[00:00:07] Speaker 03:
Okay, our second case this morning is number 162583, Merck Sharp versus Warner Chilcott.

[00:00:15] Speaker 03:
Mr. Nimrod.

[00:00:20] Speaker 01:
Thank you, Your Honor.

[00:00:21] Speaker 01:
May it please the Court?

[00:00:24] Speaker 01:
Your Honor, I'd like to start today with what I think is the clearest error by the District Court, and that is the failure to make any finding on the reasonable expectation of success, along with the lack of any evidence on such an expectation.

[00:00:36] Speaker 01:
The case involves an obviousness finding based on a single prior reference, the 015 patent, which is directed to a ring intentionally designed to deliver the required hormones from two medicated compartments.

[00:00:50] Speaker 01:
The district court modified that reference using a 100-year-old law, fixed law, to eliminate one of the compartments and change it into a ring with one compartment delivering all of the required hormones.

[00:01:02] Speaker 01:
But the 015 patent, priority patent itself, recounts the history of failed efforts to make one compartment rings where one compartment delivered the physiologically required amounts.

[00:01:13] Speaker 01:
POSE had recognized the advantages of a one compartment ring 25 years earlier due to mechanical issues, for example.

[00:01:19] Speaker 01:
It's easier to assemble.

[00:01:21] Speaker 01:
And they tried to make one compartment rings, that's rings where one compartment delivered all of the hormones, using Fick's law.

[00:01:28] Speaker 01:
But every attempt

[00:01:29] Speaker 01:
going back 25 years, failed to provide the required physiological required amounts.

[00:01:35] Speaker 01:
That is, a contraceptive ring needs to deliver estrogen and progestin at a daily basis at about the same rate over a period of time, typically 21 days.

[00:01:46] Speaker 00:
Can I ask you, this is kind of very specific, but on page 19 of the district court's opinion, he talks about what he says is a specific example in the O-15 patent.

[00:01:59] Speaker 00:
still a two ring solution, but a two ring solution where, if I'm reading it correctly, the combined compartment could be up to 97% of the ring.

[00:02:15] Speaker 00:
If you have 97% of the ring as a combined compartment, which is what your ring is 100%, is it really that big of a stretch to go from 97% combined to 100%?

[00:02:28] Speaker 01:
Your honor, the 015 patent discloses a generic teaching of saying that the second compartment can be anywhere from a 1 to 30 ratio to the first compartment to 31.

[00:02:38] Speaker 01:
It discloses release rates on preferred embodiments only.

[00:02:43] Speaker 01:
That disclosure says nothing about what would happen to release rates if you modified the compartment to go from what, in every example, the second compartment is about 10% of the overall ring.

[00:02:54] Speaker 01:
And that's a disclosure, I think, in page three of the 015 patent.

[00:02:58] Speaker 01:
And it simply states that you can make modifications.

[00:03:00] Speaker 01:
But when it gets to release rates, it talks about that as being release rates obtained in specific preferred embodiments.

[00:03:07] Speaker 01:
So it never says that you're going to get good release rates if you try and shift everything over to 97% of the ring.

[00:03:12] Speaker 03:
I don't understand what you're saying.

[00:03:15] Speaker 03:
I mean, if there's an example that shows a 97% release rate, as Judge Hughes says, why isn't it obvious to go to 100%?

[00:03:24] Speaker 03:
because of the advantages of having a single ring rather than two.

[00:03:29] Speaker 01:
Your Honor, I'm looking at it two ways, Your Honor.

[00:03:31] Speaker 01:
There's not a specific example.

[00:03:33] Speaker 01:
There's a generic, there's a teaching on page A3041, which states the lengths of the compartments of the ring-shaped device are chosen to give the required performance.

[00:03:44] Speaker 01:
Ratios of the lengths of the first and second compartment are contemplated to be between 30 to 1 and 1 to 30, but usually between 15 to 1 and 1 to 1, that is mostly

[00:03:54] Speaker 01:
the first compartment, which has all the progestin, only progestin, and preferably about 2 to 1.

[00:04:00] Speaker 01:
There's no teaching there about what would happen with respect to the release rate.

[00:04:03] Speaker 01:
So what I'm talking about is not a motivation to try things.

[00:04:07] Speaker 01:
The question we're talking about is whether there would be a reasonable expectation of success in delivering the physiologically required amounts.

[00:04:15] Speaker 01:
So there's no specific example.

[00:04:17] Speaker 01:
It just says you can make modifications.

[00:04:20] Speaker 01:
preferred release rates are talked about later in the patent with respect to preferred embodiments.

[00:04:25] Speaker 01:
So if we focus on a reasonable expectation of success, that is, did APOZA have a reasonable expectation of success that if you shifted all of the progestin into one compartment, would that give you the steady release rates that are required?

[00:04:40] Speaker 01:
That page three, A3041, does not address that.

[00:04:43] Speaker 01:
There's no specific example.

[00:04:45] Speaker 01:
There's no discussion of release rates at all.

[00:04:48] Speaker 01:
In fact, the

[00:04:49] Speaker 01:
The 015 patent is embracing the teachings of the 576 patent.

[00:04:54] Speaker 01:
It states on page 1 that all prior attempts to put everything into one compartment, all the P and all the E, have failed.

[00:05:03] Speaker 01:
And it cites the 576 patent, which gives a history of the prior as well, and then gives what I think is very crucial here, two examples.

[00:05:13] Speaker 01:
The 576 patent at page A3065 has an example 6.

[00:05:19] Speaker 01:
Example 6 has a first compartment, which is about 90% of the ring, which has only progestin.

