[00:00:05] Speaker 03:
Our next case is 18-1614, Sagenta Court Protection versus Willowwood, LLC.

[00:00:48] Speaker 03:
Let me make sure I have this correct.

[00:00:50] Speaker 03:
Mr. Levine, you reserved eight minutes of your time for rebuttal.

[00:00:54] Speaker 03:
Mr. Tiller, you're splitting your time with Ms.

[00:00:57] Speaker 03:
Barbaro.

[00:01:00] Speaker 03:
And so you have 15 minutes, and Ms.

[00:01:03] Speaker 03:
Barbaro has five minutes for her argument.

[00:01:08] Speaker 03:
OK.

[00:01:10] Speaker 03:
All right, so you may proceed.

[00:01:13] Speaker 04:
May it please the court.

[00:01:15] Speaker 04:
I am going to focus my time on three of the issues that are in the briefs, the copyright issue, the 271-G statutory interpretation issue, and the verdict issue.

[00:01:28] Speaker 04:
With respect to the copyright issue, the district court erred in two respects.

[00:01:34] Speaker 04:
First, the court erred by holding that FIFRA precludes copyright protection for the required elements of a pesticide label.

[00:01:45] Speaker 04:
The court then erred by dismissing Syngenta's copyright claims in their entirety, thereby preventing Syngenta from proving copyright infringement with respect to the non-required elements of the pesticide label.

[00:02:02] Speaker 04:
Fifth, plain language.

[00:02:04] Speaker 04:
The regulations and guidance interpreting it do not require pesticide registrants to copy the original registrant's labeling.

[00:02:14] Speaker 04:
The plain language states that the EPA shall, as expeditiously as possible, act on an application, including one that contains language that's different in composition and labeling from the original registrant's labeling.

[00:02:31] Speaker 02:
I have two questions for you on the point you just made.

[00:02:34] Speaker 02:
One is, you've distinguished Smith-Kline on this very basis that you've stated here.

[00:02:39] Speaker 02:
But do you think Smith-Kline was correctly decided

[00:02:41] Speaker 04:
Under the statute that Smith-Kline was decided, yes, it was correctly decided.

[00:02:48] Speaker 04:
Because in the Smith-Kline case and in the Smith-Kline statute, the Hatch-Watchman Act placed the burden on the applicant to show that the labeling for its new drug was the same as the labeling approved for the Lister drug.

[00:03:03] Speaker 04:
Whereas under FIFRA, the burden is on the EPA to review the labels

[00:03:09] Speaker 04:
And to ensure that the labeling does not differ in ways that would otherwise adversely affect the environment.

[00:03:15] Speaker 03:
So doesn't FIFRA require identical labels then?

[00:03:18] Speaker 03:
Not required, but the whole statute of contemplation.

[00:03:23] Speaker 03:
What we're looking at here are MeToo applicants.

[00:03:26] Speaker 03:
And they're MeToo applicants because they conform with essentially an identical, substantially same label.

[00:03:35] Speaker 04:
No, not an identical and substantially same label.

[00:03:39] Speaker 04:
They come up with a product that utilizes an active ingredient.

[00:03:43] Speaker 04:
And in that sense, it's a generic of the pesticide or herbicide or insecticide.

[00:03:49] Speaker 04:
But what Frifra says is that the label can be identical or substantially similar in the sense that there's permission that the MeToo applicant has.

[00:04:01] Speaker 03:
If you have essentially the same composition, two fungicides that are the same, substantially the same,

[00:04:08] Speaker 03:
Why under FIFA would they not bear essentially the same label?

[00:04:12] Speaker 04:
Because there are many different ways to express and to convey to the users of those pesticides.

[00:04:20] Speaker 03:
The FIFA contemplates, this has already been done before, we've already gone through the process, let's speed up the process, let's facilitate the process, so you show up with a Me Too, you're a Me Too, you show up with essentially

[00:04:31] Speaker 03:
the same label, and you're going to get an expedited process.

[00:04:34] Speaker 04:
But you can get an expedited process under the plain language of FIFRA even when there is differences in the labeling and composition.

[00:04:43] Speaker 04:
That comes right out of the statute.

[00:04:45] Speaker 02:
And I ask you, this was my second question, was what are we talking about in terms of the amount of time?

[00:04:51] Speaker 02:
What is an expedited review?

[00:04:52] Speaker 02:
What's a regular review?

[00:04:54] Speaker 02:
I think I read somewhere in the record, or maybe it was one of the other cases, that even under a non-expedited review, it took a month.

[00:05:01] Speaker 02:
I'm just trying to get a sense of what time we're talking, the amounts of time we're talking about.

[00:05:06] Speaker 04:
Generally speaking, you know, I can use an example in this case.

[00:05:10] Speaker 04:
When Willowwood itself modified its label and the EPA said, well, you need to make some more modifications to it.

[00:05:18] Speaker 04:
This was after we asserted copyright infringement.

[00:05:21] Speaker 04:
Both labels were revised and approved in under a year.

[00:05:24] Speaker 04:
And in the expedited review context, oftentimes it's in the 90-day timeframe.

[00:05:29] Speaker 04:
But the EPA has the resources.

[00:05:32] Speaker 04:
The EPA is certainly capable of looking at the labels, as the label review manual says, make a case-by-case determination on the acceptability of the language to ensure that it's conveying to the users what we, the EPA, want it to convey.

[00:05:48] Speaker 04:
There is no requirement in the statute and the regulations interpreting it.

[00:05:53] Speaker 04:
or in the guidance, as the label review manual is, saying you have to use the same language.

[00:05:59] Speaker 01:
I think, roughly speaking, nobody has suggested that identity is required.

[00:06:05] Speaker 01:
Rather, the argument is that in the context of this expedited review procedure, the policy is for expedition.

[00:06:15] Speaker 01:
And as a practical matter, expedition is

[00:06:21] Speaker 01:
at least enabled in a practical way by allowing either identity or something awfully close to identity so that the EPA, as it says in its label manual, can put the label side by side, identify quickly any changes, and then focus only on those small number of changes and ask, is that conveying misinformation or bad information?

[00:06:48] Speaker 04:
But the statute says they can do that

[00:06:51] Speaker 04:
in two contexts, when there's substantial identity, either because there's permission, there's a license, because these entities have a lot of interactions with each other potentially, and there are opportunities.

[00:07:04] Speaker 04:
Sometimes it's a customer supplier situation where the original registrant is providing the active ingredient to the generic.

[00:07:13] Speaker 04:
They could negotiate for a copyright license.

[00:07:16] Speaker 04:
They could negotiate for a copyright license independently.

[00:07:19] Speaker 04:
But most importantly, the FIFRA statute itself says that the EPA, the administrator, shall act as expeditiously as possible.

[00:07:28] Speaker 01:
The EPA says here, I'm going to summarize, we can't, as a practical matter, do that if we have to get labels that are, as a result of copyright considerations, very likely to be quite different in wording from the pioneer label.

[00:07:49] Speaker 04:
That's a policy argument, Your Honor, that ought to be directed to Congress.

