[00:00:00] Speaker 01:
Our next case for argument is 24-1965, Regeneron Pharmaceuticals versus Mylan Pharmaceuticals.

[00:00:08] Speaker 01:
Mr. Adams, please proceed.

[00:00:11] Speaker 02:
Thank you, Your Honor, and may it please the court William Adams for Samsung.

[00:00:15] Speaker 02:
Regeneron is trying to stifle fair competition by relying on a patent with only trivial differences from its expired formulation patents, and whose claimed improvement over the prior art have absolutely no bearing on consumer demand or regulatory approval.

[00:00:31] Speaker 02:
Regeneron convinced the district court to keep SB 15 off the market pending trial, but that ruling rests on several legal errors that warrant reversal.

[00:00:41] Speaker 02:
I understand that Formicon's counsel in the next appeal is going to start with personal jurisdiction.

[00:00:46] Speaker 02:
I'd like to start with reparable harm.

[00:00:49] Speaker 02:
The district court erred by entering a preliminary injunction without Regeneron showing that it will be irreparably harmed by the infringement of the asserted claims of the 865 patent.

[00:01:01] Speaker 02:
Contrary to the district court's ruling and the premise of Regeneron's causal nexus argument, the claims, the asserted claims here, are not coextensive with a drug product.

[00:01:11] Speaker 02:
It doesn't cover the drug product itself.

[00:01:14] Speaker 00:
It doesn't even cover--" Can I just make sure I understand?

[00:01:17] Speaker 00:
I think I'm remembering the following, that the district court

[00:01:24] Speaker 00:
treated the causal nexus question as a separate inquiry from other aspects of irreparable harm, and that you appealed on the causal nexus, but not the other aspects of irreparable harm.

[00:01:38] Speaker 00:
Is that wrong?

[00:01:39] Speaker 02:
That's correct, Your Honor.

[00:01:41] Speaker 00:
You confused me when you started talking about irreparable harm.

[00:01:44] Speaker 02:
Oh, but causal nexus is part of the irreparable harm analysis, Your Honor?

[00:01:47] Speaker 00:
But just that part.

[00:01:47] Speaker 00:
Understood.

[00:01:49] Speaker 02:
Understood, Your Honor.

[00:01:49] Speaker 02:
And we are not challenging the harm aspect.

[00:01:53] Speaker 02:
We're challenging whether that harm was caused by the infringement.

[00:01:58] Speaker 02:
The assertive patent claims cover very specific features of the product, including a very specific form of stability.

[00:02:08] Speaker 02:
98% stability at two months under certain storage conditions.

[00:02:13] Speaker 00:
And stability measured in a very particular way.

[00:02:17] Speaker 02:
Yes, Your Honor.

[00:02:19] Speaker 00:
Because you use the term stability to cover a pretty wide range of possible measurement devices and maybe even physical phenomena.

[00:02:27] Speaker 02:
It's very specific.

[00:02:28] Speaker 02:
It's under very specific storage conditions and we think that

[00:02:35] Speaker 02:
the district court's ruling and the causal nexus analysis that's been done by Regeneron here really turns on treating the patent and the drug as coextensive.

[00:02:49] Speaker 02:
But the formulation that's covered

[00:02:50] Speaker 02:
by the 594 patent, that's part of the public domain.

[00:02:53] Speaker 02:
It's been part of the public domain since 2021, and that includes the generic stability at four months.

[00:02:59] Speaker 02:
And so we don't think that that formulation, those expired aspects of the patent claim, are available as a matter of law to support the causal nexus.

[00:03:11] Speaker 02:
requirement.

[00:03:13] Speaker 02:
The required infringement under this court's precedent is the patented features.

[00:03:19] Speaker 02:
The patented features are what must cause the harm.

[00:03:24] Speaker 02:
And here, the patented features, according to Regeneron itself, this is what got it out of the patent office, is the very specific 98% stability limitation.

[00:03:34] Speaker 02:
They also now assert differences over the prior art, the vile or glycosylation, but at no point did they show that any of those patented features drove demand or were required for regulatory approval.

[00:03:49] Speaker 02:
Simply here, they are claiming that the harm is effectively caused by competition, by SB15 getting onto the market, not by any supposed patent infringement.

[00:04:00] Speaker 02:
And on that basis alone,

[00:04:02] Speaker 02:
We think this court should reverse the preliminary injunction.

