[00:00:00] Speaker 04:
First argued case this morning is number 191133, Biogen MA against EMD Serono, Inc.

[00:00:10] Speaker 04:
Mr. Perry.

[00:00:12] Speaker 02:
Thank you, Judge Newman, and may it please the Court.

[00:00:16] Speaker 02:
The jury made the factual finding that the asserted claims are anticipated by prior art uses of native interferon beta

[00:00:24] Speaker 02:
And that finding is supported by substantial evidence, including Dr. Lodish's testimony.

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And I quote, the beta interferon made recombinantly is the same interferon polypeptide as native human interferon.

[00:00:39] Speaker 02:
And that's page 79720 of the record.

[00:00:42] Speaker 02:
Dr. Lodish was summarizing the Interfarm Report, a comprehensive scientific study that compared these two products and concluded at page 50559, quote, recombinant beta interferon is identical to human fibroblast interferon, end quote.

[00:01:00] Speaker 02:
And the jury was instructed that the polypeptide of the claims, and these claims recite a polypeptide, not a protein or a glycoprotein, is, quote, a linear sequence of amino acids.

[00:01:12] Speaker 02:
That's at page appendix 47651.

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And Biogen itself introduced evidence that, and I'm quoting again, the amino acid sequence of rebif, which is our recombinant product,

[00:01:24] Speaker 02:
is identical to that of natural fiber blast derived from interferon beta.

[00:01:34] Speaker 04:
But wasn't the question, not so much the amino acid sequence, but whatever else, particularly the carbohydrates attached to the polypeptide, whether they were identical or not?

[00:01:47] Speaker 02:
That was not the question put to the jury.

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That's the question the district court decided after the verdict.

[00:01:52] Speaker 01:
But isn't that a question that is

[00:01:55] Speaker 01:
necessary to answer because the claim

[00:01:59] Speaker 01:
refers to a therapeutically effective amount?

[00:02:02] Speaker 02:
No, Your Honor, for two reasons.

[00:02:04] Speaker 02:
First, the claim refers to a polypeptide.

[00:02:07] Speaker 02:
And the patent defined polypeptide as the sequence.

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And the jury was instructed on the sequence.

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The jury was never instructed on three-dimensional structures, glycosylation, sugars, carbohydrates.

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And Biogen never requested such an instruction.

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None of that was part of the anticipation analysis before the jury.

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And this is of a jury finding a fact reviewed for substantial evidence.

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So they waived all those arguments.

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But second, and more importantly,

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Therapeutic effectiveness or biological activity requires a three-dimensional structure.

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Not carbohydrate groups, but a three-dimensional structure.

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And the evidence on three-dimensional structure is very clear.

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This is Appendix 505.41.

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Quote, the two protein molecules have the same three-dimensional structure.

[00:02:48] Speaker 02:
So that even if the question were the protein and not the polypeptide, they have the same three-dimensional structure.

[00:02:54] Speaker 01:
So there's no specific three-dimensional structure.

[00:02:57] Speaker 01:
issue here.

[00:02:58] Speaker 02:
They all have the same.

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They're all interferon beta proteins.

[00:03:02] Speaker 02:
There is a fundamental mischaracterization by my friends on the other side that somehow there is a difference within these populations that is false.

[00:03:09] Speaker 02:
Polypeptides of this sequence are interferon beta.

[00:03:13] Speaker 02:
If you don't have this sequence, it is not interferon beta.

[00:03:16] Speaker 02:
And by the way, the patentee here chose to define his claims, Dr. Feers, by the polypeptide because two reasons.

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He did not have possession of the complete protein.

[00:03:26] Speaker 02:
He never expressed a complete protein or characterized a complete protein.

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And Judge Newman, specifically as to the carbohydrate groups, Dr. Fears worked only in E. coli bacteria, which do not glycosylate.

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They do not create carbohydrate groups.

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So he never had possession of a carbohydrate group.

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He never disclosed or enabled a carbohydrate group.

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And he certainly did not claim a carbohydrate group.

[00:03:47] Speaker 02:
So this whole argument about carbohydrate structures that the district court latched on after the verdict

[00:03:52] Speaker 02:
was not submitted to the jury, is not part of the verdict, is irrelevant to the case, is not in the claims, and is contrary to the way the applicant did this.

[00:04:02] Speaker 02:
In fact, their infringement case, they didn't prove carbohydrate structures.

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They didn't prove three-dimensional structure.

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They proved a linear sequence of amino acids.

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And there's a difference here, by the way, between various claims in the preceding cases of this court.

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The Amgen case, which of course is front and center here,

[00:04:22] Speaker 02:
The Amgen patents claimed a glycoprotein, a glycosylated protein.

[00:04:29] Speaker 02:
And therefore, the carbohydrate groups were important.

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This patent does not claim a glycoprotein for the simple reason that Dr. Fears was never in possession of a glycoprotein.

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He never even saw a glycoprotein.

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And he could not have claimed a glycoprotein.

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And therefore, the carbohydrate groups are literally irrelevant.

