[00:00:00] Speaker 01:
Our next case is Alecann et al.

[00:00:03] Speaker 01:
versus MSN Laboratories and Sun Pharmaceuticals, 2024, 1061.

[00:00:12] Speaker 01:
Good morning, Mr. Dittman.

[00:00:19] Speaker 01:
Please proceed.

[00:00:20] Speaker 04:
May it please the Court, with regard to obvious type double patenting, the question presented is whether that doctrine's boundaries

[00:00:28] Speaker 04:
should be expanded to allow later filed, later issued continuation to serve as a reference patent against the first filed, first issued patent in the family.

[00:00:38] Speaker 01:
But what's the rule of select?

[00:00:41] Speaker 04:
The rule of select is that a PTA is not immune from double patenting.

[00:00:46] Speaker 04:
This court decided that issue and also decided that the fact that there is no gamesmanship does not mean

[00:00:53] Speaker 04:
that equitable considerations can override a double patenting problem.

[00:00:57] Speaker 04:
This court did not address the issue of what is a proper reference patent in that case, because the patentee never raised that issue on appeal.

[00:01:05] Speaker 04:
Well, I'm sorry.

[00:01:07] Speaker 03:
Go ahead.

[00:01:08] Speaker 03:
But this is different, isn't it?

[00:01:09] Speaker 03:
I mean, this is not like any of the patents or continuations that we had in collect in the sense that here, the patent that's involved

[00:01:22] Speaker 03:
uh... set the priority correct the patent and what was the first file patent that set the priority in the first issue and that factual situation was not involved in collect right you are correct judge dyke uh... the first file first issue patent select was a two five five patent which didn't have a pta but was not an issue in this court's decision to select what about our our

[00:01:49] Speaker 02:
the language in SELECT regarding the patents there being patently indistinguishable, indistinguishable.

[00:01:59] Speaker 04:
Yes, there is language in SELECT about that neither SELECT nor the PTO disputes that there are obvious variations amongst the reference patent, at least the alleged reference patent in that case, and the challenge patents.

[00:02:11] Speaker 04:
But also there was no dispute about the reference patent status.

[00:02:16] Speaker 04:
And that's at page 1229 of the SELECT opinion.

[00:02:20] Speaker 02:
How is that different from this case?

[00:02:22] Speaker 04:
In this case, the reference patent being alleged is a later-issued continuation being asserted against the original period of exclusivity, which is determined by the first file of first-issued patent.

[00:02:33] Speaker 04:
SELECT did not address those facts, and it raises a different set of concerns, namely that Section 101 authorizes a patent for an invention.

[00:02:44] Speaker 04:
And this court has interpreted this to mean that a patentee is entitled to one full

[00:02:49] Speaker 04:
original period of exclusivity, but that any later filed patent that extends that original term can be invalid for double patenting.

[00:02:57] Speaker 04:
And this is, for example, the Abbey case, that pages 1372 to 73.

[00:03:00] Speaker 04:
Here, the first filed first issue 356 patent sets the original period of exclusivity and thus cannot be invalid for double patenting.

[00:03:11] Speaker 01:
So is this case an outlier or a select an outlier?

[00:03:17] Speaker 01:
Or is this an exception to select?

[00:03:20] Speaker 04:
I would view this case as an attempted expansion of the boundaries of double patenting.

[00:03:27] Speaker 04:
I think SELECT decided that PTAs, of course, need to be considered in terms of the expiration dates of the patented issue.

[00:03:33] Speaker 04:
But it didn't decide.

[00:03:34] Speaker 04:
You need a proper reference patent.

[00:03:36] Speaker 04:
And this case presents squarely, you cannot have a reference patent being a later filed, later issued continuation against the original first filed, first issued patent.

[00:03:47] Speaker 02:
So explain those boundaries that are being

[00:03:50] Speaker 02:
expanded here.

[00:03:52] Speaker 04:
Yes.

[00:03:54] Speaker 04:
No precedent of this court has taken what is indisputably the original period of exclusivity set by the first followed first issued patent and said that that exclusivity is curtailed.

