[00:00:03] Speaker 01:
The first case for argument this morning is 17-1715, Lupo Pharmaceuticals.

[00:00:10] Speaker 01:
Mr. Quillen?

[00:00:13] Speaker 01:
Is that the way you pronounce your name?

[00:00:15] Speaker 03:
Quillen, Your Honor.

[00:00:17] Speaker 03:
May it please the Court, I'd like to address three issues.

[00:00:20] Speaker 03:
Claim construction, violation of the Administrative Procedure Act, and the Board's wrong standard for a motion to amend.

[00:00:28] Speaker 03:
There's also the issue of the

[00:00:30] Speaker 03:
lack of standing for the pharmacosmos cross appeal.

[00:00:32] Speaker 03:
For issues that I don't address this morning, we rely on our briefs.

[00:00:36] Speaker 03:
On claim construction for both patents, the board erred in construing the term substantially non-immunogenic carbohydrate component in two ways.

[00:00:47] Speaker 04:
First, in the yellow brink of 10, speaking of claim construction, you cite to the 549 patent column two, line seven to 10, where it says the, pardon me, but the risk of

[00:01:00] Speaker 04:
Anaphylactoid hypersensitivity reactions is very low compared to iron dextrin.

[00:01:07] Speaker 04:
And that portion relates to a particular iron carboxymaltose complex, which is described as preferred iron carbohydrate complex.

[00:01:21] Speaker 04:
Now, we've repeatedly warned against confining claims to a preferred embodiment, Phillips, for example.

[00:01:28] Speaker 03:
Why isn't that an improper attempt to limit the broadest reasonable interpretation?

[00:01:32] Speaker 03:
The board has correctly focused on anaphylactoid hypersensitivity reactions and has properly referred to the complex of iron dextrin.

[00:01:44] Speaker 04:
But the limit... Why adverse reactions to iron dextrin rather than merely dextrin?

[00:01:53] Speaker 03:
Because that's the complex, Your Honor.

[00:01:55] Speaker 03:
That's the complex.

[00:01:56] Speaker 03:
This...

[00:01:58] Speaker 04:
What other language in the specification compares the incidence of adverse reactions to iron dextrin rather than merely dextrin?

[00:02:06] Speaker 03:
I don't think, Your Honor, that there's any place in the spec that evaluates dextrin alone.

[00:02:13] Speaker 04:
Why isn't iron improperly limiting broadest reasonable interpretation?

[00:02:25] Speaker 03:
I'm sorry, Your Honor?

[00:02:26] Speaker 04:
Why aren't you improperly limiting the BRI to a particular embodiment?

[00:02:35] Speaker 03:
It's not a particular embodiment, Your Honor.

[00:02:36] Speaker 03:
We've got the claim recites, these components, these features in the Marquish Group, the board has

[00:02:56] Speaker 03:
properly addressed anaphylactoid hypersensitivity.

[00:03:01] Speaker 03:
And the comparison is to iron dextran.

[00:03:08] Speaker 03:
The column one, we're talking about the invention broadly relates to treating conditions with the complexes

[00:03:24] Speaker 03:
in column, and then in column, sorry, line 47, iron dextran, so that's what's being compared, the iron dextran, the first parental product that's available in the U.S.

[00:03:38] Speaker 03:
has been associated with these incident, these anaphylactoid-type reactions, citing fish vein, and this high incidence is bad, da-da-da, and it's markedly lower with other kind of products.

[00:03:50] Speaker 04:
Did the PTAB maker finding that

[00:03:54] Speaker 04:
Fishbane is incorporated by reference?

[00:03:57] Speaker 04:
Or are we supposed to make that a factual determination in the first instance?

[00:04:02] Speaker 03:
Respectfully, it's not a factual situation, Your Honor.

[00:04:08] Speaker 03:
The patent expressly says that.

[00:04:10] Speaker 03:
So you argue it should be treated as an intrinsic evidence.

[00:04:15] Speaker 03:
Exactly.

[00:04:15] Speaker 03:
Column 17, line 50, these references are incorporated by reference.

