[00:00:00] Speaker 02:
Our argument is 20-1328, Eli Lilly versus Apotec.

[00:00:05] Speaker 02:
Mr. Rukozi.

[00:00:08] Speaker 01:
Thank you, Chief Judge.

[00:00:09] Speaker 01:
May it please the Court, William Rukozi for appellant Apotecs.

[00:00:12] Speaker 01:
The Court should reverse the judgment of infringement.

[00:00:15] Speaker 01:
Three times Lilly made narrowing amendments from the broad Olympoclaim term to the Dysodium salt term.

[00:00:22] Speaker 01:
Each one indisputably was made for substantial reasons related to patentability.

[00:00:27] Speaker 01:
each gave rise to the festo presumption of surrender of all territory between the broad Olenta claim and the narrow salt claim.

[00:00:35] Speaker 01:
And on this record really cannot rebut the presumption of surrender of the well-known dipotassium salt.

[00:00:44] Speaker 02:
By the way, I'm sorry, go ahead Chief Judge.

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

[00:00:50] Speaker 02:
This is to Sharon Price.

[00:00:52] Speaker 02:
Uh, is, isn't it clear that the, you know, and Lily outlined this, that is brief, and I think that, uh, the district court judge relied on it, that, um, the changes made by Lily were for this provision in the MPEP that deals with trademarks or trade names being used.

[00:01:12] Speaker 02:
Isn't that all over the prosecution history is the basis for which Lily made the change?

[00:01:17] Speaker 01:
Actually, two responses to that, Your Honor.

[00:01:20] Speaker 01:
First off, for context, obviously, if we're talking about tangentiality now, now we've made the determination that there's been a narrowing amendment that surrenders the other salt.

[00:01:31] Speaker 01:
But having said that, Your Honor, that's not the reason that we actually gave in this record in the January 2005 amendment.

[00:01:40] Speaker 01:
Well, let me back up a second.

[00:01:41] Speaker 01:
For two amendments, Your Honor, remember there were three here.

[00:01:44] Speaker 01:
For two,

[00:01:45] Speaker 01:
in November 2005 and July 2007, really did not give any reason for the amendment.

[00:01:52] Speaker 01:
And as we know, each amendment can independently give rise to the theft or presumption of surrender, and silence can't rebut the surrender.

[00:02:00] Speaker 01:
But for the January 2005 amendment, what's key here is that really didn't just

[00:02:06] Speaker 01:
amend to get rid of the trade name.

[00:02:08] Speaker 01:
What really told the examiner was that they were canceling the Alemda terms without prejudice to move the rejection.

[00:02:16] Speaker 01:
And that's key, because Lilly has signified and agreed that when you say without prejudice, you actually are saying you don't agree with the examiner's indefiniteness and improper trade name rejection, and you are reserving the right to go after that argument in broader claim scope later.

[00:02:33] Speaker 01:
That's a familiar pattern in prosecution we see where an applicant like Willie narrows the broad pematrexate claim to the disodium salt to achieve allowance, but reserves the right to go after broader claims go blader.

[00:02:47] Speaker 01:
And that's exactly what happened here.

[00:02:49] Speaker 01:
In the November 2005 amendment, they actually amended from Olenta to a claim that said both pematrexate, disodium, and pematrexate, indicating their objective intent to go after other salts.

[00:03:02] Speaker 01:
It's even more explicit in the foreign counterpart, which is based on the exact same PCT, the same specification, and the same Olympia claim language.

[00:03:11] Speaker 01:
When the examiner rejected Olympia is unclear, Lilly amended it to mean Pematrexid.

[00:03:18] Speaker 01:
And even more critically, they told the EP examiner the basis for that was the same two parentheticals that they now rely on for this court as supposed definitions for Pematrexid dystonium.

[00:03:29] Speaker 01:
But in the foreign counterpart, they said the exact opposite.

[00:03:33] Speaker 01:
They said those parentheticals were actually support for olymptanine penetrexid.

[00:03:39] Speaker 01:
So we submit there's nothing tangential here, and Lilly has not provided a rationale that would suggest the well-known dipotassium salt is tangential.

[00:03:50] Speaker 03:
Let me ask you if I could, Mr. Rucosi.

[00:03:52] Speaker 03:
You've mentioned now twice the salt that Apotex uses.

[00:03:56] Speaker 03:
And throughout the briefs,

[00:03:58] Speaker 03:
You've marked that as confidential and I wondered why it's confidential.

[00:04:05] Speaker 03:
Are you maintaining confidentiality with respect to that other salt that Apotex uses or not?