[00:04:06] Speaker 02:
The point is that important.

[00:04:08] Speaker 04:
That's important because Section 101 as Supreme Court has explained in cases like Miller versus Eagle that the point of double patenting

[00:04:18] Speaker 04:
is to ensure the public has the right to use the invention at the expiration of the term specified in the original grant, in this avianosis language in page 1372 of its opinion.

[00:04:29] Speaker 04:
And for that reason, the court explained that, quote, the ban on double patenting ensures that the public gets the benefit of the invention after the original period of monopoly expires.

[00:04:39] Speaker 04:
That's page 1373.

[00:04:40] Speaker 04:
That's the 356 patent.

[00:04:43] Speaker 02:
Does that mean that that has some form

[00:04:46] Speaker 02:
adverse effect on terminal disclaimers and the use of terminal disclaimers here?

[00:04:51] Speaker 04:
Well, when you're talking about the original period of exclusivity, there is no other patent for which a disclaimer could be filed.

[00:04:57] Speaker 04:
In this case, when the 356 patent issued, the continuations weren't even in existence.

[00:05:02] Speaker 03:
There could have been a... You didn't file a disclaimer up until patent expiration, is that correct?

[00:05:07] Speaker 04:
You can file a disclaimer, but the point is here that there is no need for one when you have the original creative exclusivity and one was not even available to be filed when the patent issue, which the Supreme Court in return mail and other cases had said, patent validity is judged at inception.

[00:05:23] Speaker 04:
At the outset of the 356 patents issuance, there was no other patent in the family by which a terminal disclaimer could even be filed.

[00:05:30] Speaker 01:
In other words, your client did nothing to extend its monopoly.

[00:05:34] Speaker 04:
Correct, Your Honor.

[00:05:34] Speaker 01:
Which is the point of double patenting.

[00:05:37] Speaker 04:
Correct, Your Honor.

[00:05:39] Speaker 01:
Now, I would also want to switch to the gliding.

[00:05:44] Speaker 04:
Yes, your honor.

[00:05:48] Speaker 04:
Attending to written description, our brief set out the legal and clear factual errors in the district court's ruling.

[00:05:54] Speaker 04:
So in the time I have available today, I want to focus on one particular error.

[00:05:58] Speaker 04:
The district court relied solely on inference to find that, quote, oppose it would understand that using a colliding formulation would be a signal that it was necessary in order to achieve sufficient flow properties unless noted otherwise.

[00:06:13] Speaker 04:
This is at appendix 19.

[00:06:15] Speaker 04:
And the district court received extrinsic evidence that glidants are sometimes necessary to achieve flow.

[00:06:21] Speaker 04:
It noted that all exemplary embodiments in the patents had glidants, and thus inferred that glidants were necessary to the invention claimed.

[00:06:29] Speaker 01:
But the claim said, what, optional, which includes with glidants, but not with glidants.

[00:06:36] Speaker 01:
And your problem is that there are no examples without glidants, right?

[00:06:42] Speaker 04:
Yes.

[00:06:43] Speaker 04:
Well, claim 26 doesn't even discuss glidance at all.

[00:06:46] Speaker 04:
Some of the representative claims, such as claim 7 of the 179, includes glidant optional language.

[00:06:52] Speaker 03:
But there are no examples in the spec, formulations about glidants, right?

[00:06:57] Speaker 04:
There are no working embodiments, exemplary embodiments, that expressly do not have a glidant.

[00:07:02] Speaker 04:
But the summary of the disclosure, for example.

[00:07:05] Speaker 03:
Well, expressly or not, there is no example.

[00:07:07] Speaker 04:
Your honor is correct.

[00:07:08] Speaker 04:
There is no exemplary embodiment.

[00:07:10] Speaker 04:
Yes.

[00:07:11] Speaker 01:
But the glidants are?

[00:07:13] Speaker 01:
optional and they were inert, right?

[00:07:22] Speaker 01:
They indicated the glidant is colloidal silica, right?

[00:07:27] Speaker 04:
In that one example, yes, colloidal silica.

