[00:00:00] Speaker 01:
Court today is MNX Corporation versus Sandoz, case number 201037, a decision following trial and post trial motions from the District of New Jersey.

[00:00:14] Speaker 01:
I've expanded with the agreement of the panel the arguments to 20 minutes per side, but I am going to try to stay within that despite

[00:00:23] Speaker 01:
the fact that I didn't do a great job on the last one to stay within it.

[00:00:27] Speaker 01:
But having said that, Mr. Jay, you want four minutes for rebuttal?

[00:00:30] Speaker 01:
If possible.

[00:00:31] Speaker 01:
Thank you, Your Honor.

[00:00:33] Speaker 01:
OK.

[00:00:33] Speaker 01:
Yeah, you're just going to need to pick and choose your battles wisely, I guess.

[00:00:37] Speaker 01:
OK.

[00:00:38] Speaker 04:
Thank you.

[00:00:40] Speaker 04:
So may it please the court?

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Immunex has already enjoyed the full term of multiple patents based on its invention of eCANercept.

[00:00:47] Speaker 04:
What it can't do is shield its multi-billion-dollar franchise on that fusion protein for another full decade.

[00:00:53] Speaker 04:
There are multiple reasons for that, as Judge O'Malley just alluded to.

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When Immunex took over Roche's pre-GAT patent application, it was not permitted to use that to obtain a time-wise extension of what it already had, which is a patent on etanercept.

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It also could not go beyond what Roche's original specification disclosed.

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So for both reasons, the district court committed legal error by allowing Immunex to have another decade of protection.

[00:01:20] Speaker 01:
The district court made a lot of findings.

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It said, OK, you lose on point A. But even if you didn't lose on point A, you lose on point B. Even if you didn't lose on point B, you lose on point C. And it did about four or five down the line.

[00:01:34] Speaker 01:
So you're going to have to convince us that the district court

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after a two-week trial and an 80-page opinion got every single one of those wrong, right?

[00:01:42] Speaker 04:
So the district court did make alternative conclusions.

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So for example, on ODP, I agree that there are multiple steps that we were asking the court to take.

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Right.

[00:01:51] Speaker 04:
So we could win on ODP.

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We could win on written description.

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Each of those is separate.

[00:01:55] Speaker 00:
Why don't you address the ODP issue first and stick to that one for a little bit.

[00:02:00] Speaker 04:
Absolutely.

[00:02:00] Speaker 04:
And so you're right, Judge O'Malley, that the district court made a bunch of alternative conclusions.

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But we submit to you that each of those is a legal conclusion.

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The district court did not.

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insulate that by calling it factual findings for these reasons.

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Number one, what test to apply?

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That's plainly a legal question.

[00:02:18] Speaker 00:
Number two, whether the, if you're looking at the think patents... But haven't you addressed whether the 2004 agreement transferred all substantial rights

[00:02:30] Speaker 04:
I'd be happy to judge right now, because we do think that that is a central point.

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And let me just begin by saying that that, too, is a legal question, because as this Court has said in each of its all substantial rights cases, starting with the Vopel, that that's a question of law.

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In this case, what?

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That's important.

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And maybe I'm just being too much of a law professor type here.

[00:02:51] Speaker 01:
But we keep saying that what's important is, with respect to most contracts, intent of the parties.

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Is there, this is one of the first cases, what we've gone beyond 12b6 on this topic.

[00:03:05] Speaker 01:
So is there an issue with respect to intent that falls outside the four corners of the document that we're allowed to consider?

[00:03:13] Speaker 04:
I don't think so for several reasons, Your Honor.

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So of course, you're right that this court has referred to the party's intent.

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But in the first case in which the court did that, it was alluding back to contract cases going back a long way, but not to a kind of contract like this one.

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Whereas I think all of this court's case is starting with FOPAL.

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When it has looked at the party's intent, it's been dealing with an agreement between sophisticated parties.

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And it has looked only to the contract itself, because the contract is the best evidence of the party's intent.

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And that's especially so here.

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If you look at paragraph 11.12 of the agreement, the last portion of the agreement, which recites, as sophisticated parties generally do, that the agreement is the entire agreement between the parties.

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It's all written down.

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Is it governed by Delaware law, or do we have a body of law that

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that should actually control this interpretation.

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So on the question, what did the parties agree to?

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What was transferred?

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What was retained?

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You would look to Delaware law in interpreting the contract, but we think it really is just a pure question of law because the contract itself says these rights are retained, these rights are transferred.

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On the question whether that's enough to transfer all substantial rights, that's a question of federal law that this court applying the term patentee in the Patent Act has interpreted as a legal matter.

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And that is really why we're asking this court to use that same test.

[00:04:33] Speaker 01:
So you think that the test for what we now know simply to be whether or not you qualify under the statute as opposed to standing, but whether you qualify under the statute as a patentee,

[00:04:46] Speaker 01:
That's a statutory inquiry.

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This ODP is an equitable principle that was designed as an exception to what would otherwise be governing law.

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And so why do we necessarily transport that statutory analysis into this doctrine?

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To put a finer point on it, ODP is hard enough.

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Why would we want to introduce this incredibly additional complex inquiry into whether the patent owner here really has common ownership with another set of patents when they've structured some kind of licensing arrangement?

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So let me answer both of your questions together, because what we're asking the court to apply is a well-recognized test for determining what, as this course has said in at least half a dozen cases, who is the effective patentee after parties engage in a transaction like this?

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Who's the effective patentee?

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Patentee and owner are different things.

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I mean, ownership would be governed by state law, right?

[00:05:50] Speaker 04:
Potentially but for but with a term that we're asking you to look at in the statute right so if you look for example at the terminal disclaimer statute 253b that likewise refers to a patentee or an applicant who can file a terminal disclaimer What is the only purpose of the terminal disclaimer statute?

[00:06:08] Speaker 04:
it is to cure an ODP problem.

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So it makes sense, as this court said in Longhi and in other cases, for the entity that's able to file a terminal disclaimer to be the entity that is on the hook for obviousness type double patenting if it owns another patent or application that's not patentably distinct.

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And so what this court said in Longi, and I think Longi is particularly significant, because I take your point, Judge Chen, about there are some difficulties with applying this test.

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But the other side is proposing, the test the other side is proposing is already been rejected by this court in Longi, because it would rule out.

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The timing test has been rejected.

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The time of invention test.

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Exactly.

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The idea that if, at the moment of invention, even if it's going to be assigned to your employer as a matter of course the next day,

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that that should be the test.

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We think that that's clearly rejected not only by Longy, but by decades of precedent from this court, I think, collected in the Rogers decision, footnote four, which is cited in Longy itself.

[00:07:11] Speaker 01:
Just because we might not like either test that you guys proposed doesn't mean that we think that we have to choose between one or the other.

[00:07:19] Speaker 04:
I definitely take that point, Judge O'Malley, but I do think that going to a test that is, number one, this court's longstanding and, I think, now well-developed test for deciding who is the effective patentee makes perfect sense when you are deciding who is the patent owner for purposes of obvious type double patenting.

[00:07:40] Speaker 04:
That is, precisely because it is an equitable doctrine, it makes sense to look at substance and not labels

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which is exactly what, starting with the Supreme Court's decision in Waterman, the All Substantial Rights Test does.

