[00:00:00] Speaker 03:
The document is 171033, Claussen vs. Alon Pharmaceuticals.

[00:00:31] Speaker 01:
Morning, Your Honors.

[00:00:34] Speaker 03:
Morning.

[00:00:35] Speaker 01:
I'm here again on this case representing class and immunotherapies.

[00:00:40] Speaker 01:
The last time we were here, the exact same issue that was presented to the court this time was presented to the court.

[00:00:47] Speaker 01:
Whether or not certain post-approval activities are within or outside the scope of the safe harbor.

[00:00:58] Speaker 01:
The court on remand asked the district court

[00:01:02] Speaker 01:
to look only at post-approval activities, the reanalysis, the identification of inventorship, and the packaging and sale of the kit claims, which are the product by process claims.

[00:01:18] Speaker 01:
The CFC specifically said, this is quoting from the earlier decision, Klassen also asserts that certain activities that occurred after the FDA submissions infringed the 470 patent.

[00:01:30] Speaker 01:
Those activities

[00:01:32] Speaker 01:
are not exempted under the safe harbor.

[00:01:34] Speaker 01:
Because the district court did not determine whether those activities constituted infringement or whether they were exempt, we vacate the judgment of non-infringement and remand.

[00:01:44] Speaker 04:
Mr. Zito, could I ask you when the expiration date of this patent is?

[00:01:49] Speaker 04:
The expiration date seems to have been November 99.

[00:01:56] Speaker 04:
It was extended by

[00:01:59] Speaker 04:
two hundred ninety eight days, but it's subject to a terminal disclaimer.

[00:02:03] Speaker 04:
What is the expiration date?

[00:02:05] Speaker 01:
I don't know the exact date, but it expired last summer in 2016.

[00:02:08] Speaker 01:
It expired?

[00:02:09] Speaker 01:
I think in June of 2016.

[00:02:14] Speaker 01:
What's the date on that?

[00:02:15] Speaker 04:
Well, the fact of expiration is basically what I wanted to know.

[00:02:20] Speaker 01:
At least a year or two ago, yes.

[00:02:21] Speaker 04:
You answered it.

[00:02:23] Speaker 01:
And these activities occurred in the early two thousand

[00:02:28] Speaker 01:
to 2003 timeframe, the analysis activities that we're now still here on.

[00:02:35] Speaker 01:
And although the, although the district court said, accordingly the sole question now before this court is whether Elon's post-submission activities constitute infringement of the 472 patent or whether they were exempt, the court went back and looked at all those activities in light of the Teletronix case.

[00:02:57] Speaker 01:
which is, as the court, as the circuit court here said, is not applicable to Claussen's position.

[00:03:08] Speaker 01:
Briefly, the Teletronics case said, if you do some activity after submission, you don't unprotect the activity that was accused of infringement that was part of the clinical study.

[00:03:21] Speaker 01:
And that's not what's happening here.

[00:03:23] Speaker 01:
What's happening here is the activity in the clinical study is not accused of infringement.

[00:03:28] Speaker 01:
It's not the activity that would be an infringing activity.

[00:03:31] Speaker 01:
And so there's no attempt, as there was in Teltronix, to pull something out of protection based upon dissemination of information.

[00:03:40] Speaker 03:
You don't argue in your brief, as I recall, maybe I'm missing something.

[00:03:43] Speaker 03:
We had a case in Momenta, too.

[00:03:46] Speaker 01:
Yes.

[00:03:46] Speaker 03:
I did in 2015, which I think may bear on

[00:03:51] Speaker 03:
your issues here and you don't discuss it in your brief.

[00:03:54] Speaker 03:
You discuss Memento 1 but not Memento 2.

[00:03:56] Speaker 03:
Do you know the case I'm referring to?

[00:03:58] Speaker 01:
Yes.

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

[00:03:59] Speaker 03:
Do you think it helps you?

[00:04:03] Speaker 01:
I don't know, Your Honor.

[00:04:07] Speaker 03:
I know the case Memento... There may be an argument that it helps you.

