[00:00:00] Speaker 02:
rep roast therapeutics versus fish

[00:00:36] Speaker 02:
Please proceed.

[00:00:40] Speaker 00:
Good morning, Your Honors.

[00:00:42] Speaker 00:
I may please the court.

[00:00:44] Speaker 00:
Dr. Harry Fish should have been made a co-inventor of claim one of Repros's 185 patent.

[00:00:51] Speaker 03:
Mr. Nicodemus, why didn't Dr. Fish name himself as the common inventor during the first grade exam rather than by Joseph Pawlowski?

[00:01:04] Speaker 00:
The first re-examination had to do with Dr. Fish's patent, not any repro's patents or patent applications.

[00:01:11] Speaker 00:
That was a proceeding to determine patentability of Dr. Fish's patent that matured from his provisional application.

[00:01:19] Speaker 00:
That proceeding, he couldn't have made any claim for co-inventorship in a re-examination proceeding.

[00:01:28] Speaker 03:
He affirmed that the named inventor of the 360 patent in April 2005 was

[00:01:34] Speaker 00:
What he did, Your Honor, was state that that application has Mr. Podolsky listed as the inventor.

[00:01:48] Speaker 00:
He didn't acquiesce in that, him being the sole inventor, and he didn't disclaim any inventorship rights.

[00:01:55] Speaker 00:
It's like taking a prior art reference and saying it's the Smith reference.

[00:02:02] Speaker 04:
Yes, sir.

[00:02:03] Speaker 04:
I want to understand the extent to which your argument relies on or depends on actual some degree of collaboration between the parties to a joint inventorship claim.

[00:02:17] Speaker 04:
So suppose that the facts were identical to the facts of this case, except there was never a dinner meeting between Dr. Fish and the named inventors and there was never

[00:02:27] Speaker 04:
Dr. Fish has never actually handed a copy of his provisional application to them.

[00:02:33] Speaker 04:
But rather, let's say they had come by the provisional application without the participation of Dr. Fish.

[00:02:41] Speaker 04:
Let's say a disloyal lab employee of Dr. Fish has handed them the provisional application.

[00:02:48] Speaker 04:
Would he be a joint inventor under those facts?

[00:02:50] Speaker 00:
Your Honor, I think the result would be the same, and I'll tell you why.

[00:02:54] Speaker 00:
The Eli Lilly case that we cite in our brief, which cites the Kimberly Clark case.

[00:02:59] Speaker 00:
That case indicates that joint behavior and collaboration can occur where one co-inventor builds upon the report of someone else.

[00:03:10] Speaker 00:
Even though the two inventors never work together at all.

[00:03:14] Speaker 04:
So if the named inventors had actually gotten started on their whole process by finding, let's say, an unpublished PhD thesis somewhere that didn't constitute prior art, but nonetheless it got them going, that person that wrote the unpublished PhD thesis would be a co-inventor?

[00:03:36] Speaker 00:
I think the result would be the same, but here we have more than that.

[00:03:41] Speaker 04:
I wonder if that's consistent with our inventorship law that the PhD thesis writer would become a joint inventor.

[00:03:50] Speaker 04:
But I take your position that that's your position.

[00:03:54] Speaker 00:
And I think, Your Honor, it's consistent with the inventorship law of the circuit, which indicates that the two joint inventors don't have to work together at all.

[00:04:04] Speaker 00:
The contribution that Dr. Fish made.

[00:04:07] Speaker 02:
Doesn't the word collaboration simply require that they know that they're working together, though?

[00:04:12] Speaker 00:
I don't think they have to know that they're working together.

[00:04:15] Speaker 00:
They can be in two different facilities in the same company or different companies.

[00:04:19] Speaker 00:
I don't think collaboration has been construed by this court as actually working together in the context that you just described, Your Honor.

[00:04:29] Speaker 02:
But in this case, we do have... What is the nature of Mr. Fish's invention?

[00:04:36] Speaker 02:
Because I understand that both parties have stipulated that what was disclosed to Mr. Podolowski at that meeting was the provisional application, basically.

[00:04:46] Speaker 02:
That that is the nature of Mr. Fish's communication to Repros that establishes his co-inventor status.

[00:04:53] Speaker 02:
So what is it

[00:04:55] Speaker 02:
that you believe is Mr. Fish's invention as disclosed in that provisional application?

[00:05:00] Speaker 00:
It's a method of treating symptoms relating to testosterone deficiency in men with a pharmaceutically effective dosage of clomophene citrate comprised of 50 to 70 percent trans-clomophene isomer.

[00:05:12] Speaker 02:
Okay, so he directed or maybe has earned the right to patent coverage on 50 to 70 percent

[00:05:23] Speaker 02:
But the claim at issue, Repros's claim, is consisting essentially of, which is trans-chlomophene, which is defined in the spec as 71 to 100%.

[00:05:36] Speaker 02:
So these are not overlapping percentages.

[00:05:39] Speaker 02:
So Repros may well have gotten the idea from him to, hey, take a look at, I'm probably saying all these words wrong, but chlomophene.

[00:05:48] Speaker 02:
Take a look at Clomaphene.