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So that's one way in which it's entirely consistent with the purposes of ODP.

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And second, I think just as the facts of this case illustrate, when a

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the second entity, like the recipient, has the opportunity to control prosecution, write the claims, exclude everyone else from the commercial exploitation of the invention, and enforce the patent to the exclusion of others.

[00:08:17] Speaker 03:
It makes eminent sense to... Just to clarify, for you, your position is we should whole hog transport our body of law on prudential standing, who is the effective patent owner.

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Right into ODP for whether or not someone is a common owner of multiple patents.

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Yes, that the whole thing.

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We are asking you to adopt.

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Or are there other possible, I don't know, sensitivities or different sensitivities that we would have in a different context, the context here of whether to apply obviousness type double patenting that militate against just doing a mirror image or carbon copy of what we already have for whether you have the right to sue on a patent.

[00:09:02] Speaker 04:
So I would think that a case like this would raise any of the concerns like that precisely because the

[00:09:08] Speaker 04:
recipient acquired all substantial rights in the patent application during prosecution.

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So the recipient had the ability to control what the claims were going to say, had the opportunity to control, to some degree, the timing of prosecution.

[00:09:22] Speaker 01:
So in answer, then, to Judge Shen's question, I thought that you were playing in a little more conservative, that you weren't saying you should whole hog transport this analysis.

[00:09:37] Speaker 01:
You were saying,

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more narrowly that at least where one of the rights transferred is the right to prosecute the patent, this analysis ought to inform and ultimately drive the inquiry.

[00:09:51] Speaker 01:
Are you now saying something broader?

[00:09:54] Speaker 04:
No, we think that what you just said, Judge Amali, is basically all the court would need to decide in this case, to decide that we're right, that all substantial rights were transferred, including the right to prosecute, at a time when the recipient was able to actually use that right, control prosecution, and get claims that the recipient itself was able to author.

[00:10:12] Speaker 04:
And then, of course, had the opportunity, if it wanted to, to cure the ODP problem by filing a terminal disclaimer, but did not do so.

[00:10:19] Speaker 01:
Right.

[00:10:20] Speaker 01:
substantial rights, then what do you make of 3.6 of the agreement where it says that Roche retains the right to rectify infringement when Roche is the one to bring an action?

[00:10:37] Speaker 01:
Your friend on the other side is going to argue that that would then remove from IMUNIX any authority to grant an assignment with respect to that

[00:10:50] Speaker 01:
alleged infringer.

[00:10:51] Speaker 04:
Just like in this court's speed play decision, you never get to the reserved right to sue because there's a 180-day waiting period.

[00:11:00] Speaker 04:
And during that time, Immunex has the sole right to, as 3.5 of the agreement says, to rectify the infringement by granting a license or to bring suit.

[00:11:10] Speaker 04:
Those are exactly the facts that in speed play.

[00:11:13] Speaker 03:
Well, now we have to get into the weeds of what really happened in speed play because

[00:11:18] Speaker 03:
I think I agree with you that could be one reading of Speedplay, but then Alfred E. Mann issued later and explained what actually happened and what was the pivot point in Speedplay and there in

[00:11:32] Speaker 03:
we said in Alfred E. Mann that what really mattered was after that lawsuit had been initiated by the licensor, the lawsuit got basically taken away by the licensee who issued a sublicense to the defendant.

[00:11:49] Speaker 03:
It was a royalty-free sublicense, but nevertheless,

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it was illusory because after the secondary lawsuit, secondary right to sue had been triggered, then the sub-license had been granted.

[00:12:03] Speaker 03:
And in Alfred E. Mann, they said, yes, that's the same thing that happened in Alfred E. Mann, but there were pass-through royalties in that case.

[00:12:11] Speaker 03:
Here, assuming for the moment, I know there's an argument that the court understands this agreement to bar

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getting all the names confused, Immunex from granting a sublicense to a defendant after Roche's initiated that lawsuit, then the fact pattern here is outside of the fact pattern of speed play, given how we understand speed play

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through Alfred E. Mann.

[00:12:43] Speaker 03:
Am I missing something?

[00:12:45] Speaker 04:
I'm not sure I agree quite with your characterization, Judge Chen.

[00:12:48] Speaker 04:
I certainly agree that what was doing the work in Alfred E. Mann was the obligation to pass through royalties from the sublicense.

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That's what the court said distinguished the case from speed play.

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And there's no such obligation here.

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Immunex has the same ability to grant royalty-free sublicenses.

[00:13:07] Speaker 04:
And even if we get into an argument about whether it could do so after day 180, the fact is that it has the complete authority to do so

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before day 180.

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So it has a lengthy period in which it gets to choose whether to sue or whether to prevent Roche from suing.

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And we submit that that's all that you need to establish that Roche's retained right is illusory.

[00:13:28] Speaker 04:
Because during that time, Immunex has the sole right, and this is to quote the beginning of both 3.5 and 3.6, to rectify infringement, including by sublicense.

[00:13:38] Speaker 04:
And there's no obligation for the sublicensee to pay Roche a dime.

[00:13:43] Speaker 04:
That's why we think this really is on all fours with Speedplay.

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If anything, in this case, the waiting period is longer than in Speedplay, where it was 90 days.

[00:13:51] Speaker 03:
At the same time, Immunex always had that right to issue that sublicense at any point in time after the agreement was signed, right?

[00:14:01] Speaker 04:
Immunex has the right to issue a sub license at any time.

[00:14:03] Speaker 04:
Yeah.

[00:14:04] Speaker 03:
So whether it was inside that 180 day window or before the hundred and eight day window, my point is they always had that right.

[00:14:10] Speaker 03:
But once Roche files the lawsuit in compliance with the agreement, then Immunex is blocked.

[00:14:16] Speaker 04:
Well, that's the other side's argument.

[00:14:18] Speaker 04:
We don't agree with that, but we also don't think that the court needs to answer that question.

[00:14:21] Speaker 04:
And that's why I'm focusing on the 180-day point, because there is no argument that Immunex can't issue a sublicense during that first 180-day period.

[00:14:30] Speaker 04:
There is no such argument.

[00:14:31] Speaker 04:
There could not be such an argument in light of the plain text of the agreement.

[00:14:34] Speaker 04:
We think that that is what materially puts this case on all forces.

[00:14:39] Speaker 01:
OK, assuming you get past the all-substantial rights, let's go to the one-way versus two-way.

[00:14:45] Speaker 01:
I mean, you said that all of this were legal determinations, but there were specific factual findings that the trial court made about diligence and about really who was at fault here.

[00:14:59] Speaker 01:
I mean, you've got some pretty egregious conduct out of the PTO on this, right?

[00:15:06] Speaker 01:
Losing the file, admitting that they hadn't even done anything for five years, ignoring all the requests

[00:15:14] Speaker 01:
You know, a status report.

[00:15:15] Speaker 01:
I mean, there's a lot here.

[00:15:17] Speaker 01:
Why isn't that enough to say that we should use the two-way analysis?

[00:15:23] Speaker 04:
So it's not enough.