[00:05:25] Speaker 01:
Then it has a second compartment, which is 10% of the ring, having some more progestin, so it's a smaller amount, and all the estrogen.

[00:05:33] Speaker 01:
And at that page, it teaches, for example, 6, that you get a linear release rate.

[00:05:38] Speaker 01:
But the 576 patent also is in example 1, where it shifts all of the progestin into one compartment.

[00:05:44] Speaker 01:
And it teaches

[00:05:45] Speaker 01:
at page A3061 that you get release rates like Figure 5, which shows that the progestin is steady, but the estrogen drops down dramatically.

[00:05:55] Speaker 01:
So the idea of going from having some of the progestin in a second department to all of it, the only teaching in the art at all is the 576 patent, which shows the release rate goes down, and then the prior attempts

[00:06:08] Speaker 01:
that are referred to in the 015 patent.

[00:06:10] Speaker 03:
But the prior attempts failed because of mechanical problems having to do with blast stoppers and things like that, right?

[00:06:18] Speaker 01:
No, Your Honor.

[00:06:19] Speaker 01:
Example one, for example, is one where they put stoppers in to see what would happen with the release rate.

[00:06:25] Speaker 01:
They kept the compartments separate.

[00:06:27] Speaker 01:
There was no question about it.

[00:06:28] Speaker 01:
Example one of the 576 teaches, if I put those stoppers in, I put all of the progesterone estrogen into one compartment, the release rate I get,

[00:06:38] Speaker 01:
has a steady decline of estrogen over a daily basis.

[00:06:44] Speaker 01:
So the issue is not simply the stoppers.

[00:06:46] Speaker 01:
And if we go to the 015 patent itself, and that's at page A3039, the 015 patent does not teach that the problem is the stoppers.

[00:06:58] Speaker 01:
It goes through the history of these attempts at one compartment.

[00:07:01] Speaker 01:
And at line 21, it says, these above mentioned one compartment rings.

[00:07:06] Speaker 01:
have the disadvantage that when loaded with more than one active substance, release patterns of these substances cannot be adjusted independently.

[00:07:14] Speaker 01:
Such devices usually show suboptimal release patterns for the different substances, whereas it is generally preferred that all substances are released in a controlled rate and during a similar duration of time.

[00:07:27] Speaker 01:
As a consequence, the release ratio of the active substances undergoes a change after a period of time.

[00:07:32] Speaker 01:
So it's not talking about stopper problems.

[00:07:34] Speaker 01:
It's saying that if I

[00:07:36] Speaker 01:
try and load all of the progestin and estrogen into one compartment.

[00:07:41] Speaker 01:
That's before the 015, right?

[00:07:44] Speaker 01:
That's the 015.

[00:07:45] Speaker 01:
That's right.

[00:07:46] Speaker 03:
No, but the prior art references that talked about the release rate problems were before the 015.

[00:07:53] Speaker 01:
Right.

[00:07:53] Speaker 01:
So the 015 is the prior reference that's relied on by the court.

[00:07:56] Speaker 01:
And it is then teaching somebody skilled in the art reading the 015, which is the issue here, what would the person learn about attempts to put all of the progestin and estrogen

[00:08:05] Speaker 01:
into one compartment.

[00:08:07] Speaker 01:
And the answer is, you don't get the right release rates.

[00:08:10] Speaker 03:
And then if you look at the 015... Where does the 015 say you don't get the right release rates?

[00:08:15] Speaker 01:
That's in page 3039.

[00:08:18] Speaker 01:
And if we go to line 23, so from lines 10 to 20 there, we're counting these one compartment attempts.

[00:08:31] Speaker 01:
One example is the 965 patent.

[00:08:33] Speaker 01:
You see that in line 18, Your Honor?

[00:08:36] Speaker 01:
And the 965 patent is one where they use Fick's Law.

[00:08:41] Speaker 01:
And they put all of progestin and estrogen in one compartment.

[00:08:44] Speaker 01:
So there's a discussion of a three-layered one-compartment ring.

[00:08:47] Speaker 01:
There's no issue about stoppers there.

[00:08:49] Speaker 01:
And then it goes on.

[00:08:50] Speaker 01:
If you look, Your Honor, at line 23, it says, such devices usually show suboptimum release patterns for the different substances.

[00:09:01] Speaker 01:
And then it goes on and says, it's generally preferred all the substances are released in a controlled rate and during a similar duration of time.

[00:09:09] Speaker 01:
And you want the estrogen and progestin to come out at the same rate, the same dosage every day over the period of use.

[00:09:16] Speaker 01:
And it says, as a consequence, the release ratio, that's the release ratio of what you release of progestin and estrogen, undergoes a change after a period of time.

[00:09:28] Speaker 01:
You start off with estrogen and progestin at the right ratios, but one of them starts declining as to what it's supposed to be delivering.

[00:09:34] Speaker 01:
And then you get that effect that's shown in the 576 patent, where when you load it all in one compartment, one of the two substances cannot be released at the proper ratio relative to the other.

[00:09:46] Speaker 01:
Because for a contraceptive device, you need, for example, a certain amount of progestin and a certain amount of estrogen.

[00:09:52] Speaker 01:
Every day, same amount, same ratio.

[00:09:55] Speaker 05:
Am I correct that

[00:09:58] Speaker 05:
the discovery that if you supersaturate the progestin, that sort of is essential and a key to why a single compartment ring works.

[00:10:09] Speaker 01:
It was essential, yes, Your Honor.

[00:10:10] Speaker 05:
And the finding of... Tell me why the 015 patent doesn't provide a sufficient teaching of supersaturation.