[00:04:07] Speaker 02:
We know it's undisputed on this record that the 98% stability feature has no bearing on consumer demand or on regulatory approval.

[00:04:18] Speaker 00:
And can I just ask, when you say consumer

[00:04:21] Speaker 00:
Who do you mean?

[00:04:23] Speaker 00:
The person with the eyeball?

[00:04:27] Speaker 00:
Or the doctor?

[00:04:29] Speaker 00:
Or the insurance companies?

[00:04:31] Speaker 02:
We think it's either the doctor or the consumer.

[00:04:34] Speaker 02:
The information that's available to them is indistinguishable on this record.

[00:04:38] Speaker 00:
I'm sorry, why would the consumer?

[00:04:40] Speaker 00:
care at all.

[00:04:41] Speaker 00:
The consumer doesn't care how long the thing... That's exactly correct, Your Honor, because the patient... Yeah, but the doctor sure does.

[00:04:48] Speaker 02:
But the doctor doesn't know.

[00:04:50] Speaker 02:
The 98% stability limitation is not publicly facing information.

[00:04:55] Speaker 02:
It's not on the label.

[00:04:57] Speaker 02:
It's not information that the doctor is going to know.

[00:04:59] Speaker 02:
It's going to vary, perhaps, by lots.

[00:05:00] Speaker 02:
Some lots will have 98% stability at two months.

[00:05:04] Speaker 02:
Some lots may not.

[00:05:05] Speaker 02:
And the doctor

[00:05:06] Speaker 02:
who is receiving and prescribing that medication is not going to know, because the FDA itself treats 98% stability, 97% stability, 96% stability at two months as equivalent, interchangeable.

[00:05:19] Speaker 02:
The FDA is absolutely indifferent as to that stability limitation, and it's not going to be information that the consumers would know.

[00:05:27] Speaker 02:
You can look at appendix 15554 to 55.

[00:05:32] Speaker 02:
That shows that it's not publicly facing information.

[00:05:36] Speaker 02:
And in fact, we know that FDA thinks this is so unimportant, the disability limitation, that, and you can look at appendix 2753 for this, that

[00:05:47] Speaker 02:
It can be released.

[00:05:49] Speaker 02:
SB15 can be released at 98% stability, 98% purity, and then gradate down to 96% over time.

[00:05:58] Speaker 02:
If the 98% stability limitation was important to the FDA, it certainly wouldn't be the starting point at time zero.

[00:06:05] Speaker 02:
And you also don't have to take this from me or even from the FDA, but Regeneron's own expert admits that the 95% stability is all that's necessary

[00:06:14] Speaker 02:
That's an appendix 2087 to 88.

[00:06:17] Speaker 00:
All this necessary for what?

[00:06:19] Speaker 02:
Generally for regulatory approval.

[00:06:21] Speaker 02:
So here, Samsung sought and obtained approval to 96%.

[00:06:26] Speaker 02:
And in its BLA, as a general matter, the FDA sometimes will allow it to go down to 95%.

[00:06:32] Speaker 02:
There's no magic number to 98%.

[00:06:35] Speaker 02:
That's just what Regeneron claimed here to get it out of the patent office over the double patenting challenge.

[00:06:41] Speaker 02:
And, again, at Redbrief 8, we know that that was the distinguishing limitation that allowed the claim and respectfully suggests that because there's no showing of nexus or demand or a regulatory approval condition infringing the 98 percent stability limitation, that the easiest path here is to reverse based on causal nexus.

[00:07:08] Speaker 02:
But there's additional ground that we submit

[00:07:10] Speaker 02:
that warrants reversal, and that's on double patenting.

[00:07:15] Speaker 02:
The district court made two legal errors in its double patenting determination.

[00:07:22] Speaker 02:
First, it refused to treat the 594 patent as a reference patent.

[00:07:27] Speaker 02:
And second, it refused to look at the reference patent for anything beyond claim construction.

[00:07:33] Speaker 02:
on the first of those legal errors the double patenting exists to prevent a patentee from obtaining a Later filed issued an expiring patent on obvious variants of an earlier filed issued Expiring patents once an invention has been committed to the public the patentee simply can't try to claw that back In

[00:07:57] Speaker 00:
Thinking about this, it began to feel to me as though committed to the public or dedicated to the public is more a conclusion than it is a simple kind of descriptive fact.

[00:08:14] Speaker 00:
And it might matter here when there was a terminal disclaimer that was accepted by the applicant.