[00:05:49] Speaker 02:
I know the literature may suggest there are problems with side effects and using it to treat low testosterone problems in men.

[00:05:57] Speaker 02:
However, I've had some success in his invention in the 51% to 70% range.

[00:06:04] Speaker 02:
Is that what you said?

[00:06:04] Speaker 02:
Or is it 50% to 70%?

[00:06:05] Speaker 02:
I don't remember what you said.

[00:06:06] Speaker 02:
50% to 70%.

[00:06:07] Speaker 02:
50% to 70%.

[00:06:09] Speaker 02:
But then repros came along, and after some of their own effort, realized that there was an invention to be had in the 71 to 100% range.

[00:06:18] Speaker 02:
Well, that is outside of the way you just characterized Mr. Fish's invention.

[00:06:22] Speaker 02:
So why is he co-inventor on their patent?

[00:06:26] Speaker 00:
Because I think what you're saying, Your Honor, goes to the issue of whether Mr. Fish would be a sole inventor, and he's not.

[00:06:34] Speaker 00:
I think you have to look at the inventive process as a continuum.

[00:06:37] Speaker 02:
He has to have contributed to at least one element of one claim to be a co-inventor.

[00:06:43] Speaker 02:
Correct.

[00:06:43] Speaker 02:
So if their claim is to 71% to 100%, how does that not completely exclude what he invented?

[00:06:50] Speaker 00:
Because you have to look at how they got there.

[00:06:54] Speaker 00:
And how they got there was they filed a provisional application that incorporated Dr. Fish's invention.

[00:07:03] Speaker 00:
Our preferred embodiment is above 50%.

[00:07:06] Speaker 02:
Their disclosure, perhaps, incorporated Dr. Fish's invention, but not their claims.

[00:07:12] Speaker 02:
And why isn't this completely identical to every improvement patent that exists?

[00:07:17] Speaker 02:
I invent a bicycle, which includes a chain.

[00:07:20] Speaker 02:
I have a patent on a bicycle.

[00:07:22] Speaker 02:
You then invent a better chain to be used on bicycles.

[00:07:27] Speaker 02:
You claim a bicycle with the better chain.

[00:07:30] Speaker 02:
You're still going to be infringing my basic bicycle patent.

[00:07:33] Speaker 02:
But yours is an improvement.

[00:07:34] Speaker 02:
Just because I invented the bike doesn't mean I have a right to be listed as a co-inventor on the claim that is really to a better chain as used on a bike.

[00:07:44] Speaker 00:
I think it's different, Your Honor, because in your hypothetical, you're comparing a patent to an improvement patent.

[00:07:50] Speaker 00:
Here we have a confidential application that was given a reproze before they had any experience in this field at all.

[00:07:57] Speaker 00:
And it disclosed a concrete solution

[00:08:00] Speaker 00:
to a concrete problem, treating symptoms relating to testosterone efficiency with clomophene citrate.

[00:08:05] Speaker 02:
But that's already in the prior art, and that's exactly why the examiner rejected the original claims of Dr. Fish.

[00:08:12] Speaker 02:
There's no doubt based on this record that what's already in the prior art is treating low testosterone using clomophene.

[00:08:19] Speaker 00:
No, symptoms relating to low testosterone using clomophene citrate with up to 70% of the trans isomers not in the prior art because

[00:08:28] Speaker 00:
He went through, Dr. Fish went through two re-examinations and got claims to that.

[00:08:33] Speaker 00:
He got generic claims to a method of treating symptoms relating to testosterone deficiency with clomophene citrate.

[00:08:42] Speaker 00:
And he even got claims 14 and 18 confirmed which say where the clomophene citrate is the trans isomer.

[00:08:50] Speaker 02:
Yes, he got those claims and I have to be honest with you.

[00:08:53] Speaker 02:
I'm glad that I don't have to try to figure out the validity of those claims because it's very hard for me to understand.

[00:08:59] Speaker 02:
I'm not a scientist and we don't have a full record, but what the examiner may have been thinking when he disallowed the claim he sought, but then allowed the claim by adding the words to treat disorders related to.

[00:09:10] Speaker 02:
That didn't really substantially narrow the claim a lot.

[00:09:14] Speaker 02:
It was a very strange addition, but that's not the case in front of me.

[00:09:18] Speaker 02:
He did get that claim, but he didn't get a claim to 71% to 100%.

[00:09:22] Speaker 02:
So I guess I don't understand.

[00:09:26] Speaker 02:
You could go after them for some sort of trade secret misappropriation if they breached a confidentiality agreement, maybe have a breach of contract action.

[00:09:34] Speaker 02:
But I don't understand why he gets to be co-inventor on what is effectively at best for your client, an improvement patent.

[00:09:41] Speaker 00:
Because they use Dr. Fish's provisional as the foundation for their work.

[00:09:45] Speaker 02:
But that's what all improvement patents do.

[00:09:47] Speaker 00:
But they didn't use a public improvement patent to do it.

[00:09:51] Speaker 00:
They used a confidential provisional.

[00:09:54] Speaker 02:
But he then got claims on it.

[00:09:56] Speaker 00:
That's right.

[00:09:57] Speaker 00:
He got claims on it.