[00:04:20] Speaker 03:
So the Fishbane and the other reference, the Fishbane is set out, as it were, although the text of Fishbane, as it were, is set out there in lines 47 to 59.

[00:04:28] Speaker 04:
OK, so Fishbane says, quote, the risk of immediate severe anaphylactoid reactions appears to be, at a minimum, approximately 0.6% with intravenous iron dextrin.

[00:04:42] Speaker 04:
They're not putting in intravenous.

[00:04:45] Speaker 04:
The reference goes on to recognize even higher rates of 1.8

[00:04:49] Speaker 04:
and 1.7% showing up in patient populations, right?

[00:04:54] Speaker 04:
Given the at a minimum language and the higher incidence rates disclosed, how does Fishmain itself support your argument that the incidence rate should be lower than 0.6%?

[00:05:05] Speaker 03:
Let me answer that in two ways, Your Honor.

[00:05:09] Speaker 03:
First, whatever the risk is, whatever the risk, it's a number.

[00:05:14] Speaker 03:
And the board declined to give us a number.

[00:05:17] Speaker 03:
Whatever the risk is,

[00:05:19] Speaker 03:
It's a numerical value.

[00:05:20] Speaker 03:
It's a number.

[00:05:20] Speaker 03:
What should that number be?

[00:05:22] Speaker 03:
It ought to be 0.6%.

[00:05:24] Speaker 03:
Fishbane is talking about a large population.

[00:05:27] Speaker 03:
Fishbane's got lots of people.

[00:05:29] Speaker 03:
The other features there in Fishbane have to do with particular populations.

[00:05:34] Speaker 03:
If we're talking about just here, the broadest reasonable construction ought to be 0.6%.

[00:05:45] Speaker 04:
Yeah.

[00:05:48] Speaker 04:
Why not the other numbers?

[00:05:49] Speaker 04:
You're saying the broadest ought to be, but they cite to as high as 1.8.

[00:06:09] Speaker 03:
I can say, Your Honor, that

[00:06:10] Speaker 03:
Those have to do with other populations, not the whole population.

[00:06:14] Speaker 03:
If you look at what Fishbane is doing broadly, Fishbane is talking about a big population, 0.6%.

[00:06:22] Speaker 03:
Other studies also have a similar number, 0.6% or 0.7%.

[00:06:39] Speaker 03:
There is a, as you point out, there is a, Fishban reports a Woodman study, which has got 1.8 percent and 1.7 percent in some other patients over a two-year period.

[00:06:53] Speaker 03:
But if you're trying to show that it's lower than iron dextran, you're trying to evaluate one thing compared to something else, then if

[00:07:09] Speaker 03:
Iron dextran produces it in 0.6%, folks.

[00:07:12] Speaker 03:
If you're higher than that, then you're not lower than iron dextran.

[00:07:24] Speaker 00:
On what maybe is the threshold question, why isn't it at least reasonable for the board to look at the carbohydrate component given the language of the claim

[00:07:39] Speaker 00:
which associates the risk with the risk of dextran, not iron dextran?

[00:07:51] Speaker 03:
Dextran is just the carbohydrate.

[00:07:54] Speaker 03:
So the iron dextran is the complex.

[00:07:56] Speaker 03:
And so our view, there's nothing in the spec that points to the carbohydrate itself as the thing that ought to be compared to.

[00:08:07] Speaker 00:
Well, you might get a little bit of that out of, what is it, the column one reference to the dextran moiety?

[00:08:17] Speaker 03:
The column one.

[00:08:18] Speaker 00:
It's not perfectly clear, I think.

[00:08:20] Speaker 00:
But we are dealing with a broadest reasonable interpretation standard.

[00:08:26] Speaker 00:
So perfect clarity is probably not quite the right.

[00:08:31] Speaker 00:
So where column one, line 52, this high incidence of anal

[00:08:38] Speaker 00:
anaphylactoid reactions is believed to be caused by the formation of antibodies to the dextran moiety?