[00:08:24] Speaker 00:
How does one

[00:08:27] Speaker 00:
How one characterizes that feels like the question about this sort of threshold question, whether the 594 counts at all as a record.

[00:08:38] Speaker 02:
Sure.

[00:08:38] Speaker 02:
I'd refer, Your Honor, to this court's decision in Yamazaki, which discusses terminal disclaimers and the legal effect

[00:08:45] Speaker 02:
thereof.

[00:08:47] Speaker 02:
And it says, when a patent issues with a terminal disclaimer, the disclaimer becomes part of the original term, it defines it, and it's treated as if the additional term never existed.

[00:09:00] Speaker 00:
But not for these purposes, right?

[00:09:04] Speaker 00:
No, it's interpreting the statute.

[00:09:06] Speaker 00:
Isn't that a little paragraph?

[00:09:07] Speaker 00:
Yeah, exactly.

[00:09:07] Speaker 02:
Exactly, Your Honor.

[00:09:08] Speaker 02:
But I think it's important that that's shown with a legal impact.

[00:09:13] Speaker 02:
So to get out of the patent office, Regeneron had to give up term.

[00:09:16] Speaker 02:
It had to give up six years of term.

[00:09:18] Speaker 02:
And that has legal meaning.

[00:09:19] Speaker 02:
And in giving up that six years of term, they committed the invention in the 594 at any obvious variance thereof to the public.

[00:09:29] Speaker 02:
And essentially, Regeneron is trying to claw that back by saying, don't even look at the initial 594 patent.

[00:09:35] Speaker 02:
That doesn't even exist for purposes of double patenting analysis.

[00:09:38] Speaker 02:
simply because it terminated in 2021 due to a terminal disclaimer.

[00:09:43] Speaker 02:
But they had to give that up.

[00:09:45] Speaker 02:
They had to give up those six years to get out of the patent office.

[00:09:48] Speaker 02:
That has to have legal meaning.

[00:09:51] Speaker 02:
And the district court, frankly, created a terminal disclaimer exception to the reference patent analysis that this court regularly conducts.

[00:10:00] Speaker 02:
So we think that was the first legal error.

[00:10:04] Speaker 01:
But, counsel, even if the court

[00:10:08] Speaker 01:
made an error in not treating this as a reference patent, it went on and alternatively found that even if it did, I think if I remember right, the court found four differences between claim five and the claims at issue here.

[00:10:27] Speaker 01:
and went through a lot of evidence about why each of those differences.

[00:10:32] Speaker 01:
And don't you have to overcome all four of those?

[00:10:35] Speaker 02:
Sure, Your Honor.

[00:10:36] Speaker 01:
That brings me to the- It feels like this district court did through the kitchen sink at you.

[00:10:41] Speaker 01:
I mean, everything.

[00:10:41] Speaker 01:
They're like, OK, this is not a reference.

[00:10:44] Speaker 01:
Even if it is a reference, you don't win.

[00:10:46] Speaker 01:
And let me give you four different reasons you don't win.

[00:10:50] Speaker 01:
So don't you have to overcome all of that to prevail?

[00:10:54] Speaker 02:
Yes, Your Honor, except that all of those factual findings that Your Honor just referenced are predicated on the second legal error that I mentioned, the failure to look at the 594 reference patent specification for anything other than claim construction.

[00:11:12] Speaker 02:
If you look at the specification, and we know under this course decisions like Basel and Vogel that it's OK to look at the specification beyond just claim construction.

[00:11:21] Speaker 02:
You can look at it to interpret the coverage of a claim

[00:11:23] Speaker 02:
You can look at it to determine if there's an obvious variant from what was previously claimed and disclosed.

[00:11:29] Speaker 01:
And here, the district court failed to look at the specification for specifically examples three and four, which are specific embodiments of- Can I understand, do you think obviousness type double patenting covers, you can't patent in the second patent anything at all that was disclosed in the spec of the first patent?

[00:11:49] Speaker 02:
No, Your Honor.

[00:11:50] Speaker 01:
No, Your Honor.

[00:11:51] Speaker 01:
So you do agree that your

[00:11:52] Speaker 01:
tethered to a comparison of the claims.

[00:11:55] Speaker 01:
And your argument, I think, if I understand it, is just that you can look to the specification to understand the scope of those claims.

[00:12:01] Speaker 01:
Is that what your argument is?