[00:10:22] Speaker 01:
Well, the 015 patent does not provide any teaching of supersaturation, nothing explicit.

[00:10:26] Speaker 01:
There are several compartments, second compartments in the 015 patent that have various concentrations of progestin.

[00:10:33] Speaker 05:
One of those.

[00:10:33] Speaker 05:
Dr. Kaiser testified that at those concentrations, one of ordinary skill in the art would understand that it's supersaturated.

[00:10:42] Speaker 01:
No, Your Honor, he actually conceded that at 0.8, which is the concentration we're talking about, it could be supersaturated or it could simply be saturated with crystals.

[00:10:51] Speaker 01:
So 0.8 wouldn't tell you one way or another.

[00:10:52] Speaker 01:
There was no dispute on that at trial.

[00:10:54] Speaker 01:
The question then is, since you have a concentration of 0.8, you either can be super saturated, or you can be saturated with crystals in it.

[00:11:02] Speaker 01:
There was no teaching in the 0.15 patent as to whether it was, in fact, saturated with crystals or super saturated.

[00:11:08] Speaker 01:
And the court's finding was based on the idea of silence.

[00:11:11] Speaker 01:
There was a reference to the first compartment.

[00:11:13] Speaker 03:
There's silence in the sense that it doesn't teach away.

[00:11:17] Speaker 01:
Well, with, with inherency, Your Honor, I think the silence went to, the, the court said that there's a strong inference that, in fact, it was super saturated.

[00:11:25] Speaker 01:
And so the question here was not the teaching away question, it was whether or not if you have silence as to whether or not there's crystals present, are you then to assume that there are no crystals present?

[00:11:35] Speaker 01:
Because you had a first compartment which said, the description was, there are crystals present in the first compartment, because that has a huge amount of progesterone, will always have crystals.

[00:11:45] Speaker 01:
With respect to the second compartment, which is the one at issue here, which had 0.8, there was no teaching one way or another whether or not crystals were present.

[00:11:52] Speaker 01:
So the court presumes.

[00:11:53] Speaker 03:
Well, that's just one particular one, right?

[00:11:56] Speaker 05:
And based on Dr. Kaiser's testimony, it could be either way.

[00:12:00] Speaker 05:
It could be supersaturated, or it could not with crystals.

[00:12:04] Speaker 01:
That's right, Your Honor.

[00:12:04] Speaker 01:
So that means that it doesn't mean it.

[00:12:06] Speaker 05:
Teaching both ways.

[00:12:07] Speaker 01:
Right, which means it doesn't meet the standards of the court here for inherent anticipation.

[00:12:11] Speaker 01:
The supersaturations required for the claims

[00:12:14] Speaker 01:
And by this court's standards, the missing feature, which is supersaturation, needs to be necessarily present.

[00:12:21] Speaker 01:
Not merely present, possibly or probably present.

[00:12:24] Speaker 01:
It has to be necessarily present.

[00:12:25] Speaker 01:
And all Dr. Kaiser could say was that there may or may not be crystals in there.

[00:12:32] Speaker 01:
There's silence on it.

[00:12:34] Speaker 01:
And if he concludes based on silence, that tells you something.

[00:12:36] Speaker 03:
It doesn't eliminate the possibility.

[00:12:37] Speaker 03:
But didn't he testify that someone skilled in the art would know to try

[00:12:42] Speaker 03:
supersaturation as a mechanism for getting this into a single compartment?

[00:12:48] Speaker 01:
No, Your Honor, he did not.

[00:12:49] Speaker 01:
He testified that there was an inherency, excuse me, in the 0.8 compartment.

[00:12:53] Speaker 01:
He did not say that someone tried to do that.

[00:12:56] Speaker 01:
In fact, there is no teaching anywhere in the art of using supersaturation as a design parameter anywhere.

[00:13:02] Speaker 01:
And he never testified to that effect.

[00:13:04] Speaker 01:
So supersaturation, there's no teaching in the art.

[00:13:06] Speaker 01:
There's no teaching in the 015 patent.

[00:13:08] Speaker 01:
It simply came down to an inherency issue for obviousness.

[00:13:12] Speaker 01:
There was no recognition anywhere that anyone pointed to that someone knew anything was supersaturated here.

[00:13:17] Speaker 01:
It was one of several compartments they say pointed to said, well, we think that's supersaturated.

[00:13:23] Speaker 01:
I'd like to just make one other point before I run out through my rebuttal time right now.

[00:13:27] Speaker 01:
But on Nexus, the court's handling of the secondary considerations went squarely against this court's requirements.

[00:13:34] Speaker 01:
The court did not find a presumption of Nexus, even though Nuvaring is, in fact, an embodiment of the claims, in fact,

[00:13:42] Speaker 01:
Newvering is example five of the 581 patent.

[00:13:46] Speaker 01:
It's completely coextensive with it.

[00:13:47] Speaker 01:
And the court should have found that there was a presumption of nexus.

[00:13:50] Speaker 01:
That was a legal error.

[00:13:52] Speaker 01:
The second legal error is that the court required us then to prove that the nexus was tied to an inventive feature of the claim.

[00:13:59] Speaker 01:
But this court's precedent says you look at the invention as a whole.

[00:14:02] Speaker 01:
So there are two legal errors with respect to nexus.

[00:14:04] Speaker 01:
There's evidence of long-felt need going back 25 years, failure of others.

[00:14:08] Speaker 01:
There has never been a successful

[00:14:10] Speaker 01:
Consciences have to ring with progesterone and estrogen on the market until nubering.

[00:14:16] Speaker 01:
Thank you, Your Honor.