[00:04:45] Speaker 02:
And all of that discussion is not germane to the patent.

[00:04:49] Speaker 02:
There's a third argument I'd like to add to this point.

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Biogen brought an expert, Dr. Garcia, to the trial to rebut the defendant's invalidity theories.

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He had three opinions, one of which was solely on anticipation.

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And it was solely that these two molecules are different because of the carbohydrate structures.

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The jury heard Dr. Garcia testify about that over and over again.

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And in closing argument, this is what

[00:05:20] Speaker 02:
Biogen told the jury they had to decide.

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If we want to get into the facts, into the facts, Dr. Garcia explained that it's wrong for this legal concept of anticipation.

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The natural human interferon would have to be exactly the same as recombinant.

[00:05:38] Speaker 02:
And it's not.

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That, in fact, was Biogen's entire argument on anticipation, and the jury rejected that.

[00:05:44] Speaker 02:
The jury found that they are exactly the same.

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And to come back to where I started, you know, this is a substantial evidence case.

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This is a jury verdict.

[00:05:52] Speaker 04:
I thought it wasn't disputed that there were differences.

[00:05:56] Speaker 04:
That the differences were not in the polypeptide portion of the interferon, but in the attachments.

[00:06:04] Speaker 02:
That is incorrect, Judge Newman, and let me explain.

[00:06:09] Speaker 02:
The Interfarm study, which is a pre-litigation, neutral, scientific examination of this question, asked, are these two products identical?

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The Interfarm study went through 13 structural measures and seven functional measures and found that the proteins are identical on every single metric.

[00:06:29] Speaker 04:
Yes, the proteins are identical.

[00:06:31] Speaker 02:
Yes, Your Honor.

[00:06:31] Speaker 04:
I think that was undisputed.

[00:06:33] Speaker 02:
That is absolutely undisputed.

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And so the only question is, is there any difference in the carbohydrate structure, which is not claimed and was not presented to the jury in the jury instructions.

[00:06:42] Speaker 02:
But even to answer that question on the science, which I submit is not before the court, given the jury verdict, we have a finding of fact here.

[00:06:49] Speaker 02:
But if we were to talk about that,

[00:06:51] Speaker 02:
The evidence on the carbohydrate structures is the populations are overlapping.

[00:06:56] Speaker 02:
There's more than 80% identicality in the molecules at the atomic level in a population of human interferon beta and recombinant interferon beta.

[00:07:06] Speaker 02:
And that's in the Kagawa study, table three.

[00:07:09] Speaker 02:
It's also in the Interfarm study.

[00:07:12] Speaker 02:
These are comprising claims.

[00:07:14] Speaker 02:
The administration of a compound comprising blah, blah, blah, the polypeptides.

[00:07:20] Speaker 02:
Patients in the prior art that received the native necessarily, absolutely received the identical, atomically identical to the carbohydrate structure of the recombinant because there's 80% population overlap.

[00:07:33] Speaker 02:
And so when we talk about the differences, Your Honor, it only is that very small port of an unclaimed... Are you saying they were the same carbohydrates?

[00:07:41] Speaker 02:
They are the same carbohydrates.

[00:07:42] Speaker 02:
Yes, Your Honor.

[00:07:43] Speaker 04:
And the Interfarm study goes through the carbohydrates very carefully at 505... It was clear that they are carbohydrates, but I thought it was undisputed that they were different carbohydrates.

[00:07:53] Speaker 02:
No, Your Honor.

[00:07:55] Speaker 02:
Let me try to explain.

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And this is at 50529 to 50531 of the Interfarm study.

[00:08:01] Speaker 02:
The bi-antenary glycan chain, which is the carbohydrate structure, is, quote, identical in its structure.

[00:08:12] Speaker 02:
So the branches of carbohydrates that come off of the polypeptides are identical.

[00:08:19] Speaker 02:
The microheterogeneity, to use the word of the InterFarm study, is that certain of the individual sugars in the glycan chain vary within the population.

[00:08:30] Speaker 02:
And Kagawa determined that there's seven different microvariants in the individual sugars.

[00:08:36] Speaker 02:
But the structure is identical.

[00:08:39] Speaker 04:
Would you turn to the use

[00:08:41] Speaker 04:
And to the point that the district court made that what's claimed is the use of the synthetic product?

[00:08:50] Speaker 02:
Well, there's two points there, Your Honor, if I'm understanding the question.

[00:08:53] Speaker 02:
The first is that this is pitched as a method of treatment patent.

[00:08:58] Speaker 02:
Biogen admitted at trial that it invented no method of treatment, so that the use was known.

[00:09:04] Speaker 02:
This is an old use of a product.

[00:09:08] Speaker 02:
Biogen's lead expert was asked, there's no new information about treatment in the patent.

[00:09:13] Speaker 02:
We agree.

[00:09:14] Speaker 02:
And in fact, again, in closing, Mr. Groombridge, who we'll hear from in a minute, says, quote, no one is suggesting that Dr. Fears came up with a new way of treating some disease with beta interferon that had never been used before.