[00:15:24] Speaker 04:
So let me first address the standard of review, because I think that's important.

[00:15:26] Speaker 04:
What's implicit in your question is how much of this is legal.

[00:15:29] Speaker 04:
And then let me address why the legal conclusion is wrong.

[00:15:32] Speaker 04:
So first, the standard of review.

[00:15:34] Speaker 04:
So from Emart, this court said that it's a legal conclusion, which test to apply, and specifically, the conclusion to be drawn from the dates.

[00:15:45] Speaker 01:
It does say underlying facts, though.

[00:15:48] Speaker 04:
Sure.

[00:15:48] Speaker 04:
So what happened on what day, that's factual.

[00:15:50] Speaker 01:
It's just like claim constructions are legal as long as there's not an underlying factual finding.

[00:15:54] Speaker 04:
Yes, that's right.

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What happened is a matter of historical fact.

[00:15:59] Speaker 04:
That's established and I don't think is disputed.

[00:16:02] Speaker 04:
But what conclusions you draw about whom to attribute fault to, that we think under Emmert and all of this court's two-way test cases, which I should say are really almost all come out as one-way test cases, that is a legal conclusion.

[00:16:17] Speaker 04:
And as I just alluded to, this court has always said that the two-way test is a very narrow exception.

[00:16:23] Speaker 04:
It only applies when the PTO and solely the PTO causes the second patent to issue after the first patent when it would have issued in the opposite sequence.

[00:16:33] Speaker 01:
That's not the case here, because if you look at the delta... Almost every one of the cases where we didn't find the PTO solely responsible is distinguishable from the facts here.

[00:16:43] Speaker 01:
I mean, it makes me a little nervous to say that anyone who just asks for normal extensions, by definition, you're at fault.

[00:16:53] Speaker 04:
I take that point, Jojo Malley.

[00:16:54] Speaker 04:
So let me just begin by saying we are not relying on just on normal extensions here.

[00:16:59] Speaker 04:
Now, Inrei Emmert talks about extensions as one factor to look at.

[00:17:02] Speaker 04:
But this is far beyond just normal extensions, because most fundamentally, what you have here is the recipient of all substantial rights, where Immunex comes in a decade into prosecution, gets rid of the P55, which has been what has been prosecuted for a decade,

[00:17:18] Speaker 04:
and swaps in P75.

[00:17:21] Speaker 04:
And so quite naturally, that is going to extend the time necessary to examine this case.

[00:17:28] Speaker 04:
It really is erasing a decade of progress and going back to the beginning.

[00:17:32] Speaker 04:
And that is on the applicant, just like in Ray Basel.

[00:17:37] Speaker 04:
You look at the changes that are made to the application.

[00:17:40] Speaker 04:
Deciding who caused what period of delay we're certainly not saying that the PTO did not cause any portion of the delay but the question that you are asking is Did the second patent issue after the first patent and so here there are two patents the largest Delta is about a little under 13 months so did the applicants cause at least 13 months of delay and both because of the change in the application and because of their

[00:18:07] Speaker 04:
failure to respond to PTO notices saying that certain claims were allowable and because of time that they took during prosecution, extension after extension, all of that adds up to you can't say that the PTO was solely responsible for the delay and solely is the test and this court has said in case after case that it means it.

[00:18:28] Speaker 04:
In order to protect the public against unjustified timewise extensions, you apply the one-way test, except in this really exceptional circumstance, which is not right.

[00:18:36] Speaker 00:
So your argument is that the Eli Lilly case supports your position that this is a one-way case?

[00:18:42] Speaker 03:
Yes.

[00:18:43] Speaker 03:
Absolutely.

[00:18:45] Speaker 03:
The 690 Jacobs patent?

[00:18:47] Speaker 03:
Yes.

[00:18:49] Speaker 03:
Is the priority date 1989 or 1992?

[00:18:53] Speaker 04:
The Jacob's patent, I believe, is 1989.

[00:18:55] Speaker 03:
But a CIP was filed in 1992.

[00:18:58] Speaker 04:
That's correct.

[00:19:02] Speaker 03:
Does the claimed invention of the 690 patent have sufficient support going all the way back to 1989?

[00:19:14] Speaker 04:
I guess the question would be whether that would matter for purposes of ODP, right?

[00:19:18] Speaker 03:
Well, the Roche patents, as I understand them, their priority date goes to 1990.

[00:19:24] Speaker 03:
Right.

[00:19:25] Speaker 03:
So now we have to figure out which one was really the first filed, the Roche patents or the Jacobs patent.

[00:19:30] Speaker 03:
Jacobs gets 1989, then the Jacobs patent is the first filed application.

[00:19:35] Speaker 03:
If Jacob's priority date is 1992, then it's the Roche patents that were the first filed.

[00:19:42] Speaker 04:
But these are both pre-gap patents, right?

[00:19:44] Speaker 04:
And so the term is 17 years from issuance.

[00:19:46] Speaker 04:
And as this court has said, you look at the issuance date and deciding what's an appropriate reference patent in that case.

[00:19:53] Speaker 03:
Yes, but I'm just trying to understand one way versus two way.

[00:19:56] Speaker 03:
One way versus two way, you look at, OK, which one was the first one filed, and was that first one filed the second one that issued?

[00:20:03] Speaker 04:
Well, if we're looking at filing and not priority, I certainly understand that point.

[00:20:07] Speaker 04:
Jacobs was filed in 1995.

[00:20:08] Speaker 03:
Yes.

[00:20:09] Speaker 03:
My understanding of one way versus two ways, you look at the priority date, the first filed application.

[00:20:15] Speaker 04:
Well, you look at the priority date only in this sense, I think, because if you're not looking at time in prosecution, but you're looking at kind of this distinct question, could the patentee have, in one of the earlier applications that that same patentee had prosecuted, have claimed the same invention?

[00:20:33] Speaker 04:
So was there an opportunity to do so?

[00:20:36] Speaker 04:
And so here the answer is yes, they did have an opportunity to do so, because it did so in Jacobs.

[00:20:45] Speaker 04:
So I don't think that whether it could do so with the full benefit of the 1989 priority date,

[00:20:54] Speaker 03:
has ever been held to be.

[00:20:55] Speaker 03:
And then we have the somewhat bizarre question whether the 690 even covers the Tanner Center, right?

[00:21:01] Speaker 04:
We do have that question, which of course is just a matter of claim construction.

[00:21:04] Speaker 04:
And we think that the district court got that wrong.

[00:21:08] Speaker 04:
If you look at claim two and claim five, which is what the other side says was the basis for its having labeled its multi-billion dollar product with this patent for a long time.

[00:21:20] Speaker 04:
They say, well, that was just claim two and claim five.

[00:21:23] Speaker 04:
Claim two and claim five claim a TNF receptor.

[00:21:26] Speaker 04:
Etanercept is not a TNF receptor.

[00:21:28] Speaker 04:
Etanercept is a fusion protein, just like what's described in claim three.

[00:21:32] Speaker 04:
I think that the only way to read this and also the insertion of the exemplary language into, which is at 27307,

[00:21:43] Speaker 04:
One specific example of a TNFRFC fusion protein is, and then there's some sequestration.

