
between
62:47
that administrative
62:48
process
62:48
and patent law.
62:50
The Supreme Court
62:51
has the nature
62:52
of that in the Lilly case
62:53
and this court
62:53
has in other cases,
62:54
including a recent one
62:55
that you were on
62:56
in Apotex
62:56
decided in January.
62:59
All I'm saying
63:00
is when you,
63:01
when you look
63:02
at that special
63:02
nature
63:03
of that infringement
63:04
action,
63:06
it's at least
63:06
open to thought
63:07
and two district courts
63:09
have so held
63:10
that there might
63:11
be room
63:11
in that case
63:12
for raising
63:13
the listing issues.
63:15
What I'm saying
63:16
to you as well
63:16
is that's been
63:17
our constant position
63:18
in this court.
63:19
Their position
63:20
in Philadelphia
63:21
remains.
63:22
Judge Mayer
But all I'm asking
63:23
is to what end
63:24
would you,
63:25
would you...
63:25
Appellee Attorney (Daniel E. Troy)
To the end,
63:26
to the end of,
63:27
of getting
63:28
that district judge
63:31
the opportunity
63:32
to say,
63:32
no,
63:33
you can't have
63:33
this,
63:36
you didn't have
63:37
to certify
63:38
to this patent
63:39
because it was
63:40
improperly listed
63:41
or you didn't
63:42
have to certify
63:43
because under
63:44
their theory
63:45
which we've
63:45
drafted on the merits
63:46
of course,
63:46
you can't have
63:47
more than
63:49
one patent
63:49
Put that in
63:49
the hands of
63:50
that court,
63:51
let that court
63:51
decide it,
63:52
then they come up
63:53
as clear patent
63:54
law questions
63:55
part of the major
63:56
patent infringement
63:57
case.
63:58
Appellee Attorney (Daniel E. Troy)
Do you think
63:59
we have jurisdiction
64:00
over this case?
64:02
Appellee Attorney (Daniel E. Troy)
Do I think you do?
64:04
My honest answer
64:05
is no,
64:06
I don't think you do.
64:07
Appellee Attorney (Daniel E. Troy)
So you agree
64:07
with Mr. Troy?
64:08
Appellee Attorney (Daniel E. Troy)
I,
64:09
that's my
64:10
honest opinion.
64:11
Appellee Attorney (Daniel E. Troy)
And if the DC Circuit
64:12
asked him,
64:13
you have the same
64:14
question I asked him,
64:14
if the DC Circuit
64:15
were to decide
64:17
this case
64:18
by holding
64:19
that the FDA
64:20
did have an obligation
64:21
to review
64:22
the patents
64:23
and there were
64:24
an APA action
64:25
for review
64:26
of that decision
64:27
in the next case
64:28
or even
64:29
in the same case,
64:30
would we then
64:30
have jurisdiction
64:31
over that question?
64:32
Appellee Attorney (Daniel E. Troy)
Then you would
64:33
have some
64:34
substantial questions
64:35
of patent law
64:36
in cases.
64:36
Appellee Attorney (Daniel E. Troy)
And that would
64:37
give us jurisdiction
64:38
in your view?
64:39
Appellee Attorney (Daniel E. Troy)
That's an alternative
64:40
probably of your
64:41
jurisdiction
64:41
as I understand it.
64:43
Then you would,
64:43
this case
64:44
doesn't present
64:45
Then we would have
64:46
jurisdiction.
64:47
Appellee Attorney (Daniel E. Troy)
It's an odd concept
64:48
that the exact
64:49
same case
64:51
goes to one court
64:52
for a preliminary
64:53
determination
64:54
and then to
64:55
another court
64:56
after that
64:57
preliminary determination
64:58
is made by
64:59
court number one.
65:00
Appellee Attorney (Daniel E. Troy)
The preliminary
65:01
determination
65:02
would be one that
65:02
once made
65:03
would be made
65:04
for all cases
65:05
of the agency.