[00:04:11] Speaker 03:
That's why I didn't see you arguing for it.

[00:04:13] Speaker 01:
Okay.

[00:04:14] Speaker 01:
We do cite a number of cases that already help us on page 43 of our brief.

[00:04:21] Speaker 01:
which talk about shipments of samples of patented products in fringe, making products and shipping them abroad in fringes, including the case of Scripps versus Research Fund, Scripps and Clinic and Research Fund versus Genentech from North District of California, 87, which says preparation of an application for a patent is beyond the protection of Section 271E1 and constitutes use of a product.

[00:04:49] Speaker 01:
serving multiple purposes, unrelated to meetings, meeting the FDA requirements.

[00:04:58] Speaker 01:
I don't think we need the help from Momentum 2, and that's why it's in our brief, because we're not, again, and what the district court did was instead of looking at post activities,

[00:05:20] Speaker 04:
The district court said that... What are the activities that you claim are infringing that are not covered by the safe harbor in previous decisions?

[00:05:35] Speaker 01:
When we look at claim 131, which is claim 33, 36, and then 131, because 131, remember there was a

[00:05:49] Speaker 01:
There was a substantial re-examination that occurred over a four and a half year period that narrowed the number of claims down.

[00:05:55] Speaker 01:
When we look at that claim, certainly, and we'll start backwards if you will, it's on page 11 and 12 of our brief, the blue brief.

[00:06:04] Speaker 03:
Are you talking about claim 33 of the 472 patent?

[00:06:09] Speaker 01:
I'm talking about claim 131 of the 472 patent.

[00:06:14] Speaker 05:
Which depends on claim 33.

[00:06:17] Speaker 05:
Which depends on claim 33?

[00:06:20] Speaker 01:
Depends on claim 36, which depends on claim 33.

[00:06:23] Speaker 01:
And the reason we go to that claim is that claim 33 and 36 did not survive re-examination, but claim 131 did.

[00:06:31] Speaker 01:
So when we look at that claim, we see that the last element is we're in commercializing further comprises documenting inventorship.

[00:06:39] Speaker 04:
Documenting inventorship?

[00:06:42] Speaker 04:
That's an abstract idea.

[00:06:45] Speaker 04:
Why does that contribute to the infringement of a claim?

[00:06:53] Speaker 01:
Documenting a bench trip is not an abstract idea.

[00:06:55] Speaker 04:
It's a process of... Determining and using an intellectual process and or writing it down.

[00:07:05] Speaker 04:
And when you go back to claim 33, analyzing data to identify

[00:07:15] Speaker 04:
commercial value?

[00:07:18] Speaker 04:
How is that infringing?

[00:07:20] Speaker 01:
And you're getting to the point of the remand, which was what this court asked the District Court to do was potentially consider those questions, potentially consider infringement questions based upon that, potentially consider other validity questions based upon these activities which had nothing to do with FDA approval.

[00:07:41] Speaker 01:
They occurred after it.

[00:07:43] Speaker 01:
and but though unfortunately none of that analysis is here before the court.

[00:07:47] Speaker 05:
Are there invalidity contentions whether defenses or counterclaims in this case or were there?

[00:07:55] Speaker 01:
There were invalidity contentions and counterclaims which were parallel to the defendant here filed the re-examination of the original two patents that were in this case.

[00:08:07] Speaker 01:
Now we're down to one patent with reduced number of claims because the invalidity contentions

[00:08:11] Speaker 05:
As to the claims that are right now in front of us, were there invalidity contentions, whether by way of defense or counterclaim, in this case?

[00:08:23] Speaker 01:
Yes, there were.

[00:08:24] Speaker 05:
What's the status of those?

[00:08:28] Speaker 05:
Because they were... Were they dismissed without prejudice to reinstatement?

[00:08:36] Speaker 01:
Essentially, yes, in order to have the first appeal.

[00:08:38] Speaker 01:
Essentially, yes, or actually, yes?