[00:21:49] Speaker 01:
And that issue with respect to the marking, that was one where the district court did rely a lot on expert testimony, right?

[00:21:56] Speaker 04:
So the district court, no, I don't think that that's right, Your Honor.

[00:21:59] Speaker 04:
The district court concluded that this patent did not claim each intercept based on the district court's construction of the constant domain and whether the constant domain has to be in a completely unmodified constant domain.

[00:22:13] Speaker 01:
We're gonna have to stop.

[00:22:14] Speaker 01:
I'll restore your four minutes for rebuttal.

[00:22:16] Speaker 01:
I'll give you five minutes extra if you need it.

[00:22:19] Speaker 01:
Thank you, your honor.

[00:22:20] Speaker 01:
Mr. Trela, okay.

[00:22:25] Speaker 02:
Thank you, your honor, and may it please the court.

[00:22:28] Speaker 02:
I want to talk about ownership for ODP purposes and all substantial rights and all that, but I... Can I just do... Of course.

[00:22:37] Speaker 03:
I want to understand Immunex's portfolio.

[00:22:41] Speaker 03:
excluding the Roche patents for the moment.

[00:22:43] Speaker 03:
What patents does or did Immunex have that were directed to or, I guess, covered Etanercept?

[00:22:53] Speaker 03:
Beyond the 690 and then the 225, which is a method of treatment.

[00:22:58] Speaker 02:
Well, really none other than there are some what we call the Fink patents.

[00:23:03] Speaker 02:
There were two other Fink patents.

[00:23:06] Speaker 02:
The 225 is a Fink patent.

[00:23:07] Speaker 02:
What's the treatment method?

[00:23:08] Speaker 02:
A method of treatment of specific

[00:23:10] Speaker 02:
For example, the FINK-225 is a method of treating psoriasis, providing for certain clinical results and so on.

[00:23:18] Speaker 02:
And then you mentioned the Jacobs pen, which is actually what I wanted to talk about before I get to the broader ownership questions, because that's what Mr. Jay was talking about.

[00:23:30] Speaker 02:
Jacobs was filed in 1989.

[00:23:32] Speaker 02:
There was a continuation in part in 1992, where they tried to get a claim to e-Tannercept, but it was rejected because it was not supported by the 1989 application.

[00:23:44] Speaker 02:
And so Immunex dropped the attempt to get that claim because it wanted to keep that priority date.

[00:23:49] Speaker 02:
Now, Mr. Jay mentioned claims two and five of the Jacobs patent, and that is why it was listed on the Enbrel label, because those are comprising claims.

[00:24:01] Speaker 02:
He made it sound like they were limited to a TNF receptor.

[00:24:05] Speaker 02:
They're not.

[00:24:05] Speaker 02:
They're methods of treatment comprising, administering a TNF receptor.

[00:24:10] Speaker 02:
Well, that's why they were put on the Enbrel label, because... The P75?

[00:24:13] Speaker 02:
TNF?

[00:24:16] Speaker 02:
I think the Jacobs claims are broader.

[00:24:17] Speaker 02:
They're just any TNF receptor.

[00:24:19] Speaker 02:
So they would cover etanercept because it uses a TNF receptor.

[00:24:25] Speaker 02:
But they don't define etanercept.

[00:24:27] Speaker 02:
They're not fusion protein claims.

[00:24:29] Speaker 02:
Claim three, which is the only claim they relied on for ODP purposes as to Jacobs, claims a chimeric antibody.

[00:24:37] Speaker 02:
And as the district court explained, that as the claim language indicates and as the specification indicates, it requires unmodified constant domains.

[00:24:47] Speaker 02:
And that's not etanercept either.

[00:24:49] Speaker 02:
District Court also found that e-tannercept would not have been obvious in light of that claim properly construed.

[00:24:54] Speaker 02:
And they don't even challenge that on appeal.

[00:24:57] Speaker 02:
So it claims three doesn't cover e-tannercept.

[00:24:59] Speaker 02:
Claims two and five are not the basis for the ODP argument.

[00:25:03] Speaker 02:
And they just claim methods of treatment using TNF receptors.

[00:25:08] Speaker 02:
And so Jacobs is just, it doesn't apply at all.

[00:25:13] Speaker 02:
Now.

[00:25:13] Speaker 01:
So let's go back to the think patents.

[00:25:16] Speaker 01:
So you concede.

[00:25:19] Speaker 01:
that if we find all the way through that the district court was wrong and we get to the point of one way versus two way.

[00:25:29] Speaker 01:
If it's one way, then ODP applies.

[00:25:32] Speaker 02:
No, I don't concede that for two reasons, Your Honor.

[00:25:35] Speaker 02:
First of all, there's been a lot of focus, particularly in Sandoz's brief on the 1A2 patent, which is the patent that claims the tenorcept compound.

[00:25:46] Speaker 02:
We shouldn't forget the 522 patent, which claims methods of producing the fusion protein.

[00:25:52] Speaker 02:
Now, a claim to a method of treatment using a compound doesn't tell you anything at all about how to produce that compound.

[00:26:00] Speaker 02:
They don't make any argument.

[00:26:01] Speaker 02:
If you look at their briefs, there's no argument that somehow the 522 claims to methods of producing etanercept

[00:26:09] Speaker 02:
are made obvious by a claim to a method of treating plaque psoriasis.

[00:26:13] Speaker 03:
Once you have possession of the etanercept compound, is there something in your claimed method of producing it that makes it a non-obvious way of producing it, the possessed known compound of etanercept?

[00:26:26] Speaker 02:
Well, sure.

[00:26:26] Speaker 02:
Well, first of all, their separate obviousness case as to those claims failed.

[00:26:33] Speaker 02:
So there is that.

[00:26:36] Speaker 02:
For example, one of the claims, one of the asserted claims in the 522 patent, claims using a particular kind of host cell, the CHO Chinese hamster ovary cell, to produce eutanasia.

[00:26:47] Speaker 02:
There's no way you read the faint claims and know anything at all about that.

[00:26:51] Speaker 02:
And again, pardon me.

[00:26:52] Speaker 01:
The district court didn't reach this particular, this precise issue, right?

[00:26:56] Speaker 02:
Well, the district court

[00:26:58] Speaker 02:
found that the two-way test applies so correct.

[00:27:01] Speaker 02:
Although there is a footnote, I don't have the right in front of me, but there's a footnote in that part of the district court's discussion where the court notes that the same issues and arguments would apply under the one-way test.

[00:27:16] Speaker 02:
I think it might be going a little too far to say that she was holding that, but she did seem to think that the analysis might well be the same under the one-way test.

[00:27:27] Speaker 02:
Now, as I was saying on the 522, there's nothing in a method of treatment claim that tells you anything at all about how to produce the compound.

[00:27:39] Speaker 02:
And even as to the compound claim, if general foods is still good law, and I have no reason to think it's not, it says you have to look at the claims for ODP purposes in their entirety.

[00:27:50] Speaker 02:
You can't just pick out

[00:27:52] Speaker 02:
you know, one step of a claim process or one component of an apparatus or compound claim, and say, oh, well, this later claim would have been obvious in light of that one component.