65:05
Appellee Attorney (Daniel E. Troy)
It sounds like
65:08
what you're saying
65:08
is that the DC Circuit
65:09
could address
65:10
the question
65:10
of the obligation
65:12
of the FDA
65:13
to decide
65:14
this issue
65:15
but couldn't
65:16
go ahead
65:17
and say
65:18
anything
65:18
about the merits.
65:20
Appellee Attorney (Daniel E. Troy)
And probably
65:21
it shouldn't.
65:22
Probably,
65:22
of course.
65:23
Judge Mayer
We have jurisdiction
65:25
to address
65:26
the merits
65:27
but we wouldn't
65:27
have jurisdiction
65:28
to address
65:29
the question
65:29
of whether
65:30
we have jurisdiction
65:31
to address
65:32
the merits.
65:33
Judge Newman
That's not so.
65:35
Appellee Attorney (Daniel E. Troy)
I was going
65:35
to complete
65:36
my answer
65:40
but I don't want
65:40
if in fact
65:41
the agency
65:43
violated
65:43
the law
65:44
by not
65:44
deciding things
65:46
as I indicated
65:47
they certainly
65:48
did decide
65:48
something
65:49
in the citizen
65:49
position
65:50
but if that's
65:52
Appellee Attorney (Daniel E. Troy)
so then
65:52
Appellee Attorney (Daniel E. Troy)
the classic
65:54
remedy
65:54
of the
65:55
Administrative
65:55
Procedure Act
65:56
is to command
65:56
the agency
65:57
for a decision
65:57
not for the
65:58
court of
65:59
appeals.
66:10
Judge Newman
that the FDA do take the action,
66:16
but wasn't the district court also asked to decide
66:19
that the patent did not cover?
66:22
Appellee Attorney (Daniel E. Troy)
That's right, and again,
66:23
but that just puts the principle down
66:26
that the district court, rather than the Court of Appeals,
66:28
if Judge Jackson had agreed with the arguments
66:31
that Patrotex advanced about what the FDA should and should not do,
66:36
he should have sent it back to the agency
66:38
to make those determinations.
66:41
So that's what happens.
66:43
Judge Mayer
How about if there was an appeal from his decision?
66:46
He says, I'm going to send it back to the agency,
66:49
and the government says, oh, no, you're not.
66:51
We're appealing.
66:52
Where would that appeal go?
66:52
Appellee Attorney (Daniel E. Troy)
That would then depend on whether a stay or a decision.
66:55
Judge Mayer
Where would that appeal go?
66:58
He says, agency, you should have...
67:01
Oh, that goes to the D.C. Circuit.
67:02
Appellee Attorney (Daniel E. Troy)
Yeah, I think that'd have to be so, in your view and Mr. Troy's view.
67:06
I don't want to put words in his mouth,
67:07
but I think that's what the burden of the argument would be.
67:10
That would go to the D.C. Circuit,
67:11
and then that would go to the D.C. Circuit.
67:11
If you lost there, and it went back to the agency,
67:14
and there were determinations on the merits,
67:16
then it would come to us.
67:16
That's correct.
67:17
Appellee Attorney (Daniel E. Troy)
Thank you so much.
67:19
Judge Newman
Okay, thank you, Mr. Bruce.
67:20
Mr. Moore?
67:30
Appellant Attorney (Moore)
The burden on the agency.
67:32
The agency has...
67:33
There is a precedent out there of FDA's regulations
67:37
that describe the emergency.
67:40
Appellee Attorney (Daniel E. Troy)
There is no reason...
67:41
Speak up, Mr. Moore.
67:42
Appellant Attorney (Moore)
There really is no reason, absolutely,
67:45
why FDA would have to read every patent submitted to it.
67:49
FDA could operate...
67:51
I'm sorry, on presumption,
67:52
that parties listening are acting...
67:55
submitting patent information are acting in good faith.
67:57
List, when there's a challenge, deal with it then.
68:02
Appellee Attorney (Daniel E. Troy)
What FDA does in administering
68:05
its Freedom of Information Act regulations
68:08
Appellant Attorney (Moore)
on classification of information's traits,
68:11
third party comes in and challenges that.
68:15
FDA's regulation invites the submitting party
68:18
to come in and intervene.