[00:07:53] Speaker 04:
And the FMC decision decided in 2005, you know, 14, 15 years since then, the sky hasn't fallen.

[00:08:01] Speaker 04:
The EPA has still been approving applications and there's no evidence in the record that there's been any lack of expeditious approval or that generics have not been able to obtain the approvals in order to enter the market.

[00:08:17] Speaker 03:
So you think different labels are okay?

[00:08:21] Speaker 04:
Different labels are okay because that's what the statute and the regulations say.

[00:08:25] Speaker 03:
Why does Syngenta assert copyright infringement against the changed labels that they had?

[00:08:31] Speaker 04:
Because the changed labels are still copying.

[00:08:36] Speaker 04:
They still copied what Syngenta created in terms of the wording, the arrangement, and the layout.

[00:08:44] Speaker 04:
And that's why Syngenta was asserting, or with respect to the revised labels.

[00:08:49] Speaker 04:
There are many different ways to convey the directions of use, the other information that is contained within the label.

[00:08:56] Speaker 03:
Sounds like you want to have your cake and eat it too.

[00:08:59] Speaker 03:
I mean, on the one hand, you're saying that having different labels is OK under FIFRA.

[00:09:07] Speaker 03:
And yet, when that happens, when your competitor comes up with a different

[00:09:11] Speaker 03:
label, or a changed label, you bring a copyright infringement.

[00:09:16] Speaker 02:
What is the difference between the labels?

[00:09:19] Speaker 03:
What is the difference?

[00:09:21] Speaker 02:
Is it just the change in name?

[00:09:22] Speaker 04:
What is the... In the original label, they did simply change the name, and in some instances, they didn't even change the name from Syngenta to Willowwood.

[00:09:32] Speaker 04:
But there could be all sorts of differences with respect to how you convey the required pieces of information.

[00:09:39] Speaker 02:
My question, though, was more specific, which is just

[00:09:42] Speaker 02:
What are the differences between their original label that they submitted and their changed label that they submitted that you nonetheless contend still infringes your copyright?

[00:09:52] Speaker 04:
They tried to paraphrase and they simply didn't paraphrase enough.

[00:09:56] Speaker 04:
And that's the primary issue here is that they tried to change some of the words from being the identical verbatim copying to paraphrasing.

[00:10:07] Speaker 04:
but they stayed too close and need to go further.

[00:10:11] Speaker 01:
And what's the, you know, easily administered enough paraphrase standard that you contemplate is going to interact well with the FIFRA expedition regime?

[00:10:21] Speaker 04:
Well, what the statutes are requiring is that what the EPA is to do in reviewing the labels is to make sure that the terms used, and this comes out of 40 CFR 156.10,

[00:10:37] Speaker 04:
can be easily read and understood by the average person likely to use or supervise the use of the pesticide.

[00:10:43] Speaker 01:
So there is an element of judgment here and the EPA is more than... Do you contemplate that the EPA will consider the copyright question or that's entirely up to the applicant?

[00:10:55] Speaker 04:
The copyright issue is up to the applicant.

[00:10:58] Speaker 01:
And the EPA actually has a congressional mandate, shall we say?

[00:11:05] Speaker 01:
to expeditiously process these things.

[00:11:09] Speaker 01:
And applicants are going to have to figure out how much paraphrase is going to satisfy the pioneer.

[00:11:17] Speaker 04:
Correct.

[00:11:17] Speaker 04:
Or come to the original registrant and obtain a license.

[00:11:21] Speaker 04:
And the second problem here with the district court's holding is that she then dismissed the entirety of Syngenta's copyright claims.

[00:11:28] Speaker 01:
Where do you make that point in your blue brief?

[00:11:31] Speaker 01:
That even if the judge was right about

[00:11:35] Speaker 01:
FIFRA ousts the Copyright Act as to, let's call them, required elements.

[00:11:41] Speaker 01:
And here, required means not just required of the pioneer, but required of the generic once there's a pioneer, which is a much larger class, because there has to be at least substantial similarity.

[00:11:52] Speaker 01:
Where do you make the argument that even if the judge was right about that, that the judge incorrectly dismissed the copyright claims as a whole?

[00:12:02] Speaker 04:
Correct.

[00:12:03] Speaker 04:
Right.

[00:12:04] Speaker 01:
Where do you say that in your blue brief?

[00:12:07] Speaker 04:
In the page numbers?

[00:12:09] Speaker 01:
Yes.

[00:12:09] Speaker 01:
I'm looking for it in the heading.

[00:12:11] Speaker 01:
I don't see it.

[00:12:11] Speaker 01:
So I want help.

[00:12:13] Speaker 04:
OK.

[00:12:13] Speaker 04:
I will get you the page number itself.

[00:12:17] Speaker 02:
The concern is whether you waved it, whether you've raised it or not.

[00:12:20] Speaker 02:
So that's why we want to know where it is.

[00:12:22] Speaker 04:
OK.

[00:12:23] Speaker 04:
The page number itself, because what I can say, Your Honor, is that we highlighted the portions of the label they copied.

[00:12:32] Speaker 04:
you know, marked up the label saying these are the required portions and what's left is substantial portions, the efficacy claim.

[00:12:40] Speaker 02:
Do you agree with what they marked up as being the required portions?

[00:12:44] Speaker 04:
No.

[00:12:45] Speaker 02:
Do you have somewhere in the record where you've identified what you think are the required portions?

[00:12:48] Speaker 04:
No, because the case was dismissed before we got to that.

[00:12:51] Speaker 04:
I will get you the page number site, Your Honor.

[00:12:53] Speaker 01:
I just want to be absolutely sure you understand what I'm asking.

[00:12:59] Speaker 01:
Let me put it tendentiously.

[00:13:01] Speaker 01:
When you began your argument by saying the district court was wrong by saying FIFRA ousts the Copyright Act as to FIFRA required elements, and the district court was also wrong in dismissing your copyright claims even as to non-required elements, I immediately thought, boy, I don't remember hearing from or reading in your blue brief the second argument.

[00:13:23] Speaker 01:
So I don't care about the joint appendix.

[00:13:24] Speaker 01:
I want a citation in the blue brief where you said, even if

[00:13:29] Speaker 01:
required claims are, required aspects of the label are ousted.

[00:13:34] Speaker 01:
The district court was still wrong and we want a vacator on that ground.

[00:13:38] Speaker 04:
Okay, I'll get you that side and rebuttal.

[00:13:40] Speaker 04:
On the 271-G issue, the plain language does not require the product made by the patented process to be made by a single entity.

[00:13:48] Speaker 04:
Liability arises from the importation, use, sale... Can I just ask this?

[00:13:53] Speaker 01:
Let me stipulate for

[00:13:55] Speaker 01:
current purpose is that the language of the statute favors you, including 271G and including 154A2.

[00:14:02] Speaker 01:
Nevertheless, there is a concern reflected, I think, in a different context, most recently in the Supreme Court's Helsing decision, that when pre-existing law establishes certain kinds of limits on patents, at least in that direction,

[00:14:22] Speaker 01:
that we expect a fair degree of eyes open clarity, maybe even expression of intent to change something clear like that.