[00:28:05] Speaker 02:
And in General Foods, the court even said, even where that one component describes the essence of the later claimed invention.

[00:28:12] Speaker 02:
So we think under the General Foods approach to ODP, even the 1A2 compound claims are not

[00:28:21] Speaker 02:
obvious in light of the Fink method of treatment claim.

[00:28:26] Speaker 02:
So let me go back to the threshold ownership questions.

[00:28:32] Speaker 02:
Sandoz is really asking the court to make some pretty surprising new law here.

[00:28:39] Speaker 02:
First of all, the statutory basis for all of this is not the statute that refers to patentees.

[00:28:45] Speaker 02:
It's section 101, which refers to one who invents or discovers.

[00:28:51] Speaker 02:
So that's the basis for our position that the correct ownership test is the entire ownership of both at the time of invention, because that links it back to the statutory foundation.

[00:29:04] Speaker 01:
Did you reject that in Lungi?

[00:29:05] Speaker 02:
Well, I don't think you did, Your Honor, because Lungi was decided in 1985.

[00:29:09] Speaker 02:
And in other words, the case actually was developed before the 1984 amendments to the statute, where Congress

[00:29:18] Speaker 02:
noted, and we cite the legislative history, when Congress amended 103 to provide for the exclusion as prior art of references that were commonly owned at the time of invention, even if they had different inventors.

[00:29:36] Speaker 02:
Congress in the legislative history said, and basically we expect the PTO to reinstitute

[00:29:42] Speaker 02:
common ownership based double patenting to deal with this loophole.

[00:29:48] Speaker 03:
And in fact, the CCPA for decades had been also expecting the PTO to do that and had been telling the PTO that its 1967 OG notice made no sense and was not in compliance with their own law.

[00:30:01] Speaker 03:
So at least according to our predecessor court,

[00:30:05] Speaker 03:
The law of applying ODP to a common owner of two different patents or patent applications with different entities was always good ODP law.

[00:30:16] Speaker 03:
Yes, I understand.

[00:30:17] Speaker 03:
1984 came along and Congress did this carve out to 103 and 103C1.

[00:30:24] Speaker 03:
But I don't see why that after the fact tale should now wag the dog in how we understand

[00:30:31] Speaker 03:
obviousness double patenting, which had been in existence for decades when it comes to common ownership with different entities.

[00:30:38] Speaker 02:
Well, I think that, I don't know that it's a tail wagging the dog, but I think ODP is obviously a doctrine that's evolved over the years.

[00:30:48] Speaker 02:
And what we've got with the 1984 amendments and the legislative history is a pretty clear indication from Congress

[00:30:55] Speaker 02:
of what it thought the scope of common ownership ODP ought to be.

[00:30:59] Speaker 02:
And it also happens to be consistent with the governing statute, which is 101, which talks about one who invents or discovers can only get one patent on that invention.

[00:31:10] Speaker 02:
And that is the standard that's now embodied in the MPEP, the Patent Office Guidelines.

[00:31:17] Speaker 03:
What about in Ray Mann, which the other side cited in its gray brief?

[00:31:22] Speaker 03:
And I think it's a CCPA opinion.

[00:31:25] Speaker 02:
It is.

[00:31:26] Speaker 02:
Inray Mann is actually not really a double patenting case.

[00:31:30] Speaker 02:
It involves what was called the doctrine of election.

[00:31:33] Speaker 02:
And it was decided in about 1935, before the 1952 Patent Act, and importantly, before 102G became part of the statute.

[00:31:48] Speaker 02:
And Inray Mann was dealing with a situation where

[00:31:51] Speaker 02:
There was a common ownership.

[00:31:53] Speaker 02:
And normally, you would declare an interference, which was the Patent Office practice at the time.

[00:32:01] Speaker 02:
But they couldn't, because there was no adversity, since there was common ownership.

[00:32:05] Speaker 02:
And the Patent Office basically said, look to the common owner and said, well, you need to elect.

[00:32:10] Speaker 02:
You tell us which is first.

[00:32:12] Speaker 02:
And that's the one that's going to issue.

[00:32:13] Speaker 02:
So that was actually a different situation.

[00:32:15] Speaker 02:
And the law changed quite a bit since then.

[00:32:18] Speaker 03:
So you think that it would be OK if some independent inventor invented something and then the next day sold that to a big company like Immunex.

[00:32:31] Speaker 03:
And then now Immunex owns the rights to file a patent application on that invention that had just been created the day before.

[00:32:41] Speaker 03:
and then that wouldn't constitute common ownership for possible ODP with respect to some of Immunex's patent portfolio?

[00:32:53] Speaker 03:
Well, I don't think- Because in your view, Immunex did not own that independent inventor's invention at the time the inventor made it.

[00:33:02] Speaker 02:
That's right.

[00:33:03] Speaker 02:
I don't think it would be common ownership for ODP purposes.

[00:33:05] Speaker 02:
And I don't think that's going to be a problem, because the 103C safe harbor won't apply, because there was not common ownership at the time of invention.

[00:33:15] Speaker 02:
So the earliest invention is going to preclude the others, assuming that they're not patently distinct.

[00:33:21] Speaker 03:
But I don't think we've ever said that it's an either-or proposition.

[00:33:24] Speaker 03:
No, that's correct.

[00:33:25] Speaker 03:
We either get the safe harbor or, you know,

[00:33:29] Speaker 03:
And then only then will ODP apply.

[00:33:32] Speaker 03:
I don't think we've ever said that.

[00:33:33] Speaker 02:
No, I don't think you've ever said that.

[00:33:34] Speaker 02:
I don't think the issue's ever been squarely presented to the court.

[00:33:36] Speaker 02:
So you haven't not said it, I guess.

[00:33:38] Speaker 02:
But correct.

[00:33:39] Speaker 02:
Correct.

[00:33:40] Speaker 01:
But we have repeatedly looked to the data issuance of the patent.

[00:33:44] Speaker 02:
You have.

[00:33:45] Speaker 02:
You have.

[00:33:45] Speaker 02:
So let me talk about also.

[00:33:47] Speaker 02:
Maybe not thoughtfully, but we have.

[00:33:49] Speaker 02:
I certainly wouldn't say that.

[00:33:51] Speaker 01:
And I say that because a couple of them are my opinions.

[00:33:58] Speaker 02:
Let me talk about all substantial rights then.

[00:34:01] Speaker 02:
Now, that's never been applied in the ODP context.

[00:34:05] Speaker 02:
And there are good reasons for that.

[00:34:07] Speaker 02:
One is that it doesn't really deal with who owns a patent for ODP or any other purposes.

[00:34:13] Speaker 02:
It's are the right parties before the court so that the defendant doesn't have to worry about a series of suits from people claiming various bundles of rights.

[00:34:22] Speaker 03:
But let's just assume, well, it's not an assumption.

[00:34:25] Speaker 03:
ODP is all about trying to prevent mischief, gamesmanship, really expanding patent term.

[00:34:33] Speaker 03:
and controlling exclusivity over something that really should be dedicated to the public.

[00:34:38] Speaker 03:
And so it's an equitable doctrine.

[00:34:41] Speaker 03:
It's an equitable judgment doctrine.