68:20
And if the...
68:21
If the submitting party does not come in to intervene
68:25
to establish the true trait secret character of this information,
68:29
FDA reserves the right to produce it.
68:33
FDA can be a stakeholder here and not spend another dollar.
68:37
Judge Mayer
Assuming, Mr. Moore, that the proposed FDA rule
68:41
for non-sequential 30-month temporary injunctions
68:47
went into...
68:49
was in effect...
68:50
was in effect...
68:51
at the beginning of this hassle,
68:53
would that have solved your problem?
68:56
Appellant Attorney (Moore)
A single 30-month stay?
68:58
Judge Mayer
Yeah.
68:59
Appellant Attorney (Moore)
Yes, it would.
69:00
In fact, it's my belief
69:01
that we would not be facing this litigation in Philadelphia.
69:04
The case would never have been filed.
69:06
These patents, if I may be permitted,
69:09
are garbage.
69:12
They are cured.
69:16
Judge Newman
Well, I think they were granted by the Patent Office,
69:20
so I think it's not before us to decide their merits
69:24
in these accusations.
69:25
Appellant Attorney (Moore)
I apologize, Your Honor.
69:26
Judge Mayer
You're entitled to your first amendment.
69:28
Appellant Attorney (Moore)
I will say, Your Honor,
69:30
there is a gamut of patents
69:32
from the very meritorious
69:35
to the less meritorious, if that's fair.
69:39
And I have my own judgment
69:41
on where in that continuum of these patents lie.
69:45
Now, important question.
69:48
Was there any legislative history
69:50
indicating that Congress,
69:54
of course, foresaw the multiple 30-month stay issue?
69:58
And there is legislative history.
70:02
And we quoted it in our briefs, in our brief.
70:05
And here, the committee report says,
70:11
well, our preface was,
70:13
Appellee Attorney (Daniel E. Troy)
when Congress enacted Hatch-Waxman,
70:15
Appellant Attorney (Moore)
it had been assured by both the Patent Office
70:17
and the private patent bar that,
70:21
I'll pick up a quote,
70:22
the so-called evergreen patent,
70:24
and it's not a problem.
70:26
No credible information was submitted to the subcommittee
70:29
showing that drug firms obtained a chain of patents
70:33
related to the same product
70:34
for the purpose of prolonging their patent.
70:37
Now, one of the issues I've had an opportunity to discuss
70:42
is whether it is legal to list patents
70:48
Appellee Attorney (Daniel E. Troy)
that do not claim the drug as originally approved.
70:52
Appellant Attorney (Moore)
We submitted that argument in our brief.
70:56
These questions,
70:56
I think, are a lot.
70:59
Much of the problem that we have today
71:04
arises from the fact that Congress contemplated,
71:10
if you read statute 3,
71:13
Congress contemplated, I think quite clearly,
71:17
in legislating within the context of patent,
71:20
substantive patent law,
71:23
that patents would be applied for patents,
71:27
therefore, and likely issued,
71:30
sometime around the original review process.
71:34
Judge Newman
But what I don't,
71:35
if the patent doesn't claim the drug,
71:38
then why should that present any problem
71:40
to a person who wishes to produce a generic version of that drug?
71:48
Appellant Attorney (Moore)
My example is this case.
71:51
The active ingredient in SmithKline's Paxil...
71:55
Judge Mayer
Well, the answer is because it triggers the 30-month delay.
71:58
Is it? Yes, it is.
71:59
Judge Newman
But then that's because you've taken the position
72:03
that it does cover the drug
72:04
and invoked the certification that it does.
72:08
I'm sorry, I didn't mean to interrupt you.
72:10
Appellant Attorney (Moore)
If I understand the question,
72:12
before your honor,
72:14
Appellee Attorney (Daniel E. Troy)
let me back up and say
72:16
the active ingredient in SmithKline's Paxil
72:20
Appellant Attorney (Moore)
is crystalline peroxide and nitrochloride,
72:22
Appellee Attorney (Daniel E. Troy)
meaning Icarate.