[00:14:17] Speaker 03:
OK, I'll give you two minutes for a vote.

[00:14:25] Speaker 03:
Mr. Lombardi?

[00:14:26] Speaker 04:
May I place the court?

[00:14:27] Speaker 04:
Your Honor, may I start with where counsel started, which is what the 015 teaches.

[00:14:33] Speaker 04:
The 015 teaches.

[00:14:35] Speaker 04:
that you can get a single compartment that comprises 97% of a contraceptive ring that has more progestin than estrogen, that has supersaturated amounts of progestin, and that delivers in the proper manner, that in other words has a good release.

[00:14:52] Speaker 04:
That's what the 015 teaches.

[00:14:54] Speaker 05:
Where does the 015 teach the appropriate release rates when the ring with the mixture is 97%?

[00:15:05] Speaker 04:
The 015 doesn't have a teaching that specifically says, at 97%, this is the rate.

[00:15:13] Speaker 05:
But the 015... I thought that's what you said just a minute ago.

[00:15:16] Speaker 04:
No, what I'm saying, Your Honor, is that the 97% shows that you have a ring that can have both progestin and... This is what it's taught.

[00:15:26] Speaker 04:
The ring can be 97% of the ring in the compartment that has both progestin and estrogen in it.

[00:15:33] Speaker 04:
and that has a greater amount of progestin estrogen based on the ranges taught in the 015.

[00:15:39] Speaker 04:
And it teaches that the rings of this invention, the 015 invention, are in fact good releases, have good releases.

[00:15:46] Speaker 03:
So where does it teach that, I guess is the question.

[00:15:50] Speaker 04:
It teaches generally, Your Honor, and I think it's on the second page of the 015.

[00:15:59] Speaker 04:
It's at appendix 3040.

[00:16:03] Speaker 04:
that it's an objective of the present invention to provide a safe ring-shaped device with a good release pattern.

[00:16:10] Speaker 00:
But the problem is you have to go to one place to get the 97%.

[00:16:16] Speaker 00:
You have to go to a different place to get the concentration.

[00:16:21] Speaker 00:
And then you're relying on this general statement of reaching good release rates, and you're pulling them all together without any suggestion

[00:16:30] Speaker 00:
in the 015 that there's a reasonable expectation of success when you can combine this one very different from the embodiments proportions and very different from the embodiments concentrations.

[00:16:46] Speaker 00:
So yes, you may be able to point to specific places, but given that it's so different than the actual embodiments, how is there any

[00:16:55] Speaker 00:
support for reasonable expectation of success.

[00:16:58] Speaker 04:
Well there's support because it's in a printed publication your honor that is out there and the question is what does it teach a person of skill?

[00:17:05] Speaker 00:
These pharmaceutical cases seem to me sometimes be a little different because you may have a broad range of combinations and things like that and it may cover a lot of things and but they may not specifically identify certain different combinations and

[00:17:22] Speaker 00:
without identifying the specific combination, how do we know that that actually works?

[00:17:28] Speaker 04:
Well, you know that it works because it's taught in the patent application that it works, Your Honor.

[00:17:32] Speaker 04:
That's the answer.

[00:17:34] Speaker 04:
Patent applications are printed publications which are presumed enabled.

[00:17:39] Speaker 00:
And this specific patent application also teaches us that one ring solutions don't work.

[00:17:45] Speaker 04:
Well, certain some one-ring solutions don't work.

[00:17:48] Speaker 04:
And the district court dealt with that factual issue of teaching away very specifically and very carefully.

[00:17:54] Speaker 04:
And the district court pointed out that the prior art one-ring solutions that counsel has referred to and that are referred to in the 015 are different.

[00:18:03] Speaker 04:
They either use a different polymer, or don't use a polymer, they use silicone, or they use a different structure or both.

[00:18:11] Speaker 04:
And so it was a different situation with those specific single compartment approaches.

[00:18:19] Speaker 04:
What happened in the 015 was it used a different structure and a different material, not silicone.

[00:18:27] Speaker 04:
And it was that that led the 015 to be able to put everything in one compartment.

[00:18:33] Speaker 04:
And so the 015 teaching on its face is that this 97% compartment

[00:18:41] Speaker 04:
can have both progesterone and estrogen in it, and can have supersaturated progesterone in it, and can get good release rates.

[00:18:52] Speaker 03:
Did your expert address this?

[00:18:54] Speaker 04:
Yes.

[00:18:55] Speaker 03:
Our expert absolutely.

[00:18:58] Speaker 03:
It's all interesting what the lawyer argument is on this.

[00:19:02] Speaker 03:
We have a factual finding by the district court.

[00:19:05] Speaker 03:
The question is whether it's clearly erroneous or not.

[00:19:08] Speaker 03:
What evidence?

[00:19:09] Speaker 03:
was there from the expert in addition to the language of the reference that you're relying on that leads to this conclusion?

[00:19:17] Speaker 04:
The expert essentially testified that the understanding of one of skill in the art would be when you have a 90... Where did he say that?

[00:19:25] Speaker 04:
Where?

[00:19:26] Speaker 04:
I will get a page site for you on it.

[00:19:29] Speaker 04:
But this was all fully testified to by Dr. Kaiser.

[00:19:33] Speaker 02:
You're supposed to come with the references, you know?

[00:19:36] Speaker 02:
You're supposed to be more familiar with the record than we are.

[00:19:39] Speaker 02:
so that you can help us.

[00:19:41] Speaker 04:
And I will help you, Your Honor.

[00:19:43] Speaker 04:
I will have the page reference and just the exact page reference in just a moment, Your Honor.