[00:12:03] Speaker 02:
That's part of it.

[00:12:03] Speaker 02:
You can look to the specification to understand the scope of the claims and for disclosed utility

[00:12:10] Speaker 02:
for example, as well.

[00:12:11] Speaker 02:
That's under the Sun Pharmaceuticals case.

[00:12:14] Speaker 02:
What you can't do is you can't... Kaplan is a good example.

[00:12:18] Speaker 02:
In Kaplan, this court said that it was improper.

[00:12:23] Speaker 02:
There were two inventions disclosed in the specification.

[00:12:26] Speaker 02:
One was with respect to the claim that was at issue, and another was from a joint inventor.

[00:12:32] Speaker 02:
So it was a different patenting entity.

[00:12:34] Speaker 02:
And this court said you can't look

[00:12:36] Speaker 02:
at the part of the spec that discloses that other invention.

[00:12:40] Speaker 02:
That's using the specification as prior art, and that's improper as a matter of law.

[00:12:44] Speaker 02:
But you can look to the disclosures with respect to the claim that is at issue.

[00:12:53] Speaker 02:
That's not impermissible.

[00:12:54] Speaker 01:
I feel like what you're trying to do is read limitations from the spec into claim five of the other patent.

[00:13:02] Speaker 01:
Like, for example, the 98%, right?

[00:13:04] Speaker 01:
That's not in that claim.

[00:13:06] Speaker 02:
But it's not.

[00:13:07] Speaker 01:
It is an example 3 and 4, but it's not in the claim.

[00:13:10] Speaker 01:
So what you're trying to do is take embodiments of the spec, read them into the claim, and once they're read in as limitations that aren't present in those claims, then say, there's obviousness type double banding.

[00:13:23] Speaker 02:
Your Honor, I'm not going to disagree with your description of what we're trying to do, but I think it's appropriate and permissible under this court's decision, like Basel and Abbvie.

[00:13:35] Speaker 02:
Those decisions, both the reference claim there involved

[00:13:43] Speaker 02:
Genus types claims, the specification disclosed the species that was particularly at issue in the asserted claim.

[00:13:53] Speaker 02:
And this court held that that was appropriate to look at and was subject to obvious type double patenting.

[00:14:02] Speaker 02:
This court affirmed the board in Basel on just that ground.

[00:14:05] Speaker 02:
So I agree with your description, but I think it's OK under this court's case law.

[00:14:09] Speaker 02:
And if there are any further questions now, I'd like to reserve the balance of my time.

[00:14:12] Speaker 00:
Can I ask one point?

[00:14:13] Speaker 00:
Yes.

[00:14:14] Speaker 00:
Factual question.

[00:14:15] Speaker 00:
Are there any generic pre-filled syringes?

[00:14:20] Speaker 02:
Any generic pre-filled syringes?

[00:14:22] Speaker 02:
I don't know the answer to that, Your Honor, but I'll find out for you.

[00:14:26] Speaker 02:
Thank you.

[00:14:34] Speaker 03:
Good morning.

[00:14:35] Speaker 03:
May it please the court, David Burrell on behalf of the Regeneron.

[00:14:38] Speaker 03:
I'd like to start where my opponent ended, which is with double patenting.

[00:14:45] Speaker 03:
I think the law is exactly as Chief Judge Moore articulated it.

[00:14:48] Speaker 03:
It is impermissible and always has been.

[00:14:51] Speaker 03:
for a court to use the patent specification to reading limitations into a later claim, or to find motivation or reasonable expectation of the success for a later claim, I would submit that Samsung gives the game away on page 17 of its reply brief, where they ask about the motivation issue we raised, and they say, the motivation is solved.

[00:15:12] Speaker 03:
Just look at example three.

[00:15:14] Speaker 03:
That's our own specification.

[00:15:16] Speaker 03:
And our own specification under Otsuka can't be used against us.

[00:15:20] Speaker 03:
They cite two cases to try to disturb that proposition.

[00:15:24] Speaker 03:
First, they cite Vogel, then they cite Basel, and they also actually cite Abdi, so there are three.

[00:15:30] Speaker 03:
Those cases all reflect that there are two recognized exceptions for which a court may look to a specification in the obviousness type double patent inquiry.

[00:15:40] Speaker 03:
First, to understand the scope of the claims.

[00:15:43] Speaker 03:
That's what was going on in Vogel.