72:24
These patents that we're talking about today
72:27
involve antimicrobial,
72:28
hand-hydrated,
72:30
three of them involve hand-hydrated forms.
72:33
Appellant Attorney (Moore)
There's a difference in water calibration
72:35
between semi-hydrated and these hand-hydrated forms.
72:39
Judge Newman
That's why I don't understand
72:40
why you would raise a Section 4 certification
72:43
against a patent that doesn't cover
72:46
the product for which you've filed the ANDA.
72:51
Appellant Attorney (Moore)
Our paragraph...
72:53
We have paragraph 4 certifications
72:57
stating non-infringement
72:59
of these anhydrate polymorph patents.
73:03
But that is fundamentally and essentially irrelevant to,
73:07
I submit,
73:08
to the question before the Court today
73:10
whether these anhydrate polymorph patents
73:12
claim the hemihydrate,
73:15
which is the active ingredient
73:18
covered by SmithKline's approved new drug application.
73:22
An entirely different question.
73:25
And I submit
73:27
the claim construction question there is quite easy.
73:31
Now...
73:32
Judge Mayer
I think that Newman is asking
73:36
why did you even file paragraph 4
73:38
against those patents
73:41
if those patents didn't cover the claim
73:44
of the original ANDA?
73:46
Appellant Attorney (Moore)
We have no...
73:48
We have no discretion in that respect.
73:51
We have no right to decide.
73:52
FDA has made the judgment
73:54
in the regulation that we are attacking
73:57
that it will not resolve...
73:58
If it's listed, you have to file?
74:00
...listing disputes,
74:01
we must file a certification.
74:03
Judge Newman
Because you have...
74:04
Because your ANDA is based on
74:07
identity of product, is that right?
74:10
Appellant Attorney (Moore)
No, Your Honor, it is not.
74:12
Let me get to the same drug...
74:14
I...
74:14
Judge Newman
Well, I've taken us pretty far afield
74:17
and I don't want to lead you...
74:18
Well, this is a good...
74:19
Appellee Attorney (Daniel E. Troy)
I think this is a profitable...
74:21
I'd like to hear the answer.
74:24
Appellant Attorney (Moore)
I think we're getting into
74:26
another different area.
74:31
355J,
74:32
which is the provision statute
74:35
Appellee Attorney (Daniel E. Troy)
and J2,
74:37
in particular,
74:38
it sets forth what one must include
74:40
in an abbreviated new drug application.
74:42
There is a sub-paragraph
74:43
Appellant Attorney (Moore)
that says that
74:47
you must supply information
74:48
to show that the active ingredient
74:51
covered by your abbreviated
74:53
new drug application
74:54
is, quote,
74:55
Appellee Attorney (Daniel E. Troy)
the same as,
74:56
quote,
74:56
Appellant Attorney (Moore)
the same as
74:58
the active ingredient
74:59
in the approved new drug
75:04
that you are referencing.
75:06
Now, here,
75:08
and Smith-Kline did not mention it,
75:11
the issue has been decided
75:14
by the D.C. Circuit
75:15
in a case in the name of
75:16
Serona Laboratories,
75:17
quoted,
75:18
or cited,
75:19
what the court tells you
75:20
in Serona
75:22
was that FDA,
75:23
in administering
75:25
the provisions of 505J
75:28
regarding AMBAs,
75:31
had,
75:31
or enhanced,
75:33
discretion
75:33
to approve
75:35
abbreviated new drug application
75:41
Appellee Attorney (Daniel E. Troy)
whose active ingredient
75:42
Appellant Attorney (Moore)
has a different chemical structure
75:45
Appellee Attorney (Daniel E. Troy)
than the chemical structure
75:48
of the active ingredient
75:50
in the innovator's drug,
75:52
Appellant Attorney (Moore)
provided that
75:53
there is no evidence
75:55
that the structure
75:57
or structural difference
75:59
affects the safety
76:00
and efficacy of the drug.
76:02
Judge Newman
In other words,
76:03
if it's irrelevant
76:03
Appellant Attorney (Moore)
for clinical purposes,
76:05
FDA can approve it.