[00:07:30] Speaker 01:
I'm looking at column four of the 179 patent and it refers to these as inert

[00:07:43] Speaker 01:
Inert ingredients.

[00:07:49] Speaker 04:
Yes, and column four is important, Your Honor.

[00:07:53] Speaker 04:
If you look at, for example, lines 55 to 62, it talks about you can have an oral tablet formulation comprising eluxe adaline and an inert ingredient, and then list five possibilities of what this ingredient could be, only one of which is a glidant.

[00:08:10] Speaker 04:
So the summary of the disclosure makes plain that the invention does not require a glidant.

[00:08:16] Speaker 04:
And this is also consistent with the original claims as they were filed in the original application.

[00:08:21] Speaker 04:
They also did not require the presence of a glidant.

[00:08:24] Speaker 04:
So really, the core of the error here by the district court

[00:08:27] Speaker 04:
is that extrinsic evidence was the basis by which to infer the need for gliding, simply because it's an exemplary embodiment, and that it sometimes... Extrinsic evidence is how to read the specification.

[00:08:39] Speaker 03:
That happens all the time, right?

[00:08:41] Speaker 04:
Yes, but the basis, what was the unreasonable inference that the district court made here is that because gliders are sometimes needed, and because I see it in the exemplary embodiments, that means there must be gliders that have to provide sufficient flow, and that's the problem here.

[00:08:55] Speaker 04:
The specification never even mentions sufficient flow.

[00:08:59] Speaker 04:
Nowhere is it even discussed, let alone does the specification ever say that glidants are required.

[00:09:04] Speaker 04:
So there's nothing in the specification, which is what really governs a written description analysis, that says there must be a glidant.

[00:09:12] Speaker 04:
Examples alone aren't enough to limit the invention.

[00:09:15] Speaker 04:
And here, the claims do not require a glidant.

[00:09:18] Speaker 04:
There's no dispute that the remaining ingredients are glidants.

[00:09:21] Speaker 03:
You have expert testimony reading the specifications saying we would read this as requiring a glidant.

[00:09:28] Speaker 04:
There is expert testimony to that extent, but there's nothing rooted in the specification, which is what controls.

[00:09:35] Speaker 04:
Certainly, extrinsic evidence, of course, can be considered, and we don't dispute that.

[00:09:40] Speaker 04:
But there has to be something in the specification that makes clear to oppose that a glident is clearly required.

[00:09:48] Speaker 04:
And here, again, the basis for the district court's inference was on it's needed for flow.

[00:09:53] Speaker 04:
Whether flow is preferred for commercial tablets

[00:09:56] Speaker 04:
and may be preferable in some circumstance, doesn't mean it's required for these claims, which are simply directed to pharmaceutical tablets and nothing more.

[00:10:04] Speaker 04:
They are about as simple of a formulation claim as you can imagine.

[00:10:07] Speaker 04:
It's got four ingredients and specified amounts.

[00:10:11] Speaker 04:
That's all this claim requires.

[00:10:13] Speaker 04:
And that, we submit, is amply supported by the specification.

[00:10:20] Speaker 04:
And I would also say that it's made further clear, if you look at column 12, lines 47 to 54, that's also discusses the possibility of having one or more ingredients.

[00:10:32] Speaker 04:
And we think that's another of three places.

[00:10:35] Speaker 04:
The summary of disclosure, the pre-formulation embodiment in column 12, and also, as importantly, the original claims do not limit the formulations to requiring colliant.

[00:10:47] Speaker 04:
Your honors, at this point, unless you have further questions, I'd like to save the remainder of my time for rebuttal.

[00:10:53] Speaker 01:
We will save it for you.

[00:10:58] Speaker 01:
Mr. Klein.

[00:11:04] Speaker 00:
Good morning.

[00:11:04] Speaker 00:
May it please the court.

[00:11:06] Speaker 00:
The Patent Act grants one patent term per invention.

[00:11:11] Speaker 00:
Plaintiffs want two patent terms for the same invention.

[00:11:15] Speaker 01:
Well, they file one patent application.

[00:11:18] Speaker 01:
They got, without asking for it, an extension.