[00:04:14] Speaker 01:
We are not any longer, Your Honor.

[00:04:16] Speaker 01:
The reason that we initially sealed it is because it had not been disclosed to the public up until that day.

[00:04:23] Speaker 03:
But let me ask you then, you mentioned the two references, but they look very definitional to me.

[00:04:30] Speaker 03:
And they have been in the application since they were first filed, where the applicant says, chemotrexid, disodium, parenthesis, alempta.

[00:04:42] Speaker 03:
and that appears twice.

[00:04:44] Speaker 03:
Why isn't that clear definitional language that identifies OLYMPTA, regardless of what may have been done or said in the European application for purposes of the U.S.

[00:04:57] Speaker 03:
application and the U.S.

[00:04:59] Speaker 03:
prosecution, why doesn't that establish that we now know exactly what OLYMPTA is for all purposes relevant to this patent?

[00:05:08] Speaker 01:
Several responses to that, Your Honor.

[00:05:10] Speaker 01:
First off, there's no authority that a parenthetical alone is a definition, and Lilly has never taken that position.

[00:05:17] Speaker 03:
Well, it's not technically a definition, but it's so close to being a definition that, to me, it has definitional impact, import.

[00:05:28] Speaker 03:
I can't see how one could argue that a limta to the patent drafter

[00:05:35] Speaker 03:
The application drafter meant anything other than pimotrexate disodium.

[00:05:41] Speaker 01:
The problem with that, Your Honor, is that it ignores the rest of the intrinsic evidence in the specification itself.

[00:05:47] Speaker 01:
We can look at the claim term, olymptah.

[00:05:50] Speaker 01:
The claim nine said wherein B antifolate is olymptah.

[00:05:54] Speaker 01:
Antifolate is defined in that very same paragraph with one of those parentheticals to mean the chemical compound that inhibits the enzymes.

[00:06:03] Speaker 01:
All parties agree that is only Pematrexid.

[00:06:06] Speaker 01:
Even Willie has admitted that it's Pematrexid that targets the enzymes.

[00:06:10] Speaker 01:
Pematrexid is the antifolate as defined in the specification.

[00:06:14] Speaker 01:
So at most, Your Honor, that parenthetical which resides in that same definitional paragraph of antifolate, which must mean Pematrexid,

[00:06:23] Speaker 01:
is nothing more than an association with penetrexid disodium, as the language indicates, the most preferred example that contains the antifolate, olympo, or penetrexid.

[00:06:35] Speaker 01:
But then we go on to the rest of the specification, your honor.

[00:06:38] Speaker 01:
And while we have those two isolated parentheticals, we have over 28 different uses in the specification methods section where Olypta is not just associated with Pematrexid, it actually means Pematrexid.

[00:06:50] Speaker 01:
And I'm referring to every administration and dosing reference of Olypta.

[00:06:55] Speaker 01:
We know from the specification and the sheet references cited in the specification that that means Pematrexid.

[00:07:01] Speaker 01:
But perhaps most critically, Your Honor, to your question, you can go to the specification and you can see where Olympta is used interchangeably with the term MTA.

[00:07:12] Speaker 01:
MTA is an acronym for multi-targeted antifolate.

[00:07:16] Speaker 01:
And we know from the prior art, including the sheet references cited in the specification, MTA is pematrexid.

[00:07:23] Speaker 01:
There's nothing indirect or transitive about the name MTA.

[00:07:27] Speaker 01:
It is pematrexid.

[00:07:28] Speaker 01:
And the specification uses

[00:07:31] Speaker 01:
olymptah interchangeably with MTA in the human clinical trials portion of the specification.

[00:07:38] Speaker 01:
So we would submit that those are not definitions.

[00:07:42] Speaker 01:
The case law doesn't support the fact they're definitions.

[00:07:45] Speaker 01:
Willie never told any examiner in the US or the foreign counterpart that those were definitions for pematrixid disodium.

[00:07:53] Speaker 01:
In fact, they told the EP examiner just the opposite, that those were support for olymptah to mean pematrixid.

[00:08:00] Speaker 01:
We can also go on to the rest of the prosecution history record, Your Honor, including the Olinta package insert that really made of record.

[00:08:08] Speaker 01:
So it's now intrinsic evidence.

[00:08:10] Speaker 01:
There's no dispute that dozens of references in that package insert all, in fact, show that Olinta is being used to mean pematrexin.

[00:08:19] Speaker 01:
The clinical trials, the mechanism of action, the dosing administration, all are using Olinta to mean pematrexin.