76:06
FDA does it all the time.
76:07
Judge Newman
Different chemical structure?
76:09
That's correct.
76:10
I doubt that.
76:10
It's not formulation
76:12
or actually
76:14
a different chemical?
76:16
Appellant Attorney (Moore)
A, actually,
76:17
a different chemical.
76:19
Now, what we have here,
76:21
Appellee Attorney (Daniel E. Troy)
from a chemical standpoint,
76:22
is we have a...
76:23
But you have to have
76:25
bioequivalence.
76:26
That's right.
76:26
They have to be bioequivalent.
76:29
Appellant Attorney (Moore)
And that's the touchstone
76:31
for approval of AMBAs.
76:33
And we have to go out
76:35
and affirmatively demonstrate
76:36
the bioequivalence.
76:38
Appellee Attorney (Daniel E. Troy)
Let me come back
76:39
just very briefly
76:39
to Judge Newman's question,
76:41
which I...
76:41
Maybe there's a simple
76:43
answer to this,
76:44
but I'm missing it,
76:46
if there is.
76:48
Your contention
76:49
is that these patents
76:50
that were listed
76:51
do not claim the listed drug.
76:53
Correct.
76:54
Right.
76:54
The obligation
76:55
in paragraph seven
76:58
of J2A7
77:03
is the obligation
77:04
to certify,
77:05
with respect to each patent
77:06
which claims the listed drug,
77:07
either certification one,
77:09
two, three, or four.
77:10
Four is the one at issue here.
77:11
And the question is,
77:13
why don't you say,
77:14
we don't have to file four.
77:15
It's not claiming
77:16
the listed drug.
77:19
And is it your position
77:20
that FDA prohibits you
77:23
from making that independent judgment?
77:25
Appellant Attorney (Moore)
That's correct.
77:26
Appellee Attorney (Daniel E. Troy)
And what's the...
77:27
the regulatory mechanism
77:30
by which they do prevent you
77:32
from making
77:32
that independent judgment?
77:34
Appellant Attorney (Moore)
Uh,
77:34
FDA's regulation
77:35
in which it refuses to police...
77:38
Appellee Attorney (Daniel E. Troy)
Well, no,
77:38
it's not the refusing to police.
77:39
There's a...
77:40
It's really a separate
77:40
legal question.
77:42
Why is it not the case
77:43
that you could simply say,
77:45
um,
77:46
it...
77:47
the, uh,
77:48
the patents don't claim
77:49
the listed drug?
77:50
That's our judgment.
77:51
Our...
77:51
We're the ones
77:52
that have to file
77:52
this certification.
77:53
We're not filing
77:54
the certification
77:55
because we've made
77:55
this independent judgment.
77:57
Appellant Attorney (Moore)
We have no room for that
77:58
Judge Mayer
under FDA's regulations.
78:00
What would be the consequence
78:01
of your refusing to file...
78:03
This is really the question.
78:05
If you refuse to file
78:06
a paragraph four certification
78:09
with regard to any of 12 patents
78:12
that's listed under Paxil,
78:14
what would be the consequences
78:16
in terms of your ANDA?
78:18
Appellant Attorney (Moore)
The regulatory consequence
78:19
would be a refusal
78:20
to grant final approval
78:21
of our ANDA
78:22
for failure to file
78:24
certain patents.
78:24
Judge Mayer
In other words,
78:26
FDA takes the position
78:28
if it's listed,
78:30
you're not going to get
78:32
an approved ANDA
78:33
until you have certified
78:35
every one of those patents
78:37
that are listed.
78:38
Yes, Your Honor.
78:38
You don't have a choice
78:39
of saying,
78:40
but that one's not applicable.
78:43
Is that right?
78:43
Yes, Your Honor.
78:44
That's correct.
78:45
Appellee Attorney (Daniel E. Troy)
It's a different question
78:46
from the FDA review issue.
78:48
At least,
78:49
it seems to me.
78:50
Judge Newman
You're saying
78:51
you're going to be forced
78:51
to litigate 12
78:53
to use the number
78:54
of patents
78:54
that you're not,
78:56
in any sense,
78:58
infringing
78:59
in order to
79:01
get your application approved?