[00:09:58] Speaker 00:
But when you look at Repros's R&D efforts, you can't just take a snapshot in time to when they amended claims to add the words consisting essentially of.

[00:10:07] Speaker 00:
You have to look at the event of process from the beginning until the end.

[00:10:10] Speaker 00:
They had no experience in the field whatsoever.

[00:10:12] Speaker 04:
Is your position that

[00:10:15] Speaker 04:
The fact that the source of the inspiration or the beginning of the process was a piece of prior art, a published patent, disallows the patentee in the prior art patent from being a co-inventor.

[00:10:31] Speaker 04:
But if it had not been the actual prior art, that the inventor of the predecessor prior non-prior art would be a joint inventor.

[00:10:43] Speaker 04:
I hope I'm going to answer.

[00:10:45] Speaker 04:
If that's a distinction you're drawing.

[00:10:46] Speaker 04:
In other words, I'm trying to see if, to go back to my thesis writer, if that was an unpublished thesis, he's a co-inventor.

[00:10:54] Speaker 04:
But if he published the thesis, then he can't be a co-inventor.

[00:10:57] Speaker 04:
Is that your position?

[00:10:58] Speaker 00:
I hope I'm going to answer your question, Your Honor.

[00:11:00] Speaker 00:
I'm going to try very hard.

[00:11:03] Speaker 00:
To me, Dr. Fish giving this provisional.

[00:11:07] Speaker 00:
to repros was no different than Dr. Fish sitting in a room with them for days on end and explaining everything that was in the provisional.

[00:11:14] Speaker 00:
He was at the forefront of the inventive process.

[00:11:17] Speaker 00:
He was the foundation for them to even consider using clomophene citrate or consider

[00:11:24] Speaker 00:
amounts of trans-chlomophene above 70%.

[00:11:26] Speaker 00:
It's a difference in degree and not in time.

[00:11:28] Speaker 04:
That would be equally true whether he had actually published his article the day before he met with them or the article was not published.

[00:11:37] Speaker 04:
Is that the distinction you're asking us to draw?

[00:11:40] Speaker 00:
I think the distinction is that this was something confidential that was not in the prior art.

[00:11:45] Speaker 00:
It was not some patent that they did a patent search on and got, and then they tried to design around it or patent around it.

[00:11:51] Speaker 02:
I still don't understand, though, and your answers to Judge Bryson's question keeps reminding me that I don't understand, what did Dr. Fish convey to them vis-a-vis this provisional application that wasn't already in the prior art?

[00:12:03] Speaker 02:
Because you're wrong.

[00:12:05] Speaker 02:
I mean, clomaphene citrate was already in the prior art.

[00:12:08] Speaker 02:
So your response to Judge Bryson didn't include the 50% to 70% limitation when you responded to him.

[00:12:13] Speaker 00:
It should have.

[00:12:14] Speaker 02:
OK.

[00:12:14] Speaker 02:
It should have.

[00:12:15] Speaker 02:
Because you admit clomaphene citrate and using it to treat low testosterone was already in the prior art.

[00:12:21] Speaker 00:
Right, but we're not talking about treating low testosterone.

[00:12:24] Speaker 00:
That's claim one of the 360.

[00:12:26] Speaker 00:
This is treating symptoms relating to low testosterone or androgen deficiency.

[00:12:31] Speaker 02:
Well, one of the two patents, that's not the case.

[00:12:33] Speaker 02:
One of the two patents claim one does not relate to treating symptoms, right?

[00:12:37] Speaker 02:
Let's see.

[00:12:38] Speaker 02:
Claim seven of the 360 says a method for treating secondary hypogonadism in a human male.

[00:12:47] Speaker 02:
That's not about symptoms.

[00:12:48] Speaker 02:
That's about the low testosterone overall.

[00:12:50] Speaker 00:
No, it's not, Your Honor.

[00:12:52] Speaker 00:
It's about symptoms, because you have to look at the agreed upon claim construction of the term treating secondary hypogonadism in a human male, which is, and I'll quote it so I don't get it wrong, therapeutic or prophylactic management of a human male with low testosterone levels, the human male being with or without at least one related symptom.

[00:13:11] Speaker 02:
And that last part is a- With or without.

[00:13:13] Speaker 00:
Right, but Your Honor, that last part is important because

[00:13:18] Speaker 00:
of the words therapeutic or prophylactic management, which is part of the claim construction.

[00:13:24] Speaker 00:
In the repros patents, in the 360 patent, in the summary of the invention, the patent says the present invention is directed to.

[00:13:35] Speaker 00:
And one of the things it's directed to is ameliorating or preventing the symptoms of low testosterone.

[00:13:42] Speaker 00:
That's one of the inventive aspects of it.

[00:13:45] Speaker 00:
And that's right within that claim construction.

[00:13:47] Speaker 00:
Therapeutic, which is part of the construction, is ameliorating.

[00:13:52] Speaker 00:
Provolactic, which is part of the construction, is preventing.

[00:13:56] Speaker 00:
And that has to do with symptoms.

[00:13:58] Speaker 00:
And that's why the end of the construction, which says with or without the disjunctive, at least one related symptom, makes sense because of the terms therapeutic or prophylactic.