[00:08:47] Speaker 03:
Not sitting alone, Your Honor.

[00:08:48] Speaker 03:
The dextran moiety as complex as part of the whole thing, as part of the product, which goes on that the very next line of that column says the incidence of anaphylaxis with these products

[00:09:04] Speaker 00:
Right, but then I guess where I really started that the moiety may have been a detour, but where I was starting with was with the claim language, wherein a low risk is an incidence of adverse events lower than dextran.

[00:09:22] Speaker 00:
That sounds like a thing whose risk you're comparing is, in that instance, dextran, namely the carbohydrate.

[00:09:31] Speaker 00:
not the complex that includes the carbohydrate as a component.

[00:09:40] Speaker 03:
That's not the... You're talking about the claim language, Your Honor?

[00:09:48] Speaker 03:
Yes.

[00:09:51] Speaker 00:
Have I got the claim language wrong?

[00:09:55] Speaker 03:
That was the board's construction.

[00:09:57] Speaker 00:
Oh, the board's construction.

[00:09:58] Speaker 00:
I'm sorry.

[00:09:58] Speaker 00:
That's not the claim.

[00:09:59] Speaker 00:
I apologize.

[00:10:00] Speaker 03:
That's not the claim.

[00:10:02] Speaker 03:
So as we say, the construction is wrong.

[00:10:06] Speaker 03:
If I may, given my time, I'll go on to the APA violation.

[00:10:21] Speaker 03:
The board erred with regard to the 549 patent with regard to a different term, construing polyisomaltose for the first time in its final written decision.

[00:10:32] Speaker 03:
Because polyisomaltose was not construed in the institution decision, the board failed to inform Lewitt-Pold.

[00:10:40] Speaker 03:
The trial was being instituted on the ground that Roman supposedly disclosed the claimed polyisomaltose species of the Marcuse group.

[00:10:49] Speaker 03:
The board's subsequent determination in the final written decision thus amounted to a new ground of unpatability, depriving Lewitt-Pold of notice and an opportunity to respond.

[00:11:02] Speaker 03:
Lewis Poll did not have a fair opportunity to react to the thrust of the board's eventual reliance on Grohmann.

[00:11:08] Speaker 03:
The Farma-Cosmos reply brief and the oral argument during the IPR don't cure the board's error in relying on the new ground in the final written decision.

[00:11:19] Speaker 03:
The petition, the Farma-Cosmos petition, offered two alternative constructions of iron-poly-isomaltose and a view of Grohmann as teaching

[00:11:32] Speaker 03:
iron poly isomaltose contingent on the board adopting one of those alternative plane constructions.

[00:11:38] Speaker 03:
That's the appendix of 174.

[00:11:40] Speaker 03:
The board shows not to construe the term.

[00:11:44] Speaker 03:
That's appendix 4970.

[00:11:46] Speaker 03:
Consequently, there's no notice to Lewitt-Pold that the IPR was being instituted on the ground that Grohmann allegedly taught iron poly isomaltose.

[00:11:56] Speaker 03:
At the oral hearing, even the APJ who authored the institution decision

[00:12:02] Speaker 03:
was unaware that there was a ground based on Grumman allegedly teaching an iron poly isomaltose.

[00:12:09] Speaker 03:
That's the appendix 5097 to 5098.

[00:12:12] Speaker 03:
There's no notice to him.

[00:12:15] Speaker 03:
He certainly wasn't any notice to us, Your Honor.

[00:12:20] Speaker 03:
And that decision should be reversed for that reason.

[00:12:23] Speaker 01:
We're into your rebuttal.

[00:12:28] Speaker 03:
I just mentioned the motion to amend or to properly impose the duty on Lewitbold.

[00:12:34] Speaker 00:
And you don't think the two footnotes?

[00:12:37] Speaker 03:
The two footnotes don't cure that, Your Honor.

[00:12:39] Speaker 03:
The footnotes, there's no notice.

[00:12:41] Speaker 03:
And footnotes, a footnote isn't enough.