[00:09:25] Speaker 04:
Well, it can't be an old use of a product before the product existed.

[00:09:29] Speaker 02:
Your Honor, that's the whole point.

[00:09:30] Speaker 02:
The product did exist.

[00:09:31] Speaker 02:
The polypeptide, the 166 amino acids arranged in a linear sequence is identical.

[00:09:37] Speaker 02:
There is absolutely no difference.

[00:09:39] Speaker 02:
As the natural product and the recombinant product.

[00:09:41] Speaker 02:
Figure 4 of the patent shows the DNA sequence and the amino acid sequence.

[00:09:45] Speaker 02:
They are identical.

[00:09:47] Speaker 02:
Identical, identical.

[00:09:48] Speaker 03:
But there's no prior art, is there, that explicitly discloses this method using the recombinant interferon?

[00:09:55] Speaker 02:
The prior art shows everything except the recombinant source limitation, which brings us to how we got here, right?

[00:10:01] Speaker 02:
Let's remember what happened.

[00:10:02] Speaker 02:
Let's rewind the tape a little bit.

[00:10:03] Speaker 03:
I mean, what baffles me in this case is how the jury could have found anticipation, but not obviousness, when it seemed like there was a method out there that everybody knew using the natural form

[00:10:17] Speaker 03:
And the recombinant versions were also in the prior art, but just not put together.

[00:10:22] Speaker 03:
But since they did find no obviousness for whatever reason, and you're not challenging it on appeal, then it seems to me that it's still an important question whether, for anticipation, there's enough difference between the recombinant form and the natural form that the method is not explicitly anticipated.

[00:10:45] Speaker 02:
Judge Hughes, I agree with the last part of that, which is it was our burden, the defendant's burden to prove.

[00:10:51] Speaker 02:
that the two molecules were identical.

[00:10:53] Speaker 02:
That was the challenge set to us by the Amgen case, which says it's a question of fact.

[00:10:59] Speaker 02:
Quote, does the source limitation distinguish the recombinant protein from the native protein?

[00:11:04] Speaker 02:
That's the holding of Amgen.

[00:11:05] Speaker 02:
That's the factual question when you have a source limitation.

[00:11:08] Speaker 02:
And there's no dispute in this case that the recombinant production is a source limitation.

[00:11:13] Speaker 02:
And we proved with multiple evidence.

[00:11:17] Speaker 02:
I mean, we've got pages and pages of evidence

[00:11:19] Speaker 02:
that they are identical.

[00:11:21] Speaker 02:
Certainly the claimed polypeptides, the polypeptides of the claims are identical.

[00:11:26] Speaker 03:
Before you run out of time, and there are a lot of issues in this case, but can I just ask you about the jury instruction on the contributory infringement and not allowing them to consider reasonable belief in non-infringement?

[00:11:40] Speaker 03:
Yes, Your Honor.

[00:11:40] Speaker 03:
Can you just address that?

[00:11:42] Speaker 02:
Surely.

[00:11:43] Speaker 02:
The point is very simple.

[00:11:44] Speaker 02:
The Supreme Court made clear that

[00:11:47] Speaker 02:
A good faith belief in non-infringement is a defense to both contributory and inducement, which is obvious because they both have the knowledge requirement.

[00:11:55] Speaker 02:
The Supreme Court said that in so many words.

[00:11:58] Speaker 02:
We asked for that instruction to be given, and the district court refused.

[00:12:01] Speaker 02:
And the prejudice was enormous.

[00:12:03] Speaker 02:
Mr. Groombridge, my friend here, stood up in closing argument and said, what's in their heads doesn't matter.

[00:12:09] Speaker 02:
Now, remember, their burden of proof was to show that we knew

[00:12:12] Speaker 02:
that the product acts on MS through immunomodulation.

[00:12:16] Speaker 02:
And he said, what's in our heads doesn't matter.

[00:12:18] Speaker 02:
And that jury instruction didn't give the jury any way to evaluate what was in our heads, because the evidence, again, was undisputed that we did not know, and we do not know to this day, how it works.

[00:12:27] Speaker 03:
And if we find error on that, the remedy is what?

[00:12:31] Speaker 02:
That's a new trial.

[00:12:32] Speaker 03:
A new trial on that issue.

[00:12:33] Speaker 03:
And how does that affect the inducement prong?

[00:12:37] Speaker 03:
I know it's a little bit different, but.

[00:12:39] Speaker 03:
Does there need to be a new trial on inducement as well?

[00:12:42] Speaker 02:
We would submit that the jury's verdict on inducement is amply supported and not to be reinstated as with the verdict on anticipation.

[00:12:48] Speaker 02:
The district court took away the no-inducement verdict based on this flawed contributory verdict and a finding that no reasonable jury could find that we didn't know how the product worked, even though the evidence is undisputed that we do not know how the product worked.

[00:13:03] Speaker 02:
If I could reserve the balance of my time.