[00:08:41] Speaker 01:
It gets complicated because of the intervening reexamination.

[00:08:43] Speaker 05:
Your jurisdiction, you know, may actually turn on the answer to this question?

[00:08:49] Speaker 01:
Okay.

[00:08:56] Speaker 01:
They were not dismissed.

[00:09:00] Speaker 01:
They were dismissed without prejudice to reinstate pending the appeal.

[00:09:04] Speaker 01:
So they were not, they were not dismissed from the case.

[00:09:06] Speaker 01:
They still exist in the case.

[00:09:08] Speaker 01:
They're not affected because it was re-examination, not an inter-party's review, so they were not mooted by those same issues being brought before the Patent Office.

[00:09:19] Speaker 02:
But again, there's been... Did you hear a 101 allegation in this case?

[00:09:27] Speaker 01:
There's been no briefing or detailed 101 allegations, but it has been raised by a defendant where they have said,

[00:09:35] Speaker 01:
we believe that even if this comes back from the next appeal, we would raise 101.

[00:09:39] Speaker 01:
They said that to the district court in pleading.

[00:09:41] Speaker 01:
So it has been raised, but not briefed, nor formulated in any manner.

[00:09:46] Speaker 03:
That's one of those contentions that has been dismissed conditionally.

[00:09:50] Speaker 01:
Correct.

[00:09:51] Speaker 01:
So it's still in the case.

[00:09:52] Speaker 05:
So can I ask, I understood, or at least in my mind, I was dividing

[00:10:02] Speaker 05:
your contentions here into two pieces, the method claims and the kit claims.

[00:10:09] Speaker 05:
The method claims, as I understand it, are about post October 16, 2001 reanalysis.

[00:10:19] Speaker 02:
Correct.

[00:10:20] Speaker 05:
Okay.

[00:10:20] Speaker 05:
And one ground, alternative ground, right at the end of the district court's opinion for granting summary judgment of non-infringement as to that,

[00:10:30] Speaker 05:
was the conclusion that you just didn't have the evidence to show that such reanalysis took place.

[00:10:41] Speaker 05:
Correct.

[00:10:41] Speaker 05:
Is it my understanding, is my understanding correct that that piece of the district court's analysis applies only to the method claims and not to the kit claims, the claims that say

[00:10:53] Speaker 05:
We claim the sale of a product with a label or a package insert that includes some information.

[00:11:02] Speaker 05:
Because those claims, the kit claims, don't depend, or do they depend, on the post-October 16, 2001 analysis.

[00:11:13] Speaker 01:
The kit claims are dependent upon the method claims, so they are a product-by-process claim.

[00:11:18] Speaker 01:
The defendant would argue that they do depend upon that.

[00:11:21] Speaker 05:
But do they depend on

[00:11:24] Speaker 05:
such analysis as took place after October 16, 2001 or not?

[00:11:34] Speaker 01:
Yes, they would depend because they depend from the method claim from which the claims depend is parallel to claim 33.

[00:11:40] Speaker 01:
It's just claim 73 that have to depend from.

[00:11:44] Speaker 01:
Now the district court found that that activity did occur.

[00:11:48] Speaker 01:
They didn't find there was no evidence.

[00:11:49] Speaker 01:
They found that there was evidence and what their statement was

[00:11:53] Speaker 01:
the evidence of commercialization is insufficient to overcome teletronics to bring the, again, they misapplied, insufficient to overcome teletronics to bring it out of the protected harbor.

[00:12:09] Speaker 01:
But they agree.

[00:12:09] Speaker 01:
They said the reanalysis that was done by Elon, the argument that no reanalysis is done doesn't make any sense because they filed a group of

[00:12:19] Speaker 01:
of researchers filed a submission to the FDA.

[00:12:24] Speaker 01:
No, that submission didn't file itself at the Patent Office as a patent application.

[00:12:28] Speaker 01:
The patent application is completely rewritten.

[00:12:31] Speaker 01:
It addresses prior art, which is an evaluation.