[00:15:45] Speaker 03:
The court said it's hard to understand what this claim means.

[00:15:47] Speaker 03:
We need to look at a tangible example in order to understand it better, and it did that.

[00:15:52] Speaker 03:
And by the way, it then used prior R, not the specification, to assess obviousness, the Ellie's reference in that case.

[00:15:58] Speaker 01:
So for example, they want to read in or impute in vial, 98%, all those things.

[00:16:05] Speaker 01:
Your argument would be that that is not to help understand or interpret the scope of the claim.

[00:16:10] Speaker 01:
For example, the claim that they're using for obviousness type double patenting has absolutely no stability limitation.

[00:16:19] Speaker 01:
It's different than that.

[00:16:21] Speaker 03:
It simply says stable.

[00:16:22] Speaker 03:
There's nothing about 98%, not a particular kind of stability, stable by size exclusion chromatography after two months.

[00:16:29] Speaker 03:
I agree completely with Your Honor's observation.

[00:16:32] Speaker 03:
One can't do that.

[00:16:33] Speaker 03:
And I think the clearest case to show that is the Taplin case.

[00:16:37] Speaker 03:
What they are doing here is suggesting that any time you have both a reference claim and an asserted claim that fall within the same example in the specification, you have double patenting.

[00:16:49] Speaker 03:
Judge Rich reversed the board for applying that and implying the language of the local court.

[00:16:55] Speaker 03:
Excuse me?

[00:16:56] Speaker 03:
The court.

[00:16:56] Speaker 03:
Oh, excuse me.

[00:16:58] Speaker 03:
writing for the court, Judge Rich, said, the board got it wrong here.

[00:17:02] Speaker 03:
And the court observed in Kaplan that they have confused domination at the board with double patenting.

[00:17:09] Speaker 03:
And domination is irrelevant to double patenting.

[00:17:12] Speaker 03:
He called this proposition that one can get two different claims from the same subject matter, the domination sort of inquiry.

[00:17:19] Speaker 01:
Was he the only judge?

[00:17:20] Speaker 01:
Was that a one-judge opinion?

[00:17:22] Speaker 03:
No, it was a three-judge panel, Your Honor.

[00:17:26] Speaker 03:
But what the court said there was that this principle is one of the simplest, clearest, soundest, and most essential principles of patent law.

[00:17:35] Speaker 03:
And I would submit that Samsung is asking the court to introduce it today.

[00:17:40] Speaker 03:
What happened in Basel is totally consistent with that.

[00:17:43] Speaker 03:
In Basel, the reference claim called for Oliphant.

[00:17:47] Speaker 03:
And the court looked to the specification to understand what olefins meant.

[00:17:51] Speaker 03:
In other words, are ethylene and propylene within the scope of olefins?

[00:17:56] Speaker 03:
That's claim construction.

[00:17:57] Speaker 03:
The obviousness inquiry was separate, and it simply deferred to the board on the obviousness inquiry.

[00:18:03] Speaker 03:
Claim construction is not what Samsung is doing here.

[00:18:05] Speaker 03:
They proudly announced at page 42 of their brief that they're not disputing the claim constructions authored by the court below.

[00:18:12] Speaker 03:
They disputed it below.

[00:18:14] Speaker 03:
They don't press that argument here on appeal.

[00:18:16] Speaker 03:
The second exception comes from the old line of cases like in Rebic and was applied most recently in the AbbVie case that they cite.

[00:18:25] Speaker 03:
That exception relates to using the specification of the reference claim to determine the utility of the reference claim.

[00:18:33] Speaker 03:
Those are cases where the reference claim calls for a compound or a molecule.

[00:18:38] Speaker 03:
And the later claim calls for a use of that molecule.

[00:18:41] Speaker 03:
And the old Henry Bick case said, well, you can't get a claim for the molecule without a utility.

[00:18:47] Speaker 03:
So it's fair to look back to the specification in order to understand the utility for the molecule in assessing double patenting.

[00:18:54] Speaker 03:
The Eli Lilly case makes that very clear how narrow that exception is.

[00:18:58] Speaker 03:
And it was applied recently by this court in AbbVie.

[00:19:01] Speaker 03:
That's not what Samsung is doing here.

[00:19:03] Speaker 03:
They're not within that exception.

[00:19:05] Speaker 03:
98% stability by SEC is not the utility of the formulation.