[00:19:49] Speaker 04:
But the teaching away point, members of the panel, is that it was a different form of single compartment that was rejected in the prior art.

[00:19:59] Speaker 04:
And the 015 took us to a different method of doing that and a different type of structure

[00:20:08] Speaker 04:
and different materials being used.

[00:20:10] Speaker 04:
And that's why the 015 was the advance that it was and that's why the 015 would be expected to work where those did not or not.

[00:20:17] Speaker 05:
I want to come back to my question about where in the 015 reference there is something to suggest that when you expand the mixed compartment to 97 percent of the ring that you would get a

[00:20:35] Speaker 05:
physiologically satisfactory release rate of both components.

[00:20:41] Speaker 04:
Well, I will concede, Your Honor, that there is not an example that deals with 97%.

[00:20:45] Speaker 05:
I'm not asking for an example.

[00:20:47] Speaker 05:
I'm asking for anything, any kind of a teaching whatsoever.

[00:20:51] Speaker 04:
The teaching of the 015 is one invention, Your Honor.

[00:20:57] Speaker 04:
It is an invention that has various ranges.

[00:21:00] Speaker 04:
A progestin estrogen suggested

[00:21:02] Speaker 04:
various substances suggested that you can make the rings with.

[00:21:07] Speaker 05:
Yeah, but I don't find any suggestion in that reference.

[00:21:10] Speaker 05:
I don't find anything at all that indicates that if you go to this particular end of the range that the result would be satisfactory.

[00:21:21] Speaker 04:
Well, the suggestion is on the face of it's right on the face of the 015 that within the ranges suggested in the 015

[00:21:29] Speaker 04:
Within the range of suggestion, the 015, you get good release patterns.

[00:21:33] Speaker 03:
What did your expert say about this?

[00:21:37] Speaker 03:
That's the question.

[00:21:38] Speaker 03:
This is what Judge Sleet relied on.

[00:21:42] Speaker 03:
Show us what your expert said about it.

[00:21:48] Speaker 04:
But I'll refer, Your Honor, to appendix 2263.

[00:21:53] Speaker 04:
And appendix 2278 to 79.

[00:21:55] Speaker 04:
Wait, don't give us a ring.

[00:21:57] Speaker 03:
Just show us the specific testimony that deals with this so we can look at it.

[00:22:02] Speaker 04:
That's the testimony.

[00:22:03] Speaker 03:
Where?

[00:22:04] Speaker 04:
What page?

[00:22:05] Speaker 04:
Appendix page 2263, for instance, Your Honor.

[00:22:08] Speaker 04:
Where?

[00:22:08] Speaker 03:
OK, where?

[00:22:10] Speaker 04:
At line 10.

[00:22:11] Speaker 04:
This is where Dr. Kaiser is talking about the disclosure that you can make with more progestin than estrogen.

[00:22:23] Speaker 04:
It then goes down at line 22.

[00:22:26] Speaker 04:
It includes ratios where you would put more progestin than estrogen into this mixed component we've been talking about.

[00:22:32] Speaker 05:
And where does it say if you do that, you get physiologically appropriate release rates?

[00:22:42] Speaker 04:
Well, the physiologically appropriate release rates are a matter of fixed law.

[00:22:49] Speaker 03:
Does he address the question?

[00:22:51] Speaker 04:
Yes, he does.

[00:22:53] Speaker 04:
I don't think there's any dispute here that he addresses fixed law.

[00:22:56] Speaker 03:
No, but where does he say you would get?

[00:23:00] Speaker 03:
Where does he address the 97% and the release rates?

[00:23:03] Speaker 04:
Appendix at 2278, Your Honor, going over to 2279, line 19.

[00:23:11] Speaker 04:
Does the 015 disclose the links of the second compartment that can be changed?

[00:23:15] Speaker 04:
Yes, it does.

[00:23:16] Speaker 04:
Would you bring a demonstrative to illustrate that?

[00:23:18] Speaker 04:
And he identifies the demonstrative.

[00:23:21] Speaker 04:
at line 4 on the next page, 2279.

[00:23:23] Speaker 04:
So the inventor here is saying that you can choose to give the required performance of the IVR, which is basically delivering the physo... Excuse me.

[00:23:33] Speaker 04:
Physiologically required amount of the IVR.

[00:23:35] Speaker 04:
You can vary the relative lengths of these two compartments from 30 to 1 to 1 to 30.

[00:23:39] Speaker 04:
So this is very fungible.

[00:23:41] Speaker 04:
This works out to be 97% of the total length.

[00:23:44] Speaker 04:
It could be for the first compartment and 3% for the next compartment.

[00:23:48] Speaker 04:
Or you can invert it like I did there on the right.

[00:23:51] Speaker 04:
So whatever the concentrations of progesterone, estrogen, can that mixed compartment be effectively the entirety of the device?

[00:23:58] Speaker 04:
Repeat the question, and then he ultimately says at line 20, yes, it does.

[00:24:04] Speaker 04:
So the district court's conclusions on these matters were fully supported by what Dr. Kynes are testified to.

[00:24:13] Speaker 04:
And Dr. Kynes?

[00:24:14] Speaker 05:
I'm not sure this is that clear and convincing.

[00:24:19] Speaker 05:
The answer that Dr. Kaiser gave, line four on page 2279, he says, yes, so the inventor here is saying that you choose to give the required performance of the IVR, which is basically delivering the psychologically required, physiologically required amount of IVR.

[00:24:40] Speaker 05:
You can vary the lengths.

[00:24:44] Speaker 05:
It seems to me that that's simply a conclusion that he's drawing without

[00:24:50] Speaker 05:
without pointing to any specific teaching in the reference, which, again, I find missing.