[00:13:05] Speaker 04:
Let's hear from the other side, and we'll save you rebuttal time.

[00:13:08] Speaker 04:
Thank you, Your Honor.

[00:13:13] Speaker 00:
Morning, judges.

[00:13:16] Speaker 00:
I'd like to start with the anticipation question.

[00:13:19] Speaker 00:
And maybe, Judge Hughes, I could talk just to the question of how could the jury have found anticipation but not obviousness.

[00:13:27] Speaker 00:
The entire focus of this five-week trial was obviousness.

[00:13:30] Speaker 00:
And it was about whether or not the recombinant material is or is not biologically active.

[00:13:35] Speaker 00:
And that's what these leading scientists around the world were in a race to try and prove.

[00:13:40] Speaker 00:
So obviousness was very much

[00:13:41] Speaker 00:
what the jury was looking at.

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And the question, I think, was all about biological activity.

[00:13:46] Speaker 00:
Now, with respect, I'd like to respond to what my good friend Mr. Perry has said about identity of molecules.

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The evidence here, the only evidence, is that the molecules are not identical.

[00:14:01] Speaker 00:
And in fact, he refers to the Interfarm report.

[00:14:05] Speaker 00:
We have some issues about that because it's many years after the priority date, but assume that that

[00:14:10] Speaker 00:
is competent evidence of what was in the prior art.

[00:14:13] Speaker 00:
The Interfarm report shows that there is not one single identical molecule in recombinant DNA and native human bait interferon.

[00:14:25] Speaker 01:
But the linear amino acid chains are the same.

[00:14:29] Speaker 00:
Exactly, Your Honor.

[00:14:30] Speaker 00:
The amino acid chain is the same, but hanging off that chain are these sugar moieties.

[00:14:39] Speaker 00:
Appendix 50528, at the top of the page, there is a handwritten drawing showing the sugar structures that are in the native product and the sugar structures, carbohydrate structures, that are in the recombinant product.

[00:14:53] Speaker 00:
And they are different.

[00:14:54] Speaker 00:
They're not the same molecules.

[00:14:56] Speaker 00:
Not one of them is the same.

[00:14:57] Speaker 00:
And the reason that Mr. Perry can say, quote, pieces are talking about saying that structures are identical, is because they are defined by structural formulae that

[00:15:09] Speaker 00:
have variables like n can be 0 or 1.

[00:15:13] Speaker 00:
And so in the native, it's 0.

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And in the recombinant, it's 1, or vice versa.

[00:15:18] Speaker 00:
They're not the same molecule.

[00:15:20] Speaker 00:
And when their expert was asked by one of their lawyers about the conclusion of the Interfarm report, this is Dr. Lodish, he disagreed with that language saying that they're identical.

[00:15:33] Speaker 00:
His response to the question was, I would not call them identical.

[00:15:37] Speaker 00:
I would call them very similar.

[00:15:39] Speaker 00:
And that is the entire point here.

[00:15:42] Speaker 00:
And by the way, the Kagawa reference at 51646 says, it literally says, recombinant beta interferon is, quote, quite similar to its native counterpart, except for, and then it lists three structural differences.

[00:16:00] Speaker 00:
And so there is no evidence here on which a jury could have found that the molecules are identical.

[00:16:07] Speaker 00:
They're not identical.

[00:16:08] Speaker 00:
And indeed, the entire reason for the non-human limitation in the claims is that, to make sure the claims don't cover the use of native beta interferon.

[00:16:17] Speaker 00:
And so we have all of that.

[00:16:20] Speaker 00:
Now, I think maybe perhaps there's a legal dispute.

[00:16:23] Speaker 00:
I take the appellant's premise here to be that as a matter of looking at the claims, their argument is, well,

[00:16:30] Speaker 00:
Even if there's a difference in these carbohydrates or sugar structures, that's not claimed.

[00:16:37] Speaker 00:
And we think that that is completely wrong.

[00:16:40] Speaker 00:
So first of all, Judge Lynn, as Your Honor commented, these claims specifically call out a therapeutically effective amount.

[00:16:49] Speaker 00:
So that the thing has to be biologically active.

[00:16:52] Speaker 04:
To be sure I understand.

[00:16:54] Speaker 04:
When you say there are three structural differences, you're not talking about the protein then.

[00:17:00] Speaker 04:
You're talking about the entire molecule.

[00:17:03] Speaker 04:
with the attached pertinent sugars?

[00:17:06] Speaker 00:
Exactly, Your Honor.

[00:17:07] Speaker 00:
The differences reside in the sugars or carbohydrates.

[00:17:11] Speaker 00:
Just as in the Angin case in this court in 2009, that's the difference.

[00:17:15] Speaker 00:
And it's what makes the recombinant product novel.

[00:17:19] Speaker 00:
It didn't exist in nature.

[00:17:22] Speaker 00:
And therefore, it can be patented.

[00:17:25] Speaker 00:
And therefore, the use of it is not anticipated by the use of native bait interfero.