79:05
Appellant Attorney (Moore)
Ultimately,
79:06
yes.
79:07
If they choose
79:08
to litigate.
79:08
If they choose,
79:09
if the innovator chooses
79:11
to file a lawsuit.
79:12
Right.
79:13
Well,
79:13
Judge Newman
but you initiate
79:15
the lawsuit
79:15
with your paragraph
79:17
or certification.
79:18
You're saying
79:19
you're forced
79:19
to initiate a lawsuit
79:21
against patents
79:22
that you know
79:23
you're not infringing?
79:24
Appellant Attorney (Moore)
We don't initiate
79:26
the notice,
79:27
Your Honor,
79:27
under the regulatory scheme.
79:29
We provide...
79:30
You don't initiate
79:31
the lawsuit.
79:32
We initiate
79:32
the notice.
79:33
Judge Newman
And they're then obliged
79:35
to file suit
79:36
or else forever
79:37
give up.
79:39
Appellant Attorney (Moore)
No,
79:39
Your Honor.
79:39
They have a 45-day window
79:41
in which to decide
79:42
whether to provide
79:43
a statutory patent
79:45
in the French Federation
79:45
under 271 .
79:47
If they don't,
79:49
they can wait
79:50
until after
79:51
final approval
79:51
and a final
79:52
conventional patent
79:54
in the French Federation.
79:54
And I shouldn't
79:55
believe there is
79:56
a French one.
79:57
Judge Mayer
So,
79:58
let's be sure
79:59
we've nailed this down.
80:00
What you're saying
80:01
is you have no choice
80:03
if you want to get
80:04
your ANDA issued.
80:06
You have no choice
80:08
but to file
80:09
a paragraph
80:11
one,
80:11
two,
80:11
three,
80:12
or four certification
80:13
against any patent
80:15
that's listed
80:16
in the Orange Book
80:17
that's relevant
80:17
to the drug
80:19
that you want
80:20
your ANDA on.
80:22
Is that right?
80:23
Appellant Attorney (Moore)
Drugs are...
80:23
All the patents
80:24
are irrelevant
80:25
in your sense,
80:26
but we have no discretion.
80:27
We must...
80:27
We must provide
80:29
a certification
80:29
or FDA will not
80:31
grant us final approval.
80:32
Judge Newman
And if they don't
80:33
file an infringement suit,
80:34
you say that
80:35
they can say,
80:36
no,
80:36
I'm not going to
80:38
file an infringement action,
80:39
let them go ahead,
80:41
put their product
80:41
on the market,
80:42
and then I'll sue them?
80:43
That is their...
80:44
Without any...
80:45
That is their option.
80:46
That doesn't sound
80:47
as if...
80:48
It doesn't sound
80:49
like the Hatch Waxman
80:50
that I remember,
80:51
although I...
80:51
The advantage...
80:53
Accepting that,
80:54
then,
80:55
the generic manufacturer
80:58
is deprived
80:59
of the opportunity
81:00
of challenging
81:02
the patent,
81:04
and whereas
81:05
the patentee
81:07
can wait
81:09
until the generic manufacturer
81:11
is in over his head
81:12
and then file suit?
81:14
Appellant Attorney (Moore)
Your Honor,
81:15
I think the best response
81:18
I have to that
81:18
is that there is
81:20
nothing in the legislative history
81:22
that indicates
81:23
that this
81:25
statutory patent
81:27
infringement
81:28
mechanism
81:29
was intended
81:30
to benefit
81:31
the generic
81:33
manufacturer.
81:36
Judge Newman
I have to argue
81:37
with you
81:38
on that.
81:39
It was
81:40
a deeply,
81:44
rigorously
81:45
negotiated
81:46
relationship
81:47
which provided
81:48
a way
81:48
for a generic
81:49
manufacturer
81:50
to challenge
81:51
a patent
81:52
without
81:53
going
81:54
to the risk
81:54
of
81:55
the patent
81:55
of marketing
81:56
an infringing
81:57
product.