[00:19:10] Speaker 03:
The utility of the formulation is ophthalmic use.

[00:19:14] Speaker 03:
This case would be like Eli Lilly and Son and Bic if we claimed the formulation in the first patent and simply claimed the ophthalmic use in the second.

[00:19:23] Speaker 03:
That's not what's going on.

[00:19:24] Speaker 03:
They are reading limitations from the specification

[00:19:28] Speaker 03:
that are not in our claim in order to have double patenting.

[00:19:32] Speaker 03:
And there has not been a single case that has invalidated a claim for double patenting on that basis in the more than 200 years that courts have been deciding double patenting cases, starting in 1819 with just a story in the Oderone case.

[00:19:48] Speaker 01:
Did he do that one on his own?

[00:19:50] Speaker 03:
No.

[00:19:51] Speaker 03:
No, he did not.

[00:19:52] Speaker 01:
OK.

[00:19:52] Speaker 01:
You would think you would learn this lesson by now.

[00:19:53] Speaker 03:
I apologize.

[00:19:54] Speaker 03:
I apologize, Your Honor.

[00:19:56] Speaker 03:
That case and all of its progeny, there's never been a case invalidating claim on the basis that Samsung is pressing here.

[00:20:05] Speaker 03:
With that, I will turn to the second argument they raised.

[00:20:08] Speaker 00:
Can I just ask, while we're still on the let's assume the 594 is in fact available, and here's why, nevertheless, it's not obvious.

[00:20:18] Speaker 00:
And the district court found several elements of the new claim that's now an obvious variance of the 594.

[00:20:30] Speaker 00:
One of them is the vile.

[00:20:32] Speaker 00:
Yes, Your Honor.

[00:20:33] Speaker 00:
You don't need this if the rest are sound, but how is that sound?

[00:20:40] Speaker 03:
We don't need that.

[00:20:41] Speaker 03:
But the factual finding by the district court was that the person of ordinary skill, starting with the pre-filled syringe of claim five of the 594, would not have wanted to use a vial.

[00:20:52] Speaker 03:
It would have been less convenient.

[00:20:53] Speaker 03:
It would have been considered a step backwards for patients and ultimately for the users in the doctor's office.

[00:21:00] Speaker 00:
So what?

[00:21:02] Speaker 03:
I mean, per some of the scores.

[00:21:04] Speaker 00:
We don't have.

[00:21:05] Speaker 00:
In fact, we have quite a number of cases that say doing something that is, at least in some respect, less desirable can still be obvious.

[00:21:17] Speaker 03:
Right.

[00:21:18] Speaker 03:
Those cases, I agree, stand for the proposition that it doesn't have to be the best option in order for something to be obvious.

[00:21:23] Speaker 03:
But it does have to be desirable.

[00:21:26] Speaker 03:
The Orexo case, the Winter versus Wang case, all stand for the proposition that what is obvious is what's desirable, not what is possible.

[00:21:33] Speaker 03:
And the question we would agree is, it may be possible to use a vile, but the obviousness question for motivation is that.

[00:21:41] Speaker 00:
Related to that, do you know the answer to the question I asked your friend about?

[00:21:44] Speaker 00:
Are there pre-filled syringes of the generic sort out there?

[00:21:47] Speaker 03:
As of today, the answer is yes.

[00:21:49] Speaker 03:
There is one.

[00:21:50] Speaker 03:
That happened after this preliminary injunction was decided.

[00:21:56] Speaker 00:
Wasn't there some very large percentage of, somewhere I read, I think it was in the district court's opinion, about

[00:22:05] Speaker 00:
Doctors or whoever the actual purchases are preferring the pre-filled syringes over the vial.

[00:22:12] Speaker 03:
Indeed, that is the preferred for most applications and for most physicians.

[00:22:16] Speaker 00:
Does that affect, I mean it probably doesn't affect our decisions, does that affect the consequences of this dispute we're deciding today?

[00:22:23] Speaker 03:
No, I don't think so your honor.

[00:22:25] Speaker 03:
I think

[00:22:28] Speaker 03:
The irreparable harm inquiry, for example, was conducted vis-a-vis the vile sales.

[00:22:34] Speaker 03:
In particular, the court found irreparable harm.

[00:22:36] Speaker 03:
And as your honor noted, I don't think they're trying to disturb any of the irreparable harm findings.

[00:22:40] Speaker 03:
The only thing that they are trying to challenge is the court's ruling on nexus.