[00:17:30] Speaker 00:
Now, we separately

[00:17:32] Speaker 00:
In our view, the mere fact that the claim recites recombinant distinguishes prior art because, as Judge Hughes asked previously, there is no prior art that shows any usage of recombinant.

[00:17:45] Speaker 03:
If the court... If they could have proved that the recombinant and the native interferon are exactly the same, would the fact that there's no prior art on the recombinant matter

[00:17:58] Speaker 00:
In our view, Your Honor, yes, and the reason is because this is a method claim, not a product claim.

[00:18:04] Speaker 00:
And why do I say that?

[00:18:06] Speaker 00:
The question with the product claim is whether the product is new or old, is it in the prior art, regardless of how it be made.

[00:18:13] Speaker 00:
But with a method claim, the question is, was this series of actions performed in the prior art?

[00:18:20] Speaker 00:
As the District Court found in claim construction, the source limitation, while it need not be performed by the direct infringer, by the person who's administering the drug, does have to be performed, quote, by someone, somewhere, at some time.

[00:18:33] Speaker 00:
And therefore, in our view, Your Honor,

[00:18:35] Speaker 00:
the proper analysis here is that this claim requires a series of activities by human beings, which activities never occurred in the prior arts and therefore can't be anticipated.

[00:18:46] Speaker 01:
If the claim is limited to the polypeptide and the native interferon is therapeutically effective, just as the recombinant interferon is therapeutically effective, then why isn't that the same?

[00:19:05] Speaker 00:
I think, Your Honor, in that situation, if one were to conclude that the structure of the carbohydrates is irrelevant and if one were to conclude that biogen is wrong and this idea that it requires people to have engaged in activities to satisfy the source limitation.

[00:19:20] Speaker 00:
then that result would flow.

[00:19:23] Speaker 00:
Yeah.

[00:19:23] Speaker 01:
Tell me why that's the wrong conclusion.

[00:19:26] Speaker 00:
So I think the first point is that the source limitation here is a meaningful limitation in this claim.

[00:19:32] Speaker 00:
I don't believe there's any dispute on that, but certainly that was what the district court found.

[00:19:36] Speaker 00:
And therefore, it requires that the recombinant creation of the molecule have been done, just not by the person who's actually then going to administer it to the patient in need thereof.

[00:19:50] Speaker 00:
And if the court accepts Bargen's view on that point, then that is the end of the story.

[00:19:55] Speaker 00:
We don't need to get into any of the questions or any of the other questions because it's conceded.

[00:20:00] Speaker 00:
There would be no anticipation.

[00:20:03] Speaker 00:
And I would also like to say that just before I leave this, Your Honor, that to this point, if it's not claimed, the sugar structures aren't claimed, that's wrong.

[00:20:14] Speaker 00:
If you apply product by process law, which of course the appellants argue one should,

[00:20:20] Speaker 00:
this court in Amgen and then following Amgen in Greenland and Purdue explicitly said, if the process limitations of a product by process claim confer structural difference over the prior art, even though that structural difference be not explicitly recited in the claim, it is nonetheless part of the claim because of the process limitations in the claim.

[00:20:46] Speaker 00:
And therefore, in our view,

[00:20:47] Speaker 00:
That absolutely brings us to say that these differences of carbohydrate structure are part of the claim, whether you think that that polypeptide means nothing more than an array of amino acids or whether you think it connotes biological activity.

[00:21:04] Speaker 00:
And that, in fact, was the very point of distinction in the Amgen case, where that principle of law was first enunciated.

[00:21:13] Speaker 00:
And so in our view, because the source limitation

[00:21:17] Speaker 00:
recombinant production necessarily leads to a difference at the molecular level.

[00:21:22] Speaker 00:
The difference at the molecular level in the carbohydrates is part of the claim.

[00:21:26] Speaker 00:
And so with that, I would turn to the intent question about contributory infringement and inducement, unless the court has further questions on anticipation.

[00:21:37] Speaker 00:
Judge Hughes, to pick up with your question, in our view, the issue is this.

[00:21:42] Speaker 00:
And maybe what it sets up is,

[00:21:46] Speaker 00:
What is the difference in Sienta between contributory infringement and inducement?

[00:21:53] Speaker 00:
And that issue has not been squarely addressed, we think, either by this court or the Supreme Court.

[00:22:00] Speaker 00:
And the question then, if we look back at that, we know that they have Sienta requirements.

[00:22:05] Speaker 00:
We know from Comel that those requirements are similar.

[00:22:08] Speaker 00:
That's the word that Comel uses, but not the same, therefore.

[00:22:12] Speaker 00:
And if we look at the origin,

[00:22:14] Speaker 00:
of contributory infringement.

[00:22:16] Speaker 00:
As, for example, Judge Rich laid it out in 1990 in the opinion in Hewlett-Backard versus Bausch and Lomb, it was a type of indirect infringement that was specifically carved out in the 1952 statute from everything else that was going to be inducement.

[00:22:35] Speaker 00:
And the reason that it existed was because if certain circumstances were met, intent to infringe

[00:22:43] Speaker 00:
And that intent to infringe could be presumed.