[00:14:10] Speaker 04:
I thought that the definition, by definition, comophenic citrate is 50% to 70%.

[00:14:18] Speaker 04:
trans-chlomophene, isn't it?

[00:14:22] Speaker 00:
By definition, I think the chlomid commercial product at the time that Dr. Fish gave that patent application.

[00:14:31] Speaker 04:
Which is chlomophene citrate, right?

[00:14:33] Speaker 00:
It's comprised of chlomophene citrate.

[00:14:35] Speaker 00:
These are not product claims, though.

[00:14:38] Speaker 04:
No, no, I understand.

[00:14:39] Speaker 04:
You said, well, what he added was that you responded to Judge Moore saying that, well,

[00:14:45] Speaker 04:
Clomaphene citrate was known in the prior article.

[00:14:47] Speaker 04:
What he added was the 50% to 70%.

[00:14:49] Speaker 04:
I thought that the 50% to 70% comes along with clomaphene citrate.

[00:14:54] Speaker 00:
I think it comes along with clomaphene citrate.

[00:14:56] Speaker 00:
However, I think where we kept going back and forth was what was not in the prior art and what Dr. Fish was able to patent is a new method of using a pharmaceutically effective dosage of clomaphene citrate comprised of 50% to 70% of the trans isomer.

[00:15:15] Speaker 00:
to treat the symptoms of low testosterone.

[00:15:18] Speaker 00:
That was not in the prior art.

[00:15:22] Speaker 00:
Your Honor, I'd like to address, well, I see I'm running out of time.

[00:15:27] Speaker 00:
I had 11 minutes.

[00:15:27] Speaker 00:
I'll reserve the rest of the time.

[00:15:28] Speaker 02:
Yeah, I think that we should reserve the rest for rebuttal, and I'll restore some rebuttal time.

[00:15:32] Speaker 00:
OK.

[00:15:32] Speaker 02:
Thank you, Your Honor.

[00:15:34] Speaker 02:
Thank you.

[00:15:40] Speaker 01:
Let's go ahead and hear from Ms.

[00:15:41] Speaker 01:
Bell.

[00:15:41] Speaker 01:
May it please the court

[00:15:44] Speaker 01:
Although co-inventorship cases can involve difficult line drawing problems, this case is not one of them.

[00:15:53] Speaker 01:
The evidence of contribution and collaboration in this case is far weaker than evidence deemed insufficient by this court in previous cases, such as Eli Lilly, Hess, and Burroughs Wellcome.

[00:16:08] Speaker 01:
A ruling in Dr. Fish's favor in this case would effectively overrule those cases

[00:16:14] Speaker 01:
lower the high bar this court has set for overcoming the presumption that the named inventors are the named inventors by clear and convincing evidence, and encourage putative co-inventors to wait in the weeds while others take risks and make investments only to surface later when the patents appear to be lucrative.

[00:16:37] Speaker 01:
The judgment should therefore be affirmed for three primary reasons.

[00:16:43] Speaker 01:
First,

[00:16:44] Speaker 01:
as Judge Moore's questioning, I think, got at.

[00:16:49] Speaker 01:
Fish contributed at most what was already well-known in the prior art, the description of a commercially available product, Clomid, copied and pasted in the provisional from its FDA-approved label.

[00:17:03] Speaker 01:
But this court has repeatedly held that contributing what is already known is not a contribution to conception as a matter of law.

[00:17:13] Speaker 01:
Second, the contribution falls well short of this court's demanding legal standard for a contribution to conception, because nothing in the FISH provisional, which my friend just clarified, is the only alleged contribution at issue here.

[00:17:33] Speaker 01:
Nothing in it suggests the invention of repros, which is using the isolated trans isomer.

[00:17:41] Speaker 01:
In other words, a composition consisting essentially of trans isomer, which means it should not and cannot contain any significant amount of the cis, which again, as I just heard my friend say, still leaves, under their best case, the 50% to 70% of trans isomer still leaves you with 30% to 50% of the cis.

[00:18:03] Speaker 04:
And that falls far short of this score standard.

[00:18:06] Speaker 04:
Do you think that 30% cis isomer would be

[00:18:11] Speaker 04:
a substance that would consist essentially of trans isomer?

[00:18:17] Speaker 01:
I think the phrase consisting essentially means it cannot contain any significant amount.

[00:18:22] Speaker 04:
Well, I guess I'm asking the question, do you think 30% is a significant portion?

[00:18:27] Speaker 01:
I would say 30% is certainly a significant, significant portion.

[00:18:32] Speaker 04:
So if I came in with a product that was 30% cis or 25%, let's say, cis isomer,

[00:18:38] Speaker 04:
that it wouldn't infringe your patent.

[00:18:44] Speaker 01:
Your Honor, the record doesn't disclose, and I'm not prepared to say exactly where that line is.

[00:18:50] Speaker 01:
I think what we can say is the facts in this case are, on their best case, it leaves 30% to 50% of the SIS.