[00:11:23] Speaker 01:
And then it expired.

[00:11:25] Speaker 01:
They didn't do anything further to extend their monopoly.

[00:11:29] Speaker 01:
Isn't that the evil against which patenting rejections are intended?

[00:11:35] Speaker 00:
But two responses, Your Honor.

[00:11:37] Speaker 00:
First, they did do something.

[00:11:39] Speaker 00:
They made a strategic decision to file continuation applications

[00:11:44] Speaker 00:
for patentably indistinct claims.

[00:11:46] Speaker 00:
That was a decision.

[00:11:47] Speaker 00:
No one forced them to do that.

[00:11:49] Speaker 00:
But they expired first.

[00:11:51] Speaker 00:
That's exactly right.

[00:11:52] Speaker 00:
And the original term, the first term to expire, is the term that expires next March.

[00:12:00] Speaker 00:
Then plaintiffs now want another 15 months of patent term for the exact same invention.

[00:12:07] Speaker 00:
It's admittedly patentably indistinct.

[00:12:11] Speaker 00:
And as this court held in select, what essentially that does is it takes the PTA from the first file patented and applies it to the two patents that expire next year.

[00:12:22] Speaker 00:
And that isn't proper.

[00:12:23] Speaker 00:
That violates section 101, which is the heart of the obviousness type double patenting statute.

[00:12:30] Speaker 03:
So just to be clear.

[00:12:33] Speaker 03:
this fact situation where the patent sets the priority date as the first file and first issue was not a situation that existed in the Collect case, right?

[00:12:44] Speaker 00:
That is correct, yes.

[00:12:47] Speaker 00:
Now, the Collect or Select, I don't know how you pronounce it, case involved earlier filed, earlier issued patents, but the issue resolved in that decision was the PTA question.

[00:12:59] Speaker 00:
But what we do have, and what's made clear in Gilead, is issuance dates don't matter.

[00:13:07] Speaker 00:
What matters is you compare the expiration dates.

[00:13:10] Speaker 00:
Why?

[00:13:10] Speaker 00:
To find out that the issuance dates... The reason, and Gilead makes this clear, is you compare the two expiration dates to see

[00:13:22] Speaker 00:
if the patentee is getting two patent terms for the same invention, because section 101 says you get a patent term.

[00:13:29] Speaker 00:
And what plaintiffs are asking for is a judicial safe harbor for the first filed, first issued patent that would allow them to have two patent terms for the same invention.

[00:13:41] Speaker 00:
That's what they're asking for.

[00:13:45] Speaker 00:
I thought you were going to ask a question.

[00:13:49] Speaker 00:
And there is a statutory safe harbor.

[00:13:52] Speaker 00:
When Congress wants to create a safe harbor to Section 101, it did so in Section 121.

[00:13:59] Speaker 00:
But Section 121

[00:14:01] Speaker 00:
Does does not exempt first filed first issued patents from the double patenting?

[00:14:07] Speaker 00:
Inquiry and that's critically important because the double patenting it may be an equitable doctor, but it's rooted in section 101.

[00:14:15] Speaker 00:
It's got a statutory

[00:14:17] Speaker 00:
So if Congress wants to create a safe harbor, Congress can do that.

[00:14:23] Speaker 00:
But the court shouldn't create a safe harbor for first filed, first issued patents that is inconsistent with Section 101, which says you get one patent term.

[00:14:33] Speaker 00:
per invention.

[00:14:34] Speaker 00:
And that's what they're asking for.

[00:14:35] Speaker 00:
They're admittedly seeking two patent terms for the same invention.

[00:14:40] Speaker 01:
Well, the issue date doesn't count so much since patent term now extends from the filing date.

[00:14:48] Speaker 01:
So for double patenting purposes, what counts is expiration, extension of monopoly.

[00:14:55] Speaker 00:
Right.

[00:14:56] Speaker 00:
That's exactly our point.

[00:14:57] Speaker 00:
And if you look at the two expiration dates.

[00:14:59] Speaker 01:
And they didn't extend the time, the expiration date, from beyond what the first filed application gave them.