[00:12:47] Speaker 03:
Heaven help us.

[00:12:49] Speaker 03:
The court's position is that counsel can't save or preserve arguments by a mere footnote.

[00:12:54] Speaker 03:
And especially for the 702,

[00:12:57] Speaker 03:
on the size of the particle, the board expressly put the burden on Lewitt-Pole to come up with the claim construction and just talk about how a person of ordinary skill in New York would, whether he would regard less than about 9 nanometers as including something bigger than that, 10.

[00:13:15] Speaker 03:
That was all put on Lewitt-Pole improperly.

[00:13:20] Speaker 03:
I'll save the rest of my time for rebuttal, Your Honor.

[00:13:22] Speaker 01:
Thank you.

[00:13:35] Speaker 02:
May it please the Court, Your Honors.

[00:13:37] Speaker 02:
I'd also like to start with the claim construction, the same issue that was discussed first this morning.

[00:13:44] Speaker 02:
Your Honors, in our view, the claim construction is supported by the clear language of the claim itself, is supported by the clear language of the specification that was discussed this morning.

[00:13:55] Speaker 02:
And Louis Pold's attempt to change that language is based upon extrinsic evidence, and I'm happy to address each one in turn.

[00:14:04] Speaker 02:
The claim language itself, I think it's self-evident, the specification that was discussed this morning starting... Can you talk about the claim language?

[00:14:14] Speaker 02:
Certainly, Your Honor.

[00:14:15] Speaker 02:
So the claim language itself has the term... Are we looking at independent claim one of 549?

[00:14:21] Speaker 02:
We are, Your Honor, yes.

[00:14:22] Speaker 02:
Thank you.

[00:14:23] Speaker 02:
And the claim language itself starts using, with the terminology, a substantially non-immunogenic carbohydrate component.

[00:14:31] Speaker 02:
it's very clear that the non-immunogenicity is tied to the component itself.

[00:14:37] Speaker 02:
The specification repeatedly refers to the component itself, starting right with the abstract on the cover of the patent, stable and non-immunogenic carbohydrate component.

[00:14:50] Speaker 02:
It continues with the passage that was discussed this morning in column one,

[00:14:55] Speaker 02:
And the other passage that I wanted to identify without identifying them all is at Column 10, Lines 58 to Column 11, Line 2, where the patent discusses the iron carbohydrate complexes for use in the methods of the patent, and specifically says that they have characteristics including a non-immunogenic carbohydrate component.

[00:15:19] Speaker 02:
So to us, it's very clear that the patent specification is consistently used.

[00:15:24] Speaker 00:
Is there anything in the specification that provides measurements of the immunogenicity of the component alone, not of a complex with a particular carbohydrate in it?

[00:15:40] Speaker 02:
No, Your Honor, there is not.

[00:15:42] Speaker 02:
The embodiment with FIT 45 does have data with respect to the overall product.

[00:15:49] Speaker 02:
That is true.

[00:15:50] Speaker 02:
There is nothing that we see that specifically is directed to the component itself.

[00:15:54] Speaker 02:
But the teaching of the patent is very clear that the concern is with respect to reactions to the component based upon prior experience with old school dextran products.

[00:16:06] Speaker 02:
And that's why the patent repeatedly talks about having dextrad antibodies.

[00:16:12] Speaker 02:
And, you know, the issue there is that if the carbohydrate is immunogenic, our odds are that the complex, including iron, will also be immunogenic.

[00:16:24] Speaker 04:
Let's turn to the motion to amend where your friend ended.

[00:16:32] Speaker 04:
You said you had the benefit of aqua product.

[00:16:35] Speaker 04:
In light of that, do you agree that the PTAP erred in improperly assigning the burden?

[00:16:43] Speaker 02:
Your Honor, the law certainly changed during these proceedings.

[00:16:46] Speaker 02:
We all recognize that.

[00:16:47] Speaker 02:
And I think the petitioner and the board thankfully recognized that that was a possibility and made care to make sure that the burden, if the burden changed, which it did, that that was recognized.