[00:18:57] Speaker 01:
Whereas the claim language, which is the key here, consisting essentially of the trance, which means you're wanting as little of the SIS as possible because

[00:19:08] Speaker 01:
The cis acts as a drag on the trans and has toxic side effects to boot, if that responds to your question.

[00:19:17] Speaker 01:
And if I may, Judge Bryson, picking up on your hypothetical involving the PhD candidate, I respectfully disagree with my friend, because I think this court does require collaboration.

[00:19:31] Speaker 01:
This court has said you don't have to be physically in the same place.

[00:19:36] Speaker 01:
And you certainly don't have to contribute to a conception of the entire.

[00:19:41] Speaker 01:
And that is all of the claims.

[00:19:42] Speaker 01:
But there certainly has to be collaboration.

[00:19:45] Speaker 01:
And there certainly has to be a contribution to the conception of the invention.

[00:19:51] Speaker 04:
Well, suppose, and I know that this is not at least objectively viewed, the fact of this case.

[00:19:58] Speaker 04:
But suppose that everything were the same except the dinner meeting.

[00:20:02] Speaker 04:
at which, is it Dr. Fish or Mr. Fish?

[00:20:04] Speaker 04:
I've lost track.

[00:20:05] Speaker 04:
It's Dr. Fish.

[00:20:06] Speaker 04:
OK, Dr. Fish, which Dr. Fish had conveyed his provisional application and presumably discussed it.

[00:20:15] Speaker 04:
Suppose he had said, you know what's interesting about this clomid is that it has this unusual disparity between the two stereoisomers.

[00:20:25] Speaker 04:
It has more trans than cis, which is unusual.

[00:20:28] Speaker 04:
In chemistry, you expect them to be, I guess.

[00:20:31] Speaker 04:
pretty much 50-50.

[00:20:33] Speaker 04:
He said, that's an interesting line to pursue.

[00:20:37] Speaker 04:
And that had been it.

[00:20:37] Speaker 04:
Do you think that that would have been enough to trigger joint inventorship?

[00:20:42] Speaker 04:
He's basically put them on the trail of something which ended up with essentially consisting essentially of transparency.

[00:20:50] Speaker 01:
Well, that's certainly a closer case than ours.

[00:20:52] Speaker 01:
But I go back to this court's decision.

[00:20:54] Speaker 01:
No, I'm just sorry.

[00:20:55] Speaker 01:
I know it's closer.

[00:20:55] Speaker 01:
Yes, I go back to this court's decision in Eli Lilly.

[00:20:58] Speaker 01:
Yeah.

[00:20:58] Speaker 01:
And in Eli Lilly,

[00:21:00] Speaker 01:
You had the patent holder say to the company, hey, have you considered aerosolizing our product, Lispro?

[00:21:11] Speaker 01:
They went back.

[00:21:13] Speaker 01:
They did it.

[00:21:14] Speaker 01:
This court held that wasn't sufficient as a matter of law, because it looked very closely and carefully at the claim.

[00:21:22] Speaker 01:
And what the claim said was that the aerosolizing, the Lispro,

[00:21:28] Speaker 01:
increased the bioavailability of human insulin by twice as much.

[00:21:34] Speaker 01:
And this court said, no, it's not enough.

[00:21:36] Speaker 01:
It's not enough just to make a suggestion or a recommendation.

[00:21:40] Speaker 01:
I think Hess is another example that shows where the line is that this court is drawn.

[00:21:44] Speaker 01:
There, the named inventors went to the co-inventor, putative co-inventor, and said, look, we're trying to come up with a balloon, an angioplasty catheter that works.

[00:21:56] Speaker 01:
We're hung up on material.

[00:21:58] Speaker 01:
And they said, well, the putative co-inventor said, well, try our product.

[00:22:01] Speaker 01:
Try our material.

[00:22:02] Speaker 01:
Made other suggestions.

[00:22:04] Speaker 01:
The named inventors took some suggestions, rejected others.

[00:22:08] Speaker 01:
And even so, this court said that was not sufficient.

[00:22:12] Speaker 01:
So I think this court, precisely to ensure that inventors don't wait in the seats, this court has just drawn a very clear line in terms of conception and collaboration.

[00:22:25] Speaker 01:
And so, of course, I think your case is closer.

[00:22:27] Speaker 01:
I think under this court's cases, I think it's arguable that even under those facts, you would not have co-inventorship.

[00:22:35] Speaker 01:
You might have a better case on collaboration.

[00:22:38] Speaker 01:
But I think co-inventorship in terms of contributing to the conception

[00:22:42] Speaker 01:
the conception of the invention, which is what's key.

[00:22:44] Speaker 04:
Well, I guess I was trying to incorporate the notion of conception, at least in a general sense, with the suggestion that something important is going on here by increasing the percentage of the trans isomer.

[00:22:57] Speaker 04:
That would be maybe not as precise the conception as the ultimate consistent essentially of, but it certainly is.

[00:23:06] Speaker 04:
I would think if they were all working in the lab together, you would say, this is part of the conception.

[00:23:12] Speaker 01:
I think perhaps, but again, what this Court has said, and it says requires a specific, settled idea.

[00:23:20] Speaker 01:
I'm quoting from Burroughs Wellcome, 1228 here.