[00:15:11] Speaker 00:
That's true.

[00:15:12] Speaker 00:
But they are extending the expiration date of the two ELUX ADELINE patents that expire next March.

[00:15:18] Speaker 00:
They want an additional 15 months for the same invention.

[00:15:22] Speaker 00:
It's admittedly the same invention.

[00:15:24] Speaker 00:
They are seeking a new safe harbor.

[00:15:26] Speaker 00:
They're asking this court to create a brand new judicial safe harbor for first filed, first issued patents.

[00:15:32] Speaker 00:
Gilead said issuing dates don't matter.

[00:15:34] Speaker 00:
So the fact that it's a first issued patent, that shouldn't matter.

[00:15:38] Speaker 00:
Now, as for first filed, they're referring to the filing of a continuation application, which has never been the focus of inquiry for double patents.

[00:15:49] Speaker 00:
All the two reference patents and the 356 patent all date back to the same effective filing date.

[00:15:56] Speaker 00:
That's the important filing date.

[00:15:58] Speaker 00:
And they all have the same filing date.

[00:16:00] Speaker 01:
Let's switch to the glidant.

[00:16:02] Speaker 01:
Yes.

[00:16:02] Speaker 01:
Which is where the district court spent most of its opinion.

[00:16:07] Speaker 00:
Yes.

[00:16:07] Speaker 00:
And that's because that's the issue we try.

[00:16:10] Speaker 00:
And written description is a factual inquiry.

[00:16:14] Speaker 00:
And Judge Andrews, after a trial, made fact findings.

[00:16:18] Speaker 00:
And those findings are entitled to deference under the clear error standard.

[00:16:25] Speaker 00:
And the claims here are specific claims to specific pharmaceutical tablets that are not described in the specification.

[00:16:34] Speaker 00:
They're not.

[00:16:35] Speaker 01:
But the glidant is a component.

[00:16:38] Speaker 01:
This is not a case where we're talking about a broad, generic claim encompassing

[00:16:44] Speaker 01:
loads of compounds, sometimes defined by function or even by structure, where there's just one or two or a small number of embodiments and examples.

[00:16:54] Speaker 01:
This is sort of a small, minor aspect of a composition, the main portion of which is the defined compound, new compound, the active ingredient here.

[00:17:11] Speaker 01:
Column 4 of the 179 calls it an inert ingredient.

[00:17:19] Speaker 00:
Yeah.

[00:17:19] Speaker 00:
I believe Column 4 is referring to all of the inactive ingredients as inert ingredients.

[00:17:24] Speaker 01:
I don't think that's the same.

[00:17:25] Speaker 01:
Well, that includes the glidant, right?

[00:17:27] Speaker 00:
Yes.

[00:17:27] Speaker 00:
Yes.

[00:17:28] Speaker 00:
Yet the gliding is one of several inert or inactive ingredients in the formulation that's disclosed as the invention in the specification.

[00:17:40] Speaker 00:
What happened here is the original claims from this padded family mirrored the specification.

[00:17:48] Speaker 00:
Then during litigation after plaintiffs learned that son's product didn't use one of the ingredients plaintiffs went to the patent office and then took an ingredient out of the patent claim to try to Capture son's product that that's what happened here I don't think they're really going to dispute that and so what they did is they took an ingredient and

[00:18:10] Speaker 00:
out of their claim.

[00:18:23] Speaker 00:
So plaintiffs went back to the pan office, took one of the ingredients out of the claims, and now, in a trial, their main argument was a glidant.

[00:18:33] Speaker 00:
A skilled artisan would know that a glidant is an optional ingredient.

[00:18:37] Speaker 00:
And ironically, plaintiffs were relying heavily on extrinsic evidence at trial to support that.

[00:18:44] Speaker 00:
Judge Andrews heard the battle of the experts on whether a gliding was always optional and ruled in our favor.

[00:18:50] Speaker 00:
And there's no basis to find clear error.

[00:18:53] Speaker 00:
There's no disclosure, just to be clear, with the

[00:18:58] Speaker 00:
What the patent does teach is that eloxadaline was known.