[00:17:01] Speaker 02:
And the opinion, in our view,

[00:17:03] Speaker 02:
not only recognizes it with the two footnotes that were discussed earlier, but with detailed analysis as to why that burden was met.

[00:17:11] Speaker 02:
So we feel there's sufficient evidence in the opinions themselves that the burden was properly allocated and that the burden was properly met.

[00:17:21] Speaker 01:
But your friend also added specifically the 702 patent and that the burden was placed on the patent with respect to, I think he said, claim construction.

[00:17:33] Speaker 01:
So do you have any response to that particular point that he made?

[00:17:37] Speaker 02:
So with respect to the 702 patent, Your Honor, with respect to viewing the issue of claim construction,

[00:17:50] Speaker 02:
Claim construction was, and I think that this goes to a couple of different issues, but claim construction didn't need to be espoused by the board.

[00:18:00] Speaker 02:
In our view, the board, with respect to the term polyisomaltose, did adopt and point to the alternative claim construction that was provided by Farmer Cosmos.

[00:18:16] Speaker 02:
And as a matter of fact, on this issue of notice,

[00:18:19] Speaker 02:
The board specifically cited to a claim chart that was included in the IPR petition, which mapped the prior reference Grumman to an example in Grumman, example 28, which specifically is for the embodiment of polyisomaltose.

[00:18:39] Speaker 02:
So the issue, as far as they're not being noticed to us as a red herring, the board did what it needed to do.

[00:18:46] Speaker 02:
It specifically cited to the alternative construction.

[00:18:49] Speaker 02:
is specifically cited to the claim chart having the reading for that construction in its institution opinion, that there should be no failure of notice on that point, Your Honor.

[00:19:01] Speaker 02:
Your Honor, I wanted to turn back to Fishbane, where there was some questions earlier.

[00:19:05] Speaker 02:
In our view, Fishbane is not incorporated by reference.

[00:19:10] Speaker 02:
I'm notwithstanding what counsel said.

[00:19:12] Speaker 02:
And as a matter of fact, Council for Louisville, during the IPR oral argument, admitted that it's not incorporated by reference.

[00:19:19] Speaker 04:
Where is that?

[00:19:20] Speaker 02:
That is in the oral argument transcript, Your Honor.

[00:19:23] Speaker 02:
And I'll get you the site right away.

[00:19:27] Speaker 02:
Actually, I'm sorry.

[00:19:27] Speaker 02:
It's also cited in the final opinion on page 11 for the 702 patent.

[00:19:35] Speaker 02:
Your Honor, the question for us is a question of law with respect to incorporation by reference.

[00:19:42] Speaker 02:
And we cited the advanced display case, which states that incorporation by reference

[00:19:49] Speaker 02:
It is a question of law.

[00:19:50] Speaker 02:
It requires details regarding which portion of the reference is being cited for what proposition.

[00:19:56] Speaker 02:
And that's not the case here.

[00:19:58] Speaker 02:
Here, there's no details in the specification, only the full site.

[00:20:02] Speaker 02:
There's no discussion as far as why it's being cited for this 0.6 as opposed to some other relevant number that Your Honor said or asked about earlier today.

[00:20:12] Speaker 02:
But even if you find, as a matter of law, that's incorporated by reference, that doesn't help Louis Bolt.

[00:20:18] Speaker 02:
doesn't help them for two reasons.

[00:20:20] Speaker 02:
One, as the Court has recognized, fish vein does disclose other numbers.

[00:20:26] Speaker 02:
The argument that 0.6 percent is associated with the population at large we think is simply incorrect.

[00:20:32] Speaker 02:
The reference says that 0.6 is associated with 481 hermiodialysis patients, not the population at large.

[00:20:42] Speaker 02:
Second, if fish vein is incorporated by reference in the CEG fish vein,

[00:20:47] Speaker 02:
Another reference is likewise listed in that same passage, and that's the Landry reference that the PTAB also recognized.

[00:20:55] Speaker 02:
And that reference discloses rates of 4.7 to 43%.