[00:14:34] Speaker 01:
Do we have that here or is that not the right question to ask?

[00:14:39] Speaker 04:
We certainly don't have here a clear expression to impose a single entity requirement on 271G because 271G

[00:14:50] Speaker 04:
is using the passive voice.

[00:14:53] Speaker 04:
It talks about whoever imports, offers to sell, sells, or uses.

[00:14:59] Speaker 01:
Maybe I can focus it this way.

[00:15:01] Speaker 01:
Assume with me that the statutory language here treats foreign and domestic manufacture identically, as indeed the language appears to do.

[00:15:14] Speaker 01:
Then 271G, in your view, would

[00:15:19] Speaker 01:
quite dramatically change the scope of protection for a domestic process patent if it was true before 1987 that you had to have a single entity practicing the process patent?

[00:15:37] Speaker 04:
No, because they're treated identically with respect to whoever uses, offers to sell, imports or sells.

[00:15:46] Speaker 04:
That's identical between 271A and 271G.

[00:15:49] Speaker 04:
There may be a case of divided importation.

[00:15:52] Speaker 04:
The single entity requirement would apply there.

[00:15:55] Speaker 04:
But 271G, the act of infringement, is the act of importation use offer to sell or sell.

[00:16:03] Speaker 04:
The product made by the patented process is not the focus of 271G.

[00:16:12] Speaker 02:
I think the concern is that

[00:16:14] Speaker 02:
If under 271A you have to have a single entity, the concern would be that if 271G could apply to a domestic process that actually results in a product, you might have a different rule applying 271A where you have to have a single entity requirement and 271G where you wouldn't have to have a single entity requirement for the performance of the process steps.

[00:16:40] Speaker 02:
And so how the question is,

[00:16:41] Speaker 02:
Does that create a problem for you in terms of your argument?

[00:16:45] Speaker 04:
No, it doesn't because under 271-G, the act of infringement, what creates liability is whoever imports, uses, offers to sell or sell.

[00:16:56] Speaker 04:
That single entity requirement is the same as it would be in 271-A.

[00:17:00] Speaker 02:
So because I understand that your point is Congress wrote what they wrote and 271-G has a different reading than 271-A, so it doesn't matter.

[00:17:10] Speaker 02:
Because that's how Congress wrote it.

[00:17:11] Speaker 02:
It doesn't matter if you might have two different situations.

[00:17:16] Speaker 04:
That's certainly true.

[00:17:17] Speaker 04:
The two statutes can be interpreted differently, just like 271F has got the language in it that limited it to in a manner that would infringe if it was performed in the US.

[00:17:30] Speaker 04:
There's no such language in 271G.

[00:17:34] Speaker 04:
So Congress in 271G was closing the loophole.

[00:17:37] Speaker 04:
But to the extent there's a single entity requirement in 271G, it's with respect to the act of infringement, which is the importation, use, and sale.

[00:17:48] Speaker 04:
And I'll reserve the remainder of my time for rebuttal, and I'll give you the page number.

[00:17:52] Speaker 03:
Well, let's hold on.

[00:17:53] Speaker 03:
Any other questions?

[00:17:55] Speaker 03:
You said you had three points, and I think you want to address two.

[00:17:58] Speaker 03:
Yes, in the interest of time.

[00:18:01] Speaker 03:
And I'll adjust time accordingly.

[00:18:02] Speaker 01:
OK.

[00:18:02] Speaker 01:
Is it about Willowwood Limited?

[00:18:04] Speaker 01:
Excuse me?

[00:18:06] Speaker 04:
Yes, the verdict issue.

[00:18:08] Speaker 01:
The district court reasoned... We owe a fair bit of discretion, don't we, to the district court's interpretation of her own jury verdict?

[00:18:17] Speaker 01:
I thought we said that in PRISM and telecordia, which is, I think, fairly standard law.

[00:18:23] Speaker 04:
Yes, but this is not a situation where there was a need to resolve any type of ambiguity under the jury verdict.

[00:18:33] Speaker 04:
What the district court had reasoned was that neither party had asked the court to submit a separate issue with respect to the question of infringement of the 138 and 761 patents as it related to Willowwood Limited.

[00:18:46] Speaker 04:
But Willowwood did, in fact, propose such a jury instruction.

[00:18:50] Speaker 04:
And Syngenta objected to that proposed jury instruction.

[00:18:54] Speaker 04:
The court's final instructions did not utilize the instruction proposed by Willowwood.

[00:19:00] Speaker 04:
And in the final instructions, Willowwood only objected to the jury instructions with respect to the 761 patent as it related to the burden shifting aspect, putting on Willowwood the burden under section 295 to prove non-infringement.

[00:19:19] Speaker 04:
The verdict form then in question seven asked the jury the question, defendants, did defendants prove non-infringement?

[00:19:28] Speaker 04:
And the jury responded, no, they did not.

[00:19:31] Speaker 04:
And significantly, Willowwood did not object to the verdict form with respect to question seven.

[00:19:38] Speaker 04:
Willowwood only objected to the verdict form with respect to question one, with respect to whether the three entities should be broken out with respect to the willfulness question.

[00:19:50] Speaker 04:
And in discussing that objection, the district court expressly stated, quote,

[00:19:55] Speaker 04:
We certainly treated them referring to all three Willowwood entities altogether for all purposes except the infringement of this compound patent question," close quote.

[00:20:08] Speaker 04:
And counsel for Willowwood agreed.

[00:20:10] Speaker 04:
That's at A7066.

[00:20:11] Speaker 04:
So the jury then returned a verdict finding that the defendants infringed the 761 patent.

[00:20:19] Speaker 04:
And defendants included Willowwood Limited

[00:20:22] Speaker 04:
And the court erred by then limiting the verdict to just Willowwood USA and Willowwood LLC.

[00:20:30] Speaker 01:
And that's why... Can I ask you a very practical question?

[00:20:34] Speaker 01:
Sure.

[00:20:35] Speaker 01:
Why do you care how many Willowwoods are liable?

[00:20:38] Speaker 04:
Because Willowwood Limited, we want them under the permanent injunction.

[00:20:43] Speaker 04:
Willowwood Limited is the source of the Asoxy technical.

[00:20:48] Speaker 04:
They sell the technical to Willowwood USA.

[00:20:51] Speaker 04:
Willow would limited might also sell the technical to other entities and we want willow would limited including Included in the permanent injunction in case in case limited in USA change their exclusivity agreement Correct or you know if there's other things that willow would limited does that?

[00:21:09] Speaker 02:
Engages in infringing conduct here I was just going to say I think maybe your blue brief has some suggestion it

[00:21:20] Speaker 02:
Page 25, footnote 6.

[00:21:22] Speaker 02:
I don't know.

[00:21:22] Speaker 04:
Yeah, I'll get the exact page numbers.

[00:21:29] Speaker 03:
OK, Mr. Tiller.

[00:21:31] Speaker 05:
May it please the court.

[00:21:32] Speaker 05:
And I want to start by apologizing.

[00:21:33] Speaker 05:
I'm battling a cold that is, I may cough a little bit here.