[00:12:33] Speaker 01:
One of the steps of evaluation is it has to be a new adverse event.

[00:12:37] Speaker 01:
So there's the obviousness and the novelty analysis that was clearly done.

[00:12:41] Speaker 01:
And Elon admits in their brief that a pre-filing validity analysis was done.

[00:12:50] Speaker 01:
That's part of the analysis that was done.

[00:12:51] Speaker 01:
There are different people named as inventors than the people that were researchers.

[00:12:55] Speaker 01:
So there was a re-analysis and a reworking of the, and clearly they, whether it's an intellectual step or not, they clearly did the documenting inventorship because they named who the inventors were and documented why.

[00:13:09] Speaker 01:
So yes, one of the things that the court said was go back and see if there's evidence of infringement.

[00:13:14] Speaker 01:
And the district court said there's evidence of all these steps being done.

[00:13:19] Speaker 01:
But then they just simply got it wrong because they thought, I don't know why, because it's explicit in the court's decision, that they now need to analyze these infringing activities in light of teletronics and decide whether the post activities take the FDA clinical activities out of a safe harbor.

[00:13:39] Speaker 01:
And that's never been plaintiff's assertion of infringement in this case.

[00:13:46] Speaker 01:
It's that if you do these steps, which include documenting inventorship, analyzing, making sure it is patentable, which is analyzing a new adverse event, looking at potential commercial value, commercializing, all the steps which are unrefutably done, because otherwise there would not have been a patent application, there wouldn't have been a patent prosecution, wouldn't have issued, and as you said, if you sell a product with a label on it, you can't refute that you're not doing the kit claim.

[00:14:16] Speaker 01:
and the only way you get to the kit claim with the product with the label on it that's protected by Elon's three patents is by having done the other steps.

[00:14:26] Speaker 03:
We're well into rebuttal.

[00:14:28] Speaker 03:
We've saved the remainder and listen here at the other side.

[00:14:31] Speaker 03:
Thank you.

[00:14:47] Speaker 00:
May it please the court?

[00:14:49] Speaker 00:
Klassen was provided every opportunity on remand to articulate its infringement allegations with more specificity and clarity and to provide evidence supporting those allegations.

[00:14:59] Speaker 00:
Yet Klassen did neither.

[00:15:01] Speaker 00:
For example, the discussion this morning about reanalysis of data, Klassen argued to the district court that there must have been some type of reanalysis of data, but presented no evidence about that issue.

[00:15:15] Speaker 00:
And contrary to counsel's representation just now, the district court actually said that, and this is at appendix page 11 of the district court's opinion, that Classen has produced no evidence of Alon's alleged reanalysis of the data for commercial purposes so as to raise a genuine issue of material fact.

[00:15:37] Speaker 00:
Also, Classen's arguments focus on Alon's patents, Alon's labeling,

[00:15:44] Speaker 00:
and Alon's, in the brief, they talk about Alon's business activities.

[00:15:47] Speaker 04:
They're not talking about safe harboring.

[00:15:48] Speaker 04:
They're saying no infringement.

[00:15:51] Speaker 04:
Excuse me?

[00:15:51] Speaker 04:
They're just saying there was no infringement, not that there was a safe harbor.

[00:15:56] Speaker 00:
Correct.

[00:15:56] Speaker 00:
They're saying you can't look at the safe harbor.

[00:15:58] Speaker 00:
There was, there was, Klassen is arguing there was infringement separate and apart from any activity that related to the safe harbor.

[00:16:05] Speaker 00:
But they don't act, they don't identify what that activity is.

[00:16:08] Speaker 00:
They present no evidence about that.

[00:16:09] Speaker 00:
The only evidence in the record

[00:16:12] Speaker 00:
there are two deposition transcripts from two employees and the district court looked at that information and properly noted there's nothing in that transcript that talks about analyzing data at all.

[00:16:25] Speaker 00:
It's about attending a conference and also having conversations with Dr. Klassen, but nothing about actually reanalyzing data during the patenting process.