[00:24:57] Speaker 04:
Well, what he says, so the inventor here, Your Honor, at line four, that's referring back to the 015 reference.

[00:25:05] Speaker 04:
And the 015 reference has a specific language about 1 to 30 and 31, which I can point out to you, Your Honor.

[00:25:12] Speaker 05:
Yeah, but again, I don't want to beat a dead horse to death here, but the reference talks about,

[00:25:19] Speaker 05:
you know, physiologically appropriate release rates with respect to some specific examples, not necessarily the entire range of mixtures.

[00:25:30] Speaker 05:
You know, it seems to me he's drawing some sort of a conclusion without real basis to do so.

[00:25:39] Speaker 04:
Well, and Your Honor, I think

[00:25:41] Speaker 04:
I think this testimony indicates that he actually was looking at the 015 and speaking as one person of ordinary skill would have understood that portion of the 015 and would have understood it to indicate that you can use it in the suggested way.

[00:25:57] Speaker 05:
OK.

[00:25:57] Speaker 05:
Let me just pick up on that a little bit.

[00:26:02] Speaker 05:
Tell me about the supersaturation, because it seems to me that's the key to the success of the single compartment

[00:26:11] Speaker 05:
mixed ring that the progestin is supersaturated.

[00:26:16] Speaker 05:
And I just don't find a teaching again to suggest any sort of link between supersaturation and the success of a single component.

[00:26:28] Speaker 04:
There are two aspects of the supersaturation.

[00:26:30] Speaker 04:
First is, and I think counsel alluded to this, there is the

[00:26:34] Speaker 04:
amount of progestin has to be over a certain level in order for supersaturation to be possible.

[00:26:41] Speaker 04:
There's no dispute that there are teachings and examples that use an amount that would be supersaturated.

[00:26:48] Speaker 05:
That might be supersaturated.

[00:26:49] Speaker 04:
Correct.

[00:26:49] Speaker 04:
Correct.

[00:26:50] Speaker 05:
That might not be.

[00:26:52] Speaker 04:
That's right.

[00:26:52] Speaker 04:
And then the question.

[00:26:53] Speaker 05:
So that's not enough to support an inference of supersaturation.

[00:26:56] Speaker 04:
Well, but here's where, and again, this is a factual finding that the district court carefully considered.

[00:27:02] Speaker 04:
Here was the evidence on that, Your Honor,

[00:27:04] Speaker 04:
When the crystallization, which is the opposite of dissolution, obviously, when crystallization occurs, that's important to the person's skill in the art.

[00:27:13] Speaker 04:
And that is specifically pointed out in the 015, instances where crystallization occurs.

[00:27:20] Speaker 04:
Where it did not occur, it was not pointed out.

[00:27:23] Speaker 04:
And so the district court concluded that because the 015 was well aware of crystallization,

[00:27:30] Speaker 04:
and well aware of calling it out when it does occur, that when it didn't mention crystallization, it was fair to conclude that there was complete dissolution.

[00:27:40] Speaker 04:
That was the finding of the district court, which again is carefully laid out in the opinion.

[00:27:45] Speaker 04:
And that is sufficient to satisfy the requirements of inherency.

[00:27:51] Speaker 04:
You don't have to have

[00:27:52] Speaker 05:
That necessarily shows that there's supersaturation when you don't have crystallization.

[00:27:59] Speaker 05:
Maybe there's no crystallization because there's less than a saturated amount.

[00:28:06] Speaker 04:
Well, but that's not what it teaches.

[00:28:08] Speaker 04:
The patent teaches examples where there is a saturated amount, 0.8, and that's in the examples 2 and 3.

[00:28:16] Speaker 05:
It's a range, and so it could be the lower end of the range.

[00:28:20] Speaker 04:
Well, now, Your Honor, I'm talking about the example where there's a specific example of the use of an amount that potentially could be supersaturated, 0.8.

[00:28:30] Speaker 05:
0.8, I get it.

[00:28:32] Speaker 04:
0.8, and that's in examples two and three, compartment two, Your Honor, of the 015.

[00:28:39] Speaker 04:
And when that example is discussed, there's no discussion of crystallization.

[00:28:45] Speaker 04:
And the court concluded that had there been crystallization, this reference indicated it talks about it.

[00:28:55] Speaker 04:
And there was no reference to crystallization.

[00:28:57] Speaker 04:
So the conclusion was that there was dissolution and that supersaturation did, in fact, occur.

[00:29:04] Speaker 04:
Now, you can prove inherency through inference.

[00:29:10] Speaker 04:
Just like you can prove beyond a reasonable doubt, you can prove something beyond a reasonable doubt.

[00:29:15] Speaker 04:
through circumstantial evidence.

[00:29:17] Speaker 04:
The fact that it's inference doesn't make it less of a conclusion.

[00:29:21] Speaker 04:
And the court specifically noted that it had come to the conclusion, and this is at page, I believe it's page 15 to 17 of the, actually page 9 of the opinion, that the 581 patent discloses

[00:29:40] Speaker 04:
that the ETO is fully dissolved.

[00:29:43] Speaker 04:
The progestin is fully dissolved.

[00:29:44] Speaker 04:
So that's a factual finding made by the court based on the record.

[00:29:49] Speaker 00:
You're out of time, but I just want to ask you, and try to keep it brief, on the secondary consideration.

[00:29:54] Speaker 04:
Yes, Your Honor.

[00:29:54] Speaker 00:
I am not myself so worried about the accidental use of the prima facie and rebutting.