[00:20:59] Speaker 02:
So the numbers are all over the place, that there's no reason to pick and choose 0.6%.

[00:21:11] Speaker 02:
Your Honor, I could turn, unless there are any questions.

[00:21:15] Speaker 02:
The appendix site, Your Honor, is appendix 5068.

[00:21:18] Speaker 04:
Thank you.

[00:21:23] Speaker 02:
I'd like to turn to the polyisomotol question.

[00:21:30] Speaker 02:
And we discussed notice earlier with respect to the issues as far as whether or not, whether or not the construction.

[00:21:44] Speaker 02:
5068.

[00:21:45] Speaker 02:
5068, Your Honor, yes.

[00:21:52] Speaker 02:
With respect to the issue of notice, I also wanted to add that the alternative claim construction proposed by Pharmacosmos, and which was cited to by the Board, is also consistent with Louisville's.

[00:22:04] Speaker 00:
You should be aware that at least my version of the Joint Appendix doesn't, in fact, have 5068 in it.

[00:22:10] Speaker 00:
It's a very common thing.

[00:22:11] Speaker 00:
You put numbers on everything, but you only bind the stuff that you cite.

[00:22:15] Speaker 00:
So we don't have that.

[00:22:18] Speaker 02:
Our apologies, Your Honor.

[00:22:22] Speaker 04:
Judge Gerardo was being kind.

[00:22:26] Speaker 04:
I wasn't.

[00:22:32] Speaker 02:
The claim construction is also consistent with Louis Pold's own claim construction that was used during prosecution of these patents.

[00:22:40] Speaker 02:
And so the issue of notice is one, again, it's one of the red herring that Louis Bolt has known about this for years.

[00:22:46] Speaker 00:
Is this the point that Mr. Quillen was mentioning when he said that one of the administrative patent judges expressed some surprise about this, or is that a different point?

[00:22:59] Speaker 02:
So it's the same issue, Your Honor, but the point of the

[00:23:05] Speaker 02:
being used by Louis Poole during its own prosecution was not raised.

[00:23:09] Speaker 02:
And I don't want to raise that, but I'm happy to address the ALJ's discussion that was discussed earlier.

[00:23:20] Speaker 02:
So in that context, Your Honor, yes, that there was a question and answer between counsel and the judge.

[00:23:27] Speaker 02:
And perhaps there was a misunderstanding by counsel, or perhaps the counsel was answering a question while the question was being asked.

[00:23:36] Speaker 02:
But regardless, the record was clarified after the exchange that was discussed by counsel earlier this morning to state that Grumman taught two different species.

[00:23:47] Speaker 02:
It taught with respect to dextran T1, which is being equated with polyisomaltose for ground four.

[00:23:54] Speaker 02:
And it alternately taught a different species, carboxymethyl reduced dextran.

[00:23:59] Speaker 02:
And that was made very clear on the record.

[00:24:01] Speaker 02:
So there were two different bases for citing to the reference.

[00:24:04] Speaker 02:
and those two different bases were put into the record and understood by the board.

[00:24:15] Speaker 02:
Your Honours, I will now turn with your okay to the cross appeal.

[00:24:23] Speaker 02:
And the cross-appeal, in our view, is one that presents some novel issues for the Court, quite candidly.

[00:24:33] Speaker 01:
I wanted to answer the question of why it's a proper cross-appeal, why it's properly before us.

[00:24:38] Speaker 02:
Yes, Your Honor.

[00:24:39] Speaker 02:
So we believe that the cross-appeal is properly before this Court because there is, in fact, injury, in fact.

[00:24:48] Speaker 02:
And because the cross-appeal would enlarge the scope of the judgment as required under the case law.

[00:24:53] Speaker 04:
In the August 2016 press release, it says you're still conducting certain testing in the United States that will take several years and are still searching for commercialization partners.

[00:25:05] Speaker 04:
Is that still the case?

[00:25:07] Speaker 02:
It is, Your Honor, yes.