[00:16:36] Speaker 05:
Why does that point, the point you're just making based on that last page or so of the district court's opinion, apply to the kit claims?

[00:16:45] Speaker 05:
Is that because of what Mr. Zito said, that even the kit claims depend on the post-October 16th, 2001 reanalysis?

[00:16:55] Speaker 00:
That's our position, Your Honor, that the product by process claim, this is a different type of product by process claim,

[00:17:01] Speaker 00:
And it's similar to others in that the process limitations must be taken into account interpreting that claim.

[00:17:08] Speaker 00:
But in a conventional product process by claim, if it was like, for example, a method of manufacturing a product, if you've manufactured that useless process steps for manufacturing during your FDA clinical trial, that would be exempt.

[00:17:24] Speaker 00:
If you later practice those same method steps to manufacture the product unrelated to the FDA process,

[00:17:32] Speaker 00:
that would be infringement.

[00:17:34] Speaker 05:
What if you practiced the process pre-FDA submission and did it for the purposes of the FDA submission, but then you sold the product after the FDA approval and included

[00:17:52] Speaker 05:
the process, the information development in what is after all post-approval product, post-approval activity.

[00:18:02] Speaker 00:
At that point you're selling a product together with information and we argue this is similar to telectronics, you're disseminating information with this product that was developed during the FDA process and that cannot constitute infringement and in fact

[00:18:21] Speaker 05:
And the specific situation in Teletronix was what?

[00:18:26] Speaker 00:
Where there was dissemination of information to commercial investors and for business purposes.

[00:18:32] Speaker 05:
Was it just the information that was accused of infringement or was there something like this, which is a sale of a physical thing accompanied by the information?

[00:18:40] Speaker 00:
There were also allegations about business development, commercial type businesses.

[00:18:44] Speaker 05:
I mean, that's why Teletronix is actually a little bit, maybe even quite importantly, different from this.

[00:18:50] Speaker 05:
The fact is, after the FDA approval of the supplemental, the sale of the product is not within the safe harbor.

[00:18:59] Speaker 00:
Right?

[00:18:59] Speaker 00:
The sale of the physical product is not within the safe harbor.

[00:19:02] Speaker 00:
Right.

[00:19:02] Speaker 05:
So they claim the sale of the physical product with certain information.

[00:19:06] Speaker 00:
And the argument is that, Klasson's argument is that you've attached to that product this information developed during

[00:19:15] Speaker 00:
the FDA process and that information must be included in the label under FDA rules in order to maintain and continue your approval of that product.

[00:19:24] Speaker 00:
So you must include that information when you sell the product to maintain approval of your product.

[00:19:29] Speaker 00:
That's a predicate for that.

[00:19:31] Speaker 00:
We argue that is even, again, back into the safe harbor in the sense of that information.

[00:19:38] Speaker 05:
I'm not actually sure

[00:19:41] Speaker 05:
what to make of this, but forget about information.

[00:19:46] Speaker 05:
The Safe Harbor is about doing experiments, making stuff, using stuff, maybe even selling stuff, I don't know, in order to develop a product, and you submit all the information to the FDA, and the FDA says, yes, you have something.

[00:20:00] Speaker 05:
After that, you then take all of that activity which you've done for the purpose of getting FDA approval, and now you're allowed to make the product, and you sell the product.

[00:20:10] Speaker 05:
No more Safe Harbor.

[00:20:11] Speaker 05:
Even though you're using everything you did before, why in the world should this be any different?

[00:20:16] Speaker 05:
Assuming that, even assuming that all of the information, which I think Mr. Zeno says is not the case, that all the information that's relevant here is pre-October 16, 2001.

[00:20:29] Speaker 05:
That's the submission date, right?

[00:20:31] Speaker 00:
Right.

[00:20:32] Speaker 00:
And I think the difference is, we believe the difference is,

[00:20:36] Speaker 00:
Unlike most of the situations that have involved this similar scenario, those activities that you conducted during the Safe Harbor period are not being reconducted post Safe Harbor period.