[00:22:46] Speaker 03:
So if I may turn there, I would submit that Samsung is changing the standard for the nexus inquiry.

[00:22:53] Speaker 03:
The standard articulated by the court, whichever judges wrote the opinion, is that one looks to the product as a whole.

[00:23:01] Speaker 03:
This inquiry of taking one limitation out and asking the question, is the limitation that got the claim out of the patent office driving demand not a single court has

[00:23:13] Speaker 03:
used that kind of inquiry.

[00:23:14] Speaker 03:
The only case they cite is Apple II.

[00:23:17] Speaker 03:
No court, district court, or otherwise that they've cited has tried to apply Apple II to say that that's what it stands for, and it doesn't.

[00:23:25] Speaker 03:
Apple II, as clarified later by Apple III, simply stands for the proposition that one must be harmed by infringement.

[00:23:31] Speaker 03:
And you look at the claim as a whole.

[00:23:33] Speaker 03:
And the court made factual findings here, A164, that the

[00:23:38] Speaker 03:
Product here both ilia and the proposed generic product SB 15 is embodied by the claim as a whole There is no feature of the accused product that is not embodied in the claims This is not like some smartphone where I have a patent to the audio chip and someone I understand

[00:23:58] Speaker 01:
And I understand that everything that they submitted to the FDA tested at 98% stability.

[00:24:04] Speaker 01:
So I get the facts, but the question I think maybe one of their arguments is, but we can make this at only 96% stability.

[00:24:13] Speaker 01:
So since there is a non-infringing way for us to produce this product, it would not be, we should not be enjoined from producing that non-infringing alternative.

[00:24:27] Speaker 01:
Well, I think I just said something I shouldn't have.

[00:24:31] Speaker 01:
It's OK.

[00:24:31] Speaker 01:
Are you sure?

[00:24:32] Speaker 01:
Yes.

[00:24:32] Speaker 01:
Because I can have it.

[00:24:33] Speaker 02:
I said it too.

[00:24:34] Speaker 01:
Oh, OK.

[00:24:35] Speaker 01:
All right.

[00:24:36] Speaker 01:
My clerk just, you know, all red and bold and yelled at me.

[00:24:40] Speaker 03:
I won't repeat what your honor said, but I will observe that

[00:24:45] Speaker 03:
They have not, Samsung has not appealed the scope of the injunction here.

[00:24:49] Speaker 03:
The injunction was entered, and it was appropriately entered under this court's case law like Forrest Labs against the accused product, which of course here is their proposed BLA product that would infringe our patent.

[00:25:02] Speaker 03:
That's a product.

[00:25:02] Speaker 01:
And to be clear, that product is the product that was the

[00:25:07] Speaker 01:
what they submitted to the FDA, which all showed that it fell within the patented range of 98%.

[00:25:14] Speaker 01:
And so you're saying, if I understand it, that the correct course of action given this set of facts is to ask the district court

[00:25:26] Speaker 01:
for some amendment or change to the injunction if they have a different product that can be produced at a non-infringing stability.

[00:25:36] Speaker 03:
I would submit they already had an opportunity to do that, the form of the injunction.

[00:25:39] Speaker 01:
Well, they can do it at any time, right?

[00:25:41] Speaker 03:
Right.

[00:25:41] Speaker 03:
They could go forward afterwards, I think under Rule 65, and say that the circumstances have changed and we want to amend the injunction.

[00:25:47] Speaker 03:
And there's a standard for that.

[00:25:49] Speaker 03:
try to do that below.

[00:25:50] Speaker 03:
But with respect to the injunction that was entered by the court that's at issue here today.

[00:25:54] Speaker 01:
With regard to the only product that the court had in front of it at the time.

[00:25:59] Speaker 01:
Yes.

[00:26:00] Speaker 01:
Did they make this argument about we can produce a non-infringing alternative to the court below?

[00:26:06] Speaker 03:
They did.

[00:26:06] Speaker 03:
They, in fact, made it as a non-infringement argument as well.

[00:26:09] Speaker 03:
It was rejected.

[00:26:09] Speaker 03:
They don't press that.

[00:26:10] Speaker 03:
And then they also made it as an irreparable harm nexus argument.

[00:26:13] Speaker 01:
And what, if anything, did the court say about that in the context of irreparable harm?

[00:26:16] Speaker 03:
The court observed that they are harmed

[00:26:20] Speaker 03:
But that we, Regeneron, will be harmed by the sale of their product.