[00:25:10] Speaker 00:
So why are you in a different position from the position of the losing party in San

[00:25:19] Speaker 02:
Well, Your Honor, in the Sandoz decision, you know, their personal DJ action, which... It's all about case or controversy.

[00:25:29] Speaker 02:
We agree.

[00:25:30] Speaker 02:
As we understand that decision, you know, there was no jurisdiction when the only activity was FDA approval that had not yet been sought.

[00:25:39] Speaker 02:
Here we have different facts.

[00:25:40] Speaker 02:
First of all, we are going through phase three clinical trials.

[00:25:44] Speaker 00:
But more importantly... Am I remembering right?

[00:25:47] Speaker 00:
I think I am.

[00:25:49] Speaker 00:
And the would-be generic was either at that stage or maybe even beyond that stage in Sandoz.

[00:25:58] Speaker 02:
That may be the case, Your Honor.

[00:26:00] Speaker 02:
And to us, the main distinction, Your Honor, is the letter that we've cited to.

[00:26:08] Speaker 02:
And the fact that Louis Pold wrote a letter to both Pharma Cosmos and to its business partner, its potential business partner in the United States,

[00:26:19] Speaker 02:
asserting patent rights and threatening infringement, it is an act that we didn't see in the Sandoz case and we don't see in a lot of the other cases.

[00:26:28] Speaker 02:
There's an affirmative act by the patent owner to enforce patent rights against us that, you know, it makes it a distinguishing factor.

[00:26:38] Speaker 02:
Now, it's not as clear-cut as that because the patent rights asserted were not the 702 patent.

[00:26:44] Speaker 02:
I think we all recognize that.

[00:26:46] Speaker 02:
So we have a little bit of an additional hurdle to get through to convince the Court that the assertion of other patent rights, which have substantially similar claim elements, including this 15 minutes or less claim element at issue, would create a reasonable apprehension on the part of Army Cosmos that it will be sued.

[00:27:08] Speaker 02:
And Your Honor, I think it's important to recognize, and I know I'm running out of time rapidly, but every

[00:27:15] Speaker 02:
plaintiff is in the position that they believe that their product does not infringe the patents.

[00:27:22] Speaker 02:
Otherwise, they wouldn't be in court under Rule 11.

[00:27:26] Speaker 02:
We likewise are in that position.

[00:27:28] Speaker 02:
And whether we pulled believes or doesn't believe that one of its patents are more or less relevant doesn't change the apprehension on the part of Armageddon.

[00:27:39] Speaker 02:
Your Honor, I'd like to reserve my remaining minute.

[00:27:51] Speaker 03:
Just briefly, Your Honor, on the immunogenicity, that's attributed to the component only when it's present in the complex, never by itself.

[00:28:01] Speaker 03:
The comparison is made when the carbohydrate is attached to the iron.

[00:28:07] Speaker 03:
There's nowhere, there's any reference of the spec administering the carbohydrate alone.

[00:28:13] Speaker 03:
Even the art that's inside it shows the administration with iron, the iron deck stream.

[00:28:19] Speaker 03:
In column 12, this is appendix 90, the iron carbohydrate complex, vit 45, generally does not contain dextran and does not react with dextran antibodies.

[00:28:32] Speaker 03:
Therefore, the risk of anaphylaxis hypersensitivity reactions is very low compared to iron dextran.

[00:28:43] Speaker 03:
That's the comparison on those.

[00:28:46] Speaker 03:
Council has mentioned about what's in the spec, what's in the prosecution history, overlooking Appendix 31-33, the Lawrence Declaration, paragraph 7 of which compares, compares it, recites this claim language and compares it to Monifer, the complex, not a carbohydrate alone.

[00:29:11] Speaker 03:
On notice,

[00:29:14] Speaker 03:
it's the board that's required to provide notice to Lewitt-Pold.

[00:29:18] Speaker 03:
You can't, after the fact, say, oh, well, you should have been pressing.

[00:29:22] Speaker 03:
You should have figured out.

[00:29:23] Speaker 03:
You should have known what was in the board's mind based on what was in the petition.