[00:19:02] Speaker 00:
And it was clearly obvious to formulate eloxadaline in a pharmaceutical composition.

[00:19:08] Speaker 00:
So the patent says that the inventors discovered specific formulations with unique features.

[00:19:15] Speaker 00:
They said different formulations can have very different properties.

[00:19:18] Speaker 00:
And then they said, here are the formulations of the present invention in column 11.

[00:19:24] Speaker 00:
And there's a number of required ingredients, and one of them is a gliding.

[00:19:29] Speaker 00:
Column 12 then says you can add other things.

[00:19:31] Speaker 00:
Those are optional.

[00:19:32] Speaker 00:
It never says a gliding is optional.

[00:19:34] Speaker 00:
And then column 13 says this is how you prepare the formulations.

[00:19:38] Speaker 00:
The gliding is silica, right?

[00:19:40] Speaker 00:
Yes, it's colloidal silica.

[00:19:44] Speaker 00:
Colloidal silica.

[00:19:45] Speaker 00:
Colloidal silica.

[00:19:46] Speaker 00:
And I don't think there was a dispute.

[00:19:48] Speaker 00:
In fact, I know there wasn't a dispute or trial as to what the role of a glycate was.

[00:19:53] Speaker 00:
It's to ensure sufficient flow of the powder when all these ingredients are mixed together.

[00:19:58] Speaker 00:
If they don't flow, then they're not going to form a pharmaceutical tablet, which is a claim element.

[00:20:04] Speaker 01:
We're talking about written description.

[00:20:06] Speaker 00:
Right.

[00:20:07] Speaker 01:
And it says optional.

[00:20:09] Speaker 01:
Yes.

[00:20:09] Speaker 01:
Right?

[00:20:10] Speaker 01:
And there was, optional means either or.

[00:20:14] Speaker 01:
Correct.

[00:20:15] Speaker 01:
And the specification is loaded with, with, uh, with either, with, uh, with gladness.

[00:20:25] Speaker 01:
So why doesn't that constitute a written description of a limitation that says optionally?

[00:20:33] Speaker 00:
I believe you're referring to column four, or maybe the pre-formulation section.

[00:20:38] Speaker 00:
As Judge Andrews found, and the court would have to find clear error, that's just a basic idea for a formulation.

[00:20:45] Speaker 00:
It just says, combine Elex Adeline with one or more inert ingredients.

[00:20:50] Speaker 00:
And maybe sometimes in column four it lists potential ingredients, but it doesn't say which ingredients to use.

[00:20:56] Speaker 00:
Do you use more than one?

[00:20:57] Speaker 00:
How much?

[00:20:59] Speaker 00:
It's not until you get to column 11

[00:21:01] Speaker 00:
where the inventors disclose their invention.

[00:21:04] Speaker 00:
The specific formulations that have the unique features that apparently are different from features from other formulations.

[00:21:13] Speaker 00:
And every time

[00:21:14] Speaker 00:
Every time the inventors conveyed to a skilled artisan what they possessed, the formulation had to glide.

[00:21:22] Speaker 00:
That's why the original claims required a glide.

[00:21:25] Speaker 00:
And the only reason the new claims don't require a glide was because plaintiffs went back to the patent office during litigation to take out

[00:21:32] Speaker 00:
an ingredient.

[00:21:34] Speaker 00:
And there's inventor testimony in the record where the inventor didn't even know that happened.

[00:21:40] Speaker 00:
The inventor didn't remember preparing any formulations without a glident.

[00:21:45] Speaker 00:
There's no evidence that the inventors in this case actually possessed what's claimed in the asserted claims.

[00:21:52] Speaker 00:
And it's certainly not disclosed in the specification.

[00:21:55] Speaker 00:
And that's what Judge Andrews found after a trial.

[00:21:59] Speaker 00:
And his findings are entitled to significant deference.

[00:22:06] Speaker 00:
I'd like to make one last point on double-panning, if I would, which is that it's the choice.

[00:22:13] Speaker 00:
It's the fact that plaintiffs made a choice.