[00:20:50] Speaker 00:
His claims require identifying an adverse event, a new adverse event, and identifying a new use

[00:20:58] Speaker 00:
because of that new adverse event.

[00:20:59] Speaker 00:
That new adverse event was discovered, if at all, during the Safe Harbor provision.

[00:21:05] Speaker 00:
And what was new can only be new once.

[00:21:08] Speaker 00:
That new adverse event was identified during the clinical study Safe Harbor period.

[00:21:14] Speaker 00:
Later, reanalyzing data for patenting purposes or including the information on a label that was already identified is not practicing the steps of the claims, which do require identification of a new adverse event.

[00:21:32] Speaker 00:
And I think as a separate grounds, which also the district court pointed to, was the lack of any evidence related to actually tying what activities were being focused upon for purposes of infringement.

[00:21:45] Speaker 00:
The only thing alleged below was the reanalysis of the data, the alleged reanalysis of data for patenting purposes.

[00:21:53] Speaker 00:
And again, there's no evidence that that ever took place.

[00:21:57] Speaker 00:
And you can't fault the district court for not reviewing evidence that wasn't presented.

[00:22:02] Speaker 00:
in the appeal, Klassen argued in its briefs, the district court failed to consider the evidence.

[00:22:10] Speaker 00:
The district court did look at the very, very minimal record and there was no evidence of reanalysis of data.

[00:22:18] Speaker 00:
At the district court level, although Klassen complains about the district court's analysis, the issues presented to the district court were the exact same issues

[00:22:30] Speaker 00:
that were before this court on appeal.

[00:22:32] Speaker 00:
And the district court specifically asked Klassen during the summary judgment hearing, what is it what you're arguing now differ from the guidance given by the Federal Circuit?

[00:22:45] Speaker 00:
And Klassen was unable to articulate any reason that its scenario was distinct from that in the analysis that the Federal Circuit provided in its decision.

[00:22:57] Speaker 00:
Um, and I also would like to just note on this factual issue, um, this case came to the district court.

[00:23:04] Speaker 00:
Um, and this is a different judge Bennett than that decided a different judge that decided this summary judgment is different than the judge who decided the first summary judgment.

[00:23:12] Speaker 00:
Um, it came to the judge after 10 years of litigation and extensive fact and expert discovery.

[00:23:19] Speaker 00:
And after all this time and all the evidence that was collected during discovery class and has not pointed to any

[00:23:27] Speaker 00:
deposition testimony of the numerous witnesses supporting its reanalysis position.

[00:23:32] Speaker 00:
It has identified any documents supporting its reanalysis position.

[00:23:38] Speaker 00:
And for that reason, it was not surprising, and it was entirely appropriate for the district court to issue summary judgment on that independent basis, a lack of any fact issue in dispute.

[00:23:50] Speaker 03:
Can I ask you about that?

[00:23:51] Speaker 03:
And we asked your friend about there are pending counterclaims here or pending defenses here that were

[00:23:57] Speaker 03:
dismissed without prejudice?

[00:24:00] Speaker 00:
No, the claim counterclaims are not dismissed without prejudice.

[00:24:03] Speaker 00:
There are still pending claims with respect to invalidity.

[00:24:09] Speaker 00:
There was a one-on-one argument.

[00:24:10] Speaker 00:
It was in the final pretrial order.

[00:24:12] Speaker 00:
The parties did submit an entire pretrial order.

[00:24:15] Speaker 05:
They were not dismissed without prejudice?

[00:24:17] Speaker 00:
Correct.

[00:24:17] Speaker 05:
And there's no final judgment?

[00:24:19] Speaker 00:
And there's an issue with respect to, you're raising the rule 54B issue, Your Honor.

[00:24:24] Speaker 00:
I believe.

[00:24:28] Speaker 00:
Was there a 54B here?

[00:24:30] Speaker 00:
There was in the prior appeal and then the judge issued summary judgment in our position that we concede to the appeal by ZETO under the same umbrella of that prior rule 54B because the judge considered the same issues that it considered previously.