[00:22:45] Speaker 00:
And that is what the Supreme Court said in Grokster, that that is the reason why contributory infringement exists.

[00:22:52] Speaker 00:
We can presume intent to infringe.

[00:22:55] Speaker 00:
Those are the very words of the Supreme Court in Grokster.

[00:22:58] Speaker 00:
And therefore, if we were to adopt the principle that is advocated by the appellants here, it would render contributory infringement mere surplusage.

[00:23:07] Speaker 00:
Because it would say that the only reason why contributory infringement exists in the statute

[00:23:13] Speaker 00:
is for this to presume intent.

[00:23:15] Speaker 00:
If I nevertheless have to prove the same intent, then there's no reason for contributory infringement even to be there.

[00:23:22] Speaker 00:
It's simply

[00:23:23] Speaker 00:
inducement plus some extra requirements right and so that can't be the right answer and in fact we think there is guidance as the district court found in section 298 which says declining to waive privilege can't be held against you for purposes of inducement but is silent on contributory infringement we think that that is a clear indication that intent

[00:23:45] Speaker 00:
the type of intent that would be proven, for example, by reliance on advice of counsel is not an element of contributory infringement.

[00:23:55] Speaker 00:
If the appellants are right, then the law says that I can ask for an adverse inference based on your failure to waive privilege for contributory infringement, even though the statute explicitly prohibits that for inducement.

[00:24:07] Speaker 00:
In our view, that cannot be the right answer.

[00:24:10] Speaker 00:
The whole reason that contributory infringement exists is because it has a lower standard of cn

[00:24:16] Speaker 00:
And we would candidly admit, this court has never squarely addressed what is the lowest standard.

[00:24:22] Speaker 00:
It has articulated that it's lower.

[00:24:24] Speaker 00:
It has talked about it in a number of cases.

[00:24:27] Speaker 04:
Haven't we addressed from the beginning that the issue is whether there is a substantial non-infringing use?

[00:24:36] Speaker 00:
The difference?

[00:24:37] Speaker 00:
Your Honor, that aspect has certainly been addressed.

[00:24:39] Speaker 00:
And here, there is no dispute.

[00:24:40] Speaker 00:
It's not challenged.

[00:24:42] Speaker 00:
that the product in question has no, never mind substantial, has no non-infringing use whatsoever.

[00:24:48] Speaker 00:
But the purpose of... Sure, but this isn't a product claim.

[00:24:52] Speaker 03:
I mean, this is a method claim.

[00:24:54] Speaker 03:
And so if they think that because of the way they construe your claim that their sale of this doesn't infringe that method, why isn't that relevant to their

[00:25:08] Speaker 03:
reasonable belief in whether they're infringing or not.

[00:25:11] Speaker 00:
And I think I would direct the court to the Grokster case.

[00:25:14] Speaker 00:
And what I would say, Your Honor, is that that's exactly why contributory infringement exists.

[00:25:18] Speaker 00:
In the circumstance where you know of the patent, you know of the infringement, and we could have a debate about what know of the infringement means.

[00:25:27] Speaker 00:
But it's less than intend the infringement.

[00:25:30] Speaker 00:
And you make a product that has no use other than to infringe the patent intended for you.

[00:25:35] Speaker 03:
But isn't that the whole point here is that

[00:25:39] Speaker 03:
that their view of how this method works, the product can be used in a way that doesn't infringe that method.

[00:25:47] Speaker 03:
It turns out if we accept everything else, they're wrong.

[00:25:50] Speaker 03:
But their claim construction of this method meant that their sale of this product or offering it to doctors or stuff didn't infringe the method, even though the molecules may have been the same or the like.

[00:26:04] Speaker 03:
But doesn't that still go to whether they

[00:26:08] Speaker 03:
whether they had the specific level of intent for contributory infringement, putting aside inducement.

[00:26:16] Speaker 00:
I would say no, Your Honor, because in that case there would be zero difference between contributory infringement and inducement.

[00:26:22] Speaker 00:
So the only reason for contributory infringement to exist is for that not to be the case.

[00:26:28] Speaker 00:
So that if you are injecting into the stream of commerce something that has no use other than to infringe and you know.

[00:26:35] Speaker 03:
But again, I think maybe we're talking past each other and this is weird because they have a claim construction theory which I think frankly is not correct but if they reasonably believe that

[00:26:46] Speaker 03:
this incorporated the product by process and all that kind of stuff, and that was all part of the method, then their sale of interferon doesn't necessarily infringe that when they didn't make it or they didn't make it in this country or all of that.

[00:27:00] Speaker 03:
Why is that not relevant to contributory infringement?

[00:27:03] Speaker 00:
What we would say, Your Honor, is for inducement that would be true.

[00:27:07] Speaker 00:
But for contributory infringement, because there is necessarily a lower standard of Cienta,

[00:27:12] Speaker 00:
That's not true.

[00:27:14] Speaker 03:
So let me flip it then.