[00:22:15] Speaker 00:
Because I do think this is important, and it's different from those Section 121 safe harbor, which requires a restriction from the Pan Office out of the control of the Panty.

[00:22:28] Speaker 01:
You mean they made a choice to file other applications that didn't extend their monopoly?

[00:22:34] Speaker 00:
Well, no.

[00:22:36] Speaker 00:
They made a choice to file continuation applications for patentably indistinct claims.

[00:22:43] Speaker 00:
That was a strategic choice.

[00:22:44] Speaker 01:
Which didn't extend their monopoly, which is the evil that the double patenting remedy is intended to deal with.

[00:22:53] Speaker 00:
Well, I mean, the evil for double patenting is to have more than one patent term for the same invention.

[00:23:00] Speaker 00:
That's the evil.

[00:23:02] Speaker 00:
Traditionally, and most often, it's a later file patent.

[00:23:05] Speaker 00:
No question about that.

[00:23:07] Speaker 00:
But if you go to section 101, it says you get a patent, one patent term per invention.

[00:23:13] Speaker 00:
This court has said that multiple times.

[00:23:15] Speaker 00:
It shouldn't matter if that first patent term comes from a continuation or it comes from the original patent.

[00:23:22] Speaker 00:
Either way, you get one patent term.

[00:23:25] Speaker 00:
And here, plaintiffs would have gotten the full pattern term of the 356 if they filed continuations for patently distinct claims.

[00:23:34] Speaker 00:
We wouldn't be here.

[00:23:35] Speaker 00:
We wouldn't have this argument.

[00:23:36] Speaker 00:
They made a strategic decision.

[00:23:38] Speaker 00:
They got a benefit.

[00:23:39] Speaker 00:
They got more narrow claims to protect their invention, which is the way they put it in their brief.

[00:23:46] Speaker 00:
It presumably helps preserve their arguments against a validity challenge.

[00:23:54] Speaker 00:
But the downside is that their patents now expire next month.

[00:24:00] Speaker 00:
They get the full term.

[00:24:02] Speaker 00:
I want to be clear about this.

[00:24:03] Speaker 00:
The reference patents are getting their full term.

[00:24:05] Speaker 00:
They're not truncated at all.

[00:24:08] Speaker 00:
And so what's happening is,

[00:24:10] Speaker 00:
Plaintiffs are the 356.

[00:24:13] Speaker 01:
What are you calling the reference patents?

[00:24:15] Speaker 01:
The later patents?

[00:24:16] Speaker 00:
The later patents are the reference patents.

[00:24:19] Speaker 00:
They did not get PTA, so they expire next month.

[00:24:23] Speaker 00:
I'm sorry, next year.

[00:24:24] Speaker 00:
The 356 patent expires later solely because of PTA.

[00:24:28] Speaker 00:
And as a practical matter, that PTA is now going to be grafted onto those two patents that expire next March, which is what this court held in select was an ill.

[00:24:43] Speaker 00:
So that gets back to the ill.

[00:24:47] Speaker 00:
Unless there are further questions, I'll sit down.

[00:24:50] Speaker 00:
Thank you.

[00:24:52] Speaker 01:
Thank you, counsel.

[00:24:53] Speaker 01:
Mr. Dittman has some more bottle time.

[00:25:02] Speaker 04:
To begin with the double patenting issue, we're not asking, of course, for an application of the safe harbor.

[00:25:07] Speaker 04:
We're simply asking that this court's case law be followed, requiring that there must be an extension of the original period of exclusivity in order for there to be a double patenting problem.

[00:25:18] Speaker 04:
And there was some discussion about expiration dates.

[00:25:20] Speaker 04:
They're, of course, relevant, but you need to have a proper reference patent to compare those expiration dates.

[00:25:27] Speaker 04:
And as Gilead and other cases have explained, the expiration dates are, of course, determined by the earliest effective filing date.

[00:25:36] Speaker 04:
And here, the 356 patent is, indisputably, the earliest effective filing date.

[00:25:40] Speaker 01:
What about the one patent per invention?