[00:30:02] Speaker 00:
But here, it seems an awful lot like the district court made a conclusion of obviousness

[00:30:09] Speaker 00:
finished that section and said it's obvious, and then moved on to the secondary considerations.

[00:30:15] Speaker 00:
Isn't that error under our precedent?

[00:30:17] Speaker 00:
And also, just briefly address the nexus question, because I'm a little troubled by that, too.

[00:30:23] Speaker 04:
Yes, Your Honor.

[00:30:24] Speaker 04:
And I will try to be brief.

[00:30:25] Speaker 04:
I think it's clear from the context of the entire opinion that the district court understood the proper analysis for secondary considerations

[00:30:34] Speaker 04:
It considered the Graham factors and motivation combined first, and then it turned to secondary considerations.

[00:30:41] Speaker 04:
It recognized that the burden of proof never shifts expressly.

[00:30:45] Speaker 04:
It recognized that, and I can point that out, Your Honor, if that would be helpful, but it recognized that the burden of proof never changes expressly, and recognized that it stayed with Warner Chilcot throughout.

[00:31:00] Speaker 04:
And so I don't believe that there was an issue here

[00:31:03] Speaker 04:
of the court flipping the burden of proof onto the other side in this instance.

[00:31:09] Speaker 04:
And there's nothing to indicate that that's the case.

[00:31:13] Speaker 00:
But I mean, again, I don't want to belabor this.

[00:31:15] Speaker 00:
On page 24, the courts find that Merck's secondary considerations fail to look by a determination of obviousness.

[00:31:26] Speaker 00:
I mean, isn't that putting the burden on the wrong party?

[00:31:31] Speaker 04:
Well.

[00:31:33] Speaker 04:
Your Honor, it says earlier in the opinion, specifically, that the burden is on Warner Chilcot and stays on Warner Chilcot.

[00:31:40] Speaker 04:
It says at page 23, the beginning of the secondary consideration section, Your Honor, Merck contends that even if Warner Chilcot succeeded in presenting a prima facie case of obviousness, that secondary considerations of non-obviousness rebut this showing.

[00:31:56] Speaker 04:
And so that indicates to me, and I think fairly, that the Court understood

[00:32:01] Speaker 04:
that what Warner Chilcott had done was establish a prima facie case, an initial showing that then he has now to consider the secondary considerations and that the burden.

[00:32:11] Speaker 00:
But he keeps saying that Merck has to rebut them.

[00:32:14] Speaker 00:
But you agree that that's not Merck's obligation to rebut them?

[00:32:18] Speaker 04:
No, I agree that the burden is on us to establish overall, given all the evidence, that there's obviousness.

[00:32:25] Speaker 04:
I agree with that, Your Honor.

[00:32:28] Speaker 03:
This whole question of whether

[00:32:30] Speaker 03:
he used the right language, or didn't use the right language, kind of irrelevant if he misunderstood that there was significant secondary consideration evidence.

[00:32:41] Speaker 03:
Could you address that question?

[00:32:43] Speaker 03:
Because it seems as though his commercial success analysis is questionable.

[00:32:50] Speaker 04:
Well, Your Honor, I think he carefully considered the secondary consideration evidence that was provided, and the factual

[00:32:57] Speaker 04:
Findings concerning secondary considerations are not challenged on this appeal and the bottom line.

[00:33:03] Speaker 03:
I think I'm not sure that's true I think they they certainly do argue that He his dismissal of commercial success was erroneous They argue that it's erroneous on the basis of the nexus issue they don't argue that he was wrong in what he found about commercial success and

[00:33:23] Speaker 03:
Well, the underlying factual findings.

[00:33:25] Speaker 03:
But do those factual findings show that there was a lack of commercial success?

[00:33:31] Speaker 03:
I'm dubious about that.

[00:33:33] Speaker 04:
Well, they don't show that there was commercial success for purposes of obviousness, Your Honor.

[00:33:42] Speaker 03:
But the ring that was sold was an embodiment of the patented invention, right?

[00:33:47] Speaker 04:
The bring that was sold was an embodiment.

[00:33:49] Speaker 04:
That's correct.

[00:33:50] Speaker 05:
That creates a presumption of nexus.

[00:33:52] Speaker 04:
It does, which can be rebutted.

[00:33:54] Speaker 04:
And the bottom line, I think summarizing what the court found about each of the secondary consideration pieces of evidence, was that there was nothing in that evidence that taught or showed that the 581 invention was something new or novel beyond what existed in the art name with the 015.

[00:34:14] Speaker 04:
And that is what this Court is concerned with with secondary considerations, is do the secondary considerations provide evidence that there's something new about the 581 patent over the nearest prior art, which in this case was the 015?

[00:34:29] Speaker 04:
And the Court very clearly found that that kind of showing had not been made in this case.

[00:34:35] Speaker 04:
And on commercial success, Your Honor, the Court found, and this is what I mean by what was not challenged in this appeal, found factual findings that

[00:34:44] Speaker 04:
the expert on Merck's side was not reliable, that he omitted to consider marketing in the course of doing the analysis.

[00:34:58] Speaker 03:
But I mean, the analysis somehow wasn't commercially successful immediately.

[00:35:05] Speaker 03:
What does that have to do with it?

[00:35:08] Speaker 04:
Well, it has something to do with it, given the way that it was presented in court.

[00:35:13] Speaker 04:
The court, the commercial success expert, it wasn't just immediately, Your Honor.

[00:35:17] Speaker 04:
It was a period of seven years that they didn't consider the results.

[00:35:21] Speaker 04:
And the results didn't indicate that there was a profit for this drug.