81:58
I had thought
81:58
that that was
82:00
viewed
82:01
as a significant
82:02
benefit.
82:03
Appellant Attorney (Moore)
I can only...
82:04
I can only tell you,
82:05
Your Honor,
82:06
what I recall
82:07
from a careful reading
82:08
of the legislative
82:09
history
82:10
as it stands
82:10
today.
82:11
I will tell you
82:13
that there are
82:13
differences of opinion
82:14
in the generic
82:15
industry
82:16
for precisely
82:18
your point.
82:20
I will tell you
82:22
that
82:23
my client
82:24
is prepared
82:25
to go to
82:26
market
82:26
in advance
82:27
of determination
82:28
of
82:30
infringement
82:30
and validity
82:31
in appropriate
82:32
circumstances.
82:34
And it will do
82:35
so,
82:35
it is told
82:36
by FTC,
82:37
it will do
82:37
so in this
82:38
case.
82:40
And
82:42
here is
82:42
a cardinal
82:44
difference.
82:45
Here is
82:45
a cardinal
82:46
difference
82:46
and it gets
82:47
us back
82:47
to the 31st step.
82:49
That is
82:50
a free
82:51
preliminary
82:52
injunction
82:56
Judge Newman
that the
82:56
generic
82:56
manufacturer
82:57
obtained the
82:58
right to use
82:59
the patentee's
82:59
data,
83:00
clinical and
83:01
other data,
83:02
to the benefit
83:04
of its own
83:04
registration.
83:05
And that
83:06
I had
83:07
understood
83:08
at the time
83:09
as an observer
83:11
was viewed
83:13
as an enormous
83:14
benefit.
83:14
And I gather
83:15
you don't disagree
83:16
with that.
83:17
Appellant Attorney (Moore)
It was
83:18
the latter
83:19
is absolutely
83:20
right.
83:21
It was
83:22
an enormous
83:24
benefit.
83:25
And that
83:26
is a
83:27
critical
83:27
aspect
83:28
of the
83:28
legislative
83:29
compromise.
83:31
However,
83:32
Appellee Attorney (Daniel E. Troy)
however,
83:34
Appellant Attorney (Moore)
I come
83:35
back
83:35
to the
83:36
proposition
83:36
that this
83:38
statute
83:38
has to be
83:39
read,
83:40
I will say
83:41
it once,
83:41
the statute
83:42
ought to be
83:43
read as
83:44
an organic
83:45
whole,
83:46
all of its
83:47
parts
83:47
all together.
83:49
And it
83:50
has to be
83:50
read in
83:51
light of
83:52
the competing
83:52
objectives.
83:55
And it
83:56
ought to be
83:57
read,
83:57
we submit,
83:58
in light
83:59
of Kate's
84:00
law from
84:01
this court
84:01
and the
84:02
Supreme Court
84:03
which says
84:04
in a
84:07
situation
84:07
where a
84:08
statute
84:08
represents
84:09
a carefully
84:09
negotiated
84:10
compromise,
84:11
it ought
84:12
to be
84:13
carefully
84:14
construed
84:15
to avoid
84:20
Judge Mayer
consequences
84:21
colloquy
84:21
with Judge
84:22
Newman
84:22
raised an
84:23
issue I
84:23
never even
84:24
thought about
84:25
because I
84:25
never thought
84:26
it was
84:26
an issue.
84:27
And that
84:27
is,
84:28
do I
84:28
understand
84:29
there is
84:30
at least
84:30
some
84:31
question,
84:31
that it's
84:32
an open
84:32
question.
84:33
If a
84:36
paragraph four
84:37
certification
84:38
is given,
84:39
notice is
84:40
given,
84:40
if the
84:41
pioneer drug
84:42
holder,
84:43
patent holder
84:44
I should say,
84:45
pioneer patent
84:46
holder declines
84:48
to do
84:49
anything,
84:49
no action
84:50
is taken,
84:50
the ANDA
84:51
is issued,
84:52
is there
84:53
a question
84:55
as to
84:56
whether
84:56
the pioneer
84:58
could later
84:59
sue the
85:02
generic
85:03
for
85:04
infringement
85:05
of that
85:06
patent?