[00:21:38] Speaker 05:
Your Honor, I want to focus on the 271G issue right now as I think was made clear in our brief and as I think was raised in the court's questioning.

[00:21:49] Speaker 05:
271G did fill a hole.

[00:21:52] Speaker 05:
It allowed United States process patent owners to sue when the process is engaged in outside of the United States.

[00:22:01] Speaker 05:
And the product resulting from that comes into the United States.

[00:22:05] Speaker 03:
There's no dispute here that the entire process is undertaken abroad.

[00:22:13] Speaker 05:
By two different entities, no.

[00:22:14] Speaker 05:
There is no dispute that the process is undertaken

[00:22:19] Speaker 03:
I have another question here.

[00:22:21] Speaker 03:
Does the record reflect, and I went through the record, and I wasn't able to find as to who the importer of record is.

[00:22:29] Speaker 05:
The importer of record is Willowwood, USA.

[00:22:34] Speaker 05:
Okay.

[00:22:35] Speaker 05:
There was testimony to that at trial from Willowwood, USA's president, Mr. Brian Hines.

[00:22:41] Speaker 03:
There's a little bit of conflict and testimony as to who's handling the freight forwarding, who's handling the shipping.

[00:22:49] Speaker 03:
But I did see the testimony that Willow USA handled customs, and I noticed on some of the invoices I was able to pull out that Willow Wood is the assumed liability for the entire shipment from China to the buyer.

[00:23:09] Speaker 05:
Is that correct?

[00:23:11] Speaker 05:
Wait, which Willow Wood?

[00:23:12] Speaker 05:
I'm sorry.

[00:23:14] Speaker 03:
USA.

[00:23:14] Speaker 05:
Yes.

[00:23:15] Speaker 05:
Yes.

[00:23:16] Speaker 05:
I just wanted to make sure Willowwood USA assumes liability.

[00:23:19] Speaker 05:
Willowwood USA, to get down into the details, your honor, Willowwood USA tells Willowwood Limited, get it to this port, use this shipper.

[00:23:30] Speaker 05:
Willowwood Limited then does that, gets it to the port in Hong Kong or Shanghai.

[00:23:35] Speaker 05:
Then Willowwood USA pays for it, picks it up at the port, typically in California.

[00:23:43] Speaker 05:
and then arranges for everything else to happen after that, including EPA registrations, as we know, arranging for production of end-use products and formulation.

[00:23:54] Speaker 03:
So the import or record is a term of art in customs law.

[00:23:58] Speaker 03:
And you said that they are the import or record.

[00:24:02] Speaker 03:
Is that a concession here on behalf of a record?

[00:24:05] Speaker 05:
Well, I think Willowwood USA imports.

[00:24:07] Speaker 05:
I'm not sure about the exact terminology or the term of art here, but it is Willowwood USA.

[00:24:12] Speaker 02:
who's the official importer of what customs law would do.

[00:24:17] Speaker 05:
And takes it through customs.

[00:24:18] Speaker 05:
That's what I was just about to say, Your Honor.

[00:24:19] Speaker 05:
That is Willowood USA who handles that.

[00:24:22] Speaker 01:
Can I ask you another, at least to my mind, very small question?

[00:24:28] Speaker 01:
FOB Hong Kong.

[00:24:29] Speaker 01:
Is that a term that can be used if the goods never appear in Hong Kong but go through Shanghai?

[00:24:34] Speaker 01:
And was it?

[00:24:35] Speaker 05:
I think typically most of the goods went through Hong Kong, but some would go through Shanghai and they would be FOB Shanghai.

[00:24:42] Speaker 05:
Okay, you don't say FOB a place that the goods never appeared at, right?

[00:24:46] Speaker 05:
Correct.

[00:24:47] Speaker 05:
Correct.

[00:24:47] Speaker 05:
I think the party sort of focused on FOB Hong Kong as FOB not here in the United States, if that makes sense.

[00:24:57] Speaker 05:
That is a new technical term.

[00:25:01] Speaker 02:
Going back to the 271G issue, in 271A, this court held that there's a single entity requirement because the whoever

[00:25:12] Speaker 02:
performs these verb acts.

[00:25:15] Speaker 02:
And so that whoever had to be a single entity or one party directing or controlling another.

[00:25:20] Speaker 02:
But here, the 271G language, when it talks about whoever, it's not the process steps that they're talking about.

[00:25:27] Speaker 02:
It's other actions, like importing.

[00:25:30] Speaker 02:
So how do you respond to that?

[00:25:33] Speaker 05:
I respond in a couple ways, Your Honor.

[00:25:34] Speaker 05:
First of all, if you look at the legislative history of 271G, it was very, very clear what 271G

[00:25:41] Speaker 05:
and 154A1, we're trying to get it.

[00:25:44] Speaker 05:
It was trying to take care of the problem of processes taking place outside of the United States, and then the resulting product coming into the United States.

[00:25:56] Speaker 02:
But it doesn't say, using a process, that if it were performed in the US, it would infringe in the US, right?

[00:26:01] Speaker 05:
You are right.

[00:26:02] Speaker 05:
It doesn't say, it doesn't use that 271F language.

[00:26:07] Speaker 05:
But I don't think it needed to.

[00:26:09] Speaker 05:
Because the implication here is that

[00:26:12] Speaker 05:
the importation or subsequent sale or offer to sale under 271G that might create liability under 271G, I think the clear implication here is that there was infringement of the patent in the first place.

[00:26:27] Speaker 05:
Without infringement, the importation of a non-infringing product does not rise to any liability.

[00:26:33] Speaker 02:
It doesn't say that it infringes a process.

[00:26:35] Speaker 02:
It says that it was made by a process.

[00:26:38] Speaker 05:
You are correct.

[00:26:38] Speaker 02:
Well, what about this?

[00:26:39] Speaker 02:
Let me ask you something.

[00:26:40] Speaker 02:
What came first?

[00:26:42] Speaker 02:
the, you know, this court's emphasis and discussion of the single entity rule, starting with, I think it was BMC might have been the first case, or muni auction, or was it the passage of 271G?

[00:26:55] Speaker 05:
I think it was 271G, if I understand it correctly.

[00:27:00] Speaker 05:
But I think, again, what was contemplated under 271G is the idea that we're going to give process patent holders

[00:27:11] Speaker 05:
the same scope of protection, whether the process is engaged in the United States or whether the process engaged in outside of the United States with a product coming in.

[00:27:21] Speaker 05:
And I think that is made clear by the legislative history when 271-G legislative history says the process patent bill, which resulted in 271-G.

[00:27:31] Speaker 01:
I'm sorry.

[00:27:31] Speaker 01:
Their view would, in fact, give

[00:27:36] Speaker 01:
those two situations the same scope of protection on the assumption, which I guess I'd like you to indulge, that made by a process under 271G includes made in the United States by a process.

[00:27:57] Speaker 01:
Let's call it fractured manufacturing, which is to say manufacturing that wouldn't satisfy Akamai in the U.S.