[00:29:27] Speaker 00:
That's not appropriate.

[00:29:30] Speaker 00:
If the petitioner includes in the petition an argument, why is more in the way of notice

[00:29:41] Speaker 00:
needed that the board might well rely on that argument?

[00:29:47] Speaker 00:
Or is that not the situation?

[00:29:48] Speaker 03:
Down the road?

[00:29:49] Speaker 03:
So what's happened here, there were two alternatives presented by the petitioner.

[00:29:53] Speaker 03:
There was a proper claim construction and what they called an alternative claim construction.

[00:29:57] Speaker 03:
If you the board adopt this alternative, then these consequences flow.

[00:30:00] Speaker 03:
The board didn't adopt it.

[00:30:02] Speaker 03:
The reasonable view is, well, the consequence didn't flow.

[00:30:06] Speaker 03:
To allow the board to do what they're doing here is to say the board can

[00:30:11] Speaker 03:
not provide any notice to the patent owner, and then down the road, down the road, open things up and say, oh well, now here's a new thing, here's a new rationale, here's a new theory.

[00:30:24] Speaker 01:
So the board here said we'd determine, at the institution stage, that no explicit construction of any other claims necessary to determine whether to institute a trial in this case.

[00:30:36] Speaker 01:
So your view is that

[00:30:40] Speaker 01:
Therefore, they're foreclosed, notwithstanding any discussion and opportunity response that they're just foreclosed from doing any claim construction because they said that no explicit claim construction was necessary.

[00:30:53] Speaker 03:
So I view that they cannot, later on then, in light of that, giving us the impression that that alternative argument about whether Roman disclosed a different species, the polyisomalto species, that argument was off the table.

[00:31:08] Speaker 03:
That argument wasn't

[00:31:10] Speaker 03:
wasn't available.

[00:31:11] Speaker 03:
That argument wasn't being pressed.

[00:31:13] Speaker 03:
And so when trial was instituted, that wasn't an issue that we were faced with.

[00:31:22] Speaker 03:
And clearly, the judge didn't realize that.

[00:31:26] Speaker 03:
The judge who wrote the opinion, he didn't realize that was what was going on until later on.

[00:31:29] Speaker 03:
If he didn't know what was going on, heaven help us, the patent owner certainly didn't know what was going on.

[00:31:37] Speaker 03:
I'm out of my time, but finally, on the motion, on the cross-appeal, we are bereft of evidence.

[00:31:44] Speaker 03:
There's no evidence.

[00:31:46] Speaker 03:
It's their burden.

[00:31:46] Speaker 03:
They didn't carry it.

[00:31:48] Speaker 01:
And you just permitted him to be able to respond to you.

[00:31:51] Speaker 01:
So you do get your remaining minute.

[00:31:54] Speaker 01:
Thank you.

[00:31:55] Speaker 02:
On this issue of notice, we wanted to respond briefly.

[00:31:59] Speaker 00:
No, no, that's not your cross-appeal.

[00:32:02] Speaker 02:
Sorry.

[00:32:03] Speaker 02:
I'm sorry?

[00:32:04] Speaker 02:
You can't go beyond the cross-appeal.

[00:32:07] Speaker 02:
I apologize, Your Honor.

[00:32:11] Speaker 02:
On the issue of the cross-appeal, Your Honor, the evidence, I was looking at one issue for the purpose of another issue, the evidence with respect to the monifer product that was just discussed, in our view, is likewise evidence of reasonable apprehension of suit.

[00:32:28] Speaker 02:
The fact that this product, Pharmacosmos' own product was cited to

[00:32:34] Speaker 02:
as a alleged embodiment of the patents that were asserted against both Farmer Cosmos and its business partner.

[00:32:41] Speaker 02:
To us is, again, another piece of concrete evidence showing that there is reasonable apprehension of suit.

[00:32:49] Speaker 02:
Thank you.

[00:32:49] Speaker 01:
We thank both sides and the case is submitted.

[00:32:53] Speaker 01:
The next case for argument is