[00:08:26] Speaker 01:
And finally, Your Honor, the literature also indicates

[00:08:30] Speaker 01:
that skilled persons used olymptadermine temetrexid, both in the prior art, such as the Van Triest reference, but also later references, like Schultz and Agye.

[00:08:41] Speaker 01:
Dr. Schultz and Lilly's scientists, when reading the Taylor, Calvert, and Xi prior art, reasonably interpreted olymptadermine temetrexid.

[00:08:50] Speaker 01:
So the totality of the evidence we submit, Judge Bryson, shows that those two parentheticals are not definitions.

[00:08:59] Speaker 01:
And that the intrinsic record and the intrinsic evidence show that skilled persons use the limited to mean pemetrexid.

[00:09:06] Speaker 01:
And even if you go to those two parentheticals, you can see the paragraphs they're found in.

[00:09:12] Speaker 01:
One is in the prior art paragraph.

[00:09:14] Speaker 01:
One is found in the anti-folate definition paragraph.

[00:09:17] Speaker 01:
And it's undisputed that when we're talking about the prior art anti-folate, the inhibitor, that means pemetrexid, not pemetrexid disodium.

[00:09:27] Speaker 01:
Lastly, I would just like to say a brief word.

[00:09:30] Speaker 03:
You mentioned the label.

[00:09:31] Speaker 03:
At least one copy of the label, it seems to me, appears at appendix 7640, right?

[00:09:38] Speaker 03:
And at SEC?

[00:09:40] Speaker 03:
Is that right?

[00:09:41] Speaker 01:
Yes.

[00:09:42] Speaker 01:
Yes, one copy does.

[00:09:44] Speaker 01:
And a highlighted copy is at A904.

[00:09:46] Speaker 03:
Right.

[00:09:47] Speaker 03:
Well, I'm looking at the one at 7640.

[00:09:49] Speaker 03:
At the top, on the left-hand side, the very beginning of the label, it says olymptah, penitrexid disodium.

[00:09:57] Speaker 01:
Yes.

[00:09:58] Speaker 03:
That's the definition of olympt.

[00:10:01] Speaker 03:
And so it's not true, is it, that the label is entirely in terms of just pematrexate as being olympt.

[00:10:11] Speaker 01:
No, it is true, Your Honor.

[00:10:12] Speaker 01:
The label does associate olympt with pematrexate disodium in that one portion.

[00:10:18] Speaker 01:
But if we turn the page and we continue through all the other sections, administration, dosages, clinical trials, warnings,

[00:10:26] Speaker 01:
mechanism of action and pharmacokinetics, your honor, there's no dispute here that a lymth is being used to mean pematrexid in all of those other sections.

[00:10:38] Speaker 03:
And pematrexid, I gather, is just the anion of the salt, right?

[00:10:41] Speaker 03:
And it dissociates in solution from the sodium.

[00:10:45] Speaker 01:
That's correct, your honor.

[00:10:46] Speaker 03:
Pematrexid is a neutralized form of pematrexid.

[00:10:51] Speaker 03:
anion that is the operative active ingredient of the compound, right?

[00:11:01] Speaker 01:
It's correct, Your Honor.

[00:11:02] Speaker 01:
It is actually, and just very briefly, I know my time is up.

[00:11:06] Speaker 01:
I want to state something for rebuttal.

[00:11:08] Speaker 01:
But yes, time attraction is the only active ingredient.

[00:11:11] Speaker 01:
It's the only thing that actually inhibits the enzymes that acts as the anti-folate

[00:11:16] Speaker 01:
Pimetrexid disodium doesn't do anything.

[00:11:19] Speaker 01:
It doesn't cause toxicity.

[00:11:20] Speaker 01:
It doesn't act as an enzyme inhibitor.

[00:11:23] Speaker 01:
In fact, it really has conceded as much.

[00:11:25] Speaker 01:
And their own expert has admitted that disodium and dipotassium are not different anti-folate.

[00:11:31] Speaker 01:
They are both different salt forms of the exact same anti-folate, pimetrexid.

[00:11:36] Speaker 01:
With that, Your Honor, I would like to reserve rebuttal time unless you have any other questions.

[00:11:41] Speaker 02:
You will get your rebuttal time.

[00:11:43] Speaker 02:
This is Judge Proce, but this is just a tangential housekeeping.

[00:11:47] Speaker 02:
I'm sorry to use the word tangential.

[00:11:49] Speaker 02:
This is just a housekeeping matter, which is the district court concluded that you conceded infringement under DOE unless this prosecution history estoppel applies.