[00:24:45] Speaker 05:
Where is that?

[00:24:48] Speaker 05:
Do we have some piece of paper in the Joint Appendix that describes this not entirely ordinary process?

[00:24:55] Speaker 00:
There's nothing in the Joint Appendix.

[00:24:57] Speaker 05:
So we can treat this as a 54B even though there's no final judgment and there are counterclaims still pending?

[00:25:07] Speaker 00:
We concede to that, yes, Your Honor.

[00:25:11] Speaker 03:
So you mentioned the 101.

[00:25:12] Speaker 03:
I mean, it just seems a little odd, perhaps, that you just mentioned 10 or 12 years of litigation and loads of discovery and certain invalidity defenses or counterclaims that can certainly be disposed of fairly promptly.

[00:25:27] Speaker 03:
It's just a little odd how this case went down, right?

[00:25:30] Speaker 00:
Yeah.

[00:25:30] Speaker 00:
The case was moved along fairly quickly, Your Honor, and got to the point of a final pretrial order before the judge, in the first case, first time,

[00:25:40] Speaker 00:
found summary judgment.

[00:25:41] Speaker 00:
So summary judgment was found back in 2005, 2006.

[00:25:44] Speaker 00:
And on this limited basis of failure of proof as to infringement, both from a factual standpoint and from a legal standpoint under the Safe Harbor provision.

[00:25:56] Speaker 00:
And the case then was stayed pending the re-examination proceedings.

[00:26:02] Speaker 00:
And so things just did not move forward.

[00:26:05] Speaker 00:
And on remand, the district court judge, the new judge, looked at

[00:26:09] Speaker 00:
What Klassen argued on appeal, looked at the record on remand, and said, this is the exact same argument, we're going to just move forward with this, rather than open up again everything with respect to 101.

[00:26:22] Speaker 00:
There were 112 issues, priority issues, et cetera.

[00:26:27] Speaker 03:
Just to circle back on one point, just to be clear, because I thought I heard your friend say that the counterclaims of the defenses were dismissed without prejudice.

[00:26:35] Speaker 03:
And you're saying that wasn't the case.

[00:26:37] Speaker 00:
Correct, Your Honor.

[00:26:45] Speaker 00:
I have nothing further unless you have additional questions.

[00:26:59] Speaker 01:
Council stated that the district court said it's the exact same argument and that is the problem because it's not the exact same argument.

[00:27:07] Speaker 01:
This is not Teltronix and this court said explicitly this case is not Teltronix.

[00:27:12] Speaker 01:
Teletronics, in that case, there was a set of steps that had to occur in a laboratory.

[00:27:18] Speaker 01:
Those steps one through five all occurred, and they were done.

[00:27:22] Speaker 01:
A year later, they took laboratory results and brought them to investors to get money.

[00:27:28] Speaker 01:
Teletronics' argument was, aha, getting money is a commercial use, so now the steps that you've already done somehow come out of protection.

[00:27:37] Speaker 01:
We're not arguing that.

[00:27:39] Speaker 01:
So it's not Teletronics, it's not the same.

[00:27:41] Speaker 01:
And that goes back to

[00:27:43] Speaker 01:
The district court never analyzed.

[00:27:49] Speaker 01:
Let me read you from appendix page 10, which is from the district court's decision.

[00:27:57] Speaker 01:
The alleged acts of commercialization by Elon, the filing of patent applications based on the reanalyzed clinical data, and the sales collection with a revised label containing information derived from the clinical trial, appear

[00:28:10] Speaker 01:
Contrary to Carson's argument, far less commercial in nature than those activities deemed protected in teletronics.

[00:28:16] Speaker 01:
Accordingly, these activities remain within the scope of the safe harbor, and Elon is entitled to summary judgment.

[00:28:22] Speaker 01:
So the court's agreed, and in Elon's brief at page 22... Wait a minute, wait a minute.