[00:25:44] Speaker 04:
In the one patent per invention per Supreme Court case, all that's been confirmed to be relevant by this court in the post-URA double patenting context,

[00:25:52] Speaker 04:
is what's been the earliest effective filing date determines that first one period of exclusivity, and that's the one patent that you're entitled to get under the statute.

[00:26:02] Speaker 04:
And here, as was noted by the panel's questions, there's been no extension of this original one period that the patentees are entitled to.

[00:26:11] Speaker 04:
If anything, there have been later patents that have shorter terms.

[00:26:14] Speaker 04:
But that is not an extension of the original period of exercise.

[00:26:18] Speaker 03:
You could have an extension if we weren't talking about the first issued patent.

[00:26:23] Speaker 03:
If the first filed were later issued, you could then have a second continuation patent, which started earlier.

[00:26:31] Speaker 04:
There are certainly other scenarios that could raise other considerations.

[00:26:35] Speaker 04:
But in this case, we're both first filed, first issued, and first issued.

[00:26:40] Speaker 04:
We're as early as you could possibly be emanating from the original application.

[00:26:44] Speaker 04:
And I do want to briefly note the Breckenridge case, which I didn't discuss.

[00:26:49] Speaker 04:
It certainly rejects any sort of wooden application of just looking at expiration dates.

[00:26:53] Speaker 04:
Albeit, in a different circumstance, the reasoning of that case, we think, is consistent with the rule that we promulgate.

[00:27:00] Speaker 04:
And also said that a patentee's choice to file later additional patents is not relevant or dispositive to double patenting.

[00:27:07] Speaker 01:
What about the glidant and fact findings?

[00:27:12] Speaker 01:
So we have a clearly erroneous stand.

[00:27:15] Speaker 04:
Yes, and if Your Honor could indulge me one last point, just to mention that, of course, we didn't talk about the statute.

[00:27:20] Speaker 04:
There was a mention of Safe Harbor, of course, 154Bs, guaranteed PTA for diligent applicants pursuing an original application.

[00:27:27] Speaker 04:
We addressed that in our brief, so I'll leave it at that.

[00:27:30] Speaker 04:
Turning to Your Honor's question about written description, the one thing I did want to address about the factual issues, there was an argument made that the summary of the disclosure invention was somehow just a basic idea.

[00:27:44] Speaker 04:
You know, that is a patent sets forth the description of the invention.

[00:27:48] Speaker 04:
That's a summary of the inventive formulations.

[00:27:51] Speaker 04:
And it's not simply a basic idea.

[00:27:53] Speaker 04:
And it makes clear that the formulations don't have to have all five ingredients to your Judge Laurie's question.

[00:28:00] Speaker 04:
You know, the end-or or end-inner ingredient clearly connotes that you don't have to have all five that are required only in the exemplary embodiments.

[00:28:10] Speaker 04:
Claim 26 in particular.

[00:28:12] Speaker 01:
And what, that fully satisfies the optional limitation?

[00:28:17] Speaker 04:
Correct, Your Honor.

[00:28:18] Speaker 04:
It does.

[00:28:19] Speaker 04:
And also just to note that, you know, claim 26, again, it's a comprising claim with very specific ingredients and specific amounts, and it's not a genus.

[00:28:29] Speaker 04:
But even if it was thought of as a genus claim, it's properly described by the structural features of the claim that I would immediately connote to oppose all of the informulations that are covered.

[00:28:41] Speaker 04:
We have here at most maybe 100 or maybe 1,000 formulations that are all clearly described.

[00:28:48] Speaker 04:
They don't have to be set forth in detail in every particular possible embodiment.

[00:28:53] Speaker 04:
The exemplary embodiments and their other disclosure is sufficient.

[00:28:57] Speaker 04:
And unless there's anything, your honors have further.

[00:28:59] Speaker 04:
That's all I wanted to cover today.

[00:29:02] Speaker 01:
Thank you, Mr. Dippman.

[00:29:04] Speaker 01:
Thanks to both counsel.

[00:29:05] Speaker 01:
The case is taken under revising.

[00:29:07] Speaker 01:
That concludes today's argument.