[00:27:15] Speaker 03:
Let's assume their claim construction is correct and that this claim isn't just a method claim of treatment.

[00:27:22] Speaker 03:
It also incorporates the product by process limitations and everything else they asked for.

[00:27:28] Speaker 03:
Do they do all of that?

[00:27:32] Speaker 00:
They have done it.

[00:27:34] Speaker 00:
The reason why they are saying they would not infringe is because they did it.

[00:27:37] Speaker 00:
Some of it they say before the patent issued and they make the product in another country.

[00:27:40] Speaker 00:
But they certainly do it.

[00:27:42] Speaker 00:
There's no dispute that they do it.

[00:27:43] Speaker 00:
The argument is that I don't do it within the jurisdiction, or I did it before your patent issued.

[00:27:50] Speaker 00:
That's why they say they don't infringe.

[00:27:51] Speaker 03:
Well, I mean, if they did it before the patent issued, it's not infringement, right?

[00:27:56] Speaker 03:
I don't want to get tied up in extraterritorial stuff, because that stuff's really confusing, or at least

[00:28:06] Speaker 03:
If this required, and again, I know you don't agree with this, and this may not even be the correct articulation of the facts, but if part of this was the creation of whatever cell line or something to produce this, and that the only time you do that is once, and it was before the patent, that wouldn't infringe, right?

[00:28:24] Speaker 03:
Hypothetically.

[00:28:25] Speaker 00:
Under their claim construction, if you say it's a three-step method and one of the steps is creating the cell line, that's correction.

[00:28:33] Speaker 03:
I don't understand why they weren't allowed to present that to the jury, even if the claim construction ultimately turned out to be incorrect.

[00:28:40] Speaker 00:
They did present it to the jury.

[00:28:41] Speaker 00:
They presented it to the jury in the court.

[00:28:43] Speaker 03:
But they weren't allowed to present their argument that their belief in that claim construction somehow negates.

[00:28:50] Speaker 00:
Yes, they completely were, Your Honor.

[00:28:51] Speaker 00:
They presented that for inducement.

[00:28:54] Speaker 03:
But not for contributory.

[00:28:56] Speaker 00:
The district court had found that while it was relevant evidence and the jury heard it,

[00:29:00] Speaker 00:
And for example, the district court's claim construction opinion is part of the evidence here because of this.

[00:29:07] Speaker 00:
They were not allowed to argue that it negated contributory infringement.

[00:29:11] Speaker 00:
They were allowed to argue and did argue that it negated inducement.

[00:29:16] Speaker 00:
And one final point I would make here, Your Honor, just to your question of what would be the consequence if the court were to agree with the appellants on this, we haven't spoken about FISA.

[00:29:25] Speaker 00:
FISA is a co-defendant that never articulated a reasonable belief in non-infringement.

[00:29:31] Speaker 00:
And therefore, in our view, whatever the consequence may be for EMD Serono, it does not apply to Pfizer.

[00:29:37] Speaker 00:
And therefore, that part of the verdict would stand.

[00:29:41] Speaker 00:
Unless the court has further questions, I know I've already gone over my time, and I apologize.

[00:29:46] Speaker 04:
Thank you, Mr. Groombridge.

[00:29:50] Speaker 04:
We've enlarged your time a little bit.

[00:29:53] Speaker 02:
Thank you, Judge Newman.

[00:29:54] Speaker 02:
Three quick points on anticipation.

[00:29:57] Speaker 02:
Mr. Groombridge agrees that the polypeptides are identical.

[00:30:02] Speaker 02:
Under substantial evidence review and the jury instructions actually given with no objection in this case, that's the end of the appeal.

[00:30:11] Speaker 02:
The verdict has to be reinstated.

[00:30:13] Speaker 02:
The jury was only instructed on polypeptides.

[00:30:15] Speaker 02:
Mr. Groombridge's entire argument was based on sugar groups, carbohydrates.

[00:30:20] Speaker 02:
There is no instruction on sugar groups or carbohydrates.

[00:30:23] Speaker 02:
Biogen did not request one, and the district court did not give one.

[00:30:26] Speaker 02:
That was not presented to the jury in this case.

[00:30:28] Speaker 02:
They are asking for something that they didn't ask the jury for.

[00:30:31] Speaker 02:
If they had asked the jury to consider it, the jury had plenty of evidence.

[00:30:35] Speaker 02:
Let me give you just one more example, and there's reams.

[00:30:37] Speaker 02:
The Revelle patent, which is in the record, 51578, quote,

[00:30:41] Speaker 02:
Hamster cells glycosylate proteins identically to human cells.

[00:30:46] Speaker 02:
And there's more.

[00:30:46] Speaker 02:
And there's more.

[00:30:47] Speaker 02:
The jury heard all kinds of evidence that they're identical even as to the carbohydrates.

[00:30:50] Speaker 02:
Their expert didn't agree.

[00:30:51] Speaker 02:
Their paid expert brought here for that purpose.

[00:30:53] Speaker 02:
But the jury didn't have to believe him.