[00:28:28] Speaker 03:
But keep going in the opinion, because at appendix 11, they kind of deal with an alternative.

[00:28:34] Speaker 03:
Discovery Long and Complete Claussen has produced no evidence of alleged reanalysis of the data for commercial purposes, and so they go through the failure of your failure to provide any evidence to support infringement.

[00:28:48] Speaker 01:
Which is contrary to what they say in the paragraph before, which is that they reanalyzed clinical data, which is the evidence.

[00:28:59] Speaker 01:
And as Eli admits in their brief on page 22, there was a pre-examination search.

[00:29:04] Speaker 01:
There was an identification of the inventorship.

[00:29:07] Speaker 01:
There is evidence in there.

[00:29:09] Speaker 01:
What the judge didn't do was ever compare any of that evidence to whether or not it met any of the elements of the claim, which it was instructed to do.

[00:29:19] Speaker 03:
The court needs to look and see if... Something like that contradicts what I read to you said that contradicts the paragraph before.

[00:29:26] Speaker 03:
So what is the paragraph before?

[00:29:28] Speaker 03:
Give me a page and a paragraph.

[00:29:33] Speaker 01:
the the activities of the activities of ilan quote appear contrary to classes argument far less commercial nature than those activities page you on it ten or eleven I'm on appendix page ten the court's conclusion it's the paragraph begins with the court's conclusion that ilan's post submission activities fit within the scope what the court did was say

[00:30:03] Speaker 01:
These activities, though commercial in nature, don't amount to infringement because of the safe harbor.

[00:30:11] Speaker 01:
They didn't say, and then the next paragraph says, and so you've shown no commercial activities that are outside the safe harbor.

[00:30:18] Speaker 01:
Not that we've shown no commercial activities.

[00:30:22] Speaker 01:
Because clearly we've shown step six, the 131 step of documenting inventorship.

[00:30:28] Speaker 01:
There's an inventor's name.

[00:30:29] Speaker 01:
There's an application which has the inventor's signature on it.

[00:30:34] Speaker 01:
Clearly that step was done.

[00:30:36] Speaker 01:
We put that into the record.

[00:30:38] Speaker 01:
And the court is simply saying, I see that step, but I don't think it gets outside the safe harbor.

[00:30:44] Speaker 01:
There's no evidence of that step.

[00:30:46] Speaker 01:
There's no evidence that takes you outside the safe harbor.

[00:30:49] Speaker 01:
Not no evidence of commercialization.

[00:30:51] Speaker 01:
Courts certainly can't be saying that selling a product with a label on it in the market

[00:30:56] Speaker 01:
is not evidence of commercialization.

[00:30:58] Speaker 01:
That's a sale of a product.

[00:31:00] Speaker 01:
What the court is saying is I'm not analyzing this in terms of comparing it to claim language, which is what the court should be doing.

[00:31:07] Speaker 01:
I'm simply analyzing it to say no matter what happens, it doesn't take the clinical activities out of the safe harbor.

[00:31:13] Speaker 01:
So it's not evidence of infringement because infringement is precluded by the safe harbor.

[00:31:17] Speaker 01:
It's not not evidence of infringement because they didn't do those steps.

[00:31:21] Speaker 05:
Thank you.

[00:31:23] Speaker 05:
I'm sorry to be a pest about this.

[00:31:26] Speaker 05:
So, Rule 54B, as I'm looking at it, says that the judge has to expressly find that there is no just reason for delay in order for that provision to apply.

[00:31:39] Speaker 05:
You haven't presented to us anything in which the judge said that, which means we have no jurisdiction over this appeal.

[00:31:49] Speaker 01:
You may be right on that point.

[00:31:50] Speaker 01:
I stand corrected that there was no dismissal without prejudice of the other.

[00:31:55] Speaker 01:
But the previous appeal had a Rule 54B certification on it.

[00:32:01] Speaker 01:
At this point the judge simply said we're done with the case appeal.

[00:32:07] Speaker 01:
So that you may be correct that there's no jurisdiction.