[00:28:05] Speaker 01:
under the made by the process language, it doesn't say whether that manufacturing occurs abroad or here.

[00:28:17] Speaker 01:
There's a section in Chisholm that says there's no difference according to where the manufacturing is.

[00:28:22] Speaker 01:
So now the only question is, who's doing the selling?

[00:28:27] Speaker 01:
Is the selling or the importation of the resulting product going on in the United States?

[00:28:34] Speaker 05:
If I may ask, Your Honor, to make sure, are you suggesting that if the single entity rule is not required for domestic process patent infringement, that then, given Syngenta's understanding of 271G, the scope would be the same?

[00:28:52] Speaker 01:
Yes, that's right.

[00:28:53] Speaker 05:
I think if this court was inclined to say there is no more single entity rule, that the... For 271G.

[00:29:04] Speaker 01:
or 271G for the process.

[00:29:08] Speaker 05:
If the single entity rule is not found to apply to 271G but remains applicable to 271A and B, then there would be a different scope of protection for the same process patent under that circumstance.

[00:29:28] Speaker 01:
Right, but not a foreign domestic difference.

[00:29:31] Speaker 01:
It would just be a difference

[00:29:34] Speaker 01:
according to whether a product resulted from the process or a process that didn't produce a product, so that 271G just would have nothing to attach to.

[00:29:44] Speaker 05:
I have to admit, Your Honor, I'm not sure I'm following the question, but what I want to say is that obviously 271G only applies if it's going on outside, if the process is being conducted outside of the United States.

[00:29:58] Speaker 05:
I would say that's not obvious.

[00:30:00] Speaker 05:
Excuse me?

[00:30:01] Speaker 01:
I would say that's not obvious.

[00:30:03] Speaker 01:
OK.

[00:30:03] Speaker 01:
There's no language in the statute to that effect, is there?

[00:30:07] Speaker 05:
Whoever without authority imports in the United States or offers to sell or uses within the United States a product which is made by a process patented in the United States shall be liable.

[00:30:15] Speaker 05:
You are correct.

[00:30:15] Speaker 05:
Right.

[00:30:16] Speaker 05:
You are correct.

[00:30:18] Speaker 05:
So even more so, that we then would have two different guidelines of law, one applying a single entity rule and one not applying a single entity rule.

[00:30:26] Speaker 02:
The difference between 271A and 271G being

[00:30:30] Speaker 02:
maybe 271A would apply to all processes, and 271G would only apply to processes where there's a product.

[00:30:40] Speaker 05:
Where there's a product.

[00:30:40] Speaker 02:
It's not the case in all processes.

[00:30:43] Speaker 05:
Right?

[00:30:43] Speaker 05:
That is probably true, Your Honor.

[00:30:46] Speaker 05:
Yes, that is true.

[00:30:48] Speaker 05:
But I still think we would be essentially setting out two different areas of case law where 271A

[00:30:57] Speaker 05:
where there's, again, as you say, no product ultimately involving, would require a single entity.

[00:31:03] Speaker 05:
Whereas where a product does result, that there would be no requirement of a single entity.

[00:31:11] Speaker 02:
Because of the difference in the way the statutes are written.

[00:31:15] Speaker 05:
Assuming that this court found in that way, absolutely.

[00:31:20] Speaker 05:
And then what I think would be happening is we would be giving process patent owners

[00:31:27] Speaker 05:
different levels of the scope of their protection, dependent on sort of the invention that they are creating, whether the invention ultimately comes up with the product.

[00:31:38] Speaker 01:
Why didn't 271G do exactly that?

[00:31:41] Speaker 05:
Because, Your Honor, I think that would be inconsistent with the idea that 271G, when you read the legislative history, was trying to essentially fill in this loophole where

[00:31:56] Speaker 05:
It was trying to say, if a product is made outside of the United States and you import it into the United States, such as the case here, that you can still get infringement.

[00:32:07] Speaker 05:
You can still find liability.

[00:32:10] Speaker 02:
The problem you're having with your argument is you're asking me to look at the legislative history, figure out what Congress had in mind instead of looking at the plain language of the statute.

[00:32:19] Speaker 05:
You are correct, sir.

[00:32:19] Speaker 05:
Although I would argue that the plain language of the statute is still pretty clear, and to say

[00:32:25] Speaker 05:
And one of the NYIPLA amicus brief comes right out and says that they say 271G does not require infringement.

[00:32:34] Speaker 01:
That's a quote of the NYIPLA.

[00:32:37] Speaker 01:
Does not require infringement of the process patent in a 271A sense?

[00:32:43] Speaker 05:
The NYIPLA says that there is no infringement requirement.

[00:32:47] Speaker 05:
That's the quote that they use.

[00:32:49] Speaker 05:
There's no infringement.

[00:32:51] Speaker 01:
I'm sorry.

[00:32:51] Speaker 01:
271G defines a form of infringement.

[00:32:54] Speaker 05:
Correct.

[00:32:54] Speaker 05:
What I'm getting to, Your Honor, is the amicus brief talks about, yes, 271G requires certain things to happen, but it doesn't require the underlying infringement of the process patent, i.e., it doesn't require single entity.

[00:33:16] Speaker 05:
And if you think about it that way, to impose liability because one company

[00:33:24] Speaker 05:
Let's assume for a minute there is no single entity directing or controlling the overall activities to impose liability on one company that's engaging in only part of the invention and Another company that's only engaging in a part, but they wouldn't the question would be who's importing?

[00:33:45] Speaker 02:
or offering to sell or sell.

[00:33:47] Speaker 02:
That would be the party that would be liable under 271G.

[00:33:49] Speaker 02:
That is.

[00:33:50] Speaker 05:
That is.

[00:33:51] Speaker 02:
So why are you concerned about the foreign or domestic manufacturers that are only performing parts of the steps of the process pact?

[00:33:58] Speaker 02:
I don't understand how that comes in.

[00:34:00] Speaker 05:
But the point, Your Honor, is the invention.

[00:34:04] Speaker 05:
As the Supreme Court said,

[00:34:06] Speaker 05:
In Akamai, the reason for the single entity rule is because the invention is not being violated.

[00:34:12] Speaker 05:
The patent is not being violated.

[00:34:15] Speaker 02:
So in 271A, the violation is described as whoever makes, uses, or sells the process.

[00:34:22] Speaker 02:
Correct.

[00:34:22] Speaker 02:
But the violation, the act of infringement in 271G, is whoever imports, offers to sell, or sells a product made by process.

[00:34:32] Speaker 02:
So there is still an infringing act.

[00:34:33] Speaker 02:
It's just defined differently.

[00:34:35] Speaker 05:
I agree with that, Your Honor.

[00:34:36] Speaker 05:
I don't dispute that.

[00:34:37] Speaker 05:
But still, the underlying patent, what the invention is, what the patent holder has a right to exclude others from, is the right to engage in all of those steps.

[00:34:48] Speaker 05:
And that isn't occurring under that interpretation of 271G.

[00:34:54] Speaker 01:
Even in the, I guess, your 761 example, where there's no divided anything, Tahir just does that one step.

[00:35:03] Speaker 01:
So there's no divided anything.