[00:34:42] Speaker 03:
And now we can imagine there's all kinds of scenarios where parties will structure deals in a way that gives a second party everything but technical ownership.

[00:34:54] Speaker 03:
And it seems that that would be the sort of thing that ODP would want to police against to block a party from controlling patent term for 30, 40 years.

[00:35:12] Speaker 02:
It is an equitable doctrine.

[00:35:15] Speaker 02:
It is not an equitable doctrine untethered to the statute though.

[00:35:18] Speaker 02:
So I think it's not just this free-roving policy-based judgment to go around looking at patents that you may or may not think are appropriate.

[00:35:28] Speaker 02:
So that's point one.

[00:35:29] Speaker 02:
Point two is equitable judgments are typically made, in the first instance, at the district court level.

[00:35:35] Speaker 02:
The district court looked at this, found that there was no gamesmanship, no deleterious conduct on the part of immune acts.

[00:35:42] Speaker 02:
Also, incidentally, there had been a prosecution latches defense asserted originally.

[00:35:48] Speaker 02:
That was abandoned.

[00:35:49] Speaker 02:
So there's none of this fooling around that might be a legitimate concern for the ODP doctrine.

[00:35:57] Speaker 01:
How else do we determine ownership, though?

[00:36:01] Speaker 01:
Putting aside the timing question, what other factors would we consider?

[00:36:06] Speaker 01:
I admit that it's a separate statutory provision that we're trying to apply, but we are still trying to determine who is sufficiently the patent holder, patent owner, for purposes of being able to bring a lawsuit.

[00:36:20] Speaker 01:
So why aren't the factors at least informative, if not determinative?

[00:36:24] Speaker 02:
Well, I'm not sure that

[00:36:27] Speaker 02:
The All Substantial Rights Test is actually trying to decide who is even sufficiently the owner to bring a patent or patentee.

[00:36:38] Speaker 02:
For example, an exclusive licensee has standing to sue.

[00:36:41] Speaker 02:
The question is, does somebody else have to be there with him?

[00:36:45] Speaker 02:
So I think there's a mismatch between the doctrines.

[00:36:49] Speaker 02:
But let me talk about, even assuming that you apply it here, why Sandoz failed to make the case

[00:36:57] Speaker 02:
that Immunex received all substantial rights from Roche.

[00:37:01] Speaker 02:
And Judge Chen, I want to talk a little bit about the point you made about Alfred E. Mann and its reading of Speedplay.

[00:37:10] Speaker 02:
It's actually stronger in support of the district court's decision, even than it seemed.

[00:37:20] Speaker 01:
What about the royalty pass, though?

[00:37:22] Speaker 02:
Well, that's what I'm getting to, Your Honor.

[00:37:24] Speaker 02:
In Alfred E. Mann, and this is at page 1361 of the opinion, there is that royalty passage.

[00:37:31] Speaker 02:
But the court also says, before it even gets to that, that the licensee in that case, which had the first right to sue, could sue and settle immediately for nothing without any requirement for approval from the licensor, and notwithstanding that,

[00:37:48] Speaker 02:
The backup right to sue, the second right to sue, was still a substantial right.

[00:37:53] Speaker 02:
So it's true that they couldn't have the sublicense, but they could file a suit and then just let the defendant off.

[00:38:01] Speaker 02:
And that still did not negate the substantiality of that second right to sue.

[00:38:05] Speaker 03:
Because of the pass through royalties.

[00:38:06] Speaker 03:
I'm sorry?

[00:38:07] Speaker 03:
Because of the past three royalties.

[00:38:09] Speaker 02:
No.

[00:38:10] Speaker 02:
And that's the important point.

[00:38:12] Speaker 02:
They could sue and settle for nothing.

[00:38:15] Speaker 02:
There didn't have to be any royalties.

[00:38:17] Speaker 02:
They could just give them a release.

[00:38:20] Speaker 02:
And nonetheless, the second right to sue was still a substantial right.

[00:38:25] Speaker 02:
And the court was very clear about this.

[00:38:27] Speaker 02:
And again, as I said, it's at page 1361 of that opinion.

[00:38:33] Speaker 02:
So that's on Alfred E. Mann.

[00:38:35] Speaker 02:
But even before that, I think Judge O'Malley, you mentioned the intent question.

[00:38:45] Speaker 02:
And all of the court's cases on the All Substantial Rights Test mention intent as a separate element of the analysis.

[00:38:53] Speaker 02:
It's true that in most cases, the district court will just look to the terms of the agreement.

[00:38:59] Speaker 02:
Here, the district court also heard testimony.

[00:39:02] Speaker 02:
both from an Immunex witness and from a Roche witness confirming that the intent of this agreement was to provide a license, not an assignment.

[00:39:15] Speaker 02:
So I'm not suggesting that if everything else pointed to an assignment, I'm not suggesting that testimony would be enough to override it.

[00:39:22] Speaker 02:
But it is part of the analysis, and there's no challenge at all

[00:39:26] Speaker 02:
to those findings by the district court.

[00:39:28] Speaker 02:
The court found the Immunex witness credible and specifically found that the intent was for a license.

[00:39:35] Speaker 02:
And the agreement confirms that.

[00:39:37] Speaker 01:
Importantly... Do I understand that the testimony essentially was that they didn't want Roche to get away completely because they knew they would need cooperation and they didn't want him to be a third party for purposes of discovery?

[00:39:55] Speaker 02:
wanted them to be a party to any litigation so that they would participate as a party.

[00:39:59] Speaker 02:
They also wanted them to continue to be the owner because of continued patent office procedures.

[00:40:06] Speaker 02:
And they wanted Roche to be subject to the duty to be candid with the patent office, et cetera.

[00:40:12] Speaker 02:
And the district court heard that testimony and found it credible.

[00:40:15] Speaker 03:
Now, what about that one feature of the agreement where

[00:40:20] Speaker 03:
Immunex retains the right to just get an outright assignment for a mere $50,000.

[00:40:26] Speaker 03:
Which is a lot to me, but maybe not to Immunex at all.

[00:40:31] Speaker 01:
Isn't it like just one day worth of sales?

[00:40:36] Speaker 03:
Oh gosh, it's a minute.

[00:40:38] Speaker 02:
Well, here's the thing.

[00:40:41] Speaker 02:
The accord and satisfaction, essentially what Immunex bought was an option to get an assignment.

[00:40:50] Speaker 02:
That was part of the $82 million that they paid for the accord and satisfaction.

[00:40:59] Speaker 02:
you can think of in law school terms as the peppercorn, the additional consideration to support that additional step of an assignment.

[00:41:08] Speaker 02:
It was not a valuation in any sense by either side of what the assignment would be worth.

[00:41:14] Speaker 02:
It was simply to provide the necessary contractual consideration so there wouldn't be some technical problem later if they requested an assignment.

[00:41:24] Speaker 02:
Now, the assignment point.

[00:41:25] Speaker 02:
But it's an illusion, isn't it?

[00:41:27] Speaker 02:
No, I don't think it's an illusion at all.

[00:41:29] Speaker 00:
$50,000 and then Roche can't disagree.

[00:41:32] Speaker 00:
They have to sign.