[00:23:23] Speaker 01:
A specific, settled idea, a particular solution to the problem at hand.

[00:23:28] Speaker 01:
So I think when you look at it from that framework, in terms of the conception, is there the quantum that this Court has required in terms of looking at the claims?

[00:23:38] Speaker 01:
To the extent that I think what Your Honor may also be getting at,

[00:23:41] Speaker 01:
is the claim that we've heard, my friend has invoked a lot today, about a foundation or inspiration.

[00:23:48] Speaker 01:
I think those things are simply not enough by any stretch under this court's cases to amount to the required quantum of conception, contribution, or collaboration.

[00:24:01] Speaker 01:
I think at most, Dr. Fish's provisional inspired Mr. Podolsky and Wheelie

[00:24:08] Speaker 01:
to pursue an oral testosterone therapy.

[00:24:12] Speaker 01:
But not by any stretch do you get to the use of the isolated trans-isomer to address both the symptoms and also just the underlying condition, which are the two patents at issue here.

[00:24:29] Speaker 04:
So I suppose, although I know you don't want to commit your claim on this, but I suppose that your view would be that if Dr. Fish had or has any remedy, it would be in a common law action for some form of tort or breach of contract based on the confidentiality agreement, but not through the patent law.

[00:24:50] Speaker 01:
Right.

[00:24:51] Speaker 01:
Again, we don't think he would have been successful.

[00:24:53] Speaker 01:
But yes, and I think that might go to the alternative estoppel.

[00:24:57] Speaker 01:
holding in this case as well, just in terms of that there were other remedies, breach of the agreement, trade secret theft, any number of other remedies that he could have pursued that he didn't.

[00:25:14] Speaker 01:
And again, the co-inventorship

[00:25:16] Speaker 01:
We believe that the facts of this case, again, are far short.

[00:25:19] Speaker 02:
Well, but how does that fit into your equitable estoppel claim?

[00:25:22] Speaker 02:
If anything, it would actually support the idea that he prejudiced himself by waiting, but not prejudiced you all in any way.

[00:25:30] Speaker 02:
No, Your Honor, I think- Because he fell outside the crate of statute of limitations for any of these common law actions.

[00:25:35] Speaker 02:
It's only he that's been disadvantaged.

[00:25:38] Speaker 01:
Right.

[00:25:38] Speaker 01:
Well, I think my point there is that it shows that there were any number of ways along the trajectory and the path here that he could, in other words, there were alternatives he could have made to signal, just to give some signal to Repros so that Repros wasn't lulled into the belief that he would never at any point bring forth a claim.

[00:26:05] Speaker 01:
to be to become vendors.

[00:26:07] Speaker 01:
My apologies if I misspoke in terms of our defense and certainly not his claim.

[00:26:12] Speaker 01:
Several answers to that question Your Honor.

[00:26:21] Speaker 01:
I think the first answer is that he's correct.

[00:26:25] Speaker 01:
He never threatened to sue, but in my mind what he did do was even more effective in loaling repro's.

[00:26:32] Speaker 01:
in that he actively encouraged in an email he sent.

[00:26:36] Speaker 01:
He referred to the studies that were ongoing and said, well, it looks like maybe they'll be interesting.

[00:26:43] Speaker 01:
So not only was there not a threat to sue or some sense that he was going to make a claim to co-inventorship here, but there was an effective encouragement

[00:26:54] Speaker 01:
of repress going forward making investments.

[00:26:56] Speaker 02:
Well, why does encouraging someone to further build on your research lull you into believing he is therefore not going to pursue any claim against you?

[00:27:05] Speaker 02:
Doesn't, at the end of the day, it matter whether you seek a patent on that further research?

[00:27:11] Speaker 02:
And doesn't it also matter whether he obtains patent rights himself that may be so broad?

[00:27:16] Speaker 02:
Which, I mean, he did initially seek quite broad patent rights.

[00:27:20] Speaker 02:
And so had he obtained the breadth of the rights he was originally seeking at the very outset, that may well have covered the whole gamut and anything you got later on would have been a typical improvement patent where you infringe the basic patent and then you infringe the improvement patent.

[00:27:36] Speaker 02:
So why, in light of all of that, does that make his

[00:27:41] Speaker 02:
I mean, wouldn't anyone who thinks they came up with a solution to a medical issue want to encourage others to attempt to commercialize it and build upon it?

[00:27:51] Speaker 02:
He's not commercializing it himself.

[00:27:53] Speaker 02:
So why wouldn't he want to encourage someone else to commercialize it?

[00:27:56] Speaker 02:
And how in the world does that translate into, I'll never sue you?

[00:28:01] Speaker 01:
Certainly.

[00:28:01] Speaker 01:
And I think on the alternative estoppel, I would return to Judge

[00:28:08] Speaker 01:
Your Honor's questions initially about naming.

[00:28:10] Speaker 01:
So it's not just the encouragement here.

[00:28:13] Speaker 01:
There's the span of time, which as the district court held is not, we're not talking about latches, but that is an indicator that can be considered under the misconduct, is the amount of time.

[00:28:22] Speaker 02:
But there must first have been an affirmative act.