[00:12:00] Speaker 02:
And I didn't see anything that suggests that you were contesting that conclusion.

[00:12:05] Speaker 01:
So I just wanted to be clear.

[00:12:08] Speaker 01:
We were not and did not contest equivalence under the function way result test, Your Honor.

[00:12:13] Speaker 01:
Our position was that the doctrine of equivalence was barred entirely by estoppel.

[00:12:18] Speaker 02:
OK.

[00:12:19] Speaker 02:
Thank you.

[00:12:19] Speaker 02:
Thank you.

[00:12:20] Speaker 02:
We'll reserve your rebuttal.

[00:12:21] Speaker 02:
Let's hear from Mr. Perlman.

[00:12:22] Speaker 02:
Thank you.

[00:12:23] Speaker 02:
Thank you, Your Honor.

[00:12:26] Speaker 00:
Good morning, Your Honor.

[00:12:27] Speaker 00:
May it please the court.

[00:12:29] Speaker 00:
There was no narrowing amendment in this case.

[00:12:32] Speaker 00:
As Judge Bryson pointed out, the specification makes clear twice that

[00:12:37] Speaker 00:
Olympta is being used as the trade name for Pematrexid disodium, and when Lilly replaced Olympta in the claims in response to a rejection that it had improperly used the trade name in the claim, it replaced it with Pematrexid disodium, which is the generic name for the identical thing.

[00:12:55] Speaker 02:
Mr. Perlman, let me just interrupt you briefly, because your friend's response, among his responses that I understood to my question about that, was that, well, you said without prejudice.

[00:13:06] Speaker 02:
and that somehow meant that you were reserving the right to do, et cetera, et cetera.

[00:13:12] Speaker 02:
Do you have a comment about explaining this without prejudice thing?

[00:13:16] Speaker 00:
I absolutely do, Your Honor.

[00:13:18] Speaker 00:
I think that Mr. Ricozzi respectfully is reading too much into the phrase without prejudice.

[00:13:23] Speaker 00:
The question for tangentiality is what is the reason that we did what we did?

[00:13:29] Speaker 00:
The reason was to eliminate the trade name.

[00:13:31] Speaker 00:
saying without prejudice just means well we're not saying we agree with you but we're doing it anyway and so if you look to why did we do it that is what the file indicates as to why we do it why we did it and that is tangential uh... and the evidence on tangentiality is one-sided uh... they have no one who provide testimony we have our expert who read it through the eyes of the skilled person but just looking at the file history it's collusively clear the issue here with the youth

[00:14:01] Speaker 00:
of a trade.

[00:14:02] Speaker 00:
To get back to something Mr. Roccozi said about specification and about column four and the definition of antifolate and it being focused on the active form.

[00:14:13] Speaker 00:
If you look at column four, what it makes clear is that not only the active form can be called an antifolate because it says hematrexid disodium parenthesis olympta is the most preferred antifolate.

[00:14:28] Speaker 00:
And so yes, the beginning of the paragraph says

[00:14:31] Speaker 00:
that antifolate is defined based on the entity that inhibits the enzyme.

[00:14:36] Speaker 00:
But it goes on to say, in the exact same paragraph, that hematrexit disodium is the most preferred antifolate.

[00:14:44] Speaker 00:
And so when Lilly's original claim said wherein the antifolate is olymptous, that is entirely consistent with claiming the most preferred embodiment of the antifolate, hematrexit disodium.

[00:14:59] Speaker 00:
As to the point

[00:15:00] Speaker 00:
of what our experts said or what we've previously said, it's important to remember that the context of that discussion in the Hospira case was something entirely different.

[00:15:12] Speaker 00:
The issue in that case was how did the applicant distinguish the prior art, and it was distinguished based on the identity of the active antifolate, and that was the context in which this definition came up.

[00:15:26] Speaker 00:
It has nothing to do with the issue in this case.

[00:15:29] Speaker 00:
and the other thing i will point out the entire premise of the hot spirit decision from this court from last year or by the way this court twice noted that the original claims were talking about here we're limited to come attracted by podium the entire premise was that we had narrowed within the original scope of the claim when narrowing from anti-folate to come attracted by throat and so of course have attracted by podium even at full

[00:15:59] Speaker 00:
Mr. Roccozi mentioned three narrowing amendments.

[00:16:05] Speaker 00:
In fact, there's one narrowing amendment here.

[00:16:09] Speaker 00:
In 2005, we canceled the claims to the trade name Olympta, rendered that moot, and proceeded to narrow the anti-folate claims to claim Pematrex and disodium.