[00:35:05] Speaker 01:
The US seller, while Willowwood USA, doesn't do a single aspect of the underlying process.

[00:35:15] Speaker 01:
Completely different entities, but 271G, I think, more or less undisputedly would cover that.

[00:35:22] Speaker 05:
If it was just the one entity that did it?

[00:35:26] Speaker 01:
You've got two entities, a process performer and a domestic seller.

[00:35:30] Speaker 01:
Domestic seller doesn't go anywhere near the process, just buys the product.

[00:35:35] Speaker 01:
And then sells it.

[00:35:36] Speaker 01:
So what's odd about G71G plainly gets the domestic seller.

[00:35:42] Speaker 05:
I agree with that, Your Honor.

[00:35:42] Speaker 05:
I don't dispute that at all.

[00:35:44] Speaker 05:
But what I'm saying is the invention, what is claimed by the patent holder, what the patent holder came up with, this revelation that he or she had, protects a certain number of steps put together.

[00:36:01] Speaker 05:
And by not imposing a single entity rule,

[00:36:05] Speaker 05:
you would be giving broader scope of protection to that invention merely because the product resulting from those steps occurred but didn't occur through a single entity.

[00:36:20] Speaker 05:
I hope I'm making myself clear there.

[00:36:23] Speaker 05:
I did want to quickly address, and I see that I'm coming out of time, the Willowwood Limited, the jury verdict question.

[00:36:34] Speaker 05:
May I?

[00:36:34] Speaker 05:
Yes.

[00:36:35] Speaker 05:
Thank you, Your Honor.

[00:36:36] Speaker 05:
The point is, the entire trial was tried to figure out whether Willowwood Limited engaged in any activities that would subject it to jurisdiction in the United States.

[00:36:48] Speaker 05:
The jury, we talked about what it did with regard to the 138 patent, that's the subject of the 271G issue, the subject of the 791 patent.

[00:36:59] Speaker 05:
And we discussed all of that issue, and the jury came back and said, you didn't do, you, Willow Illimited, didn't do anything.

[00:37:05] Speaker 02:
Can I ask you a question related to this, which is, what evidence is there in the record that the sale of the five kilograms of a Zoxystrobin, if I said that right, could place outside the US, other than the FOB Hong Kong?

[00:37:21] Speaker 05:
Because Mr. Hines testified.

[00:37:24] Speaker 05:
All the things that we talked about a couple minutes ago that

[00:37:28] Speaker 05:
Willowwood USA arranges for, tells Willowwood Limited, drop it off here.

[00:37:34] Speaker 05:
Go with this shipper.

[00:37:36] Speaker 05:
Send it over.

[00:37:37] Speaker 05:
Do this.

[00:37:38] Speaker 05:
He testified that that was true for everything, including the five kilograms.

[00:37:43] Speaker 02:
I understand.

[00:37:44] Speaker 02:
I want to know, but so you're saying there's more than just the FOB Hong Kong.

[00:37:49] Speaker 02:
Absolutely.

[00:37:50] Speaker 02:
And the record.

[00:37:50] Speaker 02:
Absolutely.

[00:37:52] Speaker 02:
And that is the testimony of who is directing what.

[00:37:56] Speaker 05:
That was the testimony of both Mr. Hines and the gentleman that we referred to during the trial as SSJ, Shengjiao Zhen.

[00:38:02] Speaker 05:
They both essentially testified to the same arrangement between Willowwood Limited and Willowwood USA as to everything.

[00:38:12] Speaker 03:
Okay.

[00:38:12] Speaker 03:
We thank you.

[00:38:13] Speaker 03:
Thank you.

[00:38:16] Speaker 03:
Councillor Barber, you have five minutes and we'll extend you a little bit of time if you need that as well.

[00:38:23] Speaker 00:
Thank you, Your Honor.

[00:38:24] Speaker 00:
May it please the court, Megan Barbaro on behalf of the United States.

[00:38:28] Speaker 00:
In FIFA's Me Too scheme, Congress set up a system to encourage copying of pesticide labels.

[00:38:36] Speaker 00:
It wrote the words identical or substantially similar, selecting effectively the test for copyright infringement to describe the labels that the generic should use to get the expedited review from EPA to encourage competition.

[00:38:52] Speaker 00:
and expedite generic entry to the market.

[00:38:55] Speaker 00:
Now, Congress didn't write those words in a vacuum.

[00:38:57] Speaker 02:
Can I ask you something?

[00:38:59] Speaker 02:
These provisions you're talking about, we've had the Copyright Act and the FIFAs meet two provisions operating together for the past 30 years.

[00:39:09] Speaker 02:
What sort of problems have arisen?

[00:39:11] Speaker 02:
I mean, there's this case, but it seems kind of odd to me that 30 years of coexistence and now all of a sudden there's problems.

[00:39:20] Speaker 02:
How do you speak to that?

[00:39:21] Speaker 02:
Why doesn't that show that these two statutes can coexist?

[00:39:26] Speaker 00:
Your Honor, two responses.

[00:39:28] Speaker 00:
I do want to get to the actual problems, but also a decision from this court finding for Syngenta that brand names could sustain copyright infringement claims against generics would

[00:39:42] Speaker 00:
clearly create a host of problems and undermine the expedited review scheme that Congress... Your point is that... We don't have a court of appeals decision upholding copyright infringement claims on a generic label against a generic label.

[00:39:57] Speaker 00:
That said, what has... Can I ask you something?

[00:40:00] Speaker 02:
I'm sorry.

[00:40:00] Speaker 02:
Oh, of course.

[00:40:01] Speaker 02:
Okay.

[00:40:02] Speaker 02:
So there's the Eastern District of Pennsylvania case.

[00:40:04] Speaker 02:
You're saying that hasn't created any problems because it's a district court case, I guess.

[00:40:09] Speaker 02:
And you're saying that nobody has filed copyright claims before, so it hasn't been a problem.

[00:40:15] Speaker 02:
Is that your position?

[00:40:16] Speaker 00:
No, Your Honor.

[00:40:17] Speaker 00:
And let me clarify.

[00:40:19] Speaker 00:
The Eastern District of Pennsylvania case in FMC has created problems for the agency.

[00:40:25] Speaker 00:
They're problems akin to the problems you see in the record in this case, which is you have generics who are trying both to satisfy the many requirements of FIFRA in the label and also, as Willow did here, trying to

[00:40:37] Speaker 00:
avoid copyright infringement claims.

[00:40:40] Speaker 00:
That requires EPA to go back to the generic label and say, you can't make those changes you're suggesting because they don't meet the FIFRA standards.

[00:40:49] Speaker 00:
There's a lot more back and forth between the agency and the generics.

[00:40:53] Speaker 00:
There have been, in addition, we've seen other district court litigations.

[00:40:58] Speaker 00:
The United States has filed statements of interest and participated in those cases.

[00:41:03] Speaker 00:
We don't have a court of appeals decision.

[00:41:05] Speaker 00:
But in addition, we know what Congress wanted was expedited review of these, the Me Too's, because in section, it's seven USC 136W-8, which I understand is re-opted by Congress every five or 10 years, there are tables there that talk about the specific timeframes.