[00:26:24] Speaker 03:
There's only one product.

[00:26:25] Speaker 03:
It's not as if they say, we have a product that is less than 98%.

[00:26:29] Speaker 03:
We have a product that's more than 98%.

[00:26:31] Speaker 03:
So one should be enjoined.

[00:26:33] Speaker 03:
One shouldn't be enjoined.

[00:26:35] Speaker 03:
One looks at the claim as a whole and asks to be clear.

[00:26:38] Speaker 01:
So this court found, basically, a likelihood of infringement of this product.

[00:26:43] Speaker 00:
Correct.

[00:26:43] Speaker 01:
Because of the samples that the FDA had, all of which were within the claimed range.

[00:26:48] Speaker 01:
And so they have been joined this product.

[00:26:51] Speaker 03:
Exactly right.

[00:26:52] Speaker 03:
This product of the ABLA.

[00:26:53] Speaker 01:
And so they may have other products they could make that would not fall within the claims.

[00:26:58] Speaker 01:
But that's not actually the subject of this injunction.

[00:27:00] Speaker 03:
Correct.

[00:27:01] Speaker 03:
The subject of this injunction is the product for which they filed the ABLA.

[00:27:05] Speaker 03:
And under 271E.

[00:27:05] Speaker 01:
Got it.

[00:27:06] Speaker 01:
Anything further?

[00:27:07] Speaker 03:
No.

[00:27:09] Speaker 03:
Thank you very much.

[00:27:15] Speaker 02:
On causal nexus, under their theory, thank you, Your Honor, for the additional time.

[00:27:23] Speaker 02:
Under their theory, you can get an injunction based upon expired elements of a patent claim.

[00:27:29] Speaker 02:
They're getting injunctive relief that is beyond what they can get from the patent office themselves.

[00:27:34] Speaker 02:
The driver of demand has to be on the non-expired patented features of the 865 patent.

[00:27:43] Speaker 02:
That is the very specific

[00:27:45] Speaker 01:
98% stability limitation and even if we have approval and we do have approval to go down below 98% Yeah, but you submitted a product to the FDA and the only evidence in the record that the court was looking at the time Was that all of the samples that you submitted met the 98% limitation you have a product that has a name for

[00:28:06] Speaker 01:
Right?

[00:28:07] Speaker 01:
And the fact that you could manufacture it, so go back and ask the district court for an amendment to the injunction and say, you know what?

[00:28:14] Speaker 01:
We're going to issue this other product.

[00:28:16] Speaker 01:
And it's going to be at this.

[00:28:17] Speaker 01:
And we want to be clear that it's not covered by the injunction.

[00:28:20] Speaker 02:
True, you are.

[00:28:20] Speaker 02:
But the injunction itself is overbroad as a matter of law under this court's causal nexus precedence because the 98% stability limitation has no bearing on demand or regulatory approval.

[00:28:32] Speaker 01:
We submitted laws that were... They found you were likely to infringe the whole claim, right?

[00:28:36] Speaker 01:
So whether you think it's the 98% or the combination, which is what they say, they found you were likely to infringe the whole claim, all of the elements of the claim and all of them taken together.

[00:28:46] Speaker 01:
And so you are likely to infringe all of it.

[00:28:49] Speaker 02:
And, Your Honor, but the only novel features of the claim that I've heard today and in the briefing or the file, the glycosylation and the 98% stability limitation, everything else is in the public domain.

[00:29:02] Speaker 02:
And so you cannot hide behind those features, respectfully, to warrant an injunction.

[00:29:11] Speaker 02:
On double patenting, I would respectfully, again, refer the court to Basel.

[00:29:17] Speaker 02:
I think we're well within the facts there.

[00:29:19] Speaker 02:
And Kaplan is what is the impermissible use.

[00:29:22] Speaker 02:
You can't rely on an invention that's not claimed.

[00:29:26] Speaker 02:
We're not doing that.

[00:29:29] Speaker 02:
to find the disclosed embodiments.

[00:29:31] Speaker 02:
The district court found that Appendix 97, that Examples 3 and 4 are the disclosed embodiments of the 594 patent under Basel.

[00:29:38] Speaker 02:
We are permitted to look at that, and the district court should have looked at that to understand the coverage of the claims.

[00:29:44] Speaker 02:
We respectfully ask you to reverse.