[00:16:20] Speaker 00:
On two subsequent occasions, when we started new applications in the same chain, we filed preliminary amendments

[00:16:27] Speaker 00:
where we had to re-cancel the same claims.

[00:16:30] Speaker 00:
Because that is just the nature of how a preliminary amendment works.

[00:16:35] Speaker 03:
Let me make sure I understand what you just said, Mr. Pullman.

[00:16:40] Speaker 03:
Did you say that you actually narrowed the claims when you went from Olympta to Pematrexid disodium?

[00:16:48] Speaker 00:
No.

[00:16:49] Speaker 00:
No, no, no.

[00:16:49] Speaker 03:
I believe that's...

[00:16:52] Speaker 03:
Well, the recording will confirm or deny, but I thought I heard you say you only narrowed once when you went from olympto to tematrexid disodium, which came as a surprise to me.

[00:17:04] Speaker 00:
No, no, no.

[00:17:04] Speaker 00:
If I said that, I apologize.

[00:17:06] Speaker 00:
All right.

[00:17:07] Speaker 00:
No, no.

[00:17:07] Speaker 00:
We canceled the claims once.

[00:17:10] Speaker 00:
We went from olympto to tematrexid disodium.

[00:17:12] Speaker 00:
And what I intended to say is, at the same time, we narrowed from antifolate to tematrexid disodium.

[00:17:17] Speaker 00:
All right.

[00:17:18] Speaker 00:
All right.

[00:17:18] Speaker 00:
I appreciate that.

[00:17:19] Speaker 00:
I appreciate it.

[00:17:22] Speaker 00:
As to the issue of whether we tried to claim hematrexid in the November 2005 preliminary amendment, we did not.

[00:17:30] Speaker 00:
That claim is limited to the use of hematrexid disodium.

[00:17:35] Speaker 00:
It recites a method of inhibiting tumor growth by administering hematrexid disodium.

[00:17:40] Speaker 00:
Later in the claim, it refers to giving a methylmalonic acid lowering agent prior to the first administration of hematrexid.

[00:17:50] Speaker 00:
But that is obviously referring back to the previously stated hematrexate disodium, because that is the antecedent basis for that term, hematrexate.

[00:18:02] Speaker 00:
It's clearly a typographical error, which the examiner noted.

[00:18:06] Speaker 00:
The more important point is that that amendment has nothing to do with the issue in this case.

[00:18:12] Speaker 00:
That amendment is about the issue in the Hospira case, which was narrowing antifolate to hematrexate disodium.

[00:18:20] Speaker 00:
all of the action of canceling the Olympia claim to remove the trade name had happened in the previous application.

[00:18:27] Speaker 00:
And I'll just point out parenthetically, I don't know that it goes anywhere, but on Mr. Rukozi's theory, it wouldn't even be a narrowing because he says Olympia means Pematrexas and he says the amended claim says Pematrexas.

[00:18:38] Speaker 00:
And so the entire thing to me is a tempest in a teapot.

[00:18:42] Speaker 03:
Now, as to the... Can I ask you, while you're moving on, can I ask you,

[00:18:48] Speaker 03:
What, in your view, is the particular compound or portion of a compound identified as LY231514?

[00:18:59] Speaker 00:
So the prior art uses that to mean both tematrexid and tematrexid disodium.

[00:19:07] Speaker 00:
Right.

[00:19:08] Speaker 00:
For instance, the John reference that was before the examiner refers to

[00:19:13] Speaker 00:
Pematrexid disodium, LY231514, and the examiner says also known by the trade name olympta.

[00:19:20] Speaker 00:
Right.

[00:19:21] Speaker 00:
And the same is true of MTA, which was the point I was about to get to.

[00:19:26] Speaker 00:
Mr. Ricozzi says MTA and olympta were used interchangeably, and MTA can only mean Pematrexid.

[00:19:32] Speaker 03:
But it's your position that LY231514 is Pematrexid disodium, not simply Pematrexid.

[00:19:41] Speaker 00:
It has been used to mean both.

[00:19:42] Speaker 03:
But you would say, do I understand you to be saying that colloquially, because it doesn't really matter what the particular cation is, that the colloquially, this is referred to as either pematrexate or pematrexate disodium, but it actually technically means pematrexate disodium.

[00:20:05] Speaker 03:
Is that your point?

[00:20:08] Speaker 00:
I don't think that is my point.

[00:20:09] Speaker 00:
Your Honor, I think right up until the last part, that was my point.