85:06
I would have
85:07
assumed
85:08
that that
85:09
issue is always
85:10
available
85:10
as long as
85:12
the patent
85:12
is valid,
85:14
as long as
85:14
the patent
85:15
is not yet
85:16
expired.
85:16
But is there
85:17
a question
85:18
about that?
85:18
Appellant Attorney (Moore)
No.
85:19
I think
85:21
there's
85:21
no question
85:21
at all.
85:24
The patent
85:25
being in
85:25
a situation
85:26
surely pertains
85:27
to
85:28
under
85:29
271A.
85:30
Okay.
85:31
I had
85:32
Judge Newman
a question.
85:32
There wasn't
85:33
my,
85:33
maybe we
85:33
should ask
85:34
for,
85:34
could you
85:35
send us
85:36
a couple
85:36
of pages
85:37
of briefing
85:37
on that
85:38
point,
85:38
each of
85:39
you,
85:40
as to
85:41
the obligation
85:41
of the
85:42
patentee
85:44
to
85:45
respond,
85:46
or you
85:46
say there's
85:47
no obligation
85:47
to respond
85:48
to a
85:50
paragraph
85:50
for certification
85:51
with an
85:52
infringement
85:53
suit,
85:53
and that
85:54
the patentee
85:55
loses,
85:56
hasn't waived
85:57
any opportunity
85:58
to sue
85:59
for infringement?
86:00
Appellant Attorney (Moore)
Yes,
86:00
Your Honor.
86:01
Judge Newman
I think
86:03
a couple of
86:03
pages from
86:04
each of you
86:05
would be helpful.
86:06
I certainly
86:06
don't know
86:06
the answer
86:07
to that.
86:13
give us
86:13
Judge Mayer
their view
86:14
on that
86:14
subject?
86:15
Judge Newman
Within a
86:16
week and a
86:17
half or
86:17
so,
86:18
or ten
86:18
days?
86:19
Appellant Attorney (Moore)
Ten days.
86:20
Judge Newman
And try and
86:21
keep it
86:22
to just
86:22
a couple
86:22
of pages,
86:24
unless it's
86:24
even more
86:25
complicated
86:25
than,
86:27
because this
86:28
is something
86:28
that I
86:29
hadn't
86:29
thought
86:29
about.
86:30
Appellant Attorney (Moore)
It is
86:30
a
86:31
hideously
86:31
Judge Mayer
complicated
86:32
problem.
86:34
Which raises
86:35
a question
86:35
I have for
86:36
you,
86:36
Mr. Moore.
86:36
Why shouldn't
86:37
this whole
86:37
matter be
86:38
Congress's
86:39
problem instead
86:40
of ours?
86:43
Judge Newman
I think,
86:46
Appellant Attorney (Moore)
Your Honor,
86:47
from that
86:48
standpoint,
86:48
it took
86:49
years of
86:50
work for
86:50
Congress to
86:51
get to
86:52
the result
86:52
that it got
86:53
to in
86:54
1984.
86:56
Legislation
86:56
has been
86:57
Appellee Attorney (Daniel E. Troy)
introduced
86:57
in,
86:58
I think,
86:59
Appellant Attorney (Moore)
last year,
86:59
perhaps the
87:00
year before.
87:01
And it may
87:02
be forever
87:03
for any
87:05
Appellee Attorney (Daniel E. Troy)
legislative
87:05
party this
87:06
forthcoming.
87:08
And it
87:09
remains our
87:09
view that
87:10
if this
87:11
statute is
87:12
carefully
87:13
Appellant Attorney (Moore)
construed,
87:14
the fixes
87:17
aren't
87:18
there.
87:19
And that's
87:21
the reason
87:21
we went
87:23
to the
87:23
District
87:23
Court,
87:24
and that's
87:24
the reason
87:29
Judge Newman
why,
87:29
Mr.
87:30
Troy,
87:30
Mr.
87:31
Bruce,
87:31
cases
87:32
taken
87:32
under
87:33
submission.