[00:41:33] Speaker 02:
Well, that's because part of the overall transaction was the acquisition of the option for the assignment.

[00:41:40] Speaker 02:
Now, the assignment point raises another issue, and this is very important under this Court's All Substantial Rights Jurisprudence.

[00:41:49] Speaker 02:
Roche can block any assignment by immune ex of its rights under the agreement.

[00:41:55] Speaker 02:
This court, in at least one case, has said that's fatal to an argument that all substantial rights have been transferred.

[00:42:02] Speaker 02:
Other cases have said, in effect, the right to transfer property is a key hallmark of ownership.

[00:42:09] Speaker 02:
And if you don't have the right to transfer, you're not the owner.

[00:42:13] Speaker 02:
Immunex does not have the right to transfer.

[00:42:15] Speaker 02:
And now that's in contrast to Wyeth, which was involved in the non-North America patents that were at issue in the agreement.

[00:42:24] Speaker 02:
Wyeth does have the right to transfer its patents.

[00:42:26] Speaker 02:
It can't transfer its rights under the agreement because you can't transfer contractual rights because you're subjecting the other party.

[00:42:34] Speaker 01:
Wasn't that a straight out assignment to Wyeth?

[00:42:37] Speaker 02:
Exactly.

[00:42:38] Speaker 02:
Well, that's my point, Your Honor.

[00:42:40] Speaker 02:
That's why they can transfer, because they got it.

[00:42:41] Speaker 02:
Well, exactly.

[00:42:42] Speaker 02:
Exactly.

[00:42:43] Speaker 02:
And immunics can't transfer, because it didn't get it.

[00:42:46] Speaker 02:
That's really the point.

[00:42:48] Speaker 02:
So you've got that.

[00:42:49] Speaker 02:
You've got the second right to sue, which we think under Alfred E. Mann and this court's other cases is a substantial right in this case.

[00:42:57] Speaker 02:
Once that 180 days elapses,

[00:43:01] Speaker 02:
It's Roche and only Roche that has the right to rectify infringement.

[00:43:05] Speaker 02:
It has complete control over a lawsuit.

[00:43:07] Speaker 02:
It keeps any proceeds.

[00:43:09] Speaker 02:
It's Roche's claim at that point.

[00:43:12] Speaker 01:
What's your response to Mr. Jay's contention that that 180 days means that you effectively get the control because you get to sit and look at it and say, if we don't want this person sued, we'll just give them an assignment.

[00:43:25] Speaker 02:
Well, you mean a sublicense.

[00:43:28] Speaker 03:
A royalty-free sublicense.

[00:43:31] Speaker 02:
Well, first of all, in every case where there's a second right to sue, that's going to be true.

[00:43:37] Speaker 02:
The person that has the licensee or whomever has that first right to sue can do something to cut off that second right to sue.

[00:43:47] Speaker 02:
But that doesn't make the second right to sue insubstantial.

[00:43:50] Speaker 02:
And again, Alfred E. Mann, it's not the only case, but it's a clear example of that.

[00:43:55] Speaker 02:
So the fact that the first right to sue might be exercised in a way that will mean that the second right to sue never comes into being, well, that's just inherent in any second right to sue, and it doesn't make the second right to sue insubstantial.

[00:44:13] Speaker 02:
The other factors here are that at Roche's insistence, Roche retained the right to practice the patents for non-clinical research purposes.

[00:44:26] Speaker 02:
Sandoz belittles that right.

[00:44:29] Speaker 02:
But it was important enough to Roche that they insisted on it.

[00:44:32] Speaker 02:
And it was a right that Immunex believed they wanted to keep, because the concern was that Roche was likely trying to develop a competitor to Enbrel.

[00:44:42] Speaker 02:
They ultimately didn't.

[00:44:43] Speaker 03:
But that was never, in any opinion, relied on that as a pivot point.

[00:44:48] Speaker 02:
No, and I'm not suggesting that it is standing alone, Your Honor.

[00:44:51] Speaker 02:
But again, this is an inquiry where you're looking at the transaction as a whole.

[00:44:55] Speaker 02:
And there are a bunch of reasons that this is not an assignment.

[00:44:59] Speaker 02:
It is just a license.

[00:45:00] Speaker 02:
And that's one of them.

[00:45:01] Speaker 02:
And another example of that is the provision dealing with what happens if Roche goes into bankruptcy, a provision that you wouldn't need at all if this had been a transfer of these patents to Immunex rather than just a license.

[00:45:15] Speaker 02:
That provision only makes sense if this was a license.

[00:45:20] Speaker 02:
For a variety of reasons, we don't think that the all-substantial rights test is the right test.

[00:45:27] Speaker 02:
But if the court applies it, we think, as the district court did, you come out saying this was a license, this was not an assignment, and there is not the required common ownership for purposes of ODP.

[00:45:43] Speaker 02:
There are a number of other issues in the case.

[00:45:44] Speaker 02:
I'm happy to talk about any of them if the court has no further questions.

[00:45:50] Speaker 01:
You did touch on the one way versus two way, but what about the fact

[00:45:55] Speaker 01:
that these precise claims didn't come in until much later.

[00:45:59] Speaker 02:
Well, these precise claims didn't come in until much later.

[00:46:02] Speaker 02:
And actually, I'm glad you asked that, Your Honor, because this is something that I wanted to address.

[00:46:10] Speaker 03:
It reminds me of in Ray Basel, where in that particular case,

[00:46:15] Speaker 03:
The applicant waited nine years before introducing claims that resembled the claims that ultimately they thought.

[00:46:22] Speaker 03:
And here, as I understand the Roche patents, their priority dates are 1990.

[00:46:26] Speaker 03:
Then they file their pre-gat in 95.

[00:46:29] Speaker 03:
And then these claims, when Immunex finally got their hand on the wheel and held the pen, they introduced these claims in 2004, 2005.

[00:46:39] Speaker 03:
So that's roughly 15 years after the priority date of these Roche patents.

[00:46:44] Speaker 03:
I mean, that's about as per se as you can get, I think, when it comes to trying to understand why was it that the first filed applications issued second?

[00:46:55] Speaker 03:
And here we have an

[00:46:57] Speaker 03:
initial 15-year dormant period before the applicant sought these P-75, IGG-1 claims?

[00:47:06] Speaker 02:
Well, that's not entirely accurate, Your Honor.

[00:47:09] Speaker 02:
And Mr. Jay, when he was up here, made a comment about how, you know, it was not until late that, after Immunex got control, that Immunex got rid of P-55 and suddenly introduced P-75.

[00:47:25] Speaker 02:
Well, that's just not right.

[00:47:26] Speaker 02:
First, the original claims and the original application.

[00:47:31] Speaker 02:
would have covered etanercept.

[00:47:33] Speaker 02:
They covered fusions of a, I've got the language here, soluble fragments of either P55 or P75 fused to an IgG1 or IgG3 immunoglobulin.

[00:47:47] Speaker 02:
So they were broader than these claims, but they would have covered it.

[00:47:51] Speaker 03:
The constant regions, except for the first constant region, including this portion?

[00:47:55] Speaker 02:
That language was in there.

[00:47:57] Speaker 03:
That language was in there?