[00:28:25] Speaker 02:
That's the first thing.

[00:28:26] Speaker 02:
It's not just some passage of time.

[00:28:27] Speaker 02:
There has to be an affirmative act.

[00:28:29] Speaker 01:
Yes.

[00:28:29] Speaker 02:
What is the affirmative act?

[00:28:31] Speaker 01:
I think there are several.

[00:28:32] Speaker 01:
I think the email encouraging

[00:28:34] Speaker 01:
acknowledging in the studies.

[00:28:36] Speaker 02:
But you haven't answered my question then.

[00:28:37] Speaker 02:
Why does encouraging someone to commercialize your invention, because you'd like to see it commercialized, especially when we're in the medical field where it's going to help people, how does that translate into, and therefore I won't sue you?

[00:28:50] Speaker 01:
Because that together with the fact that he named, in his own filings before the PTO, that he named Mr. Podolsky

[00:29:02] Speaker 01:
as the named, named inventor.

[00:29:04] Speaker 04:
There was an awareness there.

[00:29:06] Speaker 04:
That's the way you communicate.

[00:29:09] Speaker 04:
Certainly.

[00:29:09] Speaker 04:
You say the Podolsky patent.

[00:29:12] Speaker 04:
That doesn't mean that I concede.

[00:29:14] Speaker 04:
Certainly.

[00:29:14] Speaker 01:
I agree.

[00:29:16] Speaker 01:
But I think it does show that in the fact of writing named inventor, I think that again shows there were other opportunities.

[00:29:24] Speaker 01:
There were opportunities for him during that process to provoke an interference

[00:29:30] Speaker 03:
Well, what you're really saying is that it's a combination of both the encouragement and silence.

[00:29:38] Speaker 01:
Yes, that's correct, Your Honor, and that this court and the silence is an action.

[00:29:42] Speaker 01:
Yes, in Ackerman, so that you don't just have silence here, but those things together, particularly from the standpoint of equity and it being an equitable doctrine, that we don't think the district court abused its discretion in looking at the events here and holding that they

[00:30:00] Speaker 01:
that they amount to.

[00:30:02] Speaker 01:
But again, our contention is that this court doesn't need to reach the district court's alternative holding on estoppel, which would only apply to the 360 patent.

[00:30:11] Speaker 01:
It can resolve this case on both patents at issue, the 360 and the 185, on the inventorship issue and need not reach estoppel at all.

[00:30:21] Speaker 02:
What is the prejudice?

[00:30:23] Speaker 02:
Given that everyone agrees that the only thing he communicated was what's contained within his provisional application, which is a documented writing that is not changing, what was the prejudice that your client suffered by virtue of the passage of time such that equitable staffers should apply?

[00:30:40] Speaker 01:
I think the prejudice that we suffered, and I see my red light is on, may I answer?

[00:30:45] Speaker 01:
Yes.

[00:30:45] Speaker 01:
There's both economic prejudice and evidentiary prejudice.

[00:30:48] Speaker 01:
The economic prejudice goes to the tens of millions of dollars, I think 53 million.

[00:30:53] Speaker 01:
that we spent over the course of the years experimenting and developing our product, androxil.

[00:31:00] Speaker 01:
I think the evidentiary prejudice lies not just in Dr. Fish's fading memory, but also in the fact that, and it's in the record that we... Why is his fading memory relevant?

[00:31:14] Speaker 02:
Well, because it is... The main issue is what was communicated, and that is documents.

[00:31:21] Speaker 01:
Yes, I think that does go to the documents.

[00:31:22] Speaker 01:
But there's another aspect, which is our own fading memories at repros and documents that we could have produced to further confirm, in addition to the contemporaneous memo talking about the isolation, the use of the isolated trans isomer that perhaps would have bolstered our claim that we were the ones who invented it.

[00:31:44] Speaker 01:
And at most, the provisional contributed what was well-known in the art.

[00:31:50] Speaker 04:
Just one more question.

[00:31:53] Speaker 04:
What was the date of issuance of your patent?

[00:31:57] Speaker 04:
It was relatively recent, wasn't it?

[00:32:01] Speaker 01:
Let me, 2010.

[00:32:05] Speaker 04:
Yeah, that's right.

[00:32:05] Speaker 01:
Yes, I just wanted to get the address.

[00:32:07] Speaker 01:
Thank you.

[00:32:08] Speaker 01:
Yes, 2000.

[00:32:09] Speaker 04:
Could he have brought an action before that for correction of inventorship?

[00:32:16] Speaker 01:
could have brought an interference, if I understand the correct.

[00:32:20] Speaker 01:
Just correction of inventorship.

[00:32:22] Speaker 01:
Correction of inventorship?

[00:32:23] Speaker 01:
Yeah.

[00:32:24] Speaker 01:
I believe that he could have.

[00:32:26] Speaker 01:
Yes, but he definitely could have provoked interference.

[00:32:28] Speaker 04:
I thought the rule was that you could only bring a correction of inventorship after the issuance of the patent.

[00:32:32] Speaker 01:
I'm sorry, Your Honor.

[00:32:33] Speaker 01:
I misunderstood.

[00:32:34] Speaker 01:
That's correct.