[00:20:18] Speaker 03:
There are various references to this L.Y.

[00:20:22] Speaker 03:
231514 in the record that identify that as Pematrexit.

[00:20:31] Speaker 03:
I'm wondering what your position is with respect to those.

[00:20:34] Speaker 03:
Are they simply erroneous?

[00:20:38] Speaker 03:
kind of a loose characterization of the portion of the compound that really matters.

[00:20:46] Speaker 00:
The thing that is loose about it is that the association of that with olymptah and then the suggestion that that means that because 231-514 can mean pematrexa that olymptah must necessarily mean pematrexa.

[00:21:03] Speaker 00:
There is frankly not

[00:21:05] Speaker 00:
clear answer in the record about what the right answer is.

[00:21:08] Speaker 00:
That code was used in the prior art and by Lilly to refer to both the hemitrexate disodium and to hemitrexate per se, but the point here is that whether or not that term or MTA has been used to refer to either substance, Olymptah is the trade name for an actual product as manufactured by Lilly, as the specification says, and that product

[00:21:35] Speaker 00:
always is pemotrexate disodium.

[00:21:38] Speaker 00:
And that answers the point about MTA's usage in the specification.

[00:21:44] Speaker 00:
MTA is used to mean pemotrexate disodium, just as olymptase is.

[00:21:49] Speaker 00:
And it is undisputed that in the clinical trials where MTA is discussed, their own expert admitted the person of ordinary skill would know that the only substance ever given to human patients was pemotrexate disodium.

[00:22:03] Speaker 00:
And so that has to be what MTA means in that context.

[00:22:07] Speaker 00:
And let me just say something more broadly about the literature that Judge Bryson brought up.

[00:22:12] Speaker 00:
It's important to remember that the authors of these papers were not engaged in the somewhat Talmudic dissection of the terminology that we are engaged in in this case.

[00:22:22] Speaker 00:
They were talking about a new and exciting chemotherapy drug.

[00:22:26] Speaker 00:
And when they talk about the word Pematrexid, sometimes they put olymptus in parenthesis.

[00:22:32] Speaker 00:
That's because the only way anywhere in the world any doctor could find a product that has hemitrexid in it, if they were interested, would be to look to olympto.

[00:22:42] Speaker 00:
It doesn't change what the olympto product is.

[00:22:45] Speaker 00:
It doesn't change that olympto is the trade name for hemitrexid disodium product.

[00:22:51] Speaker 00:
Because the context in which these articles are being written is not the same context that we are engaged in in this case.

[00:22:59] Speaker 00:
But my principle point is none of that makes any difference.

[00:23:02] Speaker 00:
look to the intrinsic record here, the specification is clear that olimta and pematrixid disodium are meant to be the same thing, and the examiner three times in the very office action that we are focused on here made clear that he or she understood that olimta is the trade name for pematrixid disodium.

[00:23:22] Speaker 00:
In rejecting over the John reference, the examiner expressly said that olimta is the trade name for pematrixid disodium.

[00:23:29] Speaker 00:
And then there's a rejection of claims 9, 29, and 30, where the claims said Olympta, and the examiner characterized the claims as specifically citing pematrixid disodium, which by the way is what this court did in Haspera.

[00:23:44] Speaker 00:
And then there's a second rejection of claims 29, 30, and 33, where the claims said Olympta.

[00:23:50] Speaker 00:
And the examiner said those claims specifically cite pematrixid disodium.

[00:23:56] Speaker 00:
And so three times in the very office action that we are focused on,

[00:23:59] Speaker 00:
the examiner made clear, that which is also clear from the specification, that olymptah means hematrexate disodium.

[00:24:08] Speaker 00:
I want to say a quick word about the European application because it's actually supportive of our position, not Appitex's position.

[00:24:18] Speaker 00:
Mr. Racozzi said that the examiner in Europe objected to the use of the word olymptah and we replaced that word with hematrexate.

[00:24:25] Speaker 00:
But that isn't the entire story.

[00:24:28] Speaker 00:
First of all,

[00:24:29] Speaker 00:
We did not say that we were equating Olympta and Pematrexid.

[00:24:34] Speaker 00:
What the European attorney said is that having disclosed Pematrexid disodium under European law, he felt he should be entitled to claim Pematrexid per se.

[00:24:45] Speaker 00:
That under European law, that would be a sufficient disclosure and basis.

[00:24:49] Speaker 00:
That issue has nothing to do with any issue in this country or in this case.

[00:24:54] Speaker 00:
The next thing that happened, though, is that the examiner said, no, you don't have that basis.