[00:47:58] Speaker 02:
Yes.

[00:47:58] Speaker 03:
And it also said P75 in the claim?

[00:48:00] Speaker 02:
No, the claim referred to soluble fragments of TNF binding protein and other... That includes... ...includes P55 as well.

[00:48:11] Speaker 03:
P75 and a lot of other things.

[00:48:12] Speaker 02:
Sure, sure.

[00:48:13] Speaker 02:
But my point is that this notion that covering P75 fusions was a creation of imion X, it isn't true.

[00:48:23] Speaker 02:
In 1994, way before MUNIX was on the scene, the Patent Office issued a restriction requirement between P55 and P75 constructs.

[00:48:34] Speaker 02:
So again, the Patent Office right from the beginning saw that the application applied to P75.

[00:48:40] Speaker 02:
elected to go for P55 first.

[00:48:44] Speaker 02:
It got the 279 patent in 1997, which had claims to a fusion of P55 and IgG1 specifically.

[00:48:52] Speaker 02:
It filed divisionals in 1995 to preserve the prosecution of the P75 compound and method claims.

[00:49:02] Speaker 02:
And it's from those divisionals that these two patents emerged.

[00:49:08] Speaker 03:
Did the district court say anything about this period of time between 1990 and 2005?

[00:49:14] Speaker 03:
But not specifically... I recall she was focused on the period of 1995 to 2011, 2012.

[00:49:21] Speaker 03:
Well, I don't know if she was focused on... I mean, 2005 to 2011, 2012.

[00:49:26] Speaker 02:
Well, I don't know that she was focused on that because I think when she was talking about five years with no action and losing the file and all that, that actually spanned the entire period.

[00:49:36] Speaker 02:
I don't think it was just focused on that post 2005 period.

[00:49:42] Speaker 02:
So she was describing the prosecution in general.

[00:49:46] Speaker 02:
So this notion that somehow Immunex arrived on the scene and all of a sudden these claims are transformed, it's just not accurate.

[00:49:55] Speaker 02:
And I'll just make one other quick point on that.

[00:49:58] Speaker 02:
In 1998, Immunex, having seen the European application, which stemmed from the same priority application which had been published in the meantime, Immunex sought out a license to cover it because it was launching Enbrel.

[00:50:14] Speaker 02:
So even back then,

[00:50:16] Speaker 02:
Immunex saw that Roche could get P75 claims there, as it did several years later when the European patent issued to P75 IgG fusions that again would cover Etanercept.

[00:50:31] Speaker 02:
So apparently the notion is that Immunex went out on its own in 1998, saw these applications that had nothing to do with Etanercept, voluntarily paid millions of dollars for a license that it apparently didn't need,

[00:50:45] Speaker 02:
I guess with the scheme of then later, we'll have this other transaction.

[00:50:50] Speaker 02:
We'll get control.

[00:50:51] Speaker 02:
And then we can really repurpose, which is the term that's used often in Sandoz's brief, repurposes to cover each intercept.

[00:50:58] Speaker 02:
It's just inconsistent with the history.

[00:51:01] Speaker 02:
It's inconsistent with the district court's findings.

[00:51:03] Speaker 02:
And we respectfully submit the decision should be affirmed in all respects.

[00:51:08] Speaker 02:
Thank you.

[00:51:14] Speaker 04:
Thank you, Your Honors.

[00:51:15] Speaker 04:
Just a couple points each on the test, the transfer of all substantial rights, and then the reference patents.

[00:51:21] Speaker 04:
So on the test, I think that you heard my friend say that their test is the moment of invention and that it's enough that, as Judge O'Malley brought out with her question, it could be transferred the day after invention.

[00:51:38] Speaker 04:
the agreement is structured in such a way that even the payment of a peppercorn leaves some right in the transferor, that's not a transfer of all substantial rights.

[00:51:48] Speaker 04:
So accepting either half of that argument would really create a very easy-to-follow pathway to avoid obvious assault patenting.

[00:51:57] Speaker 04:
It's an equitable doctrine that this court should apply to prevent exactly that kind of unjustified time-wise extension.

[00:52:04] Speaker 04:
So on the test, both the legislative history of the 84 statute

[00:52:11] Speaker 04:
and the 84 statute itself are discussed in Longi.

[00:52:14] Speaker 04:
And what does the legislative history say?

[00:52:17] Speaker 04:
Both the Senate report and Congressman Castenmaier, the House Chairman, had referred to ODP being applied to commonly owned applications, commonly owned applications, not this moment of invention test.

[00:52:29] Speaker 04:
And likewise, if you look at the MPEP to this day, it talks about a common owner or assignee, even in MPEP 804.

[00:52:39] Speaker 04:
The court doesn't have to apply the same test for what used to be 103C and is now in 102.

[00:52:43] Speaker 04:
It stands to reason that there doesn't have to be the same test for an exception to prior art.

[00:52:50] Speaker 04:
which should be a narrow exception, versus an exception to obviousness-type double patenting, which would allow you to get an unjustified time-wise extension.

[00:52:58] Speaker 04:
Let me just talk a little bit about the rights that each party got out of this agreement, because it's certainly true that Roche retains some rights.

[00:53:07] Speaker 04:
But our point is, and under the case law, what matters is,

[00:53:09] Speaker 04:
They weren't substantial rights.

[00:53:11] Speaker 04:
And in particular, on the non-commercial right to practice, I just point to this court's decision in Luanara, which squarely held that even a commercial but non-exclusive right to practice was not good enough.

[00:53:22] Speaker 04:
on the reference patents themselves.

[00:53:26] Speaker 04:
So first on the two-way test and the change in the application.

[00:53:31] Speaker 04:
So the original claim in this application, to the extent that it talked about P75, it was the figure four sequence, P75.

[00:53:40] Speaker 04:
And Roche said over and over again to the patent office, we're not trying to claim the Smith sequence.

[00:53:45] Speaker 04:
We're not anticipated by Smith.

[00:53:46] Speaker 04:
We're not trying to claim Smith.

[00:53:47] Speaker 04:
And so along comes ImmuneX after the accordion satisfaction and really does start to claim the Smith sequence, P75, 10 years in.

[00:53:59] Speaker 04:
And then on the 690 patent, I didn't hear my friend respond at all to the point that we made about the example.

[00:54:06] Speaker 04:
in the specification.

[00:54:08] Speaker 04:
This is dealt with at page 45 of our opening brief and 19 of our reply, where there's an example that says, one specific example of a TNFR-FC fusion protein is, and then both sides experts agree that the sequence IDs that come next are etanercept.

[00:54:21] Speaker 04:
The 690 patent claimed etanercept.

[00:54:23] Speaker 04:
They had a full 17-year pre-GAT opportunity to exploit that invention.

[00:54:27] Speaker 04:
They marked their billion-dollar invention with it.

[00:54:30] Speaker 04:
And they had the opportunity to enjoy a full patent term.

[00:54:35] Speaker 04:
If the court has no further questions, I just want to close by saying that we appreciate the court hearing this appeal on an expedited basis.

[00:54:42] Speaker 04:
Sandoz has approval and stands ready to bring the first biosimilar to this product.

[00:54:49] Speaker 01:
Thank you.