[00:30:55] Speaker 02:
And so what was actually presented to the jury was this.

[00:30:58] Speaker 02:
Judge Lindy, your question about the claims.

[00:31:00] Speaker 02:
The claim is to a polypeptide.

[00:31:03] Speaker 02:
They never sought a claim construction that said it included the sugar groups for good reason.

[00:31:08] Speaker 02:
Dr. Fears did not know, boo, about the sugar groups.

[00:31:11] Speaker 02:
They were not in his experiments.

[00:31:13] Speaker 02:
They could not have been claimed because he was not in possession of the invention.

[00:31:16] Speaker 02:
He never characterized the complete protein.

[00:31:18] Speaker 02:
They could not have got that as a claim construction.

[00:31:20] Speaker 01:
Do the words therapeutically effective in the claim have no consequence?

[00:31:24] Speaker 02:
Of course they have consequences.

[00:31:25] Speaker 02:
It says that when you put this substance, the amino acid sequence, into the body, it has to change the human functioning.

[00:31:31] Speaker 01:
That's all that therapeutically effective amount means in any... Doesn't that implicate the entire three-dimensional structure with the sugars, etc.?

[00:31:40] Speaker 02:
Not the sugars, Your Honor.

[00:31:41] Speaker 02:
In fact, let's remember what Dr. Fears' experiment was.

[00:31:44] Speaker 02:
he set out to prove that he could force an E. coli cell, a bacterium, to produce this polypeptide with no glycosylation and still have a three-dimensional structure and biological activity.

[00:31:56] Speaker 02:
In fact, that's what they now say was the invention has nothing to do with glycosylation because it was not glycosylated.

[00:32:01] Speaker 02:
So for them now to say that the point of novelty is glycosylation when his so-called invention was proving that an un-glycosylated molecule had biological activity is

[00:32:12] Speaker 02:
Had they presented that on claim construction, it never would have survived.

[00:32:15] Speaker 02:
It also, by the way, if that's really their argument.

[00:32:19] Speaker 02:
come up for the first time after the verdict in this case, it runs straight into 112, because nowhere in this patent are the glycosylation, the three-dimensional structures, enabled or described.

[00:32:29] Speaker 02:
No person of skill in the art could learn about the glycosylation structures in this patent, because he worked only in bacteria that do not glycosylate.

[00:32:36] Speaker 02:
And all of the disclosure, there's 30 pages of the specification, discloses un-glycosylated polypeptides.

[00:32:43] Speaker 02:
That's why the jury was instructed on the polypeptide.

[00:32:46] Speaker 02:
And what you heard in 15 minutes of argument

[00:32:49] Speaker 02:
was nothing that there's not substantial evidence, and this is substantial evidence review, which brings me to my final point on anticipation.

[00:32:54] Speaker 02:
Judge Hughes, you asked about the Amgen issue and the so-called the source limitation and whether it applies.

[00:32:59] Speaker 02:
First, Biogen waived that.

[00:33:01] Speaker 02:
They didn't bring it up on Rule 50A, and most importantly, they didn't object to the verdict question.

[00:33:06] Speaker 02:
The verdict question was, does native anticipate?

[00:33:09] Speaker 02:
They can't give that to the jury and then turn around and say, as a matter of law, Native can't anticipate.

[00:33:13] Speaker 02:
They accepted MGen for the purpose of the trial and then pulled out this free option to try to win later.

[00:33:18] Speaker 02:
That's unacceptable as a matter of civil procedure, trial practice.

[00:33:21] Speaker 02:
You don't get to do that.

[00:33:26] Speaker 02:
It's not a product by process claim.

[00:33:27] Speaker 02:
It doesn't matter.

[00:33:28] Speaker 02:
This is a principle of novelty.

[00:33:29] Speaker 02:
This is a principle that says if I claim a molecule, whether it's from Ohio or from a hamster or from anywhere else, that source limitation matters only if it affects the chemical structure of the molecule, the structural and functional characteristics, and we proved over and over and over and over again

[00:33:46] Speaker 02:
that these things are identical.

[00:33:48] Speaker 02:
I have to come back to the Interfarm study, the conclusion of which recombinant interferon is identical to human interferon.

[00:33:54] Speaker 02:
I mean, that's the only thing we need to know to sustain this jury verdict as the way it was actually submitted to the jury in this case.

[00:34:01] Speaker 02:
This is a jury verdict.

[00:34:03] Speaker 02:
We're not sitting to review a bench trial.

[00:34:05] Speaker 02:
This is a jury verdict.

[00:34:06] Speaker 02:
And as the jury was instructed on agreed instructions and agreed verdict form, that anticipation verdict can only be reinstated under the law.

[00:34:14] Speaker 02:
I see you've exceeded my time.

[00:34:16] Speaker 02:
Thank you for your consideration, Your Honor.

[00:34:18] Speaker 04:
Thank you.

[00:34:19] Speaker 04:
Thank you both.

[00:34:20] Speaker 04:
Case is taken under submission.