[00:24:59] Speaker 00:
You've disclosed olimta and hematrexid disodium, which are different than just hematrexid.

[00:25:06] Speaker 00:
And so you cannot claim just hematrexid because your specification in disclosing olimta is only disclosing hematrexid disodium, which is a different compound.

[00:25:17] Speaker 00:
And so Lilly then changed its claims again and said, we are now claiming our preferred embodiment, hematrexid disodium, parenthesis olimta,

[00:25:27] Speaker 00:
And we are going to go through, because this is the practice in Europe apparently, we are going to go through the specification and replace all instances of the word olympta with the word hematrexadisodium and we'll put olympta in parenthesis.

[00:25:43] Speaker 00:
Absolutely consistent with our position in this case.

[00:25:46] Speaker 00:
In my short time remaining, I want to turn briefly to tangentiality.

[00:25:51] Speaker 00:
The question for whether there was a narrowing is something that this court looked at as of today and says, looking back,

[00:25:57] Speaker 00:
objectively was there a narrowing.

[00:25:59] Speaker 00:
The question on tangentiality is what actually happened at the time in the file history and what can we glean from the objective review of that file as to what the rationale was at the time for the amendment.

[00:26:15] Speaker 00:
And this file history makes crystal clear that the reason for this amendment was to remove the trade name from the claim and to moot that rejection.

[00:26:25] Speaker 00:
there was no substantive issue with the scope of this claim.

[00:26:30] Speaker 00:
Pematrexid disodium was known in the prior art, and as this court pointed out in Haspera, it makes no sense to say that you would amend to Pematrexid disodium to avoid prior art that discloses Pematrexid disodium.

[00:26:43] Speaker 00:
The reason in the file is to avoid the trade name, and in the two subsequent preliminary amendments where the amendment is carried forward, it is the same reason carried forward again, and this court

[00:26:55] Speaker 00:
in every tangentiality case faces preliminary amendments where all the action has happened in the past and the same amendment is carried forward.

[00:27:04] Speaker 00:
And what Mr. Roccozzi is saying is, well, you have to repeat all your arguments and all the substance again every time you file a preliminary amendment or else it's an unexplained amendment.

[00:27:13] Speaker 00:
That wasn't the law in Haspera when two other parties made that exact argument a year ago or it's not been the law in any of these court cases.

[00:27:22] Speaker 00:
And I thank the court, the district court, for your time.

[00:27:25] Speaker 02:
Thank you.

[00:27:27] Speaker 02:
Mr. Cozy, will we store your five minutes of rebuttal whenever you're ready?

[00:27:31] Speaker 01:
Thank you, Chief Judge.

[00:27:33] Speaker 01:
Several points.

[00:27:34] Speaker 01:
First, we agree the intrinsic evidence should control here.

[00:27:37] Speaker 01:
In here, claim nine was directed to the anti-folate Olymptah.

[00:27:41] Speaker 01:
Olymptah was the anti-folate.

[00:27:43] Speaker 01:
There's no dispute the antifolate is defined as the inhibitor and really has admitted that the inhibitor is penetrexit.

[00:27:50] Speaker 01:
It is penetrexit not the salt that does the inhibiting.

[00:27:54] Speaker 01:
That is the quote antifolate end quote as defined in the specification.

[00:27:58] Speaker 01:
And I'm not sure why we should be able to run away from admissions from the House Bureau case about what the antifolate is.

[00:28:06] Speaker 01:
Point two, to your question Judge Bryson on LY231514,

[00:28:12] Speaker 01:
I don't want to belabor the point, but we can start with prior going back to 95, whether it's Jackman, Shee, 97, 98, Calvert, 98, Rizola, 98, Calvert, 99.

[00:28:23] Speaker 01:
These all use and define LY231514 as Pematrexid.

[00:28:29] Speaker 01:
as an actual compound inhibitor, Pematrexib.

[00:28:32] Speaker 01:
As a matter of fact, the examiner recognized as much in Worzola 1998, which also uses LY231514 and MTA to be actual Pematrexib, the inhibitor that undergoes that intracellular polyglutamation.

[00:28:48] Speaker 01:
It is not the salt.

[00:28:49] Speaker 01:
And if we look what the examiner said about Worzola, she associated LY231514

[00:28:57] Speaker 01:
followed by a parenthetical to Olympta.

[00:28:59] Speaker 01:
So she even understood what LY231514 was.

[00:29:03] Speaker 01:
And when she was talking about John, if you look carefully on A7401, she puts the parenthetical, also known by the trade name Olympta, after LY231514.