[00:41:26] Speaker 00:
Now, if you have a new active ingredient, the agency has up to 24 months to review and approve.

[00:41:33] Speaker 00:
With the Me Too's, the statutory framework allows only four months.

[00:41:37] Speaker 00:
And that makes sense because what Congress understood is that there would be a purpose to having the same label when you had the same underlying ingredient.

[00:41:48] Speaker 00:
These labels are intended to communicate important health and safety information.

[00:41:52] Speaker 00:
And EPA allows the generics to market their generic pesticides as

[00:41:59] Speaker 03:
having the same active ingredient as brand name X. Why doesn't the free for contained language yet requires a MeToo to have identical language as the other label?

[00:42:10] Speaker 00:
It does use the words identical or substantially similar.

[00:42:14] Speaker 00:
It also has a phrase differ in ways that don't substantially increase the adverse effects on the environment.

[00:42:22] Speaker 03:
That language seems to permit it to use identical or substantially same language.

[00:42:27] Speaker 03:
It doesn't say

[00:42:28] Speaker 03:
doesn't require them to do that.

[00:42:30] Speaker 00:
But of course, when Congress wrote the words identical or substantially similar, it understood that if generics submitted such labels, substantially similar labels, that those labels would infringe the copyrights in the original 30 or 50 page label for the brand name.

[00:42:49] Speaker 01:
And Congress can't have intended... When you said Congress understood, is there

[00:42:53] Speaker 01:
Legislative history evidence of that understanding or just it must be the case because everybody knows that labels are... The legislative history... Is there evidence that copyright was on the minds of the powers that be?

[00:43:09] Speaker 00:
This statute is the same as the Hatch-Waxman amendments at the Second Circuit addressed in Smith Klein Beecham to the extent there's not legislative history.

[00:43:17] Speaker 00:
The language is a little bit different.

[00:43:21] Speaker 00:
The point I was trying to make, Your Honor, is that the Second Circuit there said, had Congress considered this intersection between copyright and the Hatch-Waxman amendments?

[00:43:30] Speaker 01:
It was sort of an attributed understanding.

[00:43:32] Speaker 00:
Yes.

[00:43:33] Speaker 00:
The Second Circuit had no doubt that Congress dared to satisfy the purposes of the Hatch-Waxman amendments, which are very similar in terms of facilitating generic entry to the market, to FIFRA, that Congress would not have wanted the generics to be held up in copyright litigation.

[00:43:49] Speaker 00:
Which came first?

[00:43:51] Speaker 02:
With Fiffer or Hatch-Waxman.

[00:43:54] Speaker 02:
I thought the Me Too provision was prepared first.

[00:43:58] Speaker 02:
Am I wrong?

[00:43:59] Speaker 00:
I thought that was 1988.

[00:44:03] Speaker 01:
Does that sound right?

[00:44:06] Speaker 00:
The Me Too provision is 1988.

[00:44:09] Speaker 00:
That's correct.

[00:44:10] Speaker 00:
So that would post the Hatch-Waxman amendment.

[00:44:14] Speaker 01:
And maybe even originally in some original Hatch-Waxman proposals, chemicals were included and it was carved out.

[00:44:21] Speaker 00:
possible, Your Honor.

[00:44:23] Speaker 00:
But here, of course, we know that from the legislative history that is cited in pages 8 and 15 of our brief, that Congress intended to fast-track generics onto the market.

[00:44:35] Speaker 00:
And of course, EPA can't do that unless the labels are substantially identical.

[00:44:40] Speaker 00:
Now, under Syngenta's view, when Congress wrote those words, identical or substantially similar or differing in small ways when we're talking about communicating important health and safety information,

[00:44:51] Speaker 00:
that that was setting up a copyright trap for the unwary.

[00:44:55] Speaker 00:
And that can't be what Congress had in mind.

[00:44:58] Speaker 00:
It really is, Your Honor, the idea of reconciling and harmonizing these two statutes.

[00:45:03] Speaker 01:
We have this specific need to... Can I ask you about that?

[00:45:07] Speaker 01:
There's something on its face a little bit uncomfortable about saying we're going to find a kind of implied repeal, an ouster of one statute by another.

[00:45:21] Speaker 01:
when the to be ousted statute has a safety valve built into it, at least one, the fair use.

[00:45:29] Speaker 01:
Why on a kind of statutory equivalent of constitutional avoidance, shouldn't we send this back for fair use to be addressed?

[00:45:42] Speaker 01:
Because then you wouldn't have a conflict, or the conflict would be defined and shrunk

[00:45:48] Speaker 01:
you would simply have when there's a certain kind of activity encouraged this much by another statutory regime where the underlying economics doesn't seem to have anything to do with the speech itself, that then they would be actually quite harmonious.

[00:46:10] Speaker 00:
Well, Your Honor, we have argued fair use in the alternative.

[00:46:14] Speaker 00:
I would

[00:46:15] Speaker 00:
encourage the court if you decide the case on fair use grounds to announce some broadly applicable principles that will be of use in future cases.

[00:46:26] Speaker 01:
One problem for fair use is language at least in cases that suggest it's kind of case specific and maybe a court of appeals deciding it for the first time on its own in a categorical way when there hasn't been very much exploration even in the summary judgment

[00:46:45] Speaker 01:
briefing, it was not very elaborately treated.

[00:46:52] Speaker 01:
Maybe that should be done by the district court first.

[00:46:55] Speaker 00:
Your Honor, if, of course, this court has decided fair use as a matter of law in, for example, the Google v. Oracle case, but I am not suggesting that the court couldn't or shouldn't remand

[00:47:11] Speaker 00:
I do think there's not a lot of dispute about the underlying facts in terms of what's in the label.

[00:47:16] Speaker 01:
One of the kinds of facts that was discussed earlier, I think Judge Stoll asked you about, is there's something of a mystery about what's been happening for the last, say, 14 years since FMC and 30 years since 1988.

[00:47:32] Speaker 01:
And has this been really a practical problem?

[00:47:36] Speaker 01:
And somewhere near the core, I think, of your argument about FIFRA

[00:47:40] Speaker 01:
is that this really is a serious practical impediment to the EPA doing what Congress wants it to do.

[00:47:47] Speaker 01:
And I guess I have some uncertainty about just how reliable that is.

[00:47:52] Speaker 00:
Well, Your Honor, of course, the United States has taken the position in subsequent copyright litigation that has been brought against the generics that FMC was wrongly decided.

[00:48:01] Speaker 00:
How many cases?

[00:48:04] Speaker 00:
There are at least two that I'm aware of.

[00:48:07] Speaker 00:
There are declarations from those cases at appendix 1165 and let's see, appendix 1175 in the record here.

[00:48:21] Speaker 00:
Were those cases settled?

[00:48:25] Speaker 00:
Those cases, I believe the cases

[00:48:28] Speaker 00:
settled.

[00:48:29] Speaker 00:
I know there weren't any, there weren't appeals from those decisions.