[00:32:35] Speaker 01:
But he could have provoked an interference proceeding.

[00:32:39] Speaker 01:
My apologies.

[00:32:42] Speaker 02:
We went a bit over, so we will give you three minutes of rebuttal time, and that should even out the time.

[00:32:49] Speaker 00:
Thank you, and I'll speak quickly.

[00:32:53] Speaker 00:
This is very different from the Hess case that council mentioned.

[00:32:55] Speaker 00:
And Hess had to do with an angioplasty invention where the unnamed inventor had no experience in angioplasty.

[00:33:02] Speaker 00:
And all he did was give the named inventor some general ideas and advice.

[00:33:06] Speaker 00:
Here the situation is reversed.

[00:33:08] Speaker 00:
Repros had no experience in treating symptoms related

[00:33:11] Speaker 00:
to testosterone efficiency, and Dr. Fish gave them not just general ideas and advice, but a concrete solution to a concrete problem in the provisional.

[00:33:19] Speaker 00:
Now, when I first got a chance to speak with your honors, there was some discussion about symptoms versus raising testosterone.

[00:33:28] Speaker 00:
And the Repros 360 patent makes clear that treating symptoms is an important part of the invention.

[00:33:35] Speaker 00:
And I refer your honors to

[00:33:37] Speaker 00:
Summary to invention beginning at line 31, and I'll quote, the present invention is directed to compositions useful for increasing testosterone levels in male mammals and for ameliorating or preventing the sequelae of low testosterone levels.

[00:33:53] Speaker 00:
Sequel I mean symptoms, and in column two beginning at line eight, all of these symptoms are listed.

[00:33:58] Speaker 02:
They're the same symptoms that- Yes, but at least Claim 7 of the 360, maybe not Claim 1 of the 185, but Claim 7 of the 360 doesn't go to symptoms.

[00:34:07] Speaker 02:
It goes to the condition itself.

[00:34:11] Speaker 00:
And the condition itself, because of the words treating and their agreed upon claim construction, includes symptoms.

[00:34:17] Speaker 00:
Otherwise, that was one of Repros's arguments that, well, Claim 1 and Claim 7, they're really the same.

[00:34:22] Speaker 00:
But how could they be the same?

[00:34:24] Speaker 00:
They'd be redundant.

[00:34:24] Speaker 00:
Claim 1 says raising levels.

[00:34:28] Speaker 00:
of low testosterone, which we're not claiming co-inventorship to, because we believe that's in the prior art.

[00:34:32] Speaker 00:
Claim seven is treating secondary hypogonadism in a human male.

[00:34:38] Speaker 00:
And when you look at the difference in claim language, otherwise the claims are identical.

[00:34:42] Speaker 00:
And when you look at the difference in claim language and apply the claim construction, claim seven does incorporate symptoms.

[00:34:49] Speaker 00:
And clearly, claim one of the 185 patent does, because it goes to the symptom of wasting.

[00:34:55] Speaker 00:
And I'll note, counsel said something about what constitutes essentially consisting of in terms of the amount of cis isomer.

[00:35:04] Speaker 00:
The specification of the 185 patent in all of the embodiments is very clear.

[00:35:09] Speaker 00:
The range is 71 to 100 trans.

[00:35:13] Speaker 00:
That's one uptick.

[00:35:14] Speaker 02:
Where would you say is the best reference for that?

[00:35:17] Speaker 00:
This is A 1556.

[00:35:20] Speaker 00:
It's a summary of the invention of the 182.

[00:35:25] Speaker 00:
And you can read all of column four, and you can read all of column five up until the brief description of the drawings.

[00:35:33] Speaker 00:
Every reference is to 71 to 100.

[00:35:40] Speaker 00:
Which patent are you looking at?

[00:35:42] Speaker 00:
The 185.

[00:35:43] Speaker 00:
These are appendix sites 1556 and 1557.

[00:35:47] Speaker 00:
Now, what Dr. Fish gave them was the knowledge

[00:35:55] Speaker 00:
of a method that worked using clomophane citrate in the first place, which they had no knowledge of.

[00:36:02] Speaker 02:
That was from the prior art.

[00:36:06] Speaker 00:
Not to treat symptoms relating to testosterone deficiency was not in the prior art, Your Honor.

[00:36:12] Speaker 00:
Or else Dr. Fish wouldn't have gotten his 920 patent with all those claims talking about using clomophane citrate.

[00:36:18] Speaker 04:
It wouldn't have been the first invalid patent to successfully go through the patent office.

[00:36:24] Speaker 04:
So the fact that he got the patent is certainly not dispositive as to whether he's invented anything.

[00:36:30] Speaker 00:
But that's the evidence in this case, Your Honor.

[00:36:32] Speaker 00:
The district court made plain it was not her job to determine the validity or the infringement of Dr. Fish's 920 patent.

[00:36:38] Speaker 02:
Yeah.

[00:36:41] Speaker 02:
OK, thank you.

[00:36:42] Speaker 02:
OK, thank you, Your Honor.

[00:36:44] Speaker 02:
Thank you for your counsel.

[00:36:44] Speaker 02:
The case is taken under submission.