[00:35:25] Speaker 04:
And so they attempted to provide commercial success testimony.

[00:35:31] Speaker 04:
Their expert was not credible.

[00:35:33] Speaker 04:
We presented a contrary expert.

[00:35:35] Speaker 04:
And so the district court concluded that commercial success

[00:35:38] Speaker 04:
didn't support the idea that the 581.

[00:35:41] Speaker 03:
Well, is commercial success measured in terms of profit or in terms of revenue?

[00:35:46] Speaker 04:
I think probably both, Your Honor.

[00:35:48] Speaker 04:
It depends on the particular situation.

[00:35:52] Speaker 04:
And I'm not saying that there weren't revenues associated with the ring.

[00:35:57] Speaker 04:
But the ultimate question is, does whatever commercial success exists that happened here show that the 581 was

[00:36:06] Speaker 04:
novel as compared to the 015 and any other prior art.

[00:36:10] Speaker 03:
And additionally... Okay, thanks.

[00:36:12] Speaker 03:
I think we're out of time, unless there are further questions.

[00:36:14] Speaker 03:
Thank you.

[00:36:16] Speaker 03:
Thank you, Mr. Lombardi.

[00:36:18] Speaker 03:
Mr. Lombardi, you have two minutes here for rebuttal.

[00:36:23] Speaker 01:
Just briefly on the Nexus issue.

[00:36:25] Speaker 00:
Can you address this testimony on 2279 first?

[00:36:35] Speaker 01:
22.79%?

[00:36:36] Speaker 00:
Yeah, about the 97% and all of that.

[00:36:39] Speaker 00:
I mean, I'm not so sure that this says what your colleague says it says, but I'm not sure that it doesn't.

[00:36:48] Speaker 01:
Your Honor, this testimony is simply stating that you can deliver the physiologically required amounts in some way.

[00:36:54] Speaker 01:
But then it just goes on and says you can vary the lengths.

[00:36:56] Speaker 01:
It doesn't get to, and there's no teaching in the patent.

[00:36:59] Speaker 01:
So I'd say two things on it.

[00:37:02] Speaker 01:
It doesn't address it, which I don't think it does.

[00:37:04] Speaker 01:
It simply states there's a teaching about delivering the amounts, and then says you can make adjustments.

[00:37:08] Speaker 01:
It doesn't tell you what will happen when you make the adjustments.

[00:37:11] Speaker 01:
And if you go to the reference itself, there's no teaching at all as to what would happen when you went to something with 97%.

[00:37:17] Speaker 00:
So let me make sure I've got this.

[00:37:20] Speaker 00:
What you think this says is it says you can vary the amounts, and it can be effectively almost the entire ring, but it doesn't say anything about whether it'll work.

[00:37:28] Speaker 01:
That's right, Your Honor.

[00:37:29] Speaker 01:
It doesn't say what will happen, and there's no teaching in the patent about it.

[00:37:32] Speaker 01:
And it's completely conclusory.

[00:37:34] Speaker 01:
Your Honor, on the nexus issue, just very briefly, the counsel has stated he agrees that there should have been a presumption.

[00:37:39] Speaker 01:
If you go to page A26, long felt need, 25 years of failures.

[00:37:45] Speaker 01:
The court concludes Merck fails to show a nexus between industry recognition, long felt need, and the patented features.

[00:37:51] Speaker 01:
At the bottom of that paragraph, the court says, because there is no relationship between the inventive features and the industry recognition, they do not weigh in favor of a finding of non-obviousness

[00:38:01] Speaker 01:
The court imposed the burden on Merck.

[00:38:04] Speaker 01:
It was not an issue of whether or not he found a Nexus and found it overcome.

[00:38:08] Speaker 01:
Excuse me, presumed Nexus, and it was overcome in some way.

[00:38:11] Speaker 01:
The burden was put on us, and it was an improper burden, because he said you need to find and invent a feature after he'd already concluded that he said there was no invention.

[00:38:19] Speaker 01:
And then on the issue of inherency, Your Honor, the only teaching of inherent, of crystallinity, excuse me, is on page, in the abstract and then on page 3041 of the record.

[00:38:29] Speaker 01:
This is in the 015.

[00:38:30] Speaker 01:
It says typically,

[00:38:32] Speaker 01:
The first compartment comprises progestin in crystalline form.

[00:38:37] Speaker 01:
That's it.

[00:38:37] Speaker 01:
There's no reference every time there's crystals, because they're being very careful about it.

[00:38:40] Speaker 01:
There's one teaching that says typically the first compartment has crystals in it.

[00:38:45] Speaker 01:
It says nothing about anything going on with the second compartment, which can be subsaturated.

[00:38:49] Speaker 01:
And therefore, there would be no reference to it.

[00:38:51] Speaker 01:
And even if there was an inherency with respect to supersaturation, which there is not, that doesn't get you to a reasonable expectation of success.

[00:38:59] Speaker 01:
The court made one finding.

[00:39:01] Speaker 01:
with respect to supersaturation and stability.

[00:39:03] Speaker 01:
He said at page A-16, second, although the PCT-015 does not teach that a supersaturated ring would be stable, it also does not indicate that a supersaturated ring would be unstable.

[00:39:16] Speaker 01:
That is not an affirmative finding of anything that there be an expectation of success.

[00:39:20] Speaker 01:
It doesn't tell you if you load all the progestin and estrogen in one compartment that you'll get the required physiological

[00:39:27] Speaker 01:
delivered amounts over the 21 days that are required there.

[00:39:31] Speaker 03:
Okay, we're well over here.

[00:39:33] Speaker 03:
Thank you.