[00:48:33] Speaker 00:
They may have been appealed and then settled.

[00:48:36] Speaker 00:
That was true in the FMC decision as well.

[00:48:39] Speaker 00:
But this is, the point here is that generics reading the statute of course understand as Congress intended the whole idea was to copy the brand name label because EPA has spent a lot

[00:48:51] Speaker 00:
of resources making sure the brand name label is effective at communicating information.

[00:48:56] Speaker 00:
You don't want pesticide users to buy a pesticide with the same active ingredient and pick up a label and wonder why it's different.

[00:49:04] Speaker 03:
Why wouldn't the Fair Use Doctrine be a sufficient safeguard here in this case?

[00:49:10] Speaker 03:
An escape patch.

[00:49:12] Speaker 03:
A legislative escape patch in order to prevent copyright actions in these type of cases.

[00:49:20] Speaker 00:
And Your Honor, to be clear, we think it could.

[00:49:23] Speaker 00:
And it's because of many of the same principles that underline our top line argument.

[00:49:28] Speaker 00:
Now, of course, we think the court can resolve this case the way the Second Circuit did in Smith Klein Beach and without reaching fair use and harmonize the statutes to find that the Copyright Act yields in these very narrow circumstances given the language in FIFRA.

[00:49:42] Speaker 00:
But if the court were not to do that for the reasons that FIFRA encourages

[00:49:49] Speaker 00:
the generics to use identical or substantially similar labels, and they're doing so to comply with the statute.

[00:49:55] Speaker 00:
That would be a reason to find fair use in these circumstances.

[00:49:58] Speaker 03:
OK.

[00:49:59] Speaker 03:
We've got your argument.

[00:50:01] Speaker 03:
Mr. Levine, I gave you plenty of time during your direct.

[00:50:06] Speaker 03:
You reserved eight, but can you take four?

[00:50:09] Speaker 03:
Take four minutes.

[00:50:09] Speaker 04:
I'll try to take even less, Your Honor.

[00:50:11] Speaker 04:
Let me first just respond to Judge Toronto with respect to your question for the specific page number, as Judge Stoll pointed out, page 25.

[00:50:19] Speaker 04:
is the answer.

[00:50:21] Speaker 04:
The heading on page 25 is, the district court aired as a matter of law in holding that HIFRA precludes Syngenta's copyright claims.

[00:50:30] Speaker 04:
The first sentence then set forth the district court holding.

[00:50:33] Speaker 04:
The second sentence says that despite stating that copyright protection is precluded for the required elements of pesticide labels, the district court granted Willow Woods motion for summary judgment on Syngenta's copyright claims.

[00:50:47] Speaker 04:
Dropping a footnote, the footnote explains the

[00:50:50] Speaker 04:
difference between the required elements, non-required elements.

[00:50:53] Speaker 04:
And then the very next sentence on page 55 makes specific reference to the district court creating a judicial exception to copyright protection for pesticide labels in their entirety.

[00:51:05] Speaker 04:
With respect to the issue that the government argued about this creating a problem, as Judge Stoll you pointed out, it's been substantial time since FMC

[00:51:17] Speaker 04:
There hasn't been a logjam of litigation.

[00:51:20] Speaker 02:
The amici generics pointed out... Are you aware of any litigation other than that identified by the government?

[00:51:26] Speaker 04:
I am aware of the statement in the amici generics brief in which they said in a few instances there was litigation and in all instances they've been able to reach a resolution.

[00:51:38] Speaker 04:
Just a handful of litigation.

[00:51:40] Speaker 01:
One thing that's very interesting... Can I just ask, do you have any reason to think that that's because

[00:51:46] Speaker 01:
at least since the government, pretty fast after FMC said, we think this is wrong, that the pioneer companies have said, these copyright claims, they're really not worth much.

[00:52:00] Speaker 01:
And so we're not going to press it much.

[00:52:02] Speaker 04:
No, I think that there's so many different ways that one can express the various components of the label that these companies who oftentimes almost use a regular course work with regulatory consultants

[00:52:15] Speaker 04:
They come up with their own language to distinguish themselves.

[00:52:19] Speaker 04:
It's a rare case like we have here with Willowwood where they copied verbatim and initially didn't even change the name of Syngenta to Willowwood.

[00:52:27] Speaker 04:
So I think that the companies within the industry are able to paraphrase and come up with their own language.

[00:52:34] Speaker 01:
But I can ask what remedies, assuming you found you've got a copyright liability verdict, what are the remedies that either you have sought, would be seeking?

[00:52:45] Speaker 04:
Well, there could be statutory damages under the Copyright Act.

[00:52:49] Speaker 01:
So that would be what, minimum of $750 per label?

[00:52:54] Speaker 04:
Well, depending upon how that's interpreted in terms of whether it's per label or one label as applied to the entirety of a particular product.

[00:53:05] Speaker 04:
There could be other damages or it could just be equitable relief to prevent the

[00:53:09] Speaker 04:
copying and the use of an infringing label.

[00:53:12] Speaker 01:
Do you think an injunction would be warranted if it was, as I think it's the premise of your view, that with enough effort they could fiddle with the words of their label and get a non-infringing one?

[00:53:26] Speaker 01:
an injunction in those circumstances against the marketing of the product, really?

[00:53:30] Speaker 04:
Well, I think the injunction would prevent the copying to the extent that they can design around just like you can in patent context if they design around in the injunction.

[00:53:39] Speaker 01:
And what about loss profits or actual damages or disgorgement of their profits?

[00:53:45] Speaker 01:
on the assumption that they could have done the label perfectly.

[00:53:49] Speaker 04:
Those are available remedies, but we never got to that point at the district court level because the case was dismissed at summary judgment.

[00:53:57] Speaker 02:
Going back to the injunction question, I presume that you'd have to balance all the factors that are required for an injunction, public interest, all those different things as well in the copyright cases.

[00:54:08] Speaker 02:
Correct.

[00:54:09] Speaker 04:
Yeah, the equitable factors are set forth in eBay.

[00:54:13] Speaker 04:
And the government's arguments are really policy arguments at bottom.

[00:54:18] Speaker 04:
If they believe that there are problems with them being able to comply with what is set forth in the statute, those are issues that need to be fixed, addressed to, and fixed by Congress.

[00:54:30] Speaker 04:
Let's look at what happened.

[00:54:31] Speaker 04:
as set forth in the... I'm going to ask that you conclude.

[00:54:35] Speaker 03:
You're over your time again.

[00:54:36] Speaker 04:
Okay.

[00:54:37] Speaker 04:
The point I was going to make was simply that when there was a logjam based on the data comp revisions, Congress stepped in relatively quickly with the 1978 amendments and created binding arbitration, quickly solving the problem.

[00:54:52] Speaker 04:
So the problem the government perceives should be addressed to Congress and let them address it.

[00:54:57] Speaker 03:
Thank you.

[00:54:58] Speaker 03:
Okay.

[00:54:58] Speaker 03:
Thank you.

[00:54:58] Speaker 03:
We thank all the parties for the arguments this morning.

[00:55:01] Speaker 03:
This court will now be in recess.