[00:29:15] Speaker 01:
And again, all of the prior references make clear that that is hematrexid.

[00:29:21] Speaker 01:
As a matter of fact, Worzola in 1998 even goes out of its way to make clear

[00:29:26] Speaker 01:
and distinguish LY231514 from the salt, saying that a salt form of LY231514 was also made.

[00:29:36] Speaker 01:
And so when the specification says or uses interchangeably the terms olympta and NTA, it is using olympta interchangeably with hematrexid.

[00:29:48] Speaker 01:
Point three, on the European counterpart,

[00:29:51] Speaker 01:
We're talking about the same specification, the same PCP application that it claims priority to, the same claim language, and an examiner who found a limta unclear as well.

[00:30:02] Speaker 01:
They amended the penitrexid and then told the examiner the basis was those parentheticals.

[00:30:08] Speaker 01:
Now, the only reason really later amended was because the examiner would not allow them to claim so broadly as to capture the other faults.

[00:30:17] Speaker 01:
When they made the amendment from a lymph of the Pematrexid, they dropped in a dependent claim where Pematrexid is Pematrexid disodium, showing the world they were attempting to capture other salts.

[00:30:27] Speaker 01:
Only when the examiner did not allow them to do that did they then go back to the US language, Pematrexid disodium, and make those changes.

[00:30:36] Speaker 01:
So we submit the EU counterpart or the EPO counterpart is

[00:30:40] Speaker 01:
real-world pre-legation objective evidence of what really instilled persons believed Olinta Tameen penetrates it, and that really, by those amendments, was attempting to capture other assaults.

[00:30:53] Speaker 01:
Point four, on these amendments, there's no dispute in this record.

[00:30:57] Speaker 01:
There were three amendments made here amending the Olinta claim term.

[00:31:02] Speaker 02:
Each amendment, whether it was- Well, there was one amendment that was carried over to the two provisionals, right?

[00:31:09] Speaker 01:
There was the original November 2005, Your Honor, and then a November 2005.

[00:31:13] Speaker 01:
And that carried over to two divisional applications, right?

[00:31:18] Speaker 01:
Well, when you say carry over, Your Honor, meaning that they started with the same claims and then amended them, I would agree with that.

[00:31:24] Speaker 01:
Yes, but I would not agree that the reason for those amendments carried over.

[00:31:30] Speaker 01:
We see no authority cited by Lillian that's papered at all for this idea somehow that their trade name theory in the November 2005 amendment somehow automatically carries over to the other two amendments.

[00:31:43] Speaker 01:
The law is when you don't give a rationale, that's violence.

[00:31:46] Speaker 01:
Silence cannot rebut the theft or presumption of surrender.

[00:31:50] Speaker 01:
And on the November 2005 amendment, again, they didn't say we were amending to get rid of the trade name.

[00:31:57] Speaker 01:
They said the opposite.

[00:31:58] Speaker 01:
They said we are believing without prejudice.

[00:32:01] Speaker 01:
When you say that, that means you're reserving the right to go after that broader claims scope, which is exactly what they tried to do both in the US and Europe, signaling their intent to try and capture other salts.

[00:32:14] Speaker 01:
And the dipotassium salt was the second most well-known salt.

[00:32:18] Speaker 01:
It falls right in the bull's eye of

[00:32:20] Speaker 01:
that surrenders.

[00:32:22] Speaker 01:
In this case, it's nothing like Haspera.

[00:32:24] Speaker 01:
My final point, Haspera court did not make a finding on Alinta.

[00:32:30] Speaker 01:
It did not have a record or an occasion to do so.

[00:32:33] Speaker 01:
It involved a different phone term, a different rejection, and different amendments and rationales.

[00:32:41] Speaker 01:
And there's nothing tangential about repeatedly narrowing from pematrixid, covering all salts, to the disodium.

[00:32:48] Speaker 01:
So Lilly has not shown that a skilled person would not be reasonably expected to draft a claim that literally encompasses the well-known dipotassium salt.

[00:32:57] Speaker 01:
Thank you, Your Honor.

[00:32:59] Speaker 02:
Thank you.

[00:33:00] Speaker 02:
And we thank both sides.

[00:33:01] Speaker 02:
And that concludes the case is submitted.

[00:33:04] Speaker 02:
And that concludes our proceeding for this morning.

[00:33:06] Speaker 02:
Thank you all.

[00:33:09] Speaker 02:
The honorable court is adjourned until tomorrow